Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Biocides; animal or insect repellents or attractants
Reexamination Certificate
1998-09-24
2002-04-30
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Biocides; animal or insect repellents or attractants
C424S407000
Reexamination Certificate
active
06379685
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a bovine teat dip composition that can be mixed using two parts, a simple chlorite solution and an acid or acidulant formulation, to form a stable, effective composition that can be used in routine dairy procedures.
BACKGROUND OF THE INVENTION
Bovine mastitis is the most common and most costly disease affecting dairy herds. Some estimates suggested at least half of the dairy animal population have some degree or form of mastitis. This condition results in lowered milk yield and reduced quality. Economic loss to mastitis in the U.S. is estimated at about $1.8 billion or approximately 10% of total milk sales with about two-thirds of this loss due to reduced milk production from infected cows. Mastitis is an inflammation of the mammary gland. Similarly, inflammation is one response of a tissue or organ to insult or injury. An injury caused by physical, chemical or thermal trauma can produce an inflammatory response. In the dairy cow, mastitis typically results from microorganisms, usually bacteria, that invade the udder, multiply in the delicate milk producing tissues, and synthesize toxins, a by-product of bacterial metabolism. The characteristic features of inflammation are swelling, heat, redness, pain and disturbed function.
While the animal immune system can fight intramammary infections, many chronic infections remain sub-clinical (asymptomatic) and undetected unless diagnosed by laboratory testing. Sub-clinical mastitis can result in a reservoir of micro-organisms that leads to the infection of other animals within the herd. More than 80 species of microorganisms have been identified as causal agents, although approximately 95% of mastitis is caused by four pathogens;
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysagalactiae
, and
Streptococcus uberis
. Mastitis causing pathogens fall into two categories namely contagious and environmental. Contagious bacteria, such as
Streptococcus agalactiae
and
Staphylococcus aureus
, primarily colonize host tissue sites such as mammary glands, teat canals, teat skin lesions etc. and are spread from one infected cow to another during the milking process. Environmental bacteria, often streptococci, enterococci and coliform organisms, are commonly present within the cow's surroundings from sources such as cow feces, soil, plant material, bedding or water, and infect by casual opportunistic contact with an animal during the inter-milking period. This distinction, although not exclusive, is of practical importance because different dairy herd maintenance measures are needed for the different groups of microorganisms. In all bovine mastitis cases, whatever the causal microorganism, the route of transmission of the invading pathogen into the inner gland of the udder is through the teat orifice and teat canal.
Management of dairy herds focuses attention on treatment of both established mastitis and on prevention of new intramammary infections. Therapy and hygiene are the two fundamental components of an effective mastitis control protocol. Each is applied in concert, and each operates independently. The primary effect of therapy is to increase the rate of eliminating established infections; whereas, hygiene reduces the frequency of infection by interrupting transmission vectors. We cannot present all ancillary factors that may be employed for the elimination and prevention of mastitis, however, the most effective therapy and hygiene practices are, respectively, antibiotic infusion treatment of the udder's four quarters at the end of lactation; and, post-milking teat antisepsis or “teat dipping” during lactation.
Researchers agree, and an abundance of published evidence supports the concept, that dipping teats into an effective antimicrobial solution immediately after each milking is the single most effective procedure for decreasing new intramammary infections in lactating cows. Between 1955 to 1970, Dodd and co-workers (F. K. Neave, F. H. Dodd, and R. G. Kingwell, 1966, “A Method of Controlling Udder Disease”, Vet. Rec. 78:521; F. K. Neave, F. H. Dodd, R. G. Kingwell and D. R. Westgarth, 1969, “Control of Mastitis in the Dairy Herd by Hygiene and Management”, J. Dairy Sci. 52:696; F. H. Dodd, D. R. Westgarth, F. K. Neave and R. G. Kingwill, 1969, “Mastitis—The Strategy of Control”, J. Dairy Sci. 52:689; and F. H. Dodd, and F. K. Neave, 1970, “Mastitis Control”, Proceedings, Nat'l. Inst. Res. Dairying, pp. 21-60) conducted extensive epidemiologic investigations in commercial dairy herds. From this work, they developed the conceptual basis for modem mastitis control methods of which teat dipping is an integral component. The efficacy and value of teat dipping has since been confirmed in dozens of field trials, and it is now accepted that an effective teat dip can reduce the incidence of new intramammary infections at least 50% and often up to 90%.
To reduce mastitis, commercial teat dips have been developed containing a variety of antimicrobial agents including iodophors, quaternary ammonium compounds, chlorhexidine salts, chlorine release compounds (e.g. alkali hypochlorites), oxidizing compounds (e.g. hydrogen peroxide, peracids), protonated carboxylic acids (e.g. heptanoic, octanoic, nonanoic, decanoic, undecanoic acids), acid anionics (e.g. alkylaryl sulfonic acids), and chlorine dioxide (from chlorite). These agents, which have varying degrees of effectiveness, limit the transmission of mastitis by reducing pathogen populations on the teat. Teat dips, can also be divided into two broad classifications. The Class I type are antimicrobial and are applied to kill microorganisms already present in the teat canal or on the surface of the teat skin. By design, their microbiological effect is immediate and their targets primarily the contagious organisms that are vectored between animals during the pre-milking, milking and post milking process. The Class II type teat dip, often referred to as a “teat sealer,” is a film-forming or coating composition which may or may not be antimicrobial; and, functions by developing a residual protective barrier on the teat thus providing prophylaxis by sealing the teat off from its environment. The film which forms on the surface of the teat serves as a physical barrier through which mastitis causing pathogens cannot penetrate during the intermilking period.
General disclosures of teat dip technology are shown in: “Current Concepts of Bovine Mastitis.” 1996, Fourth Ed. National Mastitis Council, Madison Wis.; P. A. Murdough and J. W. Pankey, 1993. “Evaluation of 57 Teat Sanitizers Using Excised Cow Teats”, J. Dairy Sci. 76:2033-2038; J. W. Pankey et al., 1984, “Uptake on Post-milking Teat Antiseptics”, J. Dairy Sci. 67:1336-1353; R. J. Farnsworth, 1980, “Role of Teat Dips in Mastitis Control”, J. Am. Vet. Med. Assoc. 76:1116-1118; W. N. Philpot, 1979, “Control of Mastitis by Hygiene and Therapy”, J. Dairy Sci. 62:168-176; W. N. Philpot and J. W. Pankey, 1978, “Hygiene in the Prevention of Udder Infections V. Efficacy of Teat Dips Under Experimental Exposure to Mastitis Pathogens”, J. Dairy Sci. 61:956-963; R. P. Natzke, 1977, “Role of Teat Dips and Hygiene is Mastitis Control”, J. Amer. Vet. Med. Assoc. 170:1196-1198; W. N. Philpot and J. W. Pankey, 1975, “Hygiene in the Prevention of Udder Infections. III. Effectiveness of 59 Teat Dips for Reducing Bacterial Populations on Teat Skin”, J. Dairy Sci. 58:209-216; R. J. Eberhart and J. M. Buckalew, 1972, “Evaluation of a Hygiene and Dry Period Therapy Program for Mastitis Control”, J. Dairy Sci. 55:1683-1691; W. D. Schultze and J. W. Smith, 1972, “Effectiveness of Postmilking Teat Dips”, J. Dairy Sci. 55:426-431; D. P. Wesen and L. H. Schultz, 1970, “Effectiveness of a Post-Milking Teat Dip in Preventing New Udder Infections”, J. Dairy Sci. 53:1391-1403; and British Pat. No. 1,144,637 (Kelco Chemicals Ltd.), published March 5, 1969. U.S. Pat. No. 4,199,602 (Lentsch) issued Apr. 22, 1980, U.S. Pat. No. 4,258,056 (Lentsch) issued Mar. 24, 1981; and U.S. Pat. No. 4,376,787 (Lentsch
Paquette Cathy M.
Richter Francis L.
Staub Richard K.
Vegoe Donald R.
Ecolab Inc.
Joynes Robert M.
Merchant & Gould P.C.
Page Thurman K.
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