Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Matrices
Reexamination Certificate
2001-06-04
2003-03-25
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Matrices
C424S487000, C424S484000, C424S438000, C424S405000, C514S772100
Reexamination Certificate
active
06537577
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of preventing bovine mastitis. There is also provided a method for treating cows, which have already been affected.
BACKGROUND OF THE INVENTION
Mastitis remains the most prevalent and persistent disease of dairy cattle. This disease is an inflammatory reaction of the mammary gland associated with a response to the presence of infecting pathogens. Although the disease is obvious upon direct observation in its clinical form, sub-clinical mastitis is more prevalent than clinical mastitis, since it usually precedes the clinical form and is more difficult to detect, the disease may become a prolonged infection and more difficult to overcome. Furthermore, the sub-clinical form of mastitis involves the presence of colonies of microorganisms that can lead to cross contamination and infection in other animals within the hood. The teat canal is the portal of entry for mastitis pathogens into the mammary gland. Lesions on the teats, particularly at the apex, contribute to increased incidence of infection.
A common cause is the attraction of insects such as flies to lactating cows which carry pathogens.
Economics losses from reduced milk production and the poor quality of milk product due to mastitis alone are estimated to be more than one billion dollars in the United States. Further, the losses are escalated to an additional billion dollars if the cost of antibiotic treatment and discarded milk is factored into the overall economic analysis.
Procedures to reduce the incidence of the mastitis disease include the use of effective pre-milking hygiene, the correct use of functionally adequate milking machines, the sanitization of teats after milking, the dry cow-treatment of all quarters of all cows, the prompt treatment of clinical mastitis and the culling of cows with chronic mastitis.
It has long been known to use disinfecting compositions to reduce or substantially eliminate mastitis-causing pathogens and microflora. Generally, such formulations are based on antimicrobial agents selected from chlorhexidines, iodophors, sodium chlorite-lactic acid compositions, sodium hypochlorite and hypo-chlorous acid. Iodophor preparations have been commonly used for this purpose. Though most of these germididals are effective against common mammary pathogens, many are not completely effective due to the lack of germicidal persistence throughout the intermilking period.
U.S. Pat. No. 4,288,428 issued to Foll and Widell disclose an iodophorus udder disinfecting composition comprising an alkylphenoxylpoly (ethyleneoxcy)ethanol-iodine complex or a polyvinylpyrrolidone-iodine comples used in solution form to treat the teats of the udders to yield a sufficient bacterial effect. These complexes dramatically reduced the noxious toxic properties of elemental iodine, i.e., the chaffing and etching of the udders and teats while preserving the broad germicidal spectrum of elemental iodine. Despite the advances provided by such iodophor complexes resulting in the reduction of detrimental effects of elemental iodine, side reactions may occur and release free elemental iodine from the solution.
Further, anionic and non-ionic surface-active components in formulations tend to remove protective fats and oils from the skin. These formulations, as well as, current teat disinfecting preparations have several glaring deficiencies in that these compositions do not provide a barrier film to prevent infection and to provide an extended delivery system for an antimicrobial agent and/or other medicaments to promote healing.
Therefore, there exists a need in the diary industry to provide a thin, tough, flexible, elastic film coating, which is skin adherent, adapts very well to all skin movements, yet provides a breathable, pinhole-free microporous structure that enables antimicrobial compounds to be incorporated therein and released over extended periods of time to prevent intramammmary infection between milking operations.
U.S. Pat. No. 6,139,856 to Kaminska, et al discloses a film forming composition suitable for use as a combination surgical skin preparation and drape. Another feature is the film's ability to serve as a vehicle for delivery of an antimicrobial agent and medicament to the skin surface. The film forming composition comprises a polymer mixture, including a polyvinylidene difluoride polymer, an acrylic polymer emulsion and an amine-substituted acrylic polymer, a specific amount of water, an effective amount of an antimicrobial liquid and an organic solvent for dissolving all components.
There is no suggestion in the patent that the disclosed composition could be used as a disinfecting preparation for the teats of udders of milk cows. Further, the patented composition is described (col. 4, lines 62-63) as having a resistance to physical removal, whereas the present method requires a film forming composition to be strippable prior to the milking operation. The present invention discloses a method which satisfies the many above-stated requirements by making unforeseen improvements by forming adherent teat coatings which disinfect the teat and provide a pinhole-free antimicrobial barrier that will protect the teat including crevices and fissures in the cutaneous tissue of the cow's teats. Ultimately, the method improves the quality of milk, reduces the costs associated with the antibiotic treatment and reduces the cost of milk to consumers.
REFERENCES:
patent: 4113854 (1978-09-01), Andrews et al.
patent: 4309328 (1982-01-01), Carson
patent: 4434181 (1984-02-01), Marks, Sr. et al.
Bio Medical Development Corporation
Di Nola-Baron Liliana
Lezdey John
Page Thurman K.
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