U.S. patent application number 12/803495 was filed with the patent office on 2010-10-28 for antiseptic wipes.
Invention is credited to Albert R. Kelly, Lowell Saferstein.
Application Number | 20100272602 12/803495 |
Document ID | / |
Family ID | 42992307 |
Filed Date | 2010-10-28 |
United States Patent
Application |
20100272602 |
Kind Code |
A1 |
Kelly; Albert R. ; et
al. |
October 28, 2010 |
Antiseptic wipes
Abstract
A personal skin cleansing wipe comprising a flexible
substantially dry matrix formed from synthetic, woven, non-woven or
knitted fibers impregnated with a substantially anhydrous
antimicrobial, antiseptic, antifungal solution in an amount wherein
the matrix retains its substantially dry characteristics and the
treatment solution includes an amount of PVP-iodine as active in
solution in glycol and or glycerin. The treatment solution, in
addition to an effective amount of PVP-iodine as active, contains
surfactants, preferably Tego.RTM. Betaine CK D, and optionally a
compatible fragrance and/or moisturizer. The wipe is activated with
water just prior to use.
Inventors: |
Kelly; Albert R.;
(Douglaston, NY) ; Saferstein; Lowell; (West
Orange, NJ) |
Correspondence
Address: |
Evelyn M. Sommer, Esq.
570 Lexington Avenue, 17th Floor
New York
NY
10022-6894
US
|
Family ID: |
42992307 |
Appl. No.: |
12/803495 |
Filed: |
June 30, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12589820 |
Oct 30, 2009 |
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12803495 |
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11118197 |
May 2, 2005 |
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12589820 |
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Current U.S.
Class: |
422/28 ; 424/409;
424/78.02; 427/2.14 |
Current CPC
Class: |
A61K 33/18 20130101;
Y10T 442/2918 20150401; Y10T 442/2525 20150401 |
Class at
Publication: |
422/28 ;
424/78.02; 424/409; 427/2.14 |
International
Class: |
A01N 43/36 20060101
A01N043/36; A01N 25/08 20060101 A01N025/08; A01P 1/00 20060101
A01P001/00; B05D 5/00 20060101 B05D005/00; A61L 2/18 20060101
A61L002/18 |
Claims
1. A wipe comprising a flexible, substantially dry matrix having a
moisture content of less than 1% comprising a matrix of synthetic,
woven, non-woven or knitted fibers coated or impregnated with a
waterless formulation antimicrobial treatment solution, said
treatment solution including about 1.0 to about 15% by wt. of
polyvinyl pyrrolidine iodine as antimicrobial or antiseptic and an
anhydrous surfactant, in a non-aqueous solvent carrier selected
from the group consisting of glycol, glycerin and mixtures thereof,
said wipe being activated by wetting with water prior to use, for
transferring said treatment solution to the skin or other surface
on said water activation.
2. The wipe of claim 1 wherein said solvent is a glycol.
3. The wipe of claim 1 in which said non-aqueous solvent carrier is
propylene glycol and is present in said treatment solution in an
amount between about 25% and about 80% of said treatment
solution.
4. The wipe of claim 1 wherein said solvent is a mixture of
propylene glycol and glycerin.
5. The wipe of claim 1 in which the said matrix contains between
about 50% and about 70% polypropylene and between about 30% and
about 50% polyester fibers.
6. The wipe of claim 1 wherein said matrix comprises about 100% of
polypropylene or polyester fibers.
7. The wipe of claim 1 in which said surfactant is a nonionic or a
cationic surfactant or a mixture thereof.
8. The wipe of claim 7 in which said surfactant is present in an
amount of less than about 40% by wt. of the matrix.
9. The wipe of claim 7 wherein said surfactant is a nonionic
surfactant and/or a cationic surfactant and is present in an amount
of about 0.50% by wt. to about 15% by wt.
10. The wipe of claim 1 wherein said surfactant is an amphoteric
and is present in an amount of about 0.5% to 25% by wt.
11. The wipe of claim 1 in which said antimicrobial PVP-iodine in
said wipe is present in an amount of from about 1.0% by wt. to
about 15.0% by wt.
12. The wipe of claim 1 wherein said treatment solution contains
Tego.RTM. Betaine CK D as surfactant.
13. The wipe of claim 1 wherein said treatment solution contains a
fragrance.
14. The wipe of claim 12 wherein said Tego.RTM. Betaine CK D is
produced by spray drying.
15. The wipe of claim 14 wherein said Tego.RTM. Betaine CK D
contains less than about 1.0% of water.
16. The wipe of claim 1 wherein said matrix is substantially binder
free.
17. The wipe of claim 1 wherein said treatment solution contains a
moisturizer.
18. A method of sanitizing skin comprising the steps of a. wetting
a wipe according to claim 1 with water, b. wiping the skin using
the water activated wipe, and c. rinsing the skin with water.
19. A method for producing the wipe according to claim 1,
comprising impregnating said fabric by slot coating with said
treatment solution, and cutting and folding said coated fabric.
20. Method for sanitizing skin which comprises wetting the skin and
scrubbing the skin with a wipe according to claim 1 to produce a
solution of the composition contained in the wipe and rinsing the
skin to remove the solution and the killed bacteria, microbes,
fungi and residual debris.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of application
Ser. No. 12/589,820 filed Oct. 30, 2009, which in turn is a
continuation-in-part of application Ser. No. 11/118,197 filed May
2, 2005.
FIELD OF INVENTION
[0002] The present invention relates to a personal skin-cleansing
wipe incorporating a non-aqueous solvent, a surfactant, and an
antimicrobial/antifungal/antiseptic component. The wipe contains
PVP-iodine as active component which is incorporated in
substantially anhydrous form. The wipe is activated by the addition
of water before use and residual debris, including PVP-iodine
remaining on the skin following use is removed by rinsing with
water. The structure of the wipe should preferably comprise
synthetic fibers. The wipe can be used as an antiseptic hand
washcloth, an antifungal body or skin wipe or for first aid or
wound cleaning, among other applications.
BACKGROUND OF THE INVENTION
[0003] It is well known that topical skin surfaces of humans, from
time to time, need to be cleaned and desirably, sanitized.
[0004] Currently, there are only two over-the-counter antimicrobial
active ingredients enjoying unqualified approval by the U.S. Food
and Drug Administration for use in antiseptic skin cleansing, for
first aid and wound cleansing, and in antifungal cleansing
wipes.
[0005] The first, ethyl alcohol, has a long history of safe and
effective use. However, there is a long list of negative attributes
associated with the use of the ethyl alcohol. It dries and
irritates healthy skin and stings injured or abraded skin.
Moreover, as ethyl alcohol is highly volatile, it dissipates
rapidly if not packaged in a proper barrier container.
[0006] Other disadvantages of ethyl alcohol include its stringent
regulation by governmental agencies, its ability to erode some
metals, its tendency to remove paint and varnish and to delaminate
some plastics.
[0007] The other approved antimicrobial ingredient is PVP-iodine
(also called Povidone-iodine), which is a stable complex of
polyvinylpyrrolidone (PVP) and elemental iodine. While elemental
iodine has been used in antiseptic applications (U.S. Pat. No.
4,045,364), elemental iodine is known to possess a number of
undesirable properties. Free elemental iodine is highly toxic,
irritative, sensitizing, odorous and it also causes stains and
readily vaporizes due to sublimation. U.S. Pat. No. 2,739,922
teaches the complex of PVP and iodine, which possesses reduced
objectionable properties and increased bactericidal activity as
compared to free elemental iodine. PVP-iodine has a variety of uses
in health care on both skin and hard surfaces as an effective
germicide, bactericide, fungicide, virucide, and amebicide.
[0008] The use of pre-moistened wipes to deliver aqueous solutions
containing alcohol or PVP-iodine to sanitize skin or to disinfect
hard surfaces is longstanding. But such wet wipes are expensive
because they require barrier packaging to prevent evaporation or
"dryout". Also contributing to the expense of such wipes is the
need for special binder-free substrates for hydro-alcoholic
formulations and starch-free substrates for aqueous iodophor
formulations. Thus, the use of these ingredients has been limited
and reserved for higher risk healthcare and medical environments
where other considerations justify the higher costs.
[0009] U.S. Pat. No. 2,599,140 discloses an iodine-containing
detergent using iodine dissolved in a mixture of polyalkylene
glycol and glycerin to prevent fast evaporation of elemental
iodine. U.S. Pat. No. 4,355,021 discloses a substantially dry
virucidal wipe using a flexible paper substrate, having iodine
stabilized in polyoxyethylene (40) sorbitol septaoleate. U.S. Pat.
No. 4,045,364 discloses dry disposable paper tissues impregnated
with elemental iodine or PVP-iodine, which can be packaged and
stored for long term without undue deterioration. U.S. Pat. No.
5,919,471 discloses a substantially flexible, dry and antiseptic
wipe impregnated with PVP-iodine present in at least one glycol
compound.
SUMMARY OF THE INVENTION
[0010] The present invention is focused on an antiseptic
skin-cleansing washcloth, or an antimicrobial/antifungal
skin-cleansing wipe. The wipe is manufactured as a dry matrix into
which PVP-iodine and one or more surfactants, in a waterless
formulation are mechanically impregnated using glycols as diluents.
The matrix can comprise synthetic, woven, non-woven or knitted
fibers. In use, the treated dry matrix is wetted with water and the
wet matrix is rubbed on skin to develop a foaming and cleansing
formulation which when rinsed washes away residual debris and
PVP-iodine with no evident staining or discoloration.
DETAILED DESCRIPTION OF THE INVENTION
[0011] The presence of water is essential in all cleaning
applications, such as hand cleansing. However, if these antiseptic
wipes containing PVP-iodine as active were supplied in wet form,
the activated iodine risks rapid degradation in the presence of
water, and the aqueous iodine would leave visible stains on skin,
clothing or hard surfaces. These disadvantages not only discourage
use but also add to the cost of packaging, storing and using the
wipes, and most importantly, reduce their shelf life time. It has
now been found that wipes containing PVP-iodine can be manufactured
using an anhydrous formulation that will yield substantially dry
wipes that can be activated with water shortly before use by the
end user.
[0012] The synthetic matrix is manufactured dry, meaning no water
has been added other than the water naturally present in the basic
fibers. Typically, these synthetic materials have a moisture
content of less than 1%. The term "dry" also encompasses a finished
product, i.e., a wipe into which the anhydrous treatment solution
containing an antimicrobial and surfactant formulation has been
impregnated. The matrix with the treatment solution normally feels
dry, and lubricious to the touch.
[0013] The matrix for containing the anhydrous treatment solution
used in the present invention comprises synthetic fibers which may
be processed into woven, non-woven or knitted form. Of particular
interest for use in the invention are the following fibers:
polypropylene, polyester, and blends of these fibers and other
synthetics.
[0014] In accordance with the invention, PVP-iodine is the
antiseptic active. Commercially, PVP-iodine complex is available in
a pharmaceutical grade containing 10 parts active halogen per 100
parts of dry powder. For this reason, the commercial product has
sometimes been referred to as "PVP-iodine 10." There are two major
suppliers of PVP-iodine: BASF Fine Chemicals and Napp Technologies.
PVP-iodine is completely soluble in cold water with mild agitation
as well as propylene glycol in amounts up to and exceeding 10%
(1.0% available iodine). Aqueous solutions of PVP-iodine have been
marketed under the trademark Betadine.RTM. microbicides by Purdue
Frederick Company as a defense against topical infection from
pre-surgical scrubbing for hand and skin degerming, as being active
against both gram-positive and gram-negative bacteria, fungi,
protozoa and viruses in vivo.
[0015] In general, to reduce microorganisms on skin and prevent
infections, topical solutions containing between about 1 and 15%
PVP-iodine (0.1 and 1.5% available iodine) may be used. It is
preferred that the solution contain between about 5 and 10%
PVP-iodine (0.5 and 1% available iodine) and most preferably
between about 7.5% and about 10% PVP-iodine (0.75% and 1.0%
available iodine).
[0016] The substrate comprises synthetic, woven, non-woven or
knitted fibers, or blends thereof. The intended use (hands, body,
first aid) dictates that amount of add-on needed to achieve
effective skin antisepsis. The matrix is uniformly coated with
variable amounts of treatment solution expressed as a percentage of
the basis weight of the substrate up to a maximum of about 40% by
weight of the substrate.
[0017] The treatment solution also contains from about 0.5% to 25%
by wt. of a non-ionic or cationic surfactant, and preferably about
5% to about 15% by wt. The specific amount of the particular
non-ionic and/or cationic surfactant which is employed within this
range will depend upon the detergent activity desired as can be
readily determined by one of ordinary skill in the art. Any of the
well-known classes of non-ionic and cationic surfactants such as
nonylphenol ethoxylates, also known as Igepal, may be employed in
the wipe of the present invention. The presence of amphoteric
surfactant enhances skin cleaning efficiency. If the surfactant
comprises a combination of nonionic and/or cationic and/or
amphoteric surfactant, the total amount of surfactant will amount
to about 25% by wt. of the treatment solution.
[0018] Amphoteric or zwitterionic surfactants contain two charged
groups of a different sign. Whereas the positive charge is almost
always ammonium, the source of the negative charge may vary
(carboxylate, sulphate, sulphonate). There can be cationic
(positively charged) or non-ionic (no charge) surfactants in
solution, depending on the acidity or pH of the treatment
solution.
[0019] The amphoteric surfactants are very mild, making them
particularly suited for use in personal care and household cleaning
products. They are also used in hand dishwashing liquids because of
their high foaming properties. Amphoteric surfactants are
compatible with all other classes of surfactants and are soluble
and effective in the presence of high concentrations of
electrolytes, acids and alkalis.
[0020] The advantage of using a water-free amphoteric surfactant is
that povidone iodine is stable in the presence of these
high-foaming surfactants. On the other hand, povidone iodine is not
stable in the presence of high foaming anionic surfactants.
Cationic surfactants tend to be low foamers and non-ionic
surfactants are generally for industrial applications and are low
in foaming properties.
[0021] A preferred instance of an amphoteric surfactant is
cocamidopropyl betaine, the IUPAC name of which is
{[3-(dodecanoylamino)propyl](dimenthyl)ammonio} acetate and CAS
number is 86438-79-1. Its structure is shown below:
##STR00001##
[0022] Cocamidopropyl betaine is classed as a semi-synthetic
surfactant/foaming agent. Cocamidopropyl betaine (CAPB) is made
from coconut oil reacted with chemicals and is a zwitterionic
surfactant with a quaternary ammonium cation in its molecule. The
product Tego.RTM. Betaine, a spray dried form of cocamidopropyl
available from Evonik has been used as a surfactant in bath
products like shampoos and hand soaps, and in cosmetics as an
emulsifying agent and thickener, and to reduce irritation purely
ionic surfactants would cause. It also serves as an antistatic
agent in hair conditioners. Tego.RTM. Betaine CK D is the preferred
surfactant for use in preparing the treatment solutions of the
invention to be used for impregnating the non-woven substrates.
[0023] Cocamidopropyl betaine is a derivative of cocamide and
glycine betaine (a form of betaine). Cocamidopropyl betaine is a
medium strength surfactant which most often does not irritate skin
or mucous membranes. Some studies indicate it is an allergen. It
also has antiseptic properties, making it suitable for personal
sanitary products. It is compatible with the other cationic and
nonionic surfactants. The dissolution of Tego.RTM. Betaine CK D in
propylene glycol has not heretofore been disclosed. The literature
references all disclose water dilutions of various concentrations
and it is in this form that it is conventionally obtained from its
suppliers.
[0024] The sole supplier of spray dried cocamidopropyl betaine is
Evonik Industries under the trade name of Tego.RTM. Betaine CK D.
The use of Tego.RTM. Betaine CK D as an anhydrous surfactant is
preferred because it does not precipitate the release of free
iodine and thereby risk depletion of the effectiveness of the
treatment solution before use.
[0025] Other amphoterics include but are not limited to cocobetaine
lauryl dimethyl cabroxymethyl betaine, lauryl dimethyl
alpha-carboxyethyl betaine, cetyl dimethyl carboxymethyl betaine,
lauryl bis(2-hydroxypropyl) alpha-carboxy ethyl betaine,
cocodimethyl sulfopropyl betaine, myristyl amidopropyl betaine,
sodium lauroamphoacetate, sodium alkylaminopropionate and sodium
capryloampho hydroxypropyl sulfate. The preferred cocamidopropyl
betaine is the one just described because of its superior
solubility properties in propylene glycol and the resultant
improved effectiveness of the combination with povidone iodine in
the propylene glycol. In this connection, it has been observed by
the inventors herein that the solution formed by dissolving the
spray dried Tego.RTM. Betaine CK D in propylene glycol has per se
anti-microbial activity.
[0026] Tego.RTM. Betaine CK D as supplied by Evonik Industries is a
fatty acid amido alkyl betaine and is supplied as a pale yellow
powder which is soluble in water and unexpectedly found by the
inventors herein to also be soluble in propylene glycol. The
product is made from a 30% aqueous solution of cocamidopropyl
betaine by spray drying. Spray drying is a method of producing a
dry powder from a liquid or slurry by rapidly drying with a hot
gas. This is the preferred method of drying of many thermally
sensitive materials such as foods and pharmaceuticals. A consistent
particle size distribution is a reason for spray drying some
industrial products such as catalysts. Air is the heated drying
media; however, if the liquid is a flammable solvent such as
ethanol or the product is oxygen-sensitive then nitrogen is
used.
[0027] The spray dryer takes a liquid stream and separates the
solute or suspension as a solid and the solvent into a vapor. The
solid is usually collected in a drum or cyclone. The liquid input
stream is sprayed through a nozzle into a hot vapor stream and
vaporized. Solids separate as moisture quickly leaves the droplets.
A nozzle is usually used to make the droplets as small as possible.
Droplet sizes can range from 20 to 180 .mu.m.
[0028] The dry article optionally may contain one or more
fragrances for imparting a pleasant odor to the skin. As used
herein, the term "fragrance" includes chemicals that can mask
unpleasant odors and/or destroy unpleasant odors. When employed,
the fragrance is present in the dry wipe in amounts up to 2% by wt.
of the treatment solution.
[0029] The present invention uses a non-aqueous solvent carrier for
PVP-iodine during the manufacturing and storage of the wipes.
Glycols are preferred as non-aqueous solvents and propylene glycol
is the preferred glycol. The non-aqueous solvent functions
primarily to dissolve the PVP-iodine and the anhydrous surfactant,
and also imparts emollience and lubricity to the treatment solution
which helps prevent skin breakdown and maintain skin softness.
[0030] The use of propyl glycol instead of water as a solvent is
essential. Propylene glycol does not precipitate the release of
free iodine, and thereby deplete its effectiveness before its
actual use. Propylene glycol, unlike water, actually preserves the
stability of PVP-iodine and facilitates an extended shelf life of
the treated wipe. Propylene glycol is a lubricious emollient
imparting soothing and softening qualities to skin. Further,
propylene glycol does not freeze in cold weather. The use of
propylene glycol as a non-aqueous solvent obviates the need for
buffers, stabilizers and preservatives, which are generally
required to be used in aqueous solutions.
[0031] Propylene glycol is an active skin lubricant and emollient
as well as the solvent for the PVP-iodine and the Tego.RTM. Betaine
CK D. Typically, propylene glycol is the major component in the
treatment solutions of the present invention. However, it can also
be combined with similar glycols such as glycerin or low molecular
weight polyethylene glycols such as PEG-200, PEG-400, etc.
Preferably, not more than about 40% by wt. of the propylene glycol
is replaced with these other glycols or glycerine.
[0032] The matrix is prepared in accordance with one of the methods
described above, from which the cleaning wipe or other products of
the present invention are obtained, is preferably coated and
impregnated with the non-aqueous treatment solution using
adaptations of the conventional slot coating process.
[0033] Slot die coating is used to accommodate the critical need
for a controllable and more efficient coating method. This process
has been successful in replacing other coating methods for applying
many types of solutions. A slot coating die is a device that is
capable of maintaining a fluid's temperature, distributing a fluid
uniformly and defining a coating width. The die is comprised of
stainless steel body sections that define the fluid flow chamber.
Slot die coating has four main advantages: (1) increased production
speeds; (2) positive coat weight control; (3) cross-web
distribution control; and (4) improved waste management.
[0034] The superior control over the coating application as
provided by the slot die method is attributable to its constant
application rate. An extruder or positive displacement pump feeds
the coating fluid into the die at a pulse-free, uniform rate, and
all of the fluid that goes into the die is applied to the web. In
roll coating, only a portion of the coating on the applicator roll
is actually deposited on the web. The amount varies with such
factors as the viscosity of the fluid, the speed of the web and the
speed of the rolls.
[0035] The slot-coating die differs from embossed coating in two
critical respects: (1) it is a "pre-metered system that applies a
coating to the web at a constant rate and permits precise control
over coat weight and cross-web distribution, reducing waste,
allowing higher line speeds, and increasing product quality and
uniformity; and (2) it is an enclosed system, reducing emission of
volatiles and preventing airborne contamination.
[0036] The treated matrix, containing the measured volume of
treatment solution is cut and folded on line into the desired
product form that is saleable as a manufactured product and ready
for distribution.
[0037] The slot coating/impregnation method described above enables
a uniform and accurate application of all active ingredients to the
woven or non-woven matrix of natural and/or synthetic fibers
without the use of carriers and without the need for a separate
step to dry the residual diluted solutions from the matrix.
[0038] Prior to use by the end users, the wipes are wetted with
water. The presence of the water is needed to effect the release of
free iodine for efficient antisepsis and skin cleansing
performance. The exclusion of water from the treatment formulation,
which is applied to the substrate during manufacturing, provides
the many benefits described above in the manufacturing, storage and
distribution of the wipe products.
[0039] The following examples are given in order to more completely
illustrate the usage benefits of the invention, and are not to be
construed in limitation thereof:
Example # 1
[0040] Formulation # 1 listed below was impregnated into a 4.0
oz./sq. yd. non-woven 100% polypropylene needle-punched fabric at a
level of 22.7%-25.7% add-on of the web. Wipes of 8.times.11 inches
were cut from the fabric and were prepared using the technique
described in U.S. patent application Ser. No. 10/021,395.
TABLE-US-00001 Treatment of Wipes Weight of wipes (g.) Add-on (g.)
% add-on 7.4 1.9 25.7 7.7 1.8 23.4 7.9 1.8 22.8
TABLE-US-00002 Formulation # 1 Wt. Percent Ingredients 6.3%
Povidone iodine 30% BIO-SOFT EA 10 (100% water-free concentration
manufactured by Stepan) 47.2% Propylene glycol 15% Glycerine 1.5%
Menthol fragrance
Evaluation
[0041] The treated antiseptic hand wipes were evaluated by wetting
both hands with water under a running faucet. The wet hands were
then rubbed with the dry wipe to activate the ingredients. The wipe
foamed readily when activated with water from the wet hands. There
was very little iodine odor detected, and the cleansing action of
the wipe was quickly evident. There was no irritation and there was
a lubricious feel as the wet wipe was rubbed over the hands. The
weight of water extracted from the saturated wipe was between 5-7
grams of water remaining from the wetting. This would produce an
iodine concentration of about 1900-PPM. After a few minutes, the
wipe was discarded and the hands were rinsed under water. There was
no staining on the hands, which felt soft and refreshed with a
pleasing aroma.
Example # 2
[0042] The 4.0 oz./sq. yd. needle-punched 100% polypropylene
8.times.11-inch fabric was similarly impregnated with formulation #
2 listed below:
TABLE-US-00003 Formulation # 2 Wt. Percent Ingredients 5% Povidone
iodine 20% Glycerine 20% Igepal Co-530 (100% water-free
concentration manufactured by Stepan) 53.5% Propylene glycol 1.5%
Menthol fragrance
TABLE-US-00004 Treatment of Wipes Weight of wipes (g.) Add-on (g.)
% add-on 7.7 1.1 14.2 7.7 1.3 16.8
Evaluation
[0043] A wipe was lightly moistened with water from a faucet. The
wet wipe, which picked up 25 grams of water, was rubbed gently over
the hands for one minute. The wipes foamed extensively as the hands
were gently scrubbed with the wipe. No odor of iodine was detected.
A lubricous feel was detected as the wipe was used on the hands.
The wipe was then discarded and the hands were rinsed under water.
No staining of the hands was observed and the hands felt smooth,
soft and clean with a pleasant aroma. Based on the water pick-up of
the wipe, the iodine concentration was about 220-PPM. Substantially
identical results to those obtained in Example 1 were observed.
Example # 3
[0044] 1.5 oz./sq. yd. thermo-bonded polypropylene fabric was cut
into 8.times.10-inch wipes. Wipes were treated with formulation # 3
listed below:
TABLE-US-00005 Formulation # 3 Wt. Percent Ingredients 58.0%
Propylene glycol 25% Igepal CO-530 (100% water free concentration
manufactured by Stepan) 5.0% Povidone iodine 12.0% Glycerine
TABLE-US-00006 Treatment of Wipes Weight of wipes (g.) Add-on (g.)
% add-on 2.5 0.50 20.0 2.6 0.40 15.43 2.6 0.50 19.2
Evaluation
[0045] Hands were wet under a running faucet. A treated wipe was
rubbed over the wet hands. Foaming was observed within seconds. The
wipe was easy to manipulate through the hands and cleaned the hands
thoroughly. After 30 seconds, the wipe was discarded and the hands
rinsed under water. No staining of the hands was observed. Hands
felt refreshed and soft. It could be demonstrated that the
treatment solution was effective as an antimicrobial.
Example # 4
[0046] Formulation # 4 listed below was impregnated into non-woven,
needle-punched material obtained from NonWoven Solutions (NWS),
grade A # 1021030-16.75C, 70 gsm, 100% PET material. The treated
roll goods were cut to a preferred size of 8.375.times.6.0 inches.
The 35% add-on of treatment solution amounted to 0.8 grams of
treatment solution per wipe. The preferred add-on for this dry wipe
weighing 2.3 grams ranges from 0.5 grams (22%) to 0.9 grams (39%)
per wipe.
TABLE-US-00007 Formulation # 4 Wt. Percent Ingredients 5.0%
Povidone iodine 79.0% Propylene glycol 16.0% Cocamidopropyl betaine
(Tego .RTM. Betaine CK D)
[0047] This formulation was prepared as follows: 40 pounds of
propylene glycol were introduced into a 10-gallon stainless steel
drum. A heating band was attached around the drum and the drum was
heated to 80.degree. F. An air driven stirrer provided in the drum
stirs the propylene glycol gently.
[0048] A total of 3,677.4 grams of Tego.RTM. Betaine CK D was then
added to the drum in 10 increments over a 50-minute time
period.
[0049] When all of the Tego.RTM. Betaine was in the solution, the
temperature was increased to 100.degree. F. and a total of 1,148.6
grams of povidone iodine were introduced into the solution in five,
five-minute increments. After the last addition of the povidone
iodine, the solution was stirred for another 30 minutes.
TABLE-US-00008 Chemicals Pounds Wt. Percent Grams Propylene glycol
40.0 79.0% 18,160 PVP iodine 2.53 5.0% 1148.6 Tego .RTM. Betaine CK
D 8.10 16.0% 3,677.4 TOTAL 50.63 100% 22,986.0
[0050] The treated wipes were tested for germicidal activity using
the Rapid Germicidal Activity: Time Kill Procedures method, in
which a standard quantity of a bacteria is applied to the wipe and
the percent reduction in viable bacteria is measured at 1 minute
and 5 minute contact times. The control was an untreated wipe. The
results of the studies follow:
Control Wipe (Untreated)
TABLE-US-00009 [0051] Percent Reduction Micro-organism 1 minute 5
minutes Staphylococcus Aureus ATCC # 6538 0.0% 9.288%
Staphylococcus Aureus ATCC # 33592 5.739% 1.515% Escherichia coli
ATCC # 11229 41.068% 40.056%
Treated Wipe
TABLE-US-00010 [0052] Percent Reduction Micro-organism 1 minute 5
minutes Staphylococcus Aureus ATCC # 6538 >99.99% >99.99%
Staphylococcus Aureus ATCC # 33592 >99.99% >99.99%
Escherichia coli ATCC # 11229 >99.99% >99.99% Klebsiella
Pneumonia ATCC # 10031 >99.99% >99.99% Pseudomonas
Aueroginosa 99.894% 99.971%
Example # 5
[0053] The same 70 GSM, needle-punched non-woven material, cut to
the same dimensions as in Example # 4, was slot-coated with 0.6
grams of formulation # 5, but the concentration of povidone iodine
in this formula was increased by 50%, from 5% to 7.5%, as indicated
below.
[0054] 36.17 pounds of propylene glycol were introduced into a
10-gallon stainless steel drum. A heating band was attached around
the drum and the drum was heated to 90.degree. F. An air driven
stirrer provided in the drum stirs the propylene glycol gently.
[0055] A total of 7 pounds of Tego.RTM. Betaine CK D were then
added to the drum in increments over a 90-minute time period. The
solution formed was clear yellow in color after the addition of the
Tego.RTM. Betaine CK D.
[0056] The temperature of the solution was raised to 110.degree. F.
and 3.5 pounds of povidone iodine were added in increments over a
60-minute time period. The solution was stirred for an additional
15 minutes after the addition of all of the povidone iodine. The
final solution was dark red in color.
TABLE-US-00011 Formulation # 5 Ingredients Wt. Percent Pounds Grams
Povidone iodine 7.5% 3.5 1,589 Propylene glycol 77.5% 36.17 16,421
Cocamidopropyl betaine 15.0% 7.0 3,178 (Tego .RTM. Betaine CK D)
TOTAL 100% 46.67 21,188
[0057] A slot die coater was employed to treat Texel needle-punched
PET roll goods with 7.5% povidone iodine solution. The treated roll
was cut and folded in line to make 8-inch by 6-inch wipes with a
0.65 gram add-on of the povidone iodine solution.
[0058] An evaluation of the antimicrobial effectiveness of the
povidone iodine washcloth for use as a Health Care Personnel Hand
Wash was carried out. Twelve subjects washed their wet hands
pre-contaminated with 5 ml of Serratia marcescens culture with the
treated wash clothes for 30 seconds to eliminate or kill the
Serratia marcescens applied to their hands.
[0059] It was concluded that the Log.sub.10 reduction in CFU per
hand achieved by the test article (the 7.5% povidone iodine
washcloth) met the FDA's proposed 2.0 log.sub.10 reduction in CFU
per hand following the first wash and 3.0 log.sub.10 reduction in
CFU per hand following the tenth wash.
Example # 6
[0060] This example was developed to evaluate the effects of adding
a re-fatting or solubilizing agent called Softigen.RTM. 767, an
ethoxylated product of partial glycerides with fatty acids derived
from coconut and palm kernel oil, chemically known as
Caprylocaproyl Polyoxylglycerides, or PEG-6-Caprylic/Capric
Glycerides, to the treatment formulation that has also been
modified to reduce the surfactant concentration from 16% to 10%.
These modifications were done to provide for the higher frequency
of use of antiseptic hand washes by health care personnel as needed
to prevent nosocomial infections, and the skin irritation and
dryness that the regimen can cause.
[0061] The following Formulation # 6 was slot-coated onto a 70 GSM,
100% PET non-woven needle-punched material, from Texel, at the rate
of 0.65 grams per 6-inch by 8-inch wipe:
TABLE-US-00012 Formulation # 6 Wt. Percent Ingredients 7.5%
Povidone iodine 78.5% Propylene glycol 10.0% Cocamidopropyl betaine
(Tego .RTM. Betaine CK D) 4.0% Softigen .RTM. 767.sup.1
.sup.1Softigen .RTM. 767 is a surface active, water soluble clear
liquid which serves as refatting and solubilizing agent in cosmetic
and pharmaceutical formulations - Sasol Germany GmbH,
Arthur-Imhausen-Str. 92, 58453 Witten, Germany.
[0062] The evaluation consisted of thoroughly wetting both hands
with water, then using the treated wipes to absorb the 4 to 6 grams
of water on the wetted hands to activate the wipes to gently scrub
both hands for at least 30 seconds. Significantly, there was no
apparent diminishing of foaming action and the hands felt smooth
with no tacky after-feel. The above test evaluations were repeated
four times over a one-hour period, by two lab technicians, with
comparable results.
[0063] When the PVP-I was omitted and the Tego.RTM. Betaine was
introduced into the propylene glycol and the solution was heated to
under 110.degree. F. while stirring, the resultant solution
introduced by slot coating the fabric (0.62 and 0.80 add-on), and
the integrated fabric wetted with water and used on the hands,
strong foaming was observed. It was established that a cleaning and
de-germing had taken place following removal of the foam with
water.
* * * * *