U.S. patent application number 13/041606 was filed with the patent office on 2011-07-07 for method and composition for delivery of medicants to animals.
This patent application is currently assigned to Ronald L. Cravens. Invention is credited to Ronald L. Cravens.
Application Number | 20110165090 13/041606 |
Document ID | / |
Family ID | 39762945 |
Filed Date | 2011-07-07 |
United States Patent
Application |
20110165090 |
Kind Code |
A1 |
Cravens; Ronald L. |
July 7, 2011 |
METHOD AND COMPOSITION FOR DELIVERY OF MEDICANTS TO ANIMALS
Abstract
According to the present invention, a vaccine or
pharmaceutical-containing composition is applied to the muzzle area
of the animal, which will then naturally use its tongue to clean
itself. This behavior will cause the animal to deposit applied
composition to the mucosa of the nasal and oral cavities, thus
meeting the need for a simple, effective, and efficient vaccination
or treatment method.
Inventors: |
Cravens; Ronald L.;
(Leawood, KS) |
Assignee: |
Cravens; Ronald L.
Leawood
KS
|
Family ID: |
39762945 |
Appl. No.: |
13/041606 |
Filed: |
March 7, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10084592 |
Feb 25, 2002 |
7923023 |
|
|
13041606 |
|
|
|
|
Current U.S.
Class: |
424/10.3 ;
424/184.1 |
Current CPC
Class: |
A61K 2039/543 20130101;
A61K 2039/542 20130101; A61K 39/00 20130101; A61P 37/04 20180101;
A61K 9/0043 20130101; A61K 2039/54 20130101; A61K 2039/552
20130101; A61P 31/00 20180101 |
Class at
Publication: |
424/10.3 ;
424/184.1 |
International
Class: |
A61K 49/00 20060101
A61K049/00; A61K 39/00 20060101 A61K039/00; A61P 31/00 20060101
A61P031/00; A61P 37/04 20060101 A61P037/04 |
Claims
1. A composition for treating a bovine animal to achieve a positive
effect on the health of the bovine animal, the composition
comprising: at least a single effective dose of a prophylactic
composition including at least one prophylactic agent, the
prophylactic composition being suitable for application directly to
the nasal plane of the bovine animal.
2. The composition of claim 1 wherein the prophylactic composition
further includes a post-application identifier.
3. The composition of claim 2 wherein the post-application
identifier is a UV or other non-visible dye.
4. The composition of claim 2 wherein the post-application
identifier is a light visible dye.
5. The composition of claim 1 wherein the prophylactic composition
further includes a palatability enhancer.
6. The composition of claim 1 wherein the prophylactic agent
further comprises at least one preservative ingredient selected
from the group consisting of antibiotics, antibacterials, and
antifungal agents.
7. The composition of claim 1 wherein the prophylactic composition
is selected from the group consisting of liquids, sprays, gels,
pastes, salves, and films.
8. The composition of claim 1 wherein the prophylactic composition
is carried on a carrier web selected from the group consisting of
tapes, adhesive strips and patches.
9. The composition of claim 1 wherein the prophylactic agent is a
vaccine.
10. The composition of claim 1 wherein the prophylactic agent is a
pharmaceutical.
11. The composition of claim 1 wherein the prophylactic composition
further comprises at least one performance enhancing component
selected from the group consisting of viscosity enhancers, aroma
enhancers, sustained release agents, and adhesive enhancers.
12. The composition of claim 1 wherein the prophylactic composition
is distributed, absorbed or processed by the licking action of the
bovine animal when the animal cleans its nasal plane with its
tongue.
13. A composition for immunizing a bovine animal, the composition
comprising: at least a single effective dose of an immunizing
composition for application directly to the nasal plane of the
bovine animal, the immunizing composition including at least one
biological agent and a post-application identifier, wherein the
post-application identifier is detectable on the exterior of the
bovine animal's nasal plane.
14. The composition of claim 13 wherein the post-application
identifier is a light visible dye or a UV or other non-visible
dye.
15. The composition of claim 13 wherein the biological agent is a
vaccine.
16. The composition of claim 13 wherein the immunizing composition
is selected from the group consisting of liquids, sprays, gels,
pastes, salves, and films.
17. The composition of claim 13 wherein the single effective dose
is carried on a carrier web selected from the group consisting of
tapes, adhesive strips and patches.
Description
RELATED APPLICATION
[0001] This application is a division of application Ser. No.
10/084,592 filed Feb. 25, 2002, the entire disclosure of which is
incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] One of the most common diseases in newly received stocker
and feedlot cattle is the Bovine Respiratory Disease (BRD) complex.
BRD accounts for approximately 75% of morbidity and over 50% of
mortality in feedlots (Edwards, A. 1996. Bovine Pract. 30:5).
Studies have indicated that BRD manifests its economic losses
cumulatively--through the cost of treatment, the cost of lost
production and/or salvage, and the cost of death loss (Perino, L.
J. 1992. Compend. Cont. Educ. Pract. Vet. 14 (Suppl.):3) These
losses make BRD one of the most costly diseases affecting feedlot
cattle. Respiratory tract lesions at slaughter correlate with
feedlot and carcass performance (Gardner, B. A. et al. 1999. J.
Anim. Sci. 77:3168).
[0003] In a recent study of the affects of BRD, heifers treated
during the study period had lower average daily gain during the
period. Heifers treated for BRD had lower marbling scores resulting
in a 37.9% reduction in the percentage of carcasses grading
U.S.D.A. Choice, or above. Heifers never treated produced a net
return (carcass basis) that was $11.48/head more than heifers
treated once for BRD, and $37.34/head more than those treated two
or more times. (Stovall, T. C., et al. Impact of Bovine Respiratory
Disease During the Receiving Period on Feedlot Performance and
Carcass Traits, Animal Science Research Report. Oklahoma
Agricultural Experiment Station, Oklahoma State University,
Stillwater, Okla., USA, 2000.)
[0004] Other diseases are of equal or greater economic importance
to the cattle industry, which has historically sought to protect
livestock from disease, both for economic and public confidence
reasons. Immunization of cattle as a means of preventing disease is
a common and long-standing practice dating back to Jenner and
Pasteur. Immunization is the practice wherein pathogenic biological
agents (viruses, bacteria, fungus, rickettsia, protozoa,
mycoplasma) have been inactivated, attenuated administered with or
without immuno-modulating agents (adjuvants) to animals with the
intent of stimulating the animal's immune system such that
subsequent exposure to the immunizing or natural agent yields a
rapid and specific protective response, thereby avoiding or
reducing the severity of disease.
[0005] The common means by which commercial vaccines have been
administered to animals involves injecting (by use of hypodermic
needles) the vaccine material in the skin (intradermal "ID"), in
the muscle (intramuscular "IM"), in the subcutaneous tissue ("SC"
or "sub-Q")) or applying the product to readily available mucus
membranes (in the eye (intraocular "IO"), in the oral cavity (peros
"PO"), or in the nasal cavity (intranasal "IN")). Although the
poultry industry has used aerosols and water as means of vaccine
delivery to large numbers of birds, and the swine industry has used
water as a delivery method, there are no aerosol, water or feed
vaccines approved for commercial use in cattle, dogs, cats or
horses.
[0006] In the case of injected products (pharmaceutical or
biological), a number of concerns arise. With respect to food
safety and consumer concern about meat quality, introduction of
material into the animal via injection carries with it the
potential of altering the edible product by scaring, staining,
infection or adulteration due to components of the product and/or
by carrying foreign material into the body as a result of the
injection process as well as the potential for needles being left
in the animal. The National Cattlemen's Beef Association has
identified losses associated with injection site reactions
resulting in damage to the animal, meat, hides and undermining
consumer confidence in the safety and quality of beef.
Additionally, injection requires close physical contact between the
animal and the person administering the vaccine. This close
physical contact entails risk of injury to both the animal and the
person. There is a potential for accidental injection of workers or
non-target animals. Proper disposal of used needles is an ongoing
concern. With respect to application of the vaccine, it is
difficult to assure or identify proper deposition of the dose
volume into the approved target tissue, particularly under modern
management practices where large numbers of animals are rapidly
processed. Injection of companion animals (dog, cat, horse) has
animal welfare and owner acceptability concerns as well as the
potential for infection, pain and tissue damage at the site of
administration,
[0007] Administration via mucus membranes has several advantages
over injected vaccines. Entry of foreign material into edible
tissues is avoided. Some pharmaceutical products (insulin--West
Pharmaceuticals) have been shown to perform better when applied to
mucus membranes as compared to IM or SC injection. The natural
route of exposure to the common respiratory and enteric pathogens
is via the oral and or nasal route. Stimulation of a mucosally
active immune response is better able to prevent or minimize
colonization (a prerequisite to infection and disease) by invading
pathogens.
[0008] Additionally, intranasal administration of vaccines
typically stimulates a rapid response and has been shown to be
effective in the presence of maternal antibody. There are, however,
drawbacks to commercially available cattle vaccines. Products
approved for intranasal administration require direct deposition of
the vaccine into the nasal cavity (one or both naries). This is
stressful to the animal and requires restraint and close physical
contact between the animal and person administering the vaccine. In
addition, the animal's immediate response is to resist head
restraint and attempt to dispel the injected material from the
nasal cavity during or immediately following vaccine
administration, sometimes into the operator's face, with resulting
safety and efficacy concerns.
[0009] Water and feed have been used experimentally as a means of
vaccine delivery to cattle, however, there are concerns relating to
proper dose intake of individual animals. There are no commercial
cattle vaccines currently approved for use via feed or water.
[0010] Mucosal administration of vaccines has been shown to provide
a broad based immune response. This involves both a local and
systemic response. Traditionally, vaccines used for mucosal
administration have been live or attenuated; as killed antigens
tended to be minimally effective when given IN or PO. While live or
attenuated vaccines provide a rapid response, the duration of
immunity has typically been less than with IM administered
products. With the advancement in adjuvant technology and vaccine
formulation, it is now possible to increase the duration of
immunity as well as allow use of inactivated antigens via the
mucosal route. Advancement in formulation of pharmaceutical
preparations has also led to development efforts for orally and/or
nasally administered products (West Pharmaceutical).
[0011] Despite the advances in intranasal and other mucosal
administrations of vaccination and therapeutic materials, there
remain many needs in the development of safe, effective, and
efficient methods of administration of such materials to animals.
In particular, the following needs remain unmet by the methods of
the prior art: [0012] 1. The need to avoid use of needles which may
(a) cause damage to edible tissues and hides, (b) incite consumer
concern over pet and livestock animal welfare, (c) incite consumer
and food industry concern over food safety, (d) raise concerns
related to worker safety, and (e) give rise to issues concerning
disposal of contaminated medical waste. [0013] 2. The need and
desire to administer the vaccine to mucosal membranes which is the
natural route of infection. [0014] 3. The need to avoid (or
minimize) close physical contact between the worker and animal in
order to reduce the risk of injuries to both. [0015] 4. The need to
have a visual indicator of vaccination in order to increase
compliance and proper administration of vaccine, and to reduce
inadvertent multiple vaccination.
BRIEF DESCRIPTION OF THE INVENTION
[0016] According to the present invention, a
vaccine/pharmaceutical-containing composition is applied to the
muzzle of the animal, which will then naturally use its tongue to
clean itself. This behavior will cause the animal to deposit a
therapeutically effective amount of the applied composition to the
mucosa of the nasal and oral cavities, thus meeting the need for a
simple, effective, and efficient vaccination/treatment method of
administration.
DETAILED DESCRIPTION OF THE INVENTION
[0017] The present invention comprises a method for immunizing
and/or treating cattle or other animals via application of an
approved dose of biological vaccines (antigens) or pharmaceuticals
to the muzzle and/or nares area of cattle or other animals via
direct application such as a liquid or emulsion paint, spray,
paste, mist, roll-on or bio-film. The muzzle of an animal is
defined as the facial portion of the respiratory system and rostral
portion of the upper and lower jaws collectively, to include the
nasal plane, nostrils, medial, lateral, dorsal and ventral borders
of the nostrils, the philtrum, superior and inferior lips (labia
oris) and the angle of the mouth (angulus oris). This method of
application takes advantage of the normal behavior of cattle and
other animals to clean their muzzle with their tongue and thereby
deposit the vaccine or pharmaceutical material to the nasal and/or
oral mucosa. The method thus minimizes the need for physical
contact between the human operator and animal, and eliminates the
use of needles. The delivery composition of the present invention
may contain any formulation comprised of mucosally active antigens
and/or biologically active proteins and/or biologically active
chemicals (pharmaceuticals) and/or biologically active
carbohydrates with or without adjuvants, with or without
adherent/viscous components, with or without aromatic and palatable
components and with or without a visual or non-visible indicator of
application.
Method of Administration
[0018] The composition described above may be applied to the muzzle
of the animal in any of a variety of methods according to the
present invention. For example, the composition may have a
viscosity and concentration appropriate for application by brush or
roller. It may be applied by liquid spray, with or without
atomization. It may be manually applied as a paste, salve, or film.
It may be carried on a carrier web such as a tape, adhesive strip,
or patch. In short, any method of contacting the animal's muzzle
and transferring to it an effective dose of the composition may be
employed.
Formulation
[0019] The formulation of the compound of the present invention
includes, but is not limited to various combinations of the
following components for use in all animal species, including
cattle, sheep, pigs, cats, dogs, horses, deer, buffalo and other
wildlife:
[0020] 1. Adjuvants or other immune stimulating compounds, such as
that described in U.S. Pat. No. 6,262,029 "Chemically Modified
Saponins and the Use Thereof as Adjuvants", Aluminum hydroxide
salts, Aluminum hydroxide gels, Alum, "Superantigens" which are
molecules that stimulate, independent of antigen, those T-cells
displaying a particular beta chain variable region (Vbeta) of the
T-cell receptor. These molecules are the most powerful T-cell
mitogens known, inducing biological effects at femtomolar
concentrations. The best characterized superantigens are the
microbial toxins from Staphylococcus aureus and Streptococcus
pyogenes.
[0021] Other adjuvants useful for the present invention include
natural and synthetic immuno-modulating agents, other saponin and
saponin derivatives, mycobacterial cell wall
extract--Immnoboost..RTM. Bioniche Life Sciences Inc., oil
emulsions (water in oil or oil in water) such as Amphigen..RTM..
from Pfizer, Inc., oils (mineral oil, animal derived oils, plant
derived oils such as carbopal), or other proprietary and
non-proprietary immuno-modulating agents.
[0022] 2. Palatability enhancers, intended to be attractive to the
animal's senses of smell and taste, such as plant-derived flavoring
agents including but not limited to molasses, sucrose, fructose and
anise.
Biological AntigensNaccines
[0023] Vaccines are used to prevent and/or treat a multitude of
diseases in cattle and other animals. These include diseases of,
but are not limited to, the respiratory system, the reproductive
system, the urinary system, the gastrointestinal/digestive system,
the integument/musculoskeletal system, the hemolymphatic system,
the endocrine system, the nervous system, and disease of the eye
and ear (Current Veterinary Therapy--Food Animal Practice, Howard,
1981, W. B. Saunders Co.). Organisms included are, but are not
limited to, viruses, mycoplasma, chlamydia, protozoa, rickettsia,
coccidia, bacteria, fungus (Current Veterinary Therapy--Food Animal
Practice, Howard, 1981, W. B. Saunders Co.) and internal and
external parasites including, but not limited to, helminths and
arthropod parasites as identified in Principle Parasites of
Domestic Animals in the United States, Ivens, et. al. 1978,
University of Illinois, pp. 30-71. All current licensed products
for cattle or other animals are administered via injection, via
direct deposit in the nasal cavity, via direct deposit in the oral
cavity, in water or in feed, topically applied, or by aerosol. The
products are composed of from one to many antigens from a multitude
of pathogenic and non-pathogenic biological organisms. The specific
formulation may be composed of live, attenuated, killed or altered
individual biological organisms acting as the immunizing antigen
directly or serving as vectors to deliver the antigen of interest.
The biologically relevant protective portion of the organism, be
they recombinant or natural, can be present as the whole organism,
specific and non-specific subunits of the organisms structural and
non-structural components including cell wall, cell wall
components, endotoxins, exotoxins (e.g. leukotoxin from M.
haemolytica), culture media supernatant, intracellular proteins and
organelles including nuclear (including DNA/cDNA) and non nuclear
elements (including RNA/cRNA). All and/or part of the fore going
elements and organisms can be combined with or without
immuno-modulating substances (adjuvants) to produce a vaccine
designed to prevent and/or treat from one to many diseases
following single and/or multiple administrations.
[0024] Currently Licensed Veterinary Products may be referenced in
the Compendium of Veterinary Products (CVP); Fifth Edition, January
1999; Distributed by North American Compendium, Inc. 942 Military
Street, Port Huron, Mich. 48060
[0025] The CVP provides a list of all current Federally
(USDA/APHIS, FDA, EPA) approved products for use in cattle or other
animals in the United States. This list includes brand names,
antigens included, formulations, specific claims, and manufacturer
for each product. In addition to those listed, there are
non-USDA/APHIS approved or products with USDA/APHIS conditional
approvals sold in the United States. These include, but are not
limited to, vaccines classified as autogenous vaccines which are
compounded for individual customers with organisms originating from
the particular customers operation (provided by companies including
ImmTech, Grand Laboratories, Texas Vet Labs, American Animal
Health, individual practicing veterinarians, Universities and
others) conditional licenses are granted for disease such as
mycoplasmosis (Texas Vet Labs) where no Federally approved vaccine
has been developed. In addition, there are new vaccines, and new
claims for existing vaccines under development by many companies
that can potentially be administered to cattle and other animals
via the mucosal surfaces of the nasal and oral cavities. Outside
the United States, similar products, antigens, antigen combinations
composed and formulated in a manner similar to those produced
and/or sold in the United States are common. All known biological
agents can potentially be formulated (as the natural agent, or as a
component of the organism via traditional and/or recombinant
technology and/or as vectors) into a vaccine such that an immune
response will be engendered in an animal when administered to the
nasal and/or oral mucosa. The scope of this invention is intended
to encompass all such current or future developed products or
technologies, when the administration method involves application
to the external structure of a bovine (or other animal's) muzzle
and/or nares without the specific requirement of deposition onto or
into the internal nasal and/or oral cavity.
Viscosity
[0026] The consistency of the product should be such that it
remains in place long enough to allow proper dosage. Mediators of
viscosity may be included into the compound formulation to ensure
this goal is met.
Aroma
[0027] Ingredients may be used to enhance the aroma so as to
contribute to palatability, or not detract from animal acceptance
and natural behavior.
Identifier
[0028] In order to provide post-dosing identification of dose
animals, a Light visible (e.g. orange, yellow) or UV or other
nonvisible dye may be included in the compound formulation. In this
manner, dosed animals may be easily recognized and one may avoid
re-dosing them, ensuring proper dosage and saving on materials and
labor.
Stabilizers
[0029] Appropriate product stabilizers such as to allow for antigen
integrity and presentation may be included in the compound
formulation.
Preservatives
[0030] The compound formulation may contain appropriate
preservative ingredients such as antibiotics (e.g. gentamicin,
amphotericin B, penicillin, polymyxin B or others), antibacterials
or antifungal agents, (e.g. thimerosal, formaldehyde) as deemed
appropriate or necessary by APHIS or other relevant regulatory
authorities.
Sustained Release Substances
[0031] To promote release of active components over a longer time
period, ingredients may be included such as inert or biologically
active substances so as to extend the time of presentation of the
antigen/chemical to the animal's immune system.
Adhesive Components
[0032] The compound formulation may contain appropriate
component(s), which create additional adhesive capability of the
product to adhere to the external nasal mucosa and to the internal
oral and nasal tracts. These may include a bio-adhesive type of
material that extends the time drug/antigen is available on the
nasal or oral mucosa.
[0033] While the invention has been described in its preferred
embodiments, it is to be understood that the words which have been
used are words of description rather than of limitation and that
changes may be made within the purview of the appended claims
without departing from the true scope and spirit of the invention
in its broader aspects. The inventors further require that the
scope accorded their claims be in accordance with the broadest
possible construction available under the law as it exists on the
date of filing hereof, and that no narrowing of the scope of the
appended claims be allowed due to subsequent changes in the law, as
such a narrowing would constitute an ex post facto law, and a
taking without due process or just compensation.
* * * * *