Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2001-03-20
2003-02-25
Reamer, James H. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C514S643000
Reexamination Certificate
active
06525071
ABSTRACT:
FIELD OF THE INVENTION
The present invention is directed to antimicrobial compositions and methods of using the same. More specifically, this invention relates to water-based, antimicrobial compositions and methods of using the same for the treatment and prevention of bovine mastitis.
BACKGROUND OF THE INVENTION
It has been the trend of the dairy industry over the last few decades to increase milking frequency (i.e. cow milkings per day) with the goal of either 1) increasing net milk production or 2) maintaining existing production levels with fewer animals. For example, in the early part of the last century, the great majority of dairies milked cows once or twice daily. Presently, improvements in dairy management, along with improvements in dairy stock and animal nutrition have allowed about 30% of dairies to maintain a three-times daily milking schedule. It is very likely that within the next two decades, four-times daily milking will be commonplace due to further improvements to livestock and increased process automation.
Milking is routinely done with semi-automated milking machines in developed countries. However, frequent exposure to this process is traumatic to udder and teat tissue, due to the milking mechanism's alternation of pressure and vacuum on wet skin. Such trauma can impair the integrity of the protective layers of the skin, and result in chapping, peeling and irritation. Such roughened unhealthy skin surface has been shown to carry greater amounts of transient, potentially pathogenic, microorganisms which can increase the rate of udder-infection and concomitant mastitis in the animal. As the potential for and severity of damage resulting from automated milking trauma increases with increased daily milking frequency, the issues of skin condition, microorganism load and ultimately mastitis will be limiting factors for industrial expansion of frequent milking paradigms.
Bovine mastitis is an inflammation of the udder. This condition, which is almost exclusively initiated by pathogenic microorganisms that have entered the teat canal after the milking process, occludes milk flow and production, and can permanently impair an animal's future ability to produce milk. The usual sources of harmful microorganisms include unsanitary milking equipment, the milker, other mastitic animals, an unsanitary stable/pen environment, and the animal's own elimination (defecation/urination) processes. Financial loss due to mastitis have been estimated in the hundreds of millions of dollars in the United States alone. Furthermore, mastitis-related milk losses range from 10-25%.
It is known to perform post-milking teat sanitization with a germicidal agent to decrease mastitis. The post-milking teat decontamination should (1) eradicate most microorganisms on the teat skin, thereby reducing the number which can enter the teat canal and cause infection, and (2) heal minor skin lesions and contribute to the overall health of the udder.
Recently it has been concluded by the U.S. National Mastitis Council that the use of a pre-milking sanitization step further decreases mastitis, and presents other benefits, such as decreasing the surface pathogen load (such as
Escherichia coli
and Listeria spp.) and pathogen-related toxin content of milk. Therefore, the industrial recommendation for the use of teat sanitizers presently involves both a pre- and post-milking application. The presently-recommended process of milking is therefore as follows: prior to milking, the teats of the animal to be milked are sanitized with the pre-milking sanitizer, which is then quickly wiped off with a clean towel. The animal is then milked with the automated milker. After milking, the teat is highly susceptible to infection, because the teat-end sphincter muscle (responsible for closing the teat-end) remains open for approximately 30 minutes after milking. Therefore, a post-milking sanitizer is applied and left on the skin (i.e. not rinsed off or deliberately removed) until the next milking.
Because the teat sanitizer is left on the skin for a long period of time, the formulation must not have a tendency to irritate or damage the skin. Any toxic effects would be even more pronounced in a four-times daily milking herd, where the pre- and post-milking sanitization applications could reach up to eight times per day. Due to the difficulty in formulation of a composition which has a satisfactory antimicrobial activity but which also does not damage the skin, the majority of compositions exist in the field which are indicated for use as either a pre-milking, biocidal sanitizer, or as a post-milking biocidal sanitizer/skin conditioner. Generally, the pre-milking sanitizers contain a greater germicidal activity (usually a greater concentration of biocidal active ingredients) than post-milking sanitizers/conditioners because the pre-milking sanitizer does not remain in prolonged contact with the skin.
Active ingredients for teat sanitizer compositions include iodine, stabilized chlorine and quaternary amines, although others have been used. Iodine is perhaps the most widely used active ingredient in such compositions, mainly due to its low cost and fairly broad antimicrobial spectrum. At concentrations allowable in milk, however, iodine has a relatively slow kill time in comparison to other popular active agents, and importantly confers no persistence of antimicrobial activity (i.e. continued killing ability due to retention of the active ingredient in the target tissue) with continued use. Furthermore, at concentrations necessary for usefulness as a biocidal agent, iodine damages the udder skin in frequent milking situations and may not be compatible with other active antimicrobial agents used at other steps in the milking process. Even in once- to twice-daily milking situations, iodine can have a long-term negative effect on the udder skin condition, in part due to tissue denaturation, and to the formation of salts of the counter-ion with environmental anions (e.g. Cl
−
) on the skin surface after the formulation has dried.
Elemental chlorine is a potent germicidal agent which exerts its antibacterial action in both the elemental form and as undissociated hypochlorous acid (HOCl). The concentration of undissociated HOCl (and therefore the bactericidal activity) of chlorine is pH dependent, with antimicrobial activity falling off sharply in alkaline pH situations. Chlorine is a highly reactive element and can be bound to organic material, which decreases the bactericidal efficacy. Accordingly, in the presence of excessive organic matter, chlorine is not the disinfectant of choice. Chlorine also has a very limited application as an antiseptic agent because of the difficulty of handling the element in the gaseous state and because chlorine/water is very unstable. More useful for disinfection applications are several compounds that slowly yield hypochlorous acid. Such compounds can be regarded as chlorophors, even though the ultimate product is HOCl. The germicidal efficacy of such compounds is related to the case and extent of the liberation of HOCl. In the dairy industry, a number of teat disinfectants make use of chlorine present in the form of hypochlorite. Solutions of hypochlorite are relatively unstable and must therefore be prepared just prior to use. The utility of stabilized chlorine sanitizers is limited in the field because they are binary compositions (i.e. require the addition of an activating solution prior to use), and because they can have an extremely short shelf-life (measured in hours) once activated. Furthermore, these compositions tend to be the most expensive in the industry, in part due to manufacturing and packaging requirements for the base solutions and activators. In addition, stabilized chlorine sanitizers can be inconvenient to the end user from the standpoint of larger space requirements for on-site storage, and susceptibility to misuse (during mixing for activation) by inexperienced dairyhands. From the standpoint of tissue compatibility, chlorophors are not only germicid
MCJ, Inc.
Reamer James H.
Woodcock & Washburn LLP
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