Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – C-o-group doai
Reexamination Certificate
2002-10-31
2003-07-01
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
C-o-group doai
Reexamination Certificate
active
06586477
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is broadly concerned with aqueous germicidal compositions comprising a phenolic compound and a phenate and methods of treating the skin of animals by applying the compositions thereto.
2. Description of the Prior Art
A number of antibacterial agents are used as topical antiseptics designed to reduce intramammary infections in dairy cows and other milk producing) animals such as goats and sheep. These products, typically referred to as teat dips, generally serve to disinfect the teat skin surface and teat orifice and maintain overall skin health. In practical use, teat dips are applied by dipping or spraying the composition onto the teats of the animals following removal of the mechanical milking devices used to extract milk from the udder. The use of teat dips has proven effective in reducing the incidence rate of new intramammary infections by decreasing the exposure of the udder to mastitis causing pathogens that may be present in the residual milk film remaining on the surface of the teat skin. In some instances, teat dips are applied prior to the milking process in order to reduce exposure to pathogens which are present in the animal's environment and which reside on the teat skin surface through incidental contact.
Teat dips are commonly provided in the form of aqueous solutions which include germicidal agents such as iodine, chlorhexidene salts, sodium hypochlorite, chlorine dioxide, hydrogen peroxide, or antibacterial anionic surfactants. Because teat dips are used on food producing animals, care must be taken in the selection and use of germicidal agents so that residues which inadvertently find their way into the food product do not pose a health risk to the consumer. Phenol and various halogenated and alkylated derivatives have been used as germicides for over a century. Phenol is considered non-toxic and safe at relatively low concentrations as demonstrated by its use in FDA approved over-the-counter drug applications such as throat sprays.
U.S. Pat. No. 3,317,376 describes the use of phenol/sodium phenolate (phenate) solutions for rendering fabrics germicidal and bactericidal. Concentrations of phenol range from 2-16.5% by weight, and the ratios of phenol to sodium phenate range from 0.37 to 20.
U.S. Pat. No. 3,917,850 describes a biocide composition for surface and space disinfection comprising an aldehyde and/or dialdehyde and a phenol derivative in a solvent. Concentrations of phenol derivatives range from about 15-45% by weight.
However, phenolic compositions have not been employed in topical germicidal compositions for use in treating mammalian skin. Therefore, there is a real and unfulfilled need in the art for a composition including an effective germicidal agent that is non-toxic and safe for use on food producing animals in addition to promoting the overall health of animal skin.
SUMMARY OF THE INVENTION
The present invention overcomes the problems outlined above and provides an aqueous germicidal composition comprising from about 1-2% by weight of a phenolic compound and a quantity of a phenate. Preferably the composition has a pH of from about 6-10, more preferably from about 6.5-8.5, and most preferably from about 7-8 and a phenolic compound to phenate weight ratio of from about 0.81:1 to 10,000:1, more preferably from about 25:1 to 2,600:1, and most preferably from about 80:1 to 800:1. All weight percentages expressed herein are based on the weight of the entire composition being 100%.
Compositions according to the present invention further comprise a buffering agent for pH control. Preferred buffering agents include those selected from the group consisting of salts of boric acid, phosphoric acid, citric acid, carbonic acid, and mixtures thereof. Sodium tetraborate decahydrate is an exemplary preferred buffering agent for use with the present invention. Other buffering agents may be chosen depending on the exact pH desired for a given application of the composition. Preferably the compositions will comprise from about 0.02-2.0% by weight and most preferably from about 0.25-0.75% by weight of buffering agent.
Preferred embodiments of the present invention comprise from about 1-2% by weight, more preferably from about 1.2-1.8% by weight, and most preferably 1.4-1.7% by weight of a phenolic compound. As used herein, the term “phenolic compound” refers to any aromatic hydroxylated compound or derivative thereof, or any compound derived from or containing phenol. Preferred phenolic compounds for use with the present invention are selected from the group consisting of phenol, halogen substituted, alkyl substituted, halogen and alkyl substituted phenol derivatives, bisphenol, halogen substituted, alkyl substituted, halogen and alkyl substituted bisphenol derivatives, and mixtures thereof.
As used herein, the term “phenate” includes derivatives of phenolic compounds wherein the hydrogen from the hydroxyl group has dissociated therefrom or has been replaced with a monovalent metal. Preferably the phenate is derived from the phenolic compound, that is, the phenate is formed by the removal of hydrogen from the hydroxyl group of the phenol.
It is preferable that compositions according to the present invention include at least one component selected from the group consisting of a wetting agent, an emollient, and a thickener. It is most preferable that such compositions include all three components.
Preferred compositions of the present invention comprise from about 0.01-2% by weight, and more preferably from about 0.05-1.5% by weight of a wetting agent, from about 0.5-15% by weight, more preferably from about 2-10% by weight, and most preferably from about 5-10% by weight of an emollient, and from about 0.02-1.0% by weight, more preferably from about 0.05-0.6% by weight, and most preferably from about 0.06-0.3% by weight of a thickener.
Preferred wetting agents for use with the present invention include anionic surfactants, cationic surfactants, nonionic surfactants, amphoteric surfactants, and mixtures thereof. Preferred emollients for use with the present invention include glycerin, propylene glycol, sorbitol, allantoin, ethoxylated lanolin, aloe vera extracts and mixtures thereof. Preferred thickeners for use with the present invention include alginates, natural gums, cellulosic polymers and mixtures thereof.
Coloring agents, such as pigments or dyes, may be added to compositions prepared in accordance with the present invention. Preferred coloring agents for use with the present invention comprise any organic or inorganic dye which is a chemically acceptable trace constituent on the animal skin to which it is to be applied and the resulting food product derived from the animal. Such dyes are generally those approved for use in drug products by various regulatory bodies. Preferred coloring agents include FD&C Yellow No. 5, FD&C Blue No. 1, and FD&C Yellow No. 6. Generally, the coloring agent will be present in a concentration of from about 0.001-0.5% by weight and preferably from about 0.01-0.3% by weight.
Methods of treating animal skin according to the present invention comprise the steps of providing an aqueous germicidal composition comprising a quantity of a phenolic compound, adjusting the pH of the composition to between about 6-10, more preferably to between about 6.5-8.5, and most preferably to between about 7-8 thereby converting a portion of the phenolic compound to a phenate, and applying the compound to the skin of an animal. The composition may be applied to the animal skin by dipping, spraying, or foaming the composition onto the animal skin, or by any other means known to those skilled in the art. Preferably, the animal skin to be treated according to the invention is the skin of a bovine teat. The weight ratio of the phenolic compound to phenate is preferably from about 0.81:1 to 10,000:1, and more preferably from about 25:1 to 2,600:1, and most preferably from about 80:1 to 800:1. Preferred germicidal compositions for use with methods of the present invention incl
Henley III Raymond
Hovey & Williams, LLP
Sporicidin Company
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