Composition for topical application to humans and animals

Mastitis in bovine udders is treated and controlled by dipping the teats into a composition consisting essentially of a semi-drying oil and a fatty acid ester and allowing the teat to dry to form a water repellent film on the teat skin and across the teat orifice. The composition may also contain a bactericide, a healing agent, a hydration agent and a dye.

The present invention relates to the treatment of disease in bovine udders. 
More particularly, the present invention relates to a composition and 
method for the prevention and treatment of mastitis. 
Mastitis is a highly infectious disease which afflicts the bovine udder. 
The losses in dairy production resulting from the prevalence of this 
disease are staggering. For example, in the United States alone, these 
losses are estimated to be in the hundreds of millions of dollars. 
Mastitis not only reduces the production of higher yielding animals, but 
also shortens their productive life. 
It is well known that mastitis is transmitted from animal to animal. It has 
also been established that the only route of transmission of the disease 
is through the teat orifice. Conditions which are held primarily 
responsible for the high incidence of mastitis include poor udder hygiene 
and physical damage to the teats. Dairymen and veterinarians have long 
sought a conditioning and protective composition which is economical and 
also provides facility of use. A composition which would improve the 
normal condition of the udder and teats and would also aid in preventing 
or effectively reducing the incidence of mastitis would serve to 
substantially increase both the production and productive life of a dairy 
herd. 
Infectious mestitis is caused by microorganisms and many prior art 
treatments have been only partially effective in controlling the disease. 
For example, compounds such as sulphanilimide are useful against one type 
of microorganism which causes mastitis but are not useful against other 
types. Since the infection is usually of a mixed character, it follows 
that the effectiveness of sulphanilimide is limited for all practical 
purposes. It has also been suggested to use penicillin for the treatment 
of mastitis. However, the high cost and extraordinary conditions necessary 
for the preservation and use of penicillin result in its being of minimal 
practical value. 
It has been proposed in U.S. Pat. No. 3,222,252 to treat mastitis with a 
preparation which comprises a blend of edible semi-drying oils and drying 
oils together with a fatty acid ester skin emollient film forming agent. 
It is taught in this patent that the presence of a drying oil in the 
preparation is essential to provide the desired film forming property. 
It is an object of the present invention to provide a composition and 
method for the treatment of mastitis in bovine udders. 
It is another object of the present invention to provide such a composition 
and method which overcomes the shortcomings of treatments of the prior 
art. 
It is a further object of the present invention to provide such a 
composition which is economical and easily applied for the effective 
prevention, treatment and control of mastitis. 
It is still another object of the present invention to provide such a 
composition which is non-toxic and which may be used frequently over long 
periods of time without adversely affecting udder tissue. 
Still further objects and the entire scope of applicability of the present 
invention will become apparent from the detailed description given 
hereinafter; it should be understood, however, that the detailed 
description and specific examples, while indicating preferred embodiments 
of the invention, are given by way of illustration only, since various 
changes and modifications within the spirit and scope of the invention 
will become apparent to those skilled in the art from this detailed 
description. 
It has been found that the above objects may be attained by a composition 
which contains as essential ingredients an edible semi-drying oil or 
mixture of semi-drying oils and a fatty acid ester. As will be more fully 
explained hereinafter, the composition may also contain additives for 
various purposes. The composition may be applied in any suitable manner. 
Preferably application is by dipping the teat into the composition and 
allowing the teat to dry. Also preferably the composition is used twice 
daily, i.e. after each milking. 
Suitable semi-drying oils for use in the composition of the present 
invention include soybean oil, cotton seed oil, sesame oil, beechnut oil, 
corn oil and mixtures thereof. Preferred semi-drying oils include soybean 
oil and cotton seed oil. The above oils are non-toxic, substantially 
tasteless and odorless vegetable oils and the drying characteristics 
thereof are due partially to the degree of unsaturation and the structure 
of the component glycerides. 
Suitable fatty acid esters for use in the present invention include all 
fatty acid esters of low molecular weight monohydric alcohols, such as 
butyl stearate, isopropyl palmitate, isopropyl myristate, etc., and these 
esters are preferred. A particularly preferred ester is the combination of 
palmitate and myristate which is commercially available under the 
trademark Deltyl Extra and consists of isopropyl palmitate-myristate. Also 
suitable are all polyol esters of fatty acids such as glycerol 
monostearate, propylene glycol monostearate, ethylene glycol monostearate 
and polyethylene glycol monostearate. The fatty acid esters serve as skin 
emollients and also aid in formation of a non-tacky film when the 
composition of the present invention is dried after use. 
For purposes of the present invention, the semi-drying oil component is 
present from about 86 to about 98% by weight, preferably from about 90 to 
98% by weight, and the fatty acid ester component is included in a 
proportion of up to about 10% by weight, e.g. from about 2 to about 10% by 
weight, preferably from about 5 to 8% by weight. 
Other ingredients or additives which are beneficially included in the 
composition of the present invention include a bactericidal or 
bacteristatic agent such as tamed iodine, hexachlorophene, phenol, etc., a 
healing agent such as allantoin and a hydration agent such as cetyl 
alcohol. The composition may also optionally contain a coloring agent or 
edible dye such as carotene. 
The bactericidal agent is used for its disinfectant properties and may be 
soluble or dispersable as a suspension in the oleaginous base of the 
composition. one preferred bactericidal agent is tamed iodine or iodophor. 
These terms are applied to products wherein surface active agents (such as 
nonoxynol or Monosan-IOD) act as carriers and solubilizing agents for 
iodine. An iodophor enhances the bactericidal activity of iodine while 
reducing the vapor pressure and odor. Staining is virtually non-existent 
both to skin and natural fabrics and wide aqueous dilution is possible. 
Preparation of iodophor is disclosed, for example, in U.S. Pat. Nos. 
2,710,277 and 2,977,315. 
Iodophor is particulrly desirable for purposes of the present invention 
since it is virtually non-stinging and is also film-forming. It is a 
topical antiseptic that essentially retains the nonselective broad-range 
microbial activity of iodine, yet without the undesirable features 
inherent in iodine tincture and Lugol's solution, being nonirritating to 
skin and mucous membranes. Iodophor products kill bacteria (including 
antibiotic resistant organisms), fungi, viruses, protozoa and yeasts, and 
have a more prolonged germicidal action than ordinary iodine solutions, 
maintaining microbial action in the presence of blood, serum, pus or 
necrotic tissue. 
Tamed iodine is available commercially in several forms including the 
iodophor and solutions of varying concentrations. While not restricted to 
the same, the iodophor as such is preferably used in the present invention 
and may be used in amounts up to about 2.0% by weight, e.g. from 0.1 to 
1.0% by weight. Preferably the iodofor is used in amounts to provide from 
about 50 to about 100 ppm., e.g. about 75 ppm., available iodine in the 
final composition. Solutions of varying concentrations may be used in 
corresponding amounts. 
Other preferred bactericides include chlorhexidine or one of its salts such 
as the diacetate, cresol, paraformaldehyde, sodium hypochlorite and a 
sodium hypochlorite solution containing about 5 ppm. free chlorine. These 
bactericides may be used in amounts up to about 2.5% by weight of the 
compositions of the present invention, e.g. from about 0.1 to about 1.0% 
by weight. 
Both chlorhexidine and its diacetate are topical antiseptics. The 
chlorhexidine may be used as a suspension in, for example, glycerol, a 
glyceride, ethylene glycol or propylene glycol. The diacetate is soluble 
in these compounds. Cresol is available commercially and is a mixture of 
ortho-meta- and para-cresol. The paraformaldehyde and sodium hypochlorite 
may also be used in the form of a suspension. 
When hexachlorophene is used as the bactericidal agent, it may be included 
in amounts up to about 2.0% by weight, e.g. from about 0.1 to about 1.0% 
by weight. When phenol is used as the bactericidal agent, it is included 
in amounts up to about 0.67% by weight, e.g. from about 0.125 to 0.67% by 
weight. 
For purposes of the present invention, the bactericidal agent is said to be 
used in an effective amount, i.e. an amount which, in the final 
composition, will kill or substantially reduce the number of bacteria 
normally found on the bovine udder and especially those which tend to 
cause or aggravate mastitis. Specific amounts will vary depending upon the 
bactericidal agent included and on the comparative strength or 
concentration of the form of the agent used. Generally speaking, effective 
amounts will fall within the ranges of up to 2.5% by weight, e.g. from 0.1 
to 1.0% by weight, of the final composition. 
The healing agent is used both for its curative action and for stimulation 
of formation of new tissue. Allantoin is the preferred healing agent and 
may be used in amounts up to 0.1% by weight, e.g. from about 0.01 to 0.1% 
by weight. While not soluble in the oleaginous base of the composition, 
the allantoin is distributed therein in the form of a fine suspension 
obtained by vigorous mixing. 
The hydration agent is used to induce hydration of dry tissue and to aid in 
formation of a water repellent surface film. The preferred hydration agent 
is cetyl alcohol, although other related alcohols such as stearyl alcohol, 
lauryl alcohol and myristyl alcohol may be used. The hydration agent may 
be used in amounts up to about 2.0% by weight, e.g. from about 0.1 to 2.0% 
by weight. 
As earlier indicated, the composition of the present invention may be 
applied to the bovine udder by any suitable method. Preferably application 
is by dipping the teat into the composition immediately after milking and 
allowing the teat to dry. Regularly scheduled use of the composition of 
the present invention results in stability or reduction of bacteria counts 
and in improved skin tone with absence of chapping or roughening of the 
skin of the teat. Smooth skin is easier to maintain clean and harbors less 
bacteria than roughened and chapped teats. Each individual application of 
the composition provides, upon drying, a protective water repellent film 
over the teat tissue and across the teat orifice. 
The composition of the present invention may thus include ingredients in 
the operable and preferred amounts shown in Table I. 
Table I 
______________________________________ 
Percent by weight 
Ingredient Operable Preferred 
______________________________________ 
Semi-drying oil 
86-98 90-98 
Fatty acid ester 
2-10 5-8 
Bactericide 0-2.5 0.1-1.0 
Healing agent 0-0.1 0.01-0.1 
Hydration agent 
0-2.0 0.1-2.0 
Dye 0-Trace Trace 
______________________________________ 
The compositions are prepared by mixing the ingredients to obtain a 
homogeneous product. In one embodiment, any additives used may be premixed 
with the fatty acid ester and later mixed with the semi-drying oil, e.g. 
at time of use. Optionally, to aid in ease and speed of mixing, solid 
ingredients, e.g., phenol, may be separately melted before addition to the 
composition or any part thereof.

The following specific examples are to be considered only as illustrative 
of preferred embodiments of the present invention. 
EXAMPLE 1 
Example 1 
______________________________________ 
Amount % by 
Ingredient (pounds) weight 
______________________________________ 
Soybean oil 1389 92.60 
Isopropyl myristate 
69 
6.60 
Isopropyl palmitate 
30 
Cetyl alcohol 2 0.13 
Phenol, U.S.P. 10 0.67 
______________________________________ 
The isopropyl myristate and isopropyl palmitate were mixed in a 220 gallon 
capacity stainless steel tank and warmed to 55.degree. C. with an electric 
immersion heater, and the cetyl alcohol was added with stirring. The 
phenol was separately melted by warming to 50.degree. C. on a hot plate 
and then added to the isopropyl myristate-isopropyl palmitate-cetyl 
alcohol solution and stirred until the mixture was completely homogeneous. 
The soybean oil was then added with continued stirring to form a final 
homogeneous product which was then packaged in 1 and 5 gallon tin-lined 
containers. 
EXAMPLE 2 
Example 2 
______________________________________ 
Ingredient Amount 
______________________________________ 
Soybean oil 1389 pounds 
Isopropyl myristate 
69 pounds 
Isopropyl palmitate 
30 pounds 
Tamed iodine 13 pounds 
______________________________________ 
The procedure of Example 1 was repeated with the exception that the tamed 
iodine was added to the isopropyl myristate-isopropyl palmitate-cetyl 
alcohol solution with stirring to form a homogeneous mixture. The tamed 
iodine used provided 75 ppm. available iodine in the final composition. 
EXAMPLE 3 
Example 3 
______________________________________ 
Ingredient % by weight 
______________________________________ 
Soybean oil 90.6 
Isopropyl palmitate-myristate 
6.8 
(Deltyl Extra) 
Hexachlorophene 2.0 
Cetyl alcohol 0.5 
Allantoin 0.1 
Carotene 
______________________________________ 
The isopropyl palmitate-myristate was heated to about 80.degree. C. and the 
cetyl alcohol was dissolved therein. The resulting solution was blended 
with the remaining ingredients and stirred to form a homogeneous mixture. 
EXAMPLE 4 
Example 3 was repeated using 0.5% by weight chlorhexidine as a suspension 
in glycerol in place of the hexachlorophene and increasing the amount of 
soybean oil to 92.1% by weight. 
EXAMPLE 5 
Example 3 was repeated using 0.5% by weight tamed iodine (providing 75 ppm. 
available iodine) in place of the hexachlorophene and adjusting the amount 
of soybean oil to 92.0% by weight. 
The above examples illustrate the embodiment of the present invention 
wherein the complete composition is initially mixed together. The 
following examples illustrate the embodiment wherein the additives are 
premixed with the fatty acid ester to form a concentrate which may be 
mixed with the semi-drying oil at any time, for example at the time of 
use. 
EXAMPLE 6 
The following ingredients were combined with mixing to form a homogeneous 
mixture: 
______________________________________ 
Ingredient Amount 
______________________________________ 
Isopropyl palmitate-myristate 
7.7 pounds 
Hexachlorophene 21.4 ounces 
Cetyl alcohol 5.4 ounces 
Allantoin 0.18 ounces 
______________________________________ 
The mixture was combined with 69.3 pounds cotton seed oil. The final 
product had the following composition. 
______________________________________ 
Ingredient % by weight 
______________________________________ 
Cotton seed oil 88.07 
Isopropyl palmitate-myristate 
9.79 
Hexachlorophene 1.70 
Cetyl alcohol 0.42 
Allantoin 0.02 
______________________________________ 
EXAMPLE 7 
Example 6 was repeated using 0.5% by weight of paraformaldehyde as a 
suspension in place of the hexachlorophene and adjusting the amount of 
cottom seed oil to 89.27% by weight. 
The following example illustrates a still further embodiment of the present 
invention. 
EXAMPLE 9 
Example 9 
______________________________________ 
Amount % by 
Ingredient (pounds) weight 
______________________________________ 
Soybean oil 1389 92.60 
Isopropyl palmitate-myristate 
99 6.60 
Cetyl alcohol 2 0.13 
Chlorhexidine diacetate 
10 0.67 
______________________________________ 
The isopropyl palmitate-myristate was heated to 55.degree. C. and the cetyl 
alcohol as dissolved therein with stirring. The chlorhexidine diacetate as 
dissolved in a small amount propylene glycol and added to the isopropyl 
palmitate-myristate-cetyl alcohol solution and stirred until the mixture 
was completely homogeneous. The soybean oil was then added with continued 
stirring to form a final homogeneous product.