Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Elemental chlorine or elemental chlorine releasing inorganic...
Reexamination Certificate
2000-07-20
2003-06-24
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Elemental chlorine or elemental chlorine releasing inorganic...
C424S405000, C424S407000, C424S409000, C424S465000, C424S468000, C424S489000, C424S661000, C514S553000, C514S557000, C514S558000, C514S560000
Reexamination Certificate
active
06582734
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a two-part antimicrobial composition comprising at least one chlorine dioxide generating component comprising at least one metal chlorite and at least one acid-forming compound in a solid carrier, and at least one liquid aqueous component. The composition further comprises at least one antimicrobial fatty acid having from about 2 to about 15 carbon atoms, and preferably from about 6 to about 12 carbon atoms. The components, upon mixing, form a composition having a pH in the range of about 5 to about 10, and preferably from about 5.2 to about 8.
BACKGROUND OF THE INVENTION
Bacterial infection, particularly bovine mastitis, is the most costly and difficult problem that a dairy herdsman will typically have to deal with.
Mastitis is an inflammation of the mammary gland that occurs primarily as a result of a bacterial infection that gains entry into the udder of the mammal via the teat canal. Mastitis decreases the cow's milk production and reduces the quality of the milk. In more severe cases of mastitis, the milk will have to be discarded, and if the disease resists treatment, the cow may have to be destroyed. A further problem is that a mastitis infection can spread from cow to cow.
Mastitis can occur in two forms that are referred to as clinical and subclinical mastitis. Both decrease milk production, but the milk must be discarded if the cow has clinical mastitis, and in untreatable cases, as stated above, the cow may have to be destroyed. In the case of the clinical disease, attempts at treatment have involved infusion of an antibiotic into the udder of the animal.
There are numerous organisms that cause mastitis, but the most common are
streptococcus agalactiae
and
staphylococcus aureus.
Other environmental and contagious microorganisms that cause this disease include coliforms,
Klebsiella pneumoniae, Actinomyces pyogenes, Corynebacterium bovis, Listeria monocytogenes, Pseudomonas aeruginosa, Mycoplasma bovis,
as well as other species of staph and strep. Treatment is generally started before the species causing the disease is identified, and it is therefore desirable to have an antibiotic that has the greatest efficacy, and that acts on as many species that cause the disease as possible. These microorganisms lurking in the surrounding environment such as plants and bedding (i.e. straw, hay, grass, wood shavings and the like), feces, soil, water, feed, and so forth are opportunistic and are spread from cow to cow during the milking process. The entrance of the microorganism is through the teat orifice and teat canal of the animal.
Dairy herd management focuses on both the treatment and prevention of mastitis infections. As stated above, treatment typically involves infusion of antibiotics into the udder of the infected cow(s), and prevention involves routine hygienic practices. Routine hygienic practices used for the prevention of mastitis (as well as preventing spreading of the disease) involves treating (i.e. dipping) the teats of the udder of a cow immediately after each milking period with an antiseptic “teat dip.” This has become a standard practice for dairy herdsmen as it has been proven to be a very effective way to prevent intramammary mastitis in cows.
Teat dips may be divided into several general categories including “predip” teat dips that are used to clean the udder of the cow prior to milking, “prepost” teat dips that are applied to the udder of the cow after milking, and “barrier” teat dips that are also applied to the udder after milking and are further designed to remain on the udder of the cow in between the milking periods.
Mastitis causing microorganisms are found in both the barn in which the cow is milked and in the environment the cow enters in between the milking periods. Prepost teat dips are designed to work on those microorganisms that are found in the barn, and that are spread from cow to cow during the milking period.
The barrier teat dips are designed to remain on the cow during the nonmilking periods. Barrier teat dips therefore comprise a film-forming agent that allows the teat dip to form a barrier or phophylaxis over the teats of the cow in order to prevent entrance of microorganisms through the teat orifice from the surrounding environment in the nonmilking periods. These barrier teat dips may or may not contain an antimicrobial agent, although in recent years it has become increasingly popular that the barrier teat dips have both film-forming characteristics and antimicrobial activity because some of the mastitis causing microorganisms have been known to penetrate the barrier and migrate into the teat canal.
There now exists a variety of commercially available predip, prepost and barrier teat dips, including those based on iodophors (i.e. iodine), quaternary ammonium compounds, chlorhexidine salts, chlorine release compounds such as alkali hypochlorites; oxidizing compounds such as hydrogen peroxide and peracids; protonated carboxylic acids (i.e. fatty acids) such as heptanoic, octanoic, nonanoic, decanoic, undecanoic, and so forth; acid anionics such as alkylaryl sulfonic acids; chlorine dioxide; and so forth. Such compositions have varying degrees of effectiveness.
Chlorine dioxide has been found to be an extremely effective chemical for use as an antimicrobial and over several decades has found increasing popularity for disinfecting, sanitizing, sterilizing, deodorizing, and so forth. Further, this chemical has been found to be quite useful in the prevention and treatment of bovine mastitis. This compound is typically generated in solution (i.e. aqueous medium) by mixing a metal chlorite salt with a strong mineral acid or a large amount of a strong organic acid. The stability of such solutions is an issue, however, and mixing of the acid and the metal chlorite salt is not recommended until just prior to use.
A variety of approaches have been taken for using chlorine dioxide. Such approaches are found in U.S. Pat. No. 4,084,747 and its reissue Re. Pat. No. 31,779; U.S. Pat. Nos. 4,585,482; 4,986,990 and 5,185,161; 4,891,216 and 5,651,977; and 5,820,822.
Various problems have been encountered with teat dips that utilize chlorine dioxide generating components. One such problem has been the low pH typically required for sufficient generation of chlorine dioxide. For antimicrobial compositions used on either human or mammalian skin, an acidic pH is of concern due to the irritation caused to tissue. Another problem associated with chlorine dioxide generation is the shelf life. Once chlorine dioxide generation is initiated, the compositions begin to lose efficacy and must typically be used in a matter of days
There remains a need in the art for a simple, yet effective and long-lasting antimicrobial system based on chlorine dioxide, and that may be used for such applications as the prevention and treatment of mastitis.
SUMMARY OF THE INVENTION
The present invention relates to a novel and improved two-part antimicrobial composition having longer lasting efficacy against microbes, and is useful as a teat dip comprising at least one chlorine dioxide generating component in a solid carrier and at least one liquid aqueous component. The chlorine dioxide generating component has at least one metal chlorite and at least one acid-forming compound. The acid-forming compound is preferably a protic acid, but includes any type of acid-forming compound. It is necessary that the acid-forming compound have a pKa of less than that of the fatty acid. Chlorine dioxide will not be adequately generated at a pH of about 5-10.
The antimicrobial composition further comprises at least one antimicrobial fatty acid which may be supplied in the solid component, but is preferably supplied in solution in the aqueous component. The fatty acid is characterized as having from about 2 to about 15 carbon atoms, and preferably from about 6 to about 12 carbon atoms. The fatty acid has a pKa of about 5.
The solid component is permeable to water in liquid form, or is sensitive to or dissolvable in water in liquid fo
McSherry David Daniel
Richter Francis Lawrence
Staub Richard K.
Wei Guang-jong Jason
Ecolab Inc.
Pak John
Vidas, Arrett & Steinkrau
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