U.S. patent application number 14/641225 was filed with the patent office on 2015-12-24 for compositions and methods for treating hoof diseases.
The applicant listed for this patent is AGROCHEM, INC.. Invention is credited to John P. DeMARCO, Robert J. DeMARCO.
Application Number | 20150366819 14/641225 |
Document ID | / |
Family ID | 41622248 |
Filed Date | 2015-12-24 |
United States Patent
Application |
20150366819 |
Kind Code |
A1 |
DeMARCO; John P. ; et
al. |
December 24, 2015 |
COMPOSITIONS AND METHODS FOR TREATING HOOF DISEASES
Abstract
The present invention is generally directed to compositions and
methods for the treatment of an infectious disease of the foot of
an animal. One aspect of the invention is directed to a method for
preventing and/or treating one or more infectious diseases of the
hoof in animals, comprising: preparing a copper-free and zinc-free
composition comprising at least one cross-linking agent, wherein
the cross-linking agent is not formaldehyde; and administering the
composition to a lower leg and hoof area of said animal to prevent
and/or treat said one or more infectious diseases. Another aspect
of the invention is directed to a copper-free and zinc-free
composition for the treatment and/or prevention of one or more
infectious diseases of the hoof in animals, comprising at least one
cross-linking agent, wherein said cross-linking agent is not
formaldehyde. The present invention is also directed to a method
for treating and/or preventing papillomatous digital dermatitis in
an ungulate, comprising: preparing a copper-free and zinc-free
composition comprising at least one cross-linking agent and at
least one quaternary ammonium compound; and spraying or applying in
a foam a therapeutically effective amount of said composition to a
lower leg and hoof area of said ungulate in order to treat and/or
prevent said papillomatous digitial dermatitis.
Inventors: |
DeMARCO; John P.; (Saratoga
Springs, NY) ; DeMARCO; Robert J.; (Saratoga Springs,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AGROCHEM, INC. |
Saratoga Springs |
NY |
US |
|
|
Family ID: |
41622248 |
Appl. No.: |
14/641225 |
Filed: |
March 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13718770 |
Dec 18, 2012 |
9018262 |
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14641225 |
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12626302 |
Nov 25, 2009 |
8389581 |
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13718770 |
|
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61200367 |
Nov 28, 2008 |
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Current U.S.
Class: |
514/705 |
Current CPC
Class: |
A61K 31/74 20130101;
A61K 31/11 20130101; A61K 9/0012 20130101; A61K 45/06 20130101;
A61K 9/7015 20130101; A61K 45/00 20130101; A61P 17/00 20180101;
A61K 31/11 20130101; A61K 9/0017 20130101; A61K 31/045 20130101;
A61K 31/17 20130101; A61K 31/045 20130101; A61K 31/74 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101; A61P 31/00 20180101; A61K 31/17
20130101 |
International
Class: |
A61K 31/11 20060101
A61K031/11; A61K 45/06 20060101 A61K045/06 |
Claims
1-20. (canceled)
21. A composition comprising glutaraldehyde and glyoxal, wherein
said composition is substantially free of formaldehyde, copper and
zinc.
22. The composition of claim 21, wherein said composition is used
for the treatment and/or prevention of one or more infectious
diseases of the hoof in animals.
23. The composition of claim 22, wherein said infectious disease of
the foot is hairy heel warts, foot rot, stable foot rot, or foot
scald.
24. The composition of claim 21, further comprising at least one
other cross-linking agent.
25. The composition of claim 24, wherein said cross-linking agent
is selected from the group consisting of ortho-phthaldehyde,
carbodiimides, diisocyanates, a formaldehyde donor, sodium
hydroxymethyl glycinate, diazolidinyl urea, imidazolidinyl urea,
dimethylol-5,5-dimethylhydantoin, dimethylol urea,
2-bromo-2-nitropropane 1,3-diol, quatemium-15, parabens,
5-chloro-2methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane,
ethanol, other alcohols, and polyol.
26. The composition of claim 24, wherein said cross-linking agent
is selected from the group consisting of glyceraldehyde, dextran
dialdehyde, ethylene glycol, di(ethylene glycol), polyethylene
glycol, propylene glycol, di(propylene) glycol, polypropylene
glycol, ethylene glycol dimethacrylate, di(ethylene glycol)
dimethacrylate, poly(ethylene glycol) dimethacrylate, poly(lauryl
methacrylate-co-ethylene glycol dimethacrylate), propylene glycol
dimethacrylate, di(propylene glycol) dimethacrylate, polypropylene
glycol) dimethacrylate, malonic dihydrazide, ethylmalonic
dihydrazide, succinic dihydrazide, glutaric dihydrazide, adipic
dihydrazide, isophthalic dihydrazide, oxalyl dihydrazide, pimelic
dihydrazide, 3,3'-sulfonyldibenzenesulfonic dihydrazide, m-xylylene
isocyanate, 4-methyl-m-phenylene diisocyanate, 2-methyl-m-phenylene
diisocyanate, 3,3'-dimethoxy-4,4'-biphenylene diisocyanate,
4-Br-6-methyl-1,3-phenylene diisocyanate,
4-Cl-6-methyl-1,3-phenylene diisocyanate, toluene 2,4-diisocyanate,
1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate,
2,4,6-trimethyl-1,3-phenylene diisocyanate, 1,4-diisocyanatebutane,
1,6-diisocyanatehexane, 1,8-diisocyanateoctane, isophorone
diisocyanate, N,N-(3-dimethylaminopropyl)-N-ethyl carbodiimide
(EDC), calcium chloride, divinylsulfone, sulfonylurea, hydrolysable
polyrotaxane, L-lysine methyl ester, and genipin.
27. The composition of claim 21, wherein the composition further
comprises at least one antimicrobial essential oil or at least one
active ingredient thereof or a mixture thereof.
28. The composition of claim 21, wherein the composition further
comprises at least one poly(alkylene glycol) alkyl ether.
29. The composition of claim 21, wherein the composition further
comprises at least one gelling agent.
30. The composition of claim 21, wherein the composition further
comprises at least one quaternary ammonium compound.
31. The composition of claim 21, wherein the composition further
comprises at least one surfactant.
32. The composition of claim 21, wherein the composition further
comprises one or more ethoxylated nonlyphenols.
33. The composition of claim 21, wherein said composition comprises
about 5% to about 30% by weight of glutaraldehyde and about 5% to
about 30% by weight of glyoxal.
34. A composition for the treatment of one or more infectious
diseases of the hoof in animals, comprising one or more
cross-linking agents, excluding formaldehyde; and one or more
quaternary ammonium compounds.
35. The composition of claim 34, wherein said cross-linking agent
is selected from the group consisting of glutaraldehyde and
glyoxal.
36. The composition of claim 34, wherein said cross-linking agent
is selected from the group consisting of glutaraldehyde, glyoxal,
glyceraldehyde, dextran dialdehyde, ethylene glycol, di(ethylene
glycol), polyethylene glycol, and propylene glycol.
37. A method for treating and/or preventing papilomatous digital
dermatitis in an ungulate, comprising preparing a substantially
copper-free and zinc-free composition comprising at least one
aldehyde and at least one quaternary ammonium compound; and
administering a therapeutically effective amount of said
composition to a lower leg and hoof area of said ungulate.
38. The method of claim 37, wherein the administering step
comprises a foam that contains the active ingredients, a spray that
contains the active ingredients, or a foot bath that contains the
active ingredients.
Description
1. CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/718,770, filed Dec. 18, 2012, now U.S. Pat.
No. 9,018,262. U.S. patent application Ser. No. 13/718,770 is a
divisional application of U.S. patent application Ser. No.
12/626,302, filed Nov. 25, 2009, now U.S. Pat. No. 8,389,581, which
claims priority to U.S. Provisional Patent Application No.
61/200,367, filed Nov. 28, 2008. All prior applications listed are
hereby incorporated by reference in their entirety.
2. TECHNICAL FIELD
[0002] The present invention relates to the treatment of a diseased
animal. In particular, the present invention relates to
compositions and methods useful for the treatment of one or more
infectious diseases of a foot of an animal.
3. BACKGROUND OF THE INVENTION
[0003] Diseases among dairy herds dramatically impact the economics
of animal production and milk production in the United States. It
is estimated that the dairy cattle industry constitutes a
significant contribution to the gross national product of the
United States, accounting for an estimated $38 billion annually. A
wide range of diseases, infections and injuries to the feet of
animals, including cattle that are part of dairy herds, exist.
Livestock in a dairy herd, for example, are susceptible to forming
a variety of warts, abscesses, sole ulcers, foot rot, heel cracks
and variations of lesions and infections on their feet and/or
hooves, which may individually or collectively cause livestock to
suffer lameness, clubbed hooves, loss of body weight, decreased
milk production, and decreased rates of conception.
[0004] Infectious hoof diseases are common in farm animals such as
sheep, goats, horses, dairy cows, and beef cattle. For example,
hairy hoof warts, also referred to as digital dermatitis, hairy
footwarts, strawberry or raspberry heelwarts or hairy heel warts,
is a common disease condition in dairy cows and can cause lameness
which leads to a decline in animal health and performance as
measured by a decrease in body weight, fertility, and milk
production. Since the late 1980's, bacterial diseases such as hairy
heel warts have been a significant source of bovine lameness, and
have had a significant economic impact on farmers.
[0005] Farmers have addressed this problem using a livestock
footbath. The footbath holds a solution containing a substance to
prevent and/or treat the disease, such as copper sulfate and/or
zinc sulfate, or an antibiotic. Animals are forced to walk through
the footbath to immerse the hooves in the treatment solution. For
example, dairy cattle are usually led through a footbath on their
way to or from the milking parlor. However, there are problems
associated with the use of livestock footbaths, and they are not
the most effective method of treatment and prevention of foot
diseases. In particular, foot baths are inefficient and costly for
at least one of the following reasons.
[0006] First, the length of the foot bath is directly correlated to
the effectiveness of the treatment solution, with the longer the
bath, the greater the duration of exposure to the treatment and
prevention solution. The commonly used four foot long baths are not
long enough for proper cleaning of the feet and subsequent exposure
of the lesions to the treatment solution, especially since on
average, animals walk through a traditional foot bath for five
seconds or less. Moreover, manure attached to the animals hooves
will commonly be carried into the foot bath or the animal may
defecate into the foot bath, and since foot baths are liquid filled
reservoirs that hold all environmental contaminants, the manure,
mud and dirt rapidly degrade the treatment solution and render it
ineffective. Also, most foot baths are permanently fixed and this
prevents a farmer from locating the bath and treating the animals
at different locations on the facility.
[0007] A further limitation to use of foot baths on farms is that
they require a high level of management. The treatment solution
requires changing at specified intervals after several animals pass
through the bath in order to maintain efficacy of the treatment
solution. If the foot bath is not changed and re-charged
accordingly, the efficacy of the treatment solution is greatly
reduced. On a practical level, animals experiencing foot problems
generally walk slower and are the last animals through the foot
bath, when the bath is at its most inefficient, thereby decreasing
the effectiveness of the treatment. Yet another limitation
associated with the use of foot baths is that many of the products
available for the treatment and prevention of foot diseases are not
labeled for use in foot bath applications and are difficult to get
into solution, for example, copper sulfate and zinc sulfate. Other
products, including antibiotics, are not easy to use in the context
of a foot bath, especially due to their cost and the fact that
antibiotics degrade quickly when exposed to organic material.
[0008] Moreover, such footbaths as described supra may also cause
pollution and injury to animals and humans. For example, discharge
of copper sulfate, a compound commonly used in treating cows, from
bath treatment systems into adjacent lands may cause significant
damage. This is because most dairies dump the spent foot baths into
a manure pit or a lagoon and the copper ultimately gets spread on
production ground with the manure. The practice can lead to copper
accumulation in the soil and after several years can accumulate in
soil to levels that become toxic to soil microbes and crops. This
can slow organic matter decomposition and nutrient cycling in soil
and crop production could be reduced because of direct toxic
effects of copper on the plants as well as reduced soil fertility.
Importantly, copper accumulation in soil and forage can become
toxic to sheep, whose tolerance for copper is much lower than that
of dairy cattle. Toxic levels of copper in soil is a critical issue
because there is no practical way to reverse the problem. Moreover,
many large dairy farms use anaerobic digesters to produce methane
gas from manure, and when copper sulfate can inhibit the bacteria's
ability to produce methane gas in a digester lagoon.
[0009] Another chemical used in foot baths by the dairy industry is
formaldehyde. Numerous burns to humans and animals result annually
from use of formaldehyde; loss of eyesight and even death among
workers have occurred. For these reasons the European Union has
called for a ban of its use, and in the United States it has been
listed as a known carcinogen.
[0010] In view of the problems outlined supra, there is a need for
improved compositions and methods for treating one or more
infectious diseases of a foot of an animal, including hairy heel
warts.
4. SUMMARY OF THE INVENTION
[0011] The present invention is generally directed to compositions
and methods for the treatment of an infectious disease of the foot
of an animal. It has been surprisingly discovered that a spray or
foam application of the presently taught novel and useful
compositions offer more efficient and a better approach to treating
one or more infectious diseases of a foot of an animal, including
hairy heel warts.
[0012] One aspect of the invention is directed to a method for
preventing and/or treating one or more infectious diseases of the
hoof in animals, comprising: preparing a copper-free and zinc-free
composition comprising at least one cross-linking agent, wherein
the cross-linking agent is not formaldehyde; and administering the
composition to a lower leg and hoof area of said animal to prevent
and/or treat said one or more infectious diseases. In one
embodiment, the animal has, or is at risk for, an infectious
disease of the foot. In another embodiment, the infectious disease
of the foot is hairy heel warts, foot rot, stable foot rot, or foot
scald. In a related embodiment, the infection disease is
papillomatous digital dermatitis. In one embodiment, the animal is
an ungulate. In a related embodiment, the animal is a cow, sheep,
horse, or goat.
[0013] In one embodiment, the administering step comprises
spraying, splashing, or applying. In another embodiment, the
administering step is in the form of a spray or foam, or a mixture
thereof. In another embodiment, about three to about ten
milliliters of the composition is sprayed on to the lower leg and
hoof area of the animal. In another embodiment, the administering
step is in the form of a gel.
[0014] In one embodiment, the infectious disease comprises an open
lesion and after the administering step, said composition
facilitates the rapid formation of a scab over said lesion. In
another embodiment, the infectious disease comprises an open lesion
on the lower leg and/or hoof area of said animal, and wherein after
the administering step, said composition facilitates the rapid
formation of a scab over said lesion within about twenty minutes.
In one embodiment, the infectious disease comprises an open lesion
on the lower leg and/or hoof area of said animal, and wherein about
five to about fifteen minutes after the administering step, said
composition causes the formation of a scab over said lesion. In
another embodiment, after the administering step, the exposure time
of said composition to a lower leg and hoof area of said animal is
between about 5 to about 30 minutes. In another embodiment, the
administering step includes periodic administrations. In one
embodiment, the composition comprises at least one of colorants,
skin conditioners, and buffers.
[0015] In one embodiment, the cross-linking agent is selected from
the group consisting of glutaraldehyde, glyoxal,
ortho-phthaldehyde, carbodiimides, diisocyanates, a formaldehyde
donor, sodium hydroxymethyl glycinate, diazolidinyl urea,
imidazolidinyl urea, dimethylol-5,5-dimethylhydantoin, dimethylol
urea, 2-bromo-2-nitropropane 1,3-diol, quaternium-15, parabens,
5-chloro-2methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane,
ethanol and other alcohols, and polyol.
[0016] In another embodiment, the cross-linking agent is selected
from the group consisting of aldehydes, such as glyceraldehyde,
glutaraldehyde, dextran dialdehyde, and carbohydrates; diols, such
as ethylene glycol, di(ethylene glycol), polyethylene glycol,
propylene glycol, di(propylene) glycol, polypropylene glycol;
unsaturated diesters such as ethylene glycol dimethacrylate,
di(ethylene glycol) dimethacrylate, poly(ethylene glycol)
dimethacrylate, poly(lauryl methacrylate-co-ethylene glycol
dimethacrylate), propylene glycol dimethacrylate, di(propylene
glycol) dimethacrylate, polypropylene glycol) dimethacrylate;
dihydrazides such as malonic dihydrazide, ethylmalonic dihydrazide,
succinic dihydrazide, glutaric dihydrazide, adipic dihydrazide,
isophthalic dihydrazide, oxalyl dihydrazide, pimelic dihydrazide,
3,3'-sulfonyldibenzenesulfonic dihydrazide; diisocyanates such as
m-xylylene isocyanate, 4-methyl-m-phenylene diisocyanate,
2-methyl-m-phenylene diisocyanate, 3,3'-dimethoxy-4,4'-biphenylene
diisocyanate, 4-Br-6-methyl-1,3-phenylene diisocyanate,
4-Cl-6-methyl-1,3-phenylene diisocyanate, toluene 2,4-diisocyanate,
1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate,
2,4,6-trimethyl-1,3-phenylene diisocyanate, 1,4-diisocyanatebutane,
1,6-diisocyanatehexane, 1,8-diisocyanateoctane, isophorone
diisocyanate; carbodiimides such as
N,N-(3-dimethylaminopropyl)-N-ethyl carbodiimide (EDC); salts, such
as CaCl.sub.2; divinylsulfone, sulfonylurea, hydrolysable
polyrotaxane, L-lysine methyl ester, and genipin. In one
embodiment, the one or more cross-linking agents of the present
invention are present in the composition at a level from 5% to
30%.
[0017] In one embodiment, the composition further comprises at
least one antimicrobial essential oil or at least one active
thereof or a mixture thereof. In a related embodiment, the
antimicrobial essential oil is selected from the group consisting
of those obtained from thyme, lemongrass, citrus, lemons, orange,
anise, clove, aniseed, pine, cinnamon, geranium, roses, mint,
lavender, citronella, eucalyptus, peppermint, camphor, ajowan,
sandalwood, rosmarin, vervain, fleagrass, lemongrass, ratanhiae,
cedar and mixtures thereof. In another related embodiment, the
actives of essential oil is selected from the group consisting of
thymol, eugenol, menthol, geraniol, verbenone, eucalyptol,
pinocarvone, cedrol, anethol, carvacrol, hinokitiol, berberine,
ferulic acid, cinnamic acid, methyl salicylic acid, methyl
salycilate, terpineol, limonene and mixtures thereof. In another
embodiment, the antimicrobial essential oil or active thereof or
mixture thereof is present in the composition at a level from 0.03%
to 3%.
[0018] In one embodiment, the composition further comprises at
least one poly(alkylene glycol) alkyl ether. In a related
embodiment, the poly(alkylene glycol) alkyl ether is selected from
the group consisting of poly(propylene glycol) mono butyl ether,
poly(ethylene glycol-co-propylene glycol) mono butyl ether,
poly(ethylene glycol) dimethyl ether, poly(ethylene
glycol-co-propylene glycol) dimethyl ether, poly(ethylene glycol)
stearate or mixtures thereof. In another embodiment, the
apoly(alkylene glycol) alkyl ether is present in the composition at
a level from 0.03% to 3%.
[0019] In one embodiment, the composition further comprises at
least one gelling agent. In one embodiment, the gelling agent is
selected from the group consisting of naturally-occurring polymeric
materials such as locust bean gum, guar gum, sodium alginate,
sodium caseinate, egg albumin, gelatin agar, carrageenin gum,
sodium alginate, xanthan gum, quince seed extract, tragacanth gum,
starch, chemically modified starches, semi-synthetic polymeric
materials such as cellulose ethers (e.g. hydroxyethyl cellulose,
methyl cellulose, carboxymethyl cellulose, hydroxy propylmethyl
cellulose), hydroxypropyl guar gum, soluble starch, cationic
celluloses, cationic guars, carboxyvinyl polymers,
polyvinylpyrrolidone, polyvinyl alcohol, polyacrylic acid polymers,
polymethacrylic acid polymers, polyvinyl acetate polymers,
polyvinyl chloride polymers, acrylic acid/ethyl acrylate
copolymers, carboxyvinyl polymers, and polyvinylidene chloride
polymers. In another embodiment, the at least one gelling agent
comprises naturally-occurring polymeric materials, chemically
modified starches, semi-synthetic polymeric materials, synthetic
polymeric materials, acrylic acid/ethyl acrylate copolymers and
carboxyvinyl polymers.
[0020] In one embodiment, the at least one gelling agent is locust
bean gum, guar gum, sodium alginate, sodium caseinate, egg albumin,
gelatin agar, carrageenin gum, sodium alginate, xanthan gum, quince
seed extract, tragacanth gum, starch, a cellulose ether,
hydroxypropyl guar gum, soluble starch, cationic cellulose,
cationic guar, a carboxyvinyl polymer, polyvinylpyrrolidone,
polyvinyl alcohol, a polyacrylic acid polymer, a polymethacrylic
acid polymer, a polyvinyl acetate polymer a, a polyvinyl chloride
polymer, a polyvinylidene chloride polymer, a polyalkenyl polyether
cross-linked polymer of acrylic acid, or a mixture thereof. In
another embodiment, the at least one gelling agent is
hydroxypropylmethyl cellulose, hydroxyethyl cellulose, methyl
cellulose, carboxymethyl cellulose, or a mixture thereof. In a
related embodiment, the gelling agent is xanthan gum. In another
embodiment, the gelling agent is present in the composition at a
level from 0.03% to 3%.
[0021] In one embodiment, the composition further comprises at
least one quaternary ammonium compound. In one embodiment, the
quaternary ammonium compound is selected from the group consisting
of quaternary ammonium compounds containing alkyl or substituted
alkyl groups, alkyl amide and carboxylic acid groups, ether groups,
unsaturated alkyl groups, and cyclic quaternary ammonium compounds.
These compounds can be chlorides, dichlorides, bromides,
methylsulphates, chlorophenates, cylcohexylsulphamates or salts of
the other acids. In another embodiment, the quaternary ammonium
compound is selected from the group consisting of alkylpyridinium
chlorides and/or sulphates, the alkyl group being preferably cetyl,
dodecyl or hexadecyl group, alkylisoquinolyl chlorides and/or
bromides, the alkyl group being preferably dodecyl group, octyl
decyl dimethyl ammonium chloride, dioctyl dimethyl ammonium
chloride, didecyl dimethyl ammonium chloride, alkyl dimethyl benzyl
ammonium chloride, alkyl dimethyl benzyl ammonium chloride wherein
the alkyl is one or more of C.sub.12 C.sub.14 and C.sub.16 alkyl,
alkyl dimethyl ammonium saccharinate, cetylpyridinium and mixtures
thereof. In one embodiment, the quaternary ammonium compound is
selected from the group consisting of n-akyl dimethly benzyl
ammonium chloride, dialkyl dimethly ammonium chloride, or a mixture
thereof. In another embodiment, the at least one quaternary
ammonium compound is present in the composition at a level from 5%
to 20%.
[0022] In one embodiment, the composition further comprises at
least one surfactant. In another embodiment, the composition
further comprises at least one surfactant selected from the group
consisting of nonionic, semi-polar, anionic, cationic,
zwitterionic, and amphoteric surfactants. In another embodiment,
the composition further comprises a surfactant selected from the
group consisting of polyoxyethylene alcohols, alkyl ether sulfates,
and alkyl sulfates. In another embodiment, the composition further
comprises about 0.03% to 5% by weight of a surfactant.
[0023] In another embodiment, the composition further comprises at
least one surfactant selected from the group consisting of
glycoside, glycols, ethylene oxide and mixed ethylene
oxide/propylene oxide adducts of alkylphenols, the ethylene oxide
and mixed ethylene oxide/propylene oxide adducts of long chain
alcohols or of fatty acids, mixed ethylene oxide/propylene oxide
block copolymers, esters of fatty acids and hydrophilic alcohols,
sorbitan monooleates, alkanolamides, soaps, alkylbenzene
sulfonates, olefin sulfonates, paraffin sulfonates, propionic acid
derivatives, alcohol and alcohol ether sulfates, phosphate esters,
amines, amine oxides, alkyl sulfates, alkyl ether sulfates,
sarcosinates, sulfoacetates, sulfosuccinates, cocoamphocarboxy
glycinate, salts of higher acyl esters of isethionic acid, salts of
higher acyl derivatives of taurine or methyltaurine, phenol poly
ether sulfates, higher acyl derivatives of glycine and
methylglycine, alkyl aryl polyether alcohols, salts of higher alkyl
substituted imadazolinium dicarboxylic acids, ferchorics, tannics,
naphthosulfonates, lauryl sulfate, laurylether sulfate,
cocamidopropylbetaine, alkyl polyglycosides, amine oxides,
monochloracetics anthraflavinics, hippurics, anthranilics,
naphthoics, phthalics, carboxylic acid salts, acrylic acids,
phosphates, alkylamine ethoxylates, ethylenediamine alkoxylates,
betaines, sulfobetaines, imidazolines, polyoxyethylene alcohols,
alkyl ether sulfates, and alkyl sulfates. In one embodiment, the
composition further comprises one or more ethoxylated
nonlyphenols.
[0024] One aspect of the present invention is directed to a
copper-free and zinc-free composition for the treatment and/or
prevention of one or more infectious diseases of the hoof in
animals, comprising at least one cross-linking agent, wherein said
cross-linking agent is not formaldehyde. In one embodiment, the
composition comprises about 5% to about 30% by weight of at least
one cross-linking agent; about 5% to 20% by weight of at least one
quaternary ammonium compound; about 0.03% to 3% by weight of at
least one apoly(alkylene glycol) alkyl ether; about 0.03% to 3% by
weight of at least one gelling agent; about 0.03% to 3% by weight
of at least one antimicrobial essential oil or active thereof; and
about 0.03% to 5% by weight of at least one surfactant.
[0025] One aspect of the present invention is directed to a
composition for the treatment and/or prevention of one or more
infectious diseases of the hoof in animals, comprising one or more
cross-linking agents, excluding formaldehyde; one or more
quaternary ammonium compounds; one or more gelling agents; one or
more surfactants; one or more antimicrobial essential oils or
actives thereof; and one or more poly(alkylene glycol) alkyl
ethers.
[0026] One aspect of the present invention is directed to a method
for treating and/or preventing papilomatous digital dermatitis in
an ungulate, comprising: preparing a copper-free and zinc-free
composition comprising at least one cross-linking agent and at
least one quaternary ammonium compound; and spraying or applying in
a foam a therapeutically effective amount of said composition to a
lower leg and hoof area of said ungulate in order to treat and/or
prevent said papillomatous digitial dermatitis.
5. BRIEF DESCRIPTION OF THE FIGURES
[0027] The patent or application file contains at least one drawing
executed in color. Copies of this patent or patent application
publication with color drawing(s) will be provided by the Office
upon request and payment of the necessary fee.
[0028] Those of skill in the art will understand that the drawings,
described below, are for illustrative purposes only. The drawings
are not intended to limit the scope of the present teachings in any
way.
[0029] FIG. 1 is a line graph showing the extent of cross-linking
of the protein medium over time where three dilutions of
formaldehyde 37% was used.
[0030] FIG. 2 is a line graph showing the extent of cross-linking
of the protein medium over time where three dilutions of
glutaraldehyde 50% was used.
[0031] FIG. 3 is a line graph showing the extent of cross-linking
of the protein medium over time where three dilutions of glyoxal
40% was used.
[0032] FIG. 4 is a line graph showing the extent of cross-linking
of the protein medium over time where two dilutions of a mixture of
glutaraldehyde 50% and glyoxal 40% at a 1:2 ratio was used, with or
without a quaternary ammonium compound, QUAT at 10%.
[0033] FIGS. 5A to 5I depict results from the field testing studies
of cows affected by hairy heel warts, showing the lesion sites
before and after treatment via spray of the presently taught
composition. FIG. 5A to 5C show images from on cow before (FIG. 5B)
and after (FIG. 5C) treatment of the lesion. FIG. 5D to 5F show
images from another cow before (FIG. 5E) and after (FIG. 5F)
treatment of the lesion. FIG. 5G to 5I show images from one cow
before (FIG. 5H) and after (FIG. 5I) treatment of the lesion.
6. DETAILED DESCRIPTION OF THE INVENTION
[0034] In accordance with the present invention, it has been
discovered that compositions of the present invention can be used
to control diseases of the hoof, such as foot warts, hoof rot, and
other bacterial hoof conditions more effectively than other
products.
[0035] It has been discovered that a novel composition and a method
of administering it is highly effective at treating and/or
preventing infectious diseases of the foot of an animal, including
hairy heel warts. Unlike compositions comprising formaldehyde, the
presently taught composition has no obnoxious odors and unlike
solutions containing copper, the present composition is
biodegradable. Some of the treatments available use antimicrobials
in footbaths in order to kill the bacteria associated with the
disease condition, however, once the animal leaves the footbath,
the open wart is prone to being re-infected as the cow walks into
bacteria infested mud and manure.
[0036] The presently taught composition possesses germicidal
components and are formulated so that after their administration,
the composition facilitates creation of a natural scab where the
infectious disease may have caused ulcers. Formation of a scab is
important because it stops the outward progression of the
destructive bacteria, providing a tough waterproof barrier which
prevents contamination and re-infection, and allows the animals'
immune system to begin the healing process. Formation of the scab
occurs rapidly through a process known as cross-linking which
occurs to the protein fibers in the open wound. One of the
advantageous properties of the presently taught composition over
existing treatments, is the rapid nature in which the composition
promotes formation of a scab. In addition, unlike other treatments,
the presently taught composition does not affect normal skin.
[0037] Infectious diseases of the hoof, such as hairy heel warts
(papillomatous digital dermatitis, or "PDD") hoof rot (interdigital
phlegmon), and stable hoof rot (interdigital dermatitis) are common
in farm animals such as sheep, goats, horses, dairy cows, and beef
cattle. The benefits of the compositions and methods of the present
invention for treating and/or preventing diseases of the foot of an
animal over other compositions and methods include efficacious
non-toxic compositions, maintenance of low levels of infectious
diseases, and/or reduced amounts of copper being transferred to the
soil and water. In particular, the present invention teaches
formulating the unique composition in a unique way as a spray or
foam, and such means of administering the composition of the
present invention has superior benefits to existing methods for
treating and/or preventing diseases of the foot of an animal,
including hairy heel warts.
[0038] Hairy heel warts, also referred to as digital dermatitis,
hairy footwarts, strawberry or raspberry heelwarts or hairy hoof
warts, is a common disease condition in dairy cows. These diseases
can cause lameness, leading to animals walking on toes and
decreased body weight, fertility and milk production, with the
seriously afflicted animals being culled. Clinically, hairy heel
warts typically appear as a lameness outbreak of variable severity
within dairy herds. It is a superficial skin disease of the bovine
digit with variable presentation, depending on the stage of the
lesion, from painful, moist, strawberry-like lesions to raised,
hairy, wart-like lesions. These lesions are generally located on
the rear of the foot between the bulbs of the heel. Since the late
1980's, such bacterial diseases have harmed livestock and have
caused significant economic losses for affected dairy
producers.
[0039] Hairy heel warts is a contagious disease, based on the
spread of disease regionally, high levels of disease within
affected herds, within-herd spread after introduction of affected
cattle, and higher prevalence in younger cows and that large herd
size, the amount of moisture in corrals where cows walk, and the
introduction of dairy replacement heifers are contributing factors
to disease occurrence. The exact causative agent for hairy heel
warts is not known, however evidence suggests that one or more
species of spirochete of the genus Treponema is responsible.
Treponema bacteria can be anaerobic or microaerophilic (require
oxygen at less than atmospheric levels) and can be parasitic to
humans and to animals causing a range of diseases. Mud and manure
slurry found in dairy free stall environments are an ideal
environment for Treponema bacterial to thrive.
[0040] The lesions characteristic of hairy heel warts are
generally, but not always, at the back of the foot near
interdigital cleft and heel. Sometimes the lesions are at the front
of the foot, in the interdigital cleft or near dewclaws. An early
lesion is sharply demarcated, flat, dime-sized, round to oval,
moist, tufted, strawberry-like surface. A mature lesion, however,
is larger (up to two inches across), usually is raised, and
sometimes with long brown/black tufts or hair-like, tissue
projections on the surface. Long hairs can be present on edge of
the lesion. The lesions can be very painful to the animal and
persist for many months, having direct and indirect physiological
effect on the animal.
[0041] Hoof rot, or interdigital phlegmon, is an infection of the
soft tissue between the claws of the feet. In equine animals, it is
also known as hoof thrush. Here, the term "hoof rot" will be used
to indicate both hoof rot and hoof thrush. Hoof rot is caused by
the anaerobic bacterium, Fusobacterium necrophorum. The anaerobes
Dichelobacter (Bacteroides) nodosus and Prevotella melaninogenicus
have also been implicated. The bacteria invade the skin of the foot
at injured or damaged skin areas, and initially cause a painful
swelling of the skin between the claws. A fissure or crack then
develops along the swollen area for part or all of the length of
the interdigital space. If left untreated, hoof rot can enter the
joints, bones, and/or tendons of the foot, making recovery from the
infection unlikely. Animals with hoof rot can have a mild fever,
loss of appetite and accompanying weight loss, and develop mild to
severe lameness.
[0042] Interdigital dermatitis, or stable hoof rot, is generally a
chronic inflammation of the skin in the area between the toes of
the feet (interdigital cleft). This infection is caused by the
bacterium Dichelobacter nodosus. The skin in the area of the
interdigital cleft will appear puffy with a dry exudation which
will cause a crust to form. The condition may occasionally cause
lameness or heel crack/heel erosion but generally results in an
alteration in the animal's gait.
[0043] Control of hairy warts and associated foot diseases has
proven difficult. At present, one effective treatment of hoof
warts, hoof rot and stable hoof rot is the use of antibiotics, such
as tetracycline, lincomycin, spectinomycin, penicillin,
oxytetracycline, and ampicillin, which are topically applied to the
affected area via use of footbaths. Most commercial foot baths are
thirty inches wide, four feet long and six inches deep, and require
about thirty five gallons of treatment solution. Where footbaths
are used, the animal is led to walk through while either entering
or exiting particular areas, such as for example milking parlors,
shearing stalls, or feeding stalls, the footbath to immerse the
hooves in a treatment solution, containing an antibiotic or other
material such as copper sulfate and/or zinc sulfate.
[0044] However, there are problems associated with the use of
livestock footbaths as detailed supra. For example,
bacteria-containing organic materials on the hooves of the animals
are washed off in the footbath solution. The organic materials
build up over time and overcome the ability of the material in the
solution to prevent and/or treat the disease. In some cases, the
footbath can even become a breeding ground for bacteria, and can
thus actually accelerate the spread of an infectious hoof disease,
rather than treat and/or prevent it. Additionally, disposal of the
footbath water may raise environmental concerns, as several states
are mandating the discontinued use of products containing heavy
metals such as copper.
[0045] Application of oxytetracycline under a bandage can be
effective, but bandaging affected hooves may be labor-intensive in
large or heavily afflicted herds. Even though antibiotics can be
effective in treating these infectious diseases, there are also
several drawbacks to their use, including their expense and the
concern, especially with dairy cows, that the use of antibiotics
may result in the presence of antibiotic residues in the animal or
its milk. Further, extended use of antibiotics may result in the
development of an antibiotic-resistant bacteria strain. Finally,
the use of antibiotics for the treatment of hoof rot, stable hoof
rot or hairy heel warts is "off-label," that is, the antibiotics
are not specifically approved for these uses.
[0046] In order to treat and prevent hoof rot, hairy heel warts,
and stable hoof, chemical-based germicides have also been tried as
a treatment. Although some germicides, such as those containing
copper sulfate and zinc sulfate, have some efficacy against hoof
rot and stable hoof rot, they are ineffective against hairy heel
warts. Many of the available compounds are expensive and/or
ineffective at high dilutions, such as those used in foot baths.
Likewise, combinations of hydrogen peroxide and peracetic acid have
been used, but also are not effective against hairy heel warts, and
suffer from stability and storage problems, as well as the problem
that the chemical combination irritates the hoof at the recommended
treatment concentrations.
[0047] Hairy heel warts have been treated in a number of ways. One
form of control is to treat the larger clinically active lesions,
which are a source of infection, by surgical removal, although
additional treatments for complete healing may be necessary. This
process is laborious, time consuming and expensive, particularly
when dealing with large herds. There have been anecdotal reports of
success with formaldehyde against hairy heel warts, however, this
agent is classified as a carcinogen and toxin, and is illegal in
some parts of the United States. Further, use of too high a
concentration of formaldehyde can result in destruction of healthy
hoof tissue, or can even lead to sloughing of the hoof. Thus, the
use of formaldehyde is not desired in treating hairy heel warts and
other diseases of the hoof.
[0048] The present invention addresses the need for a composition
that is effective against foot rot, stable foot rot, and hairy heel
warts, that is affordable, copper-free and zinc-free, and that
avoids the use of antibiotics. The present invention also addresses
the need for an effective method of both treating and/or preventing
foot rot, stable foot rot, and hairy heel warts. A novel
composition has been discovered which is highly effective at
treating infectious diseases of the foot of an animal, including
hairy heel warts when applied to the lower leg and hoof area of the
animal as a spray or foam. This approach provides a more efficient
and selective means by which infectious diseases of the foot of an
animal, including hairy heel warts can be treated and/or prevented
in animals, including cows. One of the advantageous properties of
the presently taught composition is the rapid nature in which the
composition promotes formation of a scab over a lesion that may
have formed.
[0049] One aspect of the present invention is directed to a method
for preventing and/or treating one or more infectious diseases of
the hoof in animals, comprising: preparing a copper-free and
zinc-free composition comprising at least one cross-linking agent,
wherein the cross-linking agent is not formaldehyde; and
administering the composition to a lower leg and hoof area of said
animal to prevent and/or treat said one or more infectious
diseases. The animal has, or is at risk for, an infectious disease
of the foot, and the infectious disease of the foot is hairy heel
warts, foot rot, stable foot rot, or foot scald. The animal to be
treated is commonly a cow, sheep, horse, or goat.
[0050] The method of the present invention includes administering
the novel composition in the form of a spray or foam, or a mixture
thereof. Generally, about three to about ten milliliters of the
composition is sprayed on to the lower leg and hoof area of the
animal, and in particular to the site of any lesion. The
composition may also be administered in the form of a gel to the
lower leg and hoof area of the animal. Where the infectious disease
comprises an open lesion, administration of the composition
facilitates the rapid formation of a scab over said lesion, which
can occur within about five to about fifteen minutes. This rapid
formation of a scab is a desirable quality of the present
composition and is achieved in part by the novel means of
administering the novel composition. The administering step may
include periodic administrations of the composition, and the
composition may comprise at least one of colorants, skin
conditioners, and buffers.
[0051] In some embodiments, the animal has, or is at risk for, an
infectious disease of the foot. As an example, an animal can be in
need of treatment with the compositions described herein when the
animal is diagnosed with hairy heel warts, foot rot, and/or scald.
As another example, an animal can be in need of treatment with the
compositions described herein when the animal is determined at risk
for hairy heel warts, foot rot, and/or scald. Diagnosis of
infectious diseases of the foot in animals is within the skill of
the art. The determination of risk for an infectious disease of the
foot can be according to environmental conditions, susceptibility
of certain types of animals, or other factors known to one of skill
in the art.
6.1 DEFINITIONS
[0052] As used in this document, the term foot as used in this
document means not only the terminal part of a vertebrate animal's
leg, but also the hoof (the curved covering of horn that protects
the front of the terminal part), the pad, the pastern, the dewclaw,
the hock, and the portion of the leg below the knee or hock on an
animal such as a domestic bovine.
[0053] As used herein, treatment is generally understood to
encompass both prophylactic treatment as well as treatment of an
existing or diagnosed condition. For example, an animal in need of
treatment can be at risk, or determined to be at risk, for an
infection of the foot. As another example, an animal in need of
treatment can have, or be diagnosed as having, an infection of the
foot. Diagnosis and risk assessment for animal foot diseases
discussed herein is within the skill of the art. In some cases
(e.g., with hoof rot), the treatment is preferably to increase hoof
hardness, thus helping to prevent the infection.
[0054] The term ungulate is understood to include an animal having
hooves, or feet resembling hooves, or feet that are hoof-like. An
ungulate is also understood to include an animal of, or belonging
to, the former order Ungulata, now divided into the orders
Perissodactyla and Artiodactyla and composed of hoofed mammals such
as, but not limited to, a horse, a cow, a goat, a sheep, a pig,
deer, an elephant, an elk, a bison, a moose, a gazelle, and an
antelope. The term debris means at least animal waste.
[0055] The term ingredients means any combination of active and
inert chemicals and fluids, including water, that may be discharged
from dispensers for treating animal foot problems including,
without limitations, diseases, infections, abrasions, and injuries
to a foot of an animal, as well as preventative ingredients
including, for example, those useful for creating resistance to
diseases and lacerations, for hardening hooves, and similar
desirable treatments.
6.2 COMPOSITIONS AND METHODS
[0056] The subject invention provides an inexpensive, easy to use,
highly effective, composition and method of treating and/or
preventing infectious diseases of hoofed animals, including hairy
hoof warts. One aspect of the present invention is directed to a
method for preventing and/or treating one or more infectious
diseases of the hoof in animals, comprising: preparing a
copper-free and zinc-free composition comprising at least one
cross-linking agent, wherein the cross-linking agent is not
formaldehyde; and administering the composition to a lower leg and
hoof area of said animal to prevent and/or treat said one or more
infectious diseases. Formaldehyde is the simplest and smallest
aldehyde which under certain conditions can make it effective,
however dangerous. Di-aldehydes are a bit larger, less reactive,
but exhibit good crosslinking because of their two aldehyde
groups.
[0057] The cross-linking agents of the present invention are
selected from the group consisting of aldehydes, such as
glyceraldehyde, glutaraldehyde, dextran dialdehyde, and
carbohydrates; diols, such as ethylene glycol, di(ethylene glycol),
polyethylene glycol, propylene glycol, di(propylene) glycol,
polypropylene glycol; unsaturated diesters such as ethylene glycol
dimethacrylate, di(ethylene glycol) dimethacrylate, poly(ethylene
glycol) dimethacrylate, poly(lauryl methacrylate-co-ethylene glycol
dimethacrylate), propylene glycol dimethacrylate, di(propylene
glycol) dimethacrylate, polypropylene glycol) dimethacrylate;
dihydrazides such as malonic dihydrazide, ethylmalonic dihydrazide,
succinic dihydrazide, glutaric dihydrazide, adipic dihydrazide,
isophthalic dihydrazide, oxalyl dihydrazide, pimelic dihydrazide,
3,3'-sulfonyldibenzenesulfonic dihydrazide; diisocyanates such as
m-xylylene isocyanate, 4-methyl-m-phenylene diisocyanate,
2-methyl-m-phenylene diisocyanate, 3,3'-dimethoxy-4,4'-biphenylene
diisocyanate, 4-Br-6-methyl-1,3-phenylene diisocyanate,
4-Cl-6-methyl-1,3-phenylene diisocyanate, toluene 2,4-diisocyanate,
1,3-phenylene diisocyanate, 1,4-phenylene diisocyanate,
2,4,6-trimethyl-1,3-phenylene diisocyanate, 1,4-diisocyanatebutane,
1,6-diisocyanatehexane, 1,8-diisocyanateoctane, isophorone
diisocyanate; carbodiimides such as
N,N-(3-dimethylaminopropyl)-N-ethyl carbodiimide (EDC); salts, such
as CaCl.sub.2, divinylsulfone, sulfonylurea, hydrolysable
polyrotaxane, L-lysine methyl ester, and genipin. Cross-linking may
also be carried out or aided by one or more enzymes.
[0058] In another embodiment, the cross-linking agent is selected
from the group consisting of glutaraldehyde, glyoxal,
ortho-phthaldehyde, carbodiimides, diisocyanates, a formaldehyde
donor, sodium hydroxymethyl glycinate, diazolidinyl urea,
imidazolidinyl urea, dimethylol-5,5-dimethylhydantoin, dimethylol
urea, 2-bromo-2-nitropropane 1,3-diol, quaternium-15, parabens,
5-chloro-2methylisothiazolin-3-one, 1,2-dibromo-2,4-dicyanobutane,
ethanol and other alcohols, and polyol. In one embodiment, the
composition of the present invention comprises glutaraldehyde,
glyoxal, ortho-phthaldehyde or mixtures thereof.
[0059] Glutaraldehyde is a four carbon molecule terminated at both
ends by aldehyde groups. It is widely used by light and electron
microscopists for its efficacy in preserving cellular structure. It
was conceived that glutaraldehyde would be useful in the context of
the present invention because glutaraldehyde would not overly dry
the treated area or cause the treated area or hooves to become
brittle. Further, it was conceived that glutaraldehyde's
comparatively high molecular weight would aid to limit its ability
to diffuse into the tissue, especially since as the tissue is
cross-linked, its ability to penetrate over time diminishes. One of
the added benefits of the presently taught composition is that it
limits the function of the composition to the superficial skin
layers preventing the composition from being too aggressive and
penetrating too deeply into the treated area. Moreover, whereas
formaldehyde is known to cause chemical burns even to healthy
tissue, use of glutaraldehyde as the cross-linking agent of the
presently taught composition allows unscathed skin to remain
healthy.
[0060] Penetration and diffusion rates for glutaraldehyde are very
slow with typical values of under about 5 mm of penetration on rat
brain overnight. This is in sharp contrast to formaldehyde, which
exhibits fast penetration/diffusion rates but slow endpoint
fixation rates. It was conceived that since manure/urine and mud
slurry found on dairy farms typically have a pH of around 8, a
cross-linking agent such as glutaraldehyde would be effective,
whereas such organic loading would essentially render formaldehyde
and many other germicides ineffective.
[0061] Glutaraldehyde is a strong germicide and a cross-linking
agent which rapidly fixes or binds loose protein fibers.
Glutaraldehyde is an effective biocide and another of the
advantageous properties of the present composition is that
glutaraldehyde minimally penetrates into the tissue, thereby
reducing the extent to which it may circulate in the blood stream
and reach vital organs. Glyoxal is an organic compound used as a
solubilizer and cross-linking agent in polymer chemistry. It is
typically supplied as a 40% aqueous solution.
[0062] The one or more cross-linking agents of the present
invention are present in the composition at a level from 0.001% to
30%. In one embodiment, the one or more cross-linking agents of the
present invention are present in the composition at a level from
0.5% to 20%. In another embodiment, the one or more cross-linking
agents of the present invention are present in the composition at a
level from 1% to 15%. In yet another embodiment, the one or more
cross-linking agents of the present invention are present in the
composition at a level from 1% to 10%. In another embodiment, the
one or more cross-linking agents of the present invention are
present in the composition at a level from 5% to 13%. In yet
another embodiment, the one or more cross-linking agents of the
present invention are present in the composition at about 10%. In
yet another embodiment, the one or more cross-linking agents of the
present invention are present in the composition at about 25%. In
one embodiment, the one or more cross-linking agents of the present
invention are present in the composition at a level from 5% to 30%.
In another embodiment, the one or more cross-linking agents of the
present invention are present in the composition at a level of
about 40% to about 50%.
[0063] In one embodiment, the composition of the present invention
comprises an antimicrobial essential oil or an active thereof or
mixture thereof, which contribute anti-microbial and bacterial
properties to the composition. Suitable antimicrobial essential
oils for use herein are those essential oils which exhibit
antimicrobial activity. By "actives of essential oils", it is meant
herein any ingredient of essential oils that exhibit antimicrobial
activity. It is speculated that said antimicrobial essential oils
and actives thereof act as proteins denaturing agents.
[0064] Such antimicrobial essential oils include, but are not
limited to, those obtained from thyme, lemongrass, citrus, lemons,
orange, anise, clove, aniseed, pine, cinnamon, geranium, roses,
mint, lavender, citronella, eucalyptus, peppermint, camphor,
ajowan, sandalwood, rosmarin, vervain, fleagrass, lemongrass,
ratanhiae, cedar and mixtures thereof.
[0065] Actives of essential oils to be used herein include, but are
not limited to, thymol (present for example in thyme, ajowan),
eugenol (present for example in cinnamon and clove), menthol
(present for example in mint), geraniol (present for example in
geranium and rose, citronella), verbenone (present for example in
vervain), eucalyptol and pinocarvone (present in eucalyptus),
cedrol (present for example in cedar), anethol (present for example
in anise), carvacrol, hinokitiol, berberine, ferulic acid, cinnamic
acid, methyl salicylic acid, methyl salycilate, terpineol, limonene
and mixtures thereof. In one embodiment, the composition of the
present invention comprises methyl salycilate.
[0066] Thymol may be commercially available for example from
Aldrich--Manheimer Inc, eugenol may be commercially available for
example from Sigma, Systems--Bioindustries (SBI)--Manheimer Inc. In
one embodiment, the composition further comprises a component
selected from the group consisting of antimicrobial essential oils
and actives thereof, quaternary ammonium compounds, paraben,
aldehydes, phenolic compounds, alcohols, organic acids,
chlorine-type bleaches, and mixtures thereof.
[0067] The antimicrobial essential oil or active thereof or mixture
thereof is present in the composition at a level up to 20% by
weight of the total composition. In one embodiment, the level is at
least 0.003% to 10%. In another embodiment, the antimicrobial
essential oil or active thereof or mixture thereof is present in
the composition at a level from 0.006% to 10%. In another
embodiment, the antimicrobial essential oil or active thereof or
mixture thereof is present in the composition at a level from 0.01%
to 8%. In another embodiment, the antimicrobial essential oil or
active thereof or mixture thereof is present in the composition at
a level from 0.03% to 3%.
[0068] In one embodiment, the composition of the present invention
comprises propylene glycol or an equivalent thereof. In one
embodiment, the composition of the present invention comprises a
poly(alkylene glycol) alkyl ether, as defined herein after, or a
mixture thereof. Suitable poly(alkylene glycol) alkyl ethers for
use herein include poly(propylene glycol) mono butyl ether,
poly(ethylene glycol-co-propylene glycol) mono butyl ether,
poly(ethylene glycol) dimethyl ether, poly(ethylene
glycol-co-propylene glycol) dimethyl ether, poly(ethylene glycol)
stearate or mixtures thereof. Poly(propylene glycol) mono butyl
ether (average molecular weight 340) is commercially available from
Aldrich or from Union Carbide under Ucon-lb 65.RTM..
[0069] Propylene glycol can serve as an anti-freeze. One
advantageous property of the presently taught composition is that
it is useful in cold climates when traditional techniques for
treating hairy heel warts fail due to cold weather. Colder
temperatures are known to reduce the effectiveness of formaldehyde
and other agents, whereas glutaraldehyde retains its effectiveness
in colder weather. Colder temperatures can also cause freezing of
footbaths containing conventional solutions. Propylene glycol can
also serve as an emollient/skin conditioner used to combat
potential dryness that can result from the fixing agent. Propylene
glycol also serves as a carrier and gelling agent like xantham gum,
albeit to a lesser extent.
[0070] The poly(alkylene glycol) alkyl ether or a mixture thereof
is present in the composition at a level from 0.001% to 10%. In one
embodiment, the poly(alkylene glycol) alkyl ether or a mixture
thereof is present in the composition at a level from 0.3% to 3%.
In another embodiment, the poly(alkylene glycol) alkyl ether or a
mixture thereof is present in the composition at a level from
0.005% to 2%. In yet another embodiment, the poly(alkylene glycol)
alkyl ether or a mixture thereof is present in the composition at a
level from 0.01% to 1%. In another embodiment, the poly(alkylene
glycol) alkyl ether or a mixture thereof is present in the
composition at a level from 0.05% to 0.5%.
[0071] In one or more embodiments of the present invention, the
composition of the present invention includes about 0.1% to about
5% of a gelling agent. Suitable gelling agents include, in a
non-limiting manner, naturally-occurring polymeric materials such
as locust bean gum, guar gum, sodium alginate, sodium caseinate,
egg albumin, gelatin agar, carrageenin gum, sodium alginate,
xanthan gum, quince seed extract, tragacanth gum, starch,
chemically modified starches and the like, semi-synthetic polymeric
materials such as cellulose ethers (e.g. hydroxyethyl cellulose,
methyl cellulose, carboxymethyl cellulose, hydroxy propylmethyl
cellulose), hydroxypropyl guar gum, soluble starch, cationic
celluloses, cationic guars and the like and synthetic polymeric
materials such as carboxyvinyl polymers, polyvinylpyrrolidone,
polyvinyl alcohol, polyacrylic acid polymers, polymethacrylic acid
polymers, polyvinyl acetate polymers, polyvinyl chloride polymers,
polyvinylidene chloride polymers and the like. In one embodiment,
the gelling agent is xanthan gum.
[0072] Also useful herein are gelling agents such as the acrylic
acid/ethyl acrylate copolymers and the carboxyvinyl polymers sold,
for example, by the B.F. Goodrich Company under the trademark of
Carbopol resins. These resins include a colloidal water-soluble
polyalkenyl polyether cross linked polymer of acrylic acid cross
linked with from 0.75% to 2% of a cross linking agent such as
polyallyl sucrose or polyallyl pentaerythritol. Examples include
Carbopol 934, Carbopol 940, Carbopol 950, Carbopol 980, Carbopol
951 and Carbopol 981.
[0073] A gelling agent, for example, xanthan gum, acts as a
thickener and a pseudo-plasticizer which permits the composition of
the present invention to thin out under stress to flow through a
spray gun. Upon making contact with the wart, the composition gels
and stays in place, allowing for greater contact time and making it
more resistant to runoff. Since the treatment area involves regions
of cows' hoof, which by its nature is not stationary, this feature
of the presently taught composition is new and useful. Such gelling
agents (e.g., xanthan gum, polymeric thickeners, cellulose
thickeners, propylene glycol, glycerin, or the like) in the
composition allow the composition to remain in contact with the
infected area of the foot for a longer period of time than a
formulation without the thickener/gelling agent.
[0074] Xantham Gum would be classified as a gelling agent. It can
thicken the aqueous solution and it was conceived that, with the
gelling agent, one can spray once a vertical plane and the solution
will cling to the surface and stick to the intended target. This is
useful because the composition needs contact time (preferably at
least about 4 minutes) to produce successful results. In a wet,
dirty environment, a more viscous solution can adhere and keep more
of the treatment solution on the target area. Xanthan gum also
lowers the vapor pressure of the solution. Glutaraldehyde use at
high concentrations could present potential inhalation issues to
workers, and the use of gelling agents like xantham gum, and to
some extent propylene glycol, acts as a carrier for the
glutaraldehyde and prevents it from being atomizing into the air.
In one embodiment of the present invention, this property of the
final product makes the product user friendly and is beneficial and
overcomes any potential problem which could exist with use of
glutaraldehyde or other fixatives.
[0075] The composition of the present invention can include about
0.1% to about 1% of a gelling agent. In another embodiment, the
gelling agent is present in the composition at a level from 0.03%
to 3%. In another embodiment, the gelling agent is present in the
composition at a level from 0.05% to 5%. In another embodiment, the
gelling agent is present in the composition at a level from 5% to
15%.
[0076] In one embodiment, the composition of the present invention
comprises quaternary ammonium compounds. Suitable quaternary
ammonium compounds for use herein are quaternary ammonium compounds
containing alkyl or substituted alkyl groups, alkyl amide and
carboxylic acid groups, ether groups, unsaturated alkyl groups, and
cyclic quaternary ammonium compounds, which can be chlorides,
dichlorides, bromides, methylsulphates, chlorophenates,
cylcohexylsulphamates or salts of the other acids. Among the
possible cyclic quaternary ammonium compounds are the following:
alkylpyridinium chlorides and/or sulphates, the alkyl group being
preferably cetyl, dodecyl or hexadecyl group; alkylisoquinolyl
chlorides and/or bromides, the alkyl group being preferably dodecyl
group. Particularly suitable quaternary ammonium compounds for use
herein include octyl decyl dimethyl ammonium chloride, dioctyl
dimethyl ammonium chloride, didecyl dimethyl ammonium chloride,
alkyl dimethyl benzyl ammonium chloride, alkyl dimethyl benzyl
ammonium chloride wherein the alkyl is one or more of C.sub.12
C.sub.14 and C.sub.16 alkyl, alkyl dimethyl ammonium saccharinate,
cetylpyridinium and mixtures thereof.
[0077] The one or more quaternary ammonium compounds of the present
invention are present in the composition at a level from 0.001% to
30%. In one embodiment, the one or more quaternary ammonium
compounds of the present invention are present in the composition
at a level from 0.5% to 20%. In another embodiment, the one or more
quaternary ammonium compounds of the present invention are present
in the composition at a level from 1% to 15%. In yet another
embodiment, the one or more quaternary ammonium compounds of the
present invention are present in the composition at a level from 1%
to 10%. In another embodiment, the one or more quaternary ammonium
compounds of the present invention are present in the composition
at a level from 5% to 13%. In yet another embodiment, the one or
more quaternary ammonium compounds of the present invention are
present in the composition at about 10%. In yet another embodiment,
the one or more quaternary ammonium compounds of the present
invention are present in the composition at about 25%. In one
embodiment, the one or more quaternary ammonium compounds of the
present invention are present in the composition at a level from
10% to 30%.
[0078] In another aspect of the present invention, the composition
includes and/or is used in combination with an effective amount of
one or more surfactants. The inclusion of the surfactant in the
composition can improve the performance of composition (e.g.,
improve wetting properties of the composition, stabilize components
in the composition, function as an emulsifying agent, reduce
filming and/or streaking) A variety of surfactants can be used in
the composition. Such surfactants include, but are not limited to,
nonionic, semi-polar, anionic, cationic, zwitterionic, and/or
amphoteric surfactants. Many of these surfactants are described in
McCutcheon's Emulsifiers and Detergents (1997), Kirk-Othmer,
Encyclopedia of Chemical Technology, 3rd Ed., Volume 22, pp.
332-432 (Marcel-Dekker, 1983), and McCutcheon's Soaps and
Detergents (N. Amer. 1984), the contents of which are hereby
incorporated by reference. Typically the surfactant is partially or
fully soluble in water.
[0079] In one embodiment, the surfactant includes, but is not
limited to, glycoside, glycols, ethylene oxide and mixed ethylene
oxide/propylene oxide adducts of alkylphenols, the ethylene oxide
and mixed ethylene oxide/propylene oxide adducts of long chain
alcohols or of fatty acids, mixed ethylene oxide/propylene oxide
block copolymers, esters of fatty acids and hydrophilic alcohols,
sorbitan monooleates, alkanolamides, soaps, alkylbenzene
sulfonates, olefin sulfonates, paraffin sulfonates, propionic acid
derivatives, alcohol and alcohol ether sulfates, phosphate esters,
amines, amine oxides, alkyl sulfates, alkyl ether sulfates,
sarcosinates, sulfoacetates, sulfosuccinates, cocoamphocarboxy
glycinate, salts of higher acyl esters of isethionic acid, salts of
higher acyl derivatives of taurine or methyltaurine, phenol poly
ether sulfates, higher acyl derivatives of glycine and
methylglycine, alkyl aryl polyether alcohols, salts of higher alkyl
substituted imadazolinium dicarboxylic acids, ferchorics, tannics,
naphthosulfonates, monochloracetics anthraflavinics, hippurics,
anthranilics, naphthoics, phthalics, carboxylic acid salts, acrylic
acids, phosphates, alkylamine ethoxylates, ethylenediamine
alkoxylates, betaines, sulfobetaines, and/or imidazolines.
[0080] In one aspect of this embodiment, the surfactant includes,
but is not limited to, lauryl sulfate, laurylether sulfate,
cocamidopropylbetaine, alkyl polyglycosides, and/or amine oxides.
In one embodiment, the surfactant is selected from the group
consisting of polyoxyethylene alcohols, alkyl ether sulfates, and
alkyl sulfates. In one embodiment, the surfactant is an ethoxylated
nonylphenol. CO 720 ethoxylated nonylphenol, for example, helps
unwind the protein fibers, allowing them to be available for
cross-linking. The CO 720 ethoxylated nonylphenol also acts as an
emulsifier for the methyl salicylate. Ethoxylated nonylphenol is a
polyether. In another embodiment, the present aqueous
solution/composition of the present invention comprises one or more
polyethers.
[0081] CO 720 (ethodylated nonyl phenol) is a surface-active agent
that would be considered a surfactant. It prepares the surface to
be treated so that a fixing agent like glutaraldehyde can achieve
greater penetration. This helps condition the surface by unwinding
the tightly bound proteins so that the glutaraldehyde or another
cross-linking agent, for example another di-aldehyde, can then
crosslink using their two aldehyde groups. QUATS, quaternary
ammonium compound, may also act as surfactants and work in the same
way when used in combination with a fixing agent like
glutaraldehyde. Bactericidal and fungicidal activities are due to
the combination of glutaraldehyde with metabolic enzymes and with
the amino-acids. Being hydrophilic, glutaraldehyde cannot easily
cross the cell's lipid membrane.
[0082] The one or more surfactants of the present invention are
present in the composition at a level from 0.01% to 10%. In one
embodiment, the one or more surfactants of the present invention
are present in the composition at a level from 0.5% to 5%. In
another embodiment, the one or more surfactants of the present
invention are present in the composition at a level from 1% to
4%.
[0083] One aspect of the present invention is directed to a
copper-free and zinc-free composition for the treatment and/or
prevention of one or more infectious diseases of the hoof in
animals, comprising at least one cross-linking agent, wherein said
cross-linking agent is not formaldehyde. In one embodiment, the
composition comprises about 5% to about 30% by weight of at least
one cross-linking agent; about 5% to 20% by weight of at least one
quaternary ammonium compound; about 0.03% to 3% by weight of at
least one apoly(alkylene glycol) alkyl ether; about 0.03% to 3% by
weight of at least one gelling agent; about 0.03% to 3% by weight
of at least one antimicrobial essential oil or active thereof; and
about 0.03% to 5% by weight of at least one surfactant.
[0084] One aspect of the present invention is directed to a
composition for the treatment and/or prevention of one or more
infectious diseases of the hoof in animals, comprising one or more
cross-linking agents; one or more quaternary ammonium compounds;
one or more gelling agents; one or more surfactants; one or more
antimicrobial essential oils or actives thereof; and one or more
poly(alkylene glycol) alkyl ethers.
[0085] One aspect of the present invention is directed to a method
for treating and/or preventing papilomatous digital dermatitis in
an ungulate, comprising: preparing a copper-free and zinc-free
composition comprising at least one cross-linking agent and at
least one quaternary ammonium compound; and spraying or applying in
a foam a therapeutically effective amount of said composition to a
lower leg and hoof area of said ungulate in order to treat and/or
prevent said papillomatous digitial dermatitis.
[0086] In another aspect of the present invention, the composition
includes and/or is used in combination with one or more biocides.
Such biocides can include, but are not limited to, alcohols,
peroxides, boric acid and borates, chlorinated hydrocarbons,
organometallics, halogen-releasing compounds, mercury compounds,
metallic salts, pine oil, organic sulfur compounds, iodine
compounds, silver nitrate, quaternary phosphate compounds, and/or
phenolics.
[0087] In one embodiment of the present invention the compositions
may further comprise a pH buffer i.e. a system composed of a
compound or a combination of compounds, whose pH changes only
slightly when a strong acid or base is added. Suitable pH buffers
and amount to use are known to those skilled in the art. For
example, suitable organic acids for use herein include
monocarboxylic acids, dicarboxylic acids and tricarboxylic acids,
acetic acid, citric acid, malonic acid, maleic acid, malic acid,
lactic acid, glutaric acid, glutamic acid, aspartic acid, methyl
succinic acid, succinic acid or mixtures thereof. In one
embodiment, the citric acid and succinic acid or mixtures thereof
are used.
[0088] The composition can be used at a range of effective
concentrations. In some embodiments, the composition has a pH of
about 1.0 to about 6.0. In other embodiments, the composition has a
pH of about 1.0, about 1.5, about 2.0, about 2.5, about 3.0, about
3.5, about 4.0, about 4.5, about 5.0, about 5.5, or about 6.0.
[0089] The compositions described herein can be contacted with an
animal foot/hoof in an amount effective to result in a reduction
significantly greater than is achieved by washing with water, or at
least a 50% reduction, at least a 90% reduction, preferably at
least a 99% reduction, in the resident microbial preparation.
[0090] The present methods usually require a certain minimal
contact time of the composition with the foot/hoof of an animal for
the treatment and/or prevention specified. The contact time can
vary with concentration of the use composition, method of applying
the use composition, temperature of the use composition, amount of
soil and/or contamination on the hoof, number of microorganisms
present on the hoof, type and formulation of the disinfection
composition, or the like.
[0091] The minimum exposure time to the presently taught
composition is, for example, at least about 2 to about 5 seconds.
The exposure time can be, for example, at least about 15 seconds,
at least about 30 seconds, at least about 45 seconds, at least
about one minute, at least about two minutes, at least about three
minutes, at least about four minutes, at least about five minutes,
at least about six minutes, at least about seven minutes, at least
about eight minutes, at least about nine minutes, at least about
ten minutes, at least about 15 minutes, at least about 20 minutes,
at least about 25 minutes, at least about 30 minutes, at least
about 35 minutes, at least about 40 minutes, at least about 45
minutes, at least about 50 minutes, at least about 55 minutes, or
at least about 60 minutes. In one embodiment, the exposure time to
the presently taught composition is between about 5 to about 30
minutes. In one embodiment, the exposure time to the presently
taught composition is between about 5 to about 120 minutes. Even
longer exposure times are contemplated, for example, several hours
or even days. After direct exposure during administration, it is
contemplated that the disinfection composition can remain in
contact with a hoof for extended periods of time. Generally, longer
exposure times to the disinfection composition will be preferred as
the pH increases.
[0092] Application of the composition to an animal's foot can occur
in periodic applications. An effective amount of the composition
can be applied to an animal's foot several times per day and/or
several times over a period of several days. For example, the
composition can be applied to part or all of an animal's foot/hoof
about every one hour, about every two hours, about every three
hours, about every four hours, about every five hours, about every
six hours, about every seven hours, about every eight hours, about
every nine hours, about every ten hours, about every eleven hours,
or about every twelve hours. Longer periods of time between
applications are contemplated. For example, the composition may be
applied every day, every other day, every three days, or every
several days. In general, application of the present composition
once or twice on the same day or consecutive days has an
effect.
[0093] It is contemplated that the presently taught composition can
be administered in the same or different form as a single dose or
in multiple applications. In some embodiments, a first composition
and a second antimicrobial composition are applied serially to the
foot of an animal. In some embodiments, a first concentrated
composition is diluted with water to form a first antimicrobial
composition, and a second concentrated composition is diluted with
water to form a second antimicrobial composition. The first and the
second antimicrobial composition can be applied serially or jointly
to a foot of an animal at predetermined intervals. In some
embodiments, the method for treating a foot of an animal comprises
contacting a foot of an animal with any of the compositions taught
herein. The compositions of the application can be diluted in water
to prepare for use. In one embodiment, the composition is diluted
between about 10-fold to about 400-fold in water before treating
the foot of the animal. In an embodiment, the composition is
diluted about 200-fold in water.
[0094] The composition may comprise additional components,
including for example skin conditioners, such as glycerin,
propylene glycol, sorbitol, lanolin, derivates of polyethylene
glycol (PEG)-lanolin and polypropylene glycol (PPG)-lanolin, aloe
vera, and allantoin, to promote skin health and healing. Buffering
agents may be used to adjust pH. Buffers may include organic acids,
such as monocarboxylates, phosophoric acid, carbonates, and similar
products. The pH may be adjusted by adding alkalinity such as
sodium bicarbonate, sodium carbonate, sodium hydroxide and
potassium hydroxide. Film forming polymers may be used, including
polyethylene glycol resins, polyvinyl alcohol, polyacrylates,
polyvinyl pyrrolidinone, polyurethanes and corresponding
copolymers.
[0095] The composition may also comprise antimicrobial agents such
as quat based antimicrobials, phenolics, peracids, hydrogen
peroxide, acidified sodium chlorite, hypochlorous acid, iodine,
chlorhexidine, aldehyde-based germicides, and fatty acids.
Colorants selected from generally recognized dyes and pigments may
also be part of the composition. Any of these components may be
used in various combinations depending on the desired features of a
particular product.
[0096] The compositions and methods described herein, used alone or
in combination with other known treatment compositions and
modalities, can be directed to the treatment and/or prevention of
an infectious disease of the foot of an animal. The compositions
and methods of the present invention have activity against a wide
variety of microorganisms such as Gram positive and Gram negative
bacteria, yeast, molds, bacterial spores, and viruses. Treatments
with any of the compositions of the present invention can be
applied one time or repeatedly within a short period of time
(minutes or hours), or the treatments can be repeated as needed
over a longer period of time (days or months).
[0097] One aspect of the invention is directed towards treatment
and/or prevention of one or more infectious diseases of a foot of
an animal by administration of the compositions described herein.
Infectious diseases of the foot of an animal that can be treated
and/or prevented with compositions and methods described herein
include, but are not limited to hairy heel warts, foot rot, and/or
scald (foot rot includes, but is not limited to, stable foot rot)
or other conditions caused by Fusobacterium necrophorum,
Bacteroides melaninogenicus, and/or Diechelobacter nodosus. The
term animal includes cattle, and thus both cows and steers, as well
as other animals and mammals.
[0098] In various embodiments, the animal to be treated is an
ungulate. In one embodiment, the subject of various treatments
described herein is a cow, a sheep, a horse, or a goat. In another
embodiment, the ungulate to be treated with the composition of the
present invention is a cow. Infectious diseases in the hooves of
cows are most prevalent in dairy cow herds but are also problematic
in beef cattle. The treatment compositions and methodologies
described herein can be directed to dairy and/or beef cattle. In
some embodiments, the ungulate to be treated with a composition of
the present invention is a goat. In some embodiments, the ungulate
to be treated with the composition of the present invention is a
horse. In other embodiments, the ungulate to be treated with an
antimicrobial composition of the present invention is a sheep.
[0099] An animal foot can be contacted with a composition described
herein by any method or apparatus suitable for applying the
presently taught composition. For example, although extensive
studies were performed using spray and foam formulations, it is
contemplated that the presently taught composition may be
administered by other means known to those skilled in the art.
Various embodiments provides for components of the footbath, spray,
gel or foam form of the composition to be administered
sequentially. In other embodiments of the present invention, a
footbath, spray, gel or foam form of the composition can be
administered sequentially with an antimicrobial composition in the
same or another form such as a footbath, powder, spray, gel, or
foam.
[0100] As stated supra, the solution described herein is
specifically formulated to be applied to the hooves and lower legs
of the animal as a spray or foam formulation. Labor costs are a
major concern to farmers. In one embodiment, an automated system is
used to apply the solution, in order to reduce labor costs. The
automated system may use a programmable time sequence and/or
sensors that trigger dispensing. For example, in a spray
application, sensors may be used to determine a presence of an
animal requiring treatment.
[0101] In one embodiment, it is contemplated that other means of
applying the solution as taught herein may achieve results that
improve upon existing methods of treating one or more diseases of
the foot of an animal. For example, the taught solution herein may
be used in a foot bath application, whether a traditional liquid
solution or a foam, and a program may be used such that the
treatment is dispensed into the trough at specific time intervals,
and the old treatment solution is automatically drained before
dispensing the replacement treatment solution. Instead of a time
interval, the system may monitor a number of animals that have
passed through the trough and automatically replenish the trough at
a predetermined interval. Alternatively, sensors within the trough
may be used to determine when the solution falls below a
predetermined concentration (due to contamination in the trough)
and/or when waste levels in the trough reach a specific level.
[0102] In another embodiment, the use of absorptive pads saturated
with the composition may be used for treatment, however, wrapping
with pads should be loose. Generally, wrapping will prevent the
formation of a scab, the rapid formation of which is facilitated by
the presently taught methods and compositions, and which is
necessary for healing.
[0103] For dairy cows, the treatment can be applied prior to
entering a milking parlor. Milking parlors are generally kept very
clean, thus providing adequate time for contact between the
solution and the skin and the hoof before returning to a
potentially soiled environment. Alternatively, the treatment may be
applied as the cows exit the milking parlor such that the cows
receive the treatment immediately prior to moving to a housing
environment that may be dirty. The composition may be applied
periodically, such as every day, every other day, or once a week.
Generally, one or two applications either on same day or on
consecutive days facilitates formation of a scab.
[0104] In some embodiments, more than one application technique may
be used in combination or multiple applications may be used. For
example, a spray followed by foam may be used in series, or a foot
bath followed by a spray or foam administration. The first foot
bath may contain a detergent solution to remove dirt and manure
from the hooves; the second spraying or foaming containing the
solution as taught herein. In another aspect of the invention, a
rotation of treatments may be used. In one embodiment of the
present invention, the affected area is first cleaned, for example
washed with water or by a first pass through a footbath, to clear
the mud and manure for example and provide good exposure of the
lesion to the to-be administered composition of the present
invention.
6.3 FORMULATIONS
[0105] The present invention includes any known application
technique for delivering an composition to the lower leg and hoof
of the animal. The applications include, but are not limited to,
foam, direct spraying, and propellant spray. In one embodiment, an
automated system, as described further below, is used for applying
the composition to the animals.
[0106] Foot baths are currently the most common application mode
for treating hairy heel warts and other hoof related diseases. Cows
are directed to walk through troughs containing the liquid
treatment. A disadvantage of foot baths is that the liquid
treatment may easily become contaminated due to organic waste from
the cows. In some cases the foot bath may even become a vehicle for
transferring bacteria to other cows. Foot baths thus may require
frequent replenishment, as well as significant labor commitments in
some cases.
6.3.1. SPRAY
[0107] As an alternative to a foot bath, the composition may be
sprayed on the hooves. An advantage of a spray application is that
a fresh treatment is applied to each cow, as compared to a foot
bath application which may become contaminated over time. In some
embodiments, a worker may individually spray each cow as the cow is
on its way into or out of the milking parlor. Alternatively, an
automated system may be used to spray the treatment onto the
hooves.
[0108] In various embodiments, the compositions described herein
can be administered as a spray. In one embodiment, the presently
taught compositions are sprayed onto the lesion so as to adequately
cover the lesion. Depending on the lesion size, this can take about
3 ml to about 10 ml of the composition being sprayed onto the
lesion. The compositions can be applied using fixed or articulating
nozzles, at higher pressures, varying or steady flow rates, various
temperatures, and/or with or without agitation or brushes. Spraying
can be accomplished by an apparatus such as a spray cabinet with
stationary or moving spray nozzles. The nozzles can create a mist,
vapor, or spray that contacts an animal's feet. The spray can be
set up as a walk-through pen or in a holding pen. In one
embodiment, the composition as taught herein is applied either with
the 32 oz hand pump sprayer or a larger pump sprayer. In one
embodiment, the composition is a thinner formulation used to spray
either the entire herd or individual warts, named HealMax Herd
Spray.
[0109] Application of a material by spray can be accomplished, for
example, using a manual spray wand application, an automatic spray
of the animals moving through a gate or room or gateway, or the
like. Multiple spray heads to ensure complete contact or other
spray means may be used. In one embodiment, an automatic spray
application is used, involving the use of a spray booth. The spray
booth substantially confines the sprayed composition to within the
parameter of the booth. The spray booth can include steam jets that
can be used to apply the compositions of the present invention. The
spray pattern can be virtually any useful spray pattern.
[0110] When using a spray application, additional components may be
included in the composition to enhance application of the solution
onto the skin and hooves. In some embodiments, thickeners may be
used to retain a greater quantity of liquid per skin area.
Surfactants may also be used in combination with or as an
alternative to thickeners. The surfactants reduce the surface
tension of the aqueous composition on the skin and thus help the
solution to wet and spread over the skin. The composition also may
contain film forming polymers that dry to a second skin to help in
holding the composition to the skin or to provide a protective
barrier to the skin.
[0111] In some embodiments, a thickener is used in a spray
application to increase a viscosity of the composition. In other
embodiments, the viscosity of the composition is equal to or
greater than approximately 20 centipoise for spray applications.
Suitable thickeners may include polymeric thickeners, clays,
silicas, and associative thickeners. Moreover, surfactant thickened
systems may be used to form an composition having the desired
viscosity for spraying the composition onto the hooves and lower
legs of an animal. A propellant spray also may be used to apply a
composition to the hooves and lower leg area. The propellant spray
typically requires the use of volatile propellants.
[0112] 6.3.2. Other
[0113] In additional embodiments, the composition taught herein may
be applied as a foam. The foam may be applied in two ways. The foam
may be dispensed into a trough and the cows may then walk through
the foam, similar to a liquid foot bath. Alternatively, the foam
may be applied directly to the hooves using any known foam
dispensing technique. In one embodiment, where a flash foamer is
added to this spray, the product may effectively be foamed onto
warts, with the use of a foam sprayer. The presently taught foam
composition, named HealMax Foam, is an effective treatment method
because, inter alia, the foam provides improved accuracy and the
foam increases contact/treatment time.
[0114] The foam can be prepared, for example, by mixing foaming
surfactants with the composition. The foaming surfactants can be
nonionic, anionic, or cationic in nature. Examples of useful
surfactant types include, but are not limited to the following:
alcohol ethoxylates, alcohol ethoxylate carboxylate, amine oxides,
alkyl sulfates, alkyl ether sulfate, sulfonates, quaternary
ammonium compounds, alkyl sarcosines, betaines, and alkyl amides.
The foaming surfactant is typically mixed at time of use with the
composition but can be prepared in advance of the time of use. At
time of use, compressed air can be injected into the mixture, and
the foam can be applied to a foot of an animal.
[0115] Thickeners (e.g., xanthan gum, polymeric thickeners,
cellulose thickeners, propylene glycol, glycerin, or the like) can
be further combined to produce a foam which may remain in contact
with the infected area of the foot for a longer period of time than
a formulation without the thickener. In some embodiments, a foam
antimicrobial composition contains about 5 wt % to about 20 wt % of
one or more thickeners. In a foam application, two important
parameters include the density of the foam (i.e. how much liquid
per unit volume) and the stability of the foam (specifically, a
drainage rate of the foam). In one embodiment, the foam is
intrinsically viscous and allows greater foam stability. For foam
applications, an appropriate viscosity range for the composition is
between approximately 14 and 100 centipoise. Many of the same
features that beneficial to a spray application may also be useful
in a foam application. For example, surfactants and thickeners may
both be used to improve foam properties.
[0116] The foamed composition, according to one or more embodiments
of the present invention, is of exceptionally low specific gravity,
for example, the foamed composition has a specific gravity in the
range of about 0.02 gr/ml to about 0.35 gr/ml. Although of low
specific gravity, the foam is highly stable and will remain without
collapse for several minutes. Nonetheless, the foam collapses
readily upon application of mild shear stress. Low specific
gravity, high foam stability and ready collapsibility all
contribute to a foamed composition that is easily applied and
administered over large areas without rubbing or chaffing of the
affected area. A foam adjuvant is included in the composition to
improve the stability and reduce the specific gravity of the foamed
composition. In one or more embodiments of the present invention,
foam adjuvants include fatty alcohols, fatty acids, and mixtures
thereof. The foam adjuvant can include at least one fatty alcohol
and at least one fatty acid.
[0117] The foamed composition, according to one or more embodiments
of the present invention, is dispensed from a glass or plastic
container that dispenses foam in the absence of a gas or liquid
propellant. Alternatively, the composition of the present invention
further includes a liquefied or compressed gas propellant at a
concentration of about 3% to about 25% of the total composition.
Examples of suitable propellants include volatile hydrocarbons such
as butane, propane, isobutane or mixtures thereof, and fluorocarbon
gases. In another embodiment, the composition according to one or
more embodiments of the present invention is preferably placed,
together with a liquefied or compressed gas propellant in the
amount of about 3% to about 25% of the total composition, in an
aerosol container. Upon pressing the actuator, a breakable foam,
suitable for topical administration is released.
[0118] In other embodiments, the composition can be administered as
a gel. The animal's foot can be treated with a thickened or gelled
version of the composition. In the thickened or gelled state, the
composition can remain in contact with the animal's foot for longer
periods of time, thus increasing the antimicrobial efficacy. The
thickened or gelled solution can also better adhere to vertical
surfaces and crevices in the animal's foot. The composition can be
thickened or gelled using one or more thickening agents including,
but not limited to, xanthan gum, polymeric thickeners, cellulose
thickeners, propylene glycol, glycerin, or the like. The thickeners
or gel forming agents can be used, for example, in the concentrated
product or by mixing with the antimicrobial composition at time of
use. Exemplary use levels of thickeners or gel agents can range
from about 100 ppm to about 10%, by weight.
[0119] In one embodiment, a footbath is used. Immersing an animal's
foot in the aqueous solution of the present invention can be
accomplished by any of a variety of methods known to those of skill
in the art. For example, troughs can be used to immerse the feet.
The composition of the present invention, contained in the trough,
can be agitated so as to increase the application and/or absorption
of the solution into or onto the feet. Agitation can be obtained by
conventional methods, including ultrasonics, aeration by bubbling
air through the solution, by mechanical methods, such as strainers,
paddles, brushes, pump driven liquid jets, or by combinations of
these methods. The composition can be heated to increase the
efficacy of the solution in killing microorganisms. After the foot
has been immersed for a time sufficient for the desired effect, the
foot can be removed from the bath and the antimicrobial composition
can be rinsed, drained, blotted, or evaporated from the foot.
Treatments with any of the compositions of the present invention
can be applied one time or repeatedly within a short period of time
(minutes or hours), or the treatments can be repeated as needed
over a longer period of time (days or months).
6.4 KITS
[0120] In various embodiments, the present invention can also
involve kits for use in the treatment of an infectious disease of a
foot of an animal. Such kits can include the presently taught
compositions and, in certain embodiments, instructions for
administering and/or using the composition. When supplied as a kit,
the different components of the composition can be packaged in
separate containers and admixed immediately before or during use.
Such packaging of the components separately can, if desired, be
presented in a pack or dispenser device which may contain one or
more unit dosage forms containing the composition. Such packaging
of the components separately can also, in certain instances, permit
long-term storage without losing activity of the components. In
various embodiments, the different components can be packaged in
one composition for administration together.
[0121] In certain embodiments, the concentrates may be sold as a
kit, which includes instructions for mixing the concentrates to
form a composition with appropriate properties. Instructions may be
printed on paper or other substrate, and/or may be supplied as an
electronic-readable medium. Detailed instructions may not be
physically associated with the kit; instead, a user may be directed
to an internet web site specified by the manufacturer or
distributor of the kit. As an example, the instructions may include
instructions for forming a solution having a specific concentration
and/or instructions to adjust a pH level of the composition.
[0122] Having described the invention in detail, it will be
apparent that modifications, variations, and equivalent embodiments
are possible without departing the scope of the invention defined
in the appended claims. Furthermore, it should be appreciated that
all examples in the present disclosure are provided as non-limiting
examples.
7. EXAMPLES
[0123] The following non-limiting examples are provided to further
illustrate the present invention. It should be appreciated by those
of skill in the art that the techniques disclosed in the examples
that follow represent approaches the inventors have found function
well in the practice of the invention, and thus can be considered
to constitute examples of modes for its practice. However, those of
skill in the art should, in light of the present disclosure,
appreciate that many changes can be made in the specific
embodiments that are disclosed and still obtain a like or similar
result without departing from the spirit and scope of the
invention.
7.1 Example 1
HealMax Wart Spray I Development and Field Testing
TABLE-US-00001 [0124] HealMax HealMax Wart Spray I (%) Herd Spray
(%) Glutaraldehyde 50% 25 25 Deionized Water 69.34 69.68 C.O. 720
(ethoxylated nonyl phenol) 2.60 2.60 Methyl Salicylate 1.35 1.35
Propylene Glycol 1.35 1.35 Xanthan Gum 0.34 -- Green Dye 0.02
0.02
[0125] A trial was conducted on a 500 cow commercial Holstein dairy
in Hanford, Calif. (Fragosa & Sons) which was experiencing a
rapid outbreak of digital dermatitis. Dairy had been using an
acidified copper sulfate footbath once a day for 4-5 days per week.
10% of dairy cows (50) showed signs of clinical lameness due to
advanced digital dermatitis lesions. A qualified hoof trimmer,
using a trimming chute, inspected and selected 5 cows with visible
lesions due to digital dermatitis. These cows were not allowed to
pass through the regular footbath during the 4 day trial
period.
TABLE-US-00002 Lesion Severity: The severity of each lesion was
scored as follows: 0 No visible lesion. 1 Early Stage: Skin
slightly broken, redness, inflammation. 2 Moderate Stage: Visible
open lesion, redness, inflammation, some blood. 3 Advanced Stage:
Visible open lesion, redness, inflammation, very bloody.
TABLE-US-00003 Lameness: Each cows locomotion was observed and
assigned a lameness score as follows: 0 No visible lameness 1
Slight Lameness. Noticeable while walking. 2 Moderate/Severe
Lameness. Difficulty walking, visibly lifting leg to reduce
weight.
[0126] A control group of 5 cows was chosen and ranked according to
the same criteria as the test group. This group was allowed to walk
through the regular daily footbath treatment consisting of
acidified copper sulfate. Cows were milked three times per day and
the foot bath was operated for one milking per day.
[0127] Each treatment of HealMax Herd Spray was applied while the
cow was immobilized in a trimming chute. Each lesion was cleaned of
debris with water, photographed, and then sprayed with enough of
the presently taught composition to completely cover the lesion.
Treatment dosage averaged 4-6 spays or 4-6 ml of product. In one
embodiment, it is conceived that about 10 ml to about 20 ml of the
composition is administered by spray or foam to the hoof. Each cow
was then given 5 minutes to lay idle before being released from the
trimming chute.
[0128] After 4 days both the test group and control group were
sequestered from the herd and examined by the same hoof trimmer
while on the trimming chute. Each lesion was then ranked to
determine the treatment effect according to the following
criteria:
TABLE-US-00004 (-2) Lesion significantly increased in size and
severity. Additional Treatment Required. (-1) Lesion increased in
size and severity. Additional Treatment Required. (0) No visible
signs of improvement. Lesion stayed about the same size and
severity. Additional Treatment Required. (+1) Lesion shows slight
signs of improvement. Some white scabbing. Redness and/or visible
blood. Additional Treatment Required. (+2) Lesion shows significant
signs of improvement. White and/or black scab formation. Some
redness visible. Additional Treatment Optional. (+3) Lesion shows
dramatic signs of improvement. White and/or black scab. No
additional treatment required.
[0129] Post treatment lesion severity was observed and ranked
according to the initial criteria:
TABLE-US-00005 0 No visible open lesion. 1 Early Stage: Skin
slightly broken, redness, inflammation. 2 Moderate Stage: Visible
open lesion, redness, inflammation, some blood. 3 Advanced Stage:
Visible open lesion, redness, inflammation, very bloody.
[0130] Test Group--
[0131] showed a significant improvement in all test cows that were
treated with the presently taught composition (see table below).
After about five days, the warts were mostly healed and the animals
were able to walk and feed normally. Administration of the
presently taught spray composition created darkened waterproof
scabs, which sealed off the open warts. 4 out of 5 cows required no
further treatment due to complete and thorough scabbing of lesions.
Only Cow 251 which had a severe lesion prior to treatment required
one additional treatment. Lameness post treatment decreased for
each cow. Application of a second spray after one or two days of
the first spray application showed great effect on severely
affected animals.
[0132] Control Group (Acidified Copper Sulfate Footbath)--
[0133] Lesions either increased in severity or stayed the same with
no perceptible difference. Lesions with an initial severity rating
of 2 or 3 tended to increase in severity while lesions with an
initial severity rating of rated 1 or 2 stayed about the same or
slightly increased in severity. Lameness post treatment either
stayed the same or increased. This result was consistent with
copper sulfate footbaths during an outbreak of digital dermatitis.
Typically, larger and severe warts tend to get worse, while smaller
less established warts either get worse or stay the same.
TABLE-US-00006 Cow Severity - Treatment Severity - Post Lameness -
# Initial Lameness Effect Treatment Post Test Group HealMax Wart
Spray, 1 application 89 3 2 (+3) 0 0 251 3 2 (+2) 1 1 667 3 2 (+3)
0 0 524 2 2 (+3) 0 0 72 2 1 (+3) 0 0 Control Group Acidified Copper
Sulfate, once per day, 4 days 376 2 1 (-2) 3 2 492 3 2 (-1) 3 2 27
3 2 (-1) 3 2 399 2 1 0 2 1 602 1 1 0 1 1
7.2. Example 2
Cross-Linking Tests and Development of Healmax Wart Spray II
TABLE-US-00007 [0134] HealMax Components Wart Spray II (%)
Glutaraldehyde 50% 8.3 Glyoxal 40% 16.66 C.O. 720 (ethoxylated
nonyl phenol) 2.60 Methyl Salicylate 1.35 Propylene Glycol 1.35
Polymer gum 0.50 QUAT BTC855 10.00 Deionized Water Balance
[0135] Additional experiments were conducted in order to further
develop a product, optionally using substantially less
glutaraldehyde, but with the same or better performance than the
presently taught novel HealMax Wart Spray I. It was conceived that
such a novel composition for the prevention and/or treatment of one
or more infectious diseases of the hoof in animals could be
formulated by using less glutaraldehyde in order to reduce the cost
and any other potential issue associated with use of higher
concentrations of glutaraldehyde. The components used were
Glutaraldehyde (Dow, BASF), CO720 (Rhodia, Huntsman), methyl
salicylate (Polarome), propylene glycol (Dow), xanthan gum (AEP
Colloids) and green dye (Sensient by Prime Ingredients).
[0136] By reducing the amount of glutaraldehyde to less than 5%
resulted in significantly less cross-linking of test samples (see
FIG. 2). Furthermore, actual application of such a low
concentration of glutaraldehyde on digital dermatitis lesions
showed that the concentration was ineffective at facilitating
adequate scab formation in an acceptable time span. Unlike fixation
of microscopy samples or sterilization of instruments using
glutaraldehyde, there is a limited amount of time on a dairy farm
in which to achieve acceptable results. This time generally
corresponds with 5-10 minutes that milking cows spend in the
relatively clean environment of a milking parlor for example. After
that time period, cows are released into a significantly dirtier
and often wetter environment where they quickly step in a mud,
manure, urine, and water mixture known as "Slurry". Therefore,
rapid formation of the scab is necessary. In one embodiment of the
present invention, after spraying or foaming of the presently
taught composition, a scab forms within about five to about fifteen
minutes.
[0137] Several di-aldehydes with properties similar to
glutaraldehyde were considered for their ability to cross-link
samples. Glyoxal was selected because it is the smallest dialdehyde
molecule and it was conceived that this would provide a desired
efficacy in the context of germicidal (cross-linking) ability.
Glyoxal has bactericidal properties comparable with those of
glutaraldehyde and is also used as a bactericide in preparation
with other components. The bifunctionality of glyoxal is used to
cross-link functionalized macromolecules such as cellulose,
polyacrylamides, polyvinyl alcohol, keratin and other
polycondensates. Results on biodegradation are available, showing
that glyoxal is clearly readily biodegradable. In one embodiment of
the present invention, the composition as taught herein is a
biodegradable product.
[0138] Given these characteristics, glyxol was chosen as a suitable
replacement and testing commenced with glyoxal as a sole
substitute. As shown on FIG. 3, glyoxal alone did produce
cross-linking effects, however, at a low level (2.5 maximum). Next,
it was conceived that a 2:1 ratio of glyoxal-glutaraldehyde would
be effective when compared to either component alone. A quaternary
ammonium compound, QUAT, was also tested with the 2:1 ratio of
glyoxal-glutaraldehyde. It was surprisingly found that the
combination of the 2:1 ratio of glyoxal-glutaraldehyde coupled with
QUAT at 10% achieved highly desirable results as seen on the graph
(see FIG. 4). This novel composition achieved a high degree and
rapid rate of cross-linking, as indicated in FIG. 4. Further
testing in the field showed that this new composition effectively
facilitates scabbing and effectiveness similar to that of HealMax
Wart Spray I.
[0139] Tests were performed in order to obtain a skin (crust) on
the protein medium by using a cross-linking agent. Time,
temperature and skim formation were monitored. Tests were performed
at 40.degree. F.--both medium and solutions were cooled to test
temperature. Test medium was prepared by mixing a solution
containing 85% D.I. water and 15% Hydrolyzed Bovine Dry Collagen
(purchased from Milligan & Higgens). Approx 4 oz of the
preparation was put into Petri dishes, placed in a refrigerator for
thirty minutes before reacclimatizing at room temperature, ready
for testing. Subsequently, the various test solutions were poured
into 4 oz bottles with spray nozzles and 10 ml of solution was
sprayed onto the medium in the petri dishes from a distance of 6
inches, timed and viewed at 15 minute intervals and the contents of
the petri dish was then scored for skin formation. The time and
extent of skin formation was noted and transposed to graphs (see
FIGS. 1-4).
[0140] A second series of tests were run using Egg Albumin Powder
(purchased from J.T. Baker) as the protein medium, prepared by
mixing 85% D.I. water and 15% Egg Albumin Powder. Both test
produced identical results.
[0141] Lab testing was performed to assess cross-linking ability of
various compositions. Various cross-linkers were tested, including
formaldehyde (see FIG. 1), glutaraldehyde (see FIG. 2), glyoxal
(see FIG. 3), and a unique combination of components (see FIG. 4).
Varying percentages of glutaraldehyde, formaldelhyde, glyoxal and
the combination of components were sprayed onto the test medium in
Petri dishes and compared at fifteen minute time intervals. The
total test time was two to three hours.
[0142] The amount of xanthan gum to be added was determined by
testing various percentages of gum sprayed through a hand spray
gun. HealMax Wart Spray was sprayed onto a vertical surface and the
degree of cling and run was measured. Various temperatures were
tested between 40 and 90 degrees F. in order to be sure that
temperature did not affect the spraying ability.
[0143] The scoring for the skin formation was as follows:
TABLE-US-00008 Extent of skin formation (Scored from 0 to 10)
Properties of protein medium 0-2 very watery, lack of visible skin
formation, unchanged color 3-4 very thin skin formation, slight
pale yellow color change 5-6 thin to moderate skin formation, pale
to light yellow color change 7-8 firm skin, approx 2-3 mm
thickness, medium yellow color 9-10 very firm skin, approx 3 mm
thick, medium to dark yellow color
7.3 Example 3
Field Testing
[0144] HealMax Foaming Herd Spray was tested at Legacy Farm LLC,
Plainview Tex. where an outbreak of hairy heel warts was occurring.
Approximately 1000 cattle were treated with a power foamer and
HealMax Foaming Herd Spray. Of these 1000 cattle, approximately 9%
of the herd exhibited hairy heel wart lesions of various degrees of
severity. 30% of cows with hairy heel warts lesions were in
advanced stages classified as severe, 45% exhibited lesions that
were moderately severe, and 25% of lesions were in the early
stages. The foam was applied directly to open wart lesions caused
by digital dermatitis while cattle walked to the milking parlor as
well as to hooves that were unaffected by lesions. Foam was applied
for two consecutive days.
[0145] The results showed an overall 81% elimination in hairy heel
wart lesions when evaluated by the Hoof Trimmer one week after the
second application of the foam with the remaining cows requiring an
additional treatment. Of the 19% that required additional
treatment, these cows exhibited the most severe heal wart lesions,
in some cases with lesions on more than one leg, yet even these
cows exhibited post treated lesions that were either partially
scabbed or reduced in size. One or two additional product
applications would constitute an additional treatment needed to
fully scab and therefore complete the enclosure of the open
lesion.
[0146] Moreover, of the 910 cows that were treated but did not have
hairy heel wart lesions, there were no reports of new heal wart
lesions of any stage of severity. Of the 27 cows with severe hairy
heel wart lesions, 8 cows (30% of severe group) required further
treatment to ensure complete closure of the lesion, the remaining
cows exhibited closed, scabbed lesions, requiring no further
treatment. Of the 40 cows with moderately severe lesions, 6 cows
(15% of moderately severe group) required further treatments while
the remaining 36 cows showing closed, scabbed, lesions. Of the 23
cows with early stage hairy heel wart lesions, 3 cows (13% of early
stage) required further treatment.
[0147] These results demonstrate that, similar to application via
spray, application of the presently taught composition via foam is
an effective means to treat and/or prevent one or more infectious
diseases of the hoof in animals, including hairy heel warts. Unlike
the first product trial, these cows were treated during regular
production versus being sequestered and then treated on a trimming
table. The lesions and hooves were initially sprayed with water
from a hose but at a proximity that would not ensure all dirt and
debris were cleared from the lesion. Furthermore, because the cows
were standing, it was difficult to clear all debris and likewise it
was more challenging to ensure complete product coverage.
Nonetheless, the results demonstrate that the product is highly
effective when used during the daily production routine for
treatment and/or prevention of an active infectious disease, such
as hairy heel warts.
[0148] The effectiveness of HealMax Foaming Herd Spray was found to
at least approximately parallel HealMax Herd Spray, albeit the foam
application method for the customer was better suited for their
dairy operation. Large dairy operations benefit from foaming the
product because it can be integrated into their milking routine,
foaming uses less product, increased accuracy in achieving thorough
contact with lesion. Also, dairy farm management can quickly see
that cows are being properly treated with Healmax by the milking
staff. The foam may be able to better handle dirt and debris
because the foam has additional cling and continues to deliver
fresh product as the foam breaks down into liquid.
[0149] Application of HealMax Foaming Herd Spray allows, inter
alia, for more accurate application due to visibility, less product
usage, and the ability to treat areas difficult to reach such as
underneath the hoof or between cloves of the hoof. Foaming is safe
because it reduces the opportunity for a highly concentrated stream
of product with sticking capability to hit a worker in the
face/eye. Although no direct detailed comparison experiments were
done to compare the presently taught spray formulation with the
presently taught foam formulation, given that similar to the spray
formulation the foam works highly effectively, one would expect the
results of HealMax Foam to be the similar if not the same as those
observed with HealMax Spray formulations. This would be expected so
long as a similar if not identical concentration of active
ingredient was used and a similar application protocol was used of
first cleaning the treatment region with water and allowing 5-10
minutes of application time after initial contact.
7.4 Example 4
Addition of Anaesthetic
[0150] Trials are conducted where a numbing agent is added to the
novel composition taught herein. The numbing agent, Lidocaine, at
the rate of 2.5% is added to the formulation. HealMax may sting for
several minutes when applied to an open sore. While stinging is
much less severe than other products such as acidified copper, in
some cases, it may agitate the cow thus causing it to kick or move
more than normal. This could cause potential harm to the individual
spraying or if in the milking parlor the milking equipment could be
knocked loose from the udders. Testing of a formulation which
includes a numbing agent, Lidocaine, to reduce stinging sensation
is carried out. A stable HealMax solution with the addition of
lidocaine hydro chloride monohydrate USP at the rate of addition of
2.5% has been produced. This product is tested to determine if
stinging sensation is mitigated by the addition of a numbing agent
such as lidocaine. This is accomplished by observing the comfort
level of a cow directly after spraying. The numbing agent has a
beneficial and desirable effect because, inter alia, it numbs the
treated site and reduces any pain or irritation caused to the
ungulate by application of the presently taught compositions.
* * * * *