Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai
Reexamination Certificate
2000-10-13
2002-07-02
Weddington, Kevin E. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Ester doai
C514S547000, C514S557000, C514S724000
Reexamination Certificate
active
06414023
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a disinfecting composition for human and animal skin, particularly for disinfecting cow udders and teats.
2. The Prior Art
Mastitis, which is a complex and multifactorial disease, is the reaction of milk-producing tissue to influences most often caused by micro-organisms. In response to such microbial influences, a cow's immune system will bring a large number of white blood cells, leucocytes, to the infected area. The result is a battle with the leucocytes trying to engulf and digest the mastitis-causing micro-organisms and the micro-organisms struggling to multiply and get rid of the leucocytes.
As the infection develops, a high number of leucocytes and cells from the tissue, the epithelial cells, will be present in the milk. The leucocytes and epithelial cells are referred to as somatic cells and the number of these cells is an indication of the severity of the infection.
The somatic cell count of milk from uninfected udders is in average less than 200,000 cells/ml; milk from cows with minor infections contains an average of about 200,000-500,000 cells/ml and milk from cows with a major infection shows average counts of more than 500,000 cells/ml.
The presence of large numbers of somatic cells in milk have several adverse events such as:
reduced cheese yields due to lower contents of casein and fat
longer coagulation time in cheese production
lower stability of milk powder prepared from the milk
reduced shelf life of dairy products prepared from such milk and
risk of organoleptic defects in e.g. butter.
It is well-known that a number of micro-organisms may cause mastitis. Examples of such micro-organisms are
Strp. agalactiae, Staph. aureus, Streph. uberis, Streph. dysgalactiae, E. coli, P. aeruginosa
and
klebsiella
species.
To prevent mastitis, a variety of disinfecting compostions suitable for use as udder washes and teat dips has been developed. These disinfectants include iodophors, quaternary ammonium compounds, chlorhexidine, sodium hypochlorite, hydrogen peroxide, organic acids and derivatives thereof, dodecylbenzene sulfonic acid and chlorous acid.
This prior art disinfecting compositions are in various forms such as solutions, gels and skin disinfectant wipes.
WO 96/18300 discloses an adherent disinfecting composition comprising a protic acid, a metal chlorite and a gelling agent.
U.S. Pat. No. 5,569,461 discloses an antimicrobial composition which is useful for application to the teats and udders of dairy animals and which comprises one or more propylene glycol mono fatty acid esters in combination with both acidic chelating agents and edible saturated fatty acids.
2,4-dichlorbenzyl alcohol is a compound known to possess lethal activity against a wide range of bacteria, fungi and yeasts and it is also known that compositions containing said compound can be employed to combat bacterial fungal and yeast infections on the skin and are suitable for the preparation of pharmaceutical compositions for oral administration.
It has been noted that some pathogens develop a certain amount of drug resistance to 2,4-dichlorobenzyl alcohol.
It is also known, cf. U.S. Pat. No. 3,123,528, that the bactericidal and fungicidal effects of oral compositions containing 2,4-dichlorobenzyl alcohol can be enhanced by the inclusion of amyl-m-cresol, which is a well-known bactericide and fungicide.
WO 9809520 Al discloses an antimicrobial ointment for bovine teats comprising an antimicrobial fatty acid monoester of a polyhydroxy alcohol, e.g. glycerol monolaurate, a chelating agent and a vehicle composition comprising petrolatum.
U.S. Pat. No. 4,485,029 A discloses a composition for cleaning, disinfecting and preserving contact lenses comprising water, glyceryl monolaurate and a second antimicrobial agent comprising one or more esters of p-hydroxy-benzoic acid, e.g. methyl or propyl paraben. The composition may further contain chelating agents and surfactants.
WO 9606153 A2 discloses a soap formulation comprising a microbial active substance, e.g. a benzyl alcohol such as 2,4-dichlorobenzyl alcohol, hydrotropic agent, surfactant, salt of a fatty acid, dihydric alcohol, monohydric alcohol(s), and balance water.
WO 9320812 A1 discloses an antimicrobial composition comprising (A) a monoclyceride of lauric or monomyristic acid or mixture thereof, (B) a chemical substance selected from a local anesthetic of the amide type, a carbamide, an antibacterial substance in the form of a steroid antibiotic, an imidazole derivative or a nitroimidazole derivative and a 3-6C dial, and (C) optional conventional physiologically acceptable carrier and/or additives. The combination of components (A)+(B) exhibits synergism.
U.S. Pat. No. 4,067,997 A discloses a synergistic microbiocidal composition comprising at least one non-ionic surface-active mono-ester of a 12C aliphatic acid and a polyol, preferably the monolaurin of glycerol, and at least one microbiocide, preferably a phenolic compound. The composition may be applied to the teats of a mammal, such as a cow.
DE 4411664 A1 discloses a synergistic deodorising or antibacterial composition, especially for use in cosmetic or topical preparations, comprising a 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol, a phenylhydroxyalkyl ether having 1-3C in the alkyl part, a glycerol monoester of a short or medium chain length fatty acid, and optionally glycerol monolaurate.
U.S. Pat. No. 4,921,694 A discloses a deodorizing and antimicrobial composition for use in cosmetic or topical formulations containing one or more 3,7,11-trimethyl-2,6,10-dodecatrien-1-ols, a phenylhydroxyalkyl ether having not more than 3C in the alkyl radical and glycerol monolaurate.
When treating a cow's udders and/or teats with a disinfecting composition, there is the risk that part of the disinfecting composition will be introduced into the milk from the cow.
Therefore, it is important that the disinfecting composition contains such components only which are accepted by the health authorities as being non-toxic.
Accordingly, it is an object of the present invention to provide a non-toxic composition which is effective in disinfecting human or animal skin.
It is a further object of the invention to provide a disinfecting composition capable of forming a protective layer or film on the udders and/or teats during intermilking periods so as to prevent reinfection.
A still further object of the invention is to provide a composition which apart from being disinfecting has an anti-inflammatory effect.
These objects and other objects which will appear from the following description are obtained with the disinfecting composition according to the invention which composition comprises:
a) 2,4-dichlorbenzyl alcohol,
b) glycerylmonolaurate and
(c) a vehicle.
Surprisingly, it has been found that the composition of the invention, apart from possessing excellent disinfecting properties, exhibits an anti-inflammatory effect.
Inflammation is the result of extraneously provoked damages of cells or tissue. Such damages may be provoked by chemical and/or physical influences on the skin of humans and animals. Examples of physical influences are strokes, heat, cold, irradiation and electric chock and examples of chemical actions are contacts with acids, bases and allergenes. Inflammation may also be provoked by micro-organisms acting on the skin as opposed to infections which are the result of micro-organisms invading the human or animal body.
In other words, inflammation is a defence mechanism caused by extraneously provoked influences on the skin or tissue. The symptoms may be one of the following: pain, increased skin temperature, swelling, erythema and reduced or ceased function e.g. mastricating efficiency.
The anti-inflammatory effect of the disinfecting compositions of the invention is particularly advantageous when such compositions are to be applied to the udders and teats of milk producing animals such as cows, because the udders and teats are sensitive to influences which may cause inflammation with resulting redu
Borelli Preben
Brandsborg Erik
Bifodan A/S
Dykema Gossett PLLC
Weddington Kevin E.
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