Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-06-14
2001-06-26
Lee, Howard C. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S457000, C424S461000
Reexamination Certificate
active
06251879
ABSTRACT:
The present invention relates to a delivery system for delivering a volatile and/or water soluble antimethanogenic agent to an animal, a composition comprising the agent and methods of treatment of an animal.
BACKGROUND OF INVENTION
Microorganisms capable of generating methane are commonly found in the gut flora of animals including ruminants. The microorganisms which produce methane in ruminants result in the loss of energy available to the animal and are also believed to contribute significantly to greenhouse gases.
Specifically, it has been known for many years that suppression of methane production in ruminants can theoretically lead to increased production and much work has been undertaken to reduce methane biosynthesis and achieve production gains in domestic animals. This has been most successfully achieved by modifications to the diet of animals. Diet manipulation is only possible in a limited number of animal production systems and is generally only able to reduce and not completely suppress methane production. A number of approaches to methane suppression in animals are being explored, not only to increase animal production but also to reduce the level of methane in the environment because of its contribution to the “greenhouse” effect.
Bromochloromethane (BMC) and some other related substances are known to show antimethanogenic activity when administered into the rumen of cattle and sheep but they have physical properties which makes impractical their use as antimethanogens in livestock production systems, BCM for example is a volatile liquid, boiling point 69 C., which readily evaporates. Bromoethane sulphonate, another antimethanogen, is difficult to administer because it is water soluble.
While the antimethanogenic properties of BCM and other antimethanogens have been known for more than 25 years no one has identified a practical means of using them to suppress methane production in livestock and obtain production increases.
Thus there has been a long felt need in the animal production field to find a practical means of inhibiting methanogenesis in animals, in particular ruminants.
It may also be desirable to reduce methane production in other animals. Inhibition of methane production would reduce the environmental impact of animals. In the case of domestic animals that inhabit households, it may be desirable to reduce methane production to achieve more pleasant conditions.
Cyclodextrins are cyclic oligosaccharides which have been used in the pharmaceutical and food industries in the preparation of various formulations incorporating active ingredients.
SUMMARY OF THE INVENTION
It is an object of the present invention to overcome at least some of the difficulties of the prior art in delivering antimethanogenic agents to animals.
In work leading up to the present invention the inventors recognised the possibility that BMC and related antimethanogenic substances might form inclusion complexes with one or more cyclodextrins although these inclusion complexes had not been produced previously. It was also possible, but by no means certain, that these inclusion complexes might have properties which would enable them to be used as practical antimethanogen for suppressing methane production in animals.
The inventors have now demonstrated that inclusion complexes are formed with a number of antimethanogenic substances and show that these complexes have antimethanogenic properties and physical properties which made them suitable for administration of livestock by several available delivery processes. The BCM-&agr;-cyclodextrin inclusion complex is shown for example to have properties particularly suitable for administration to livestock either as a feed additive or in a controlled release device, to suppress methane production and to give production benefits in cattle and sheep.
In its broadest form the present invention provides a delivery system for delivering a volatile and/or water soluble antimethanogenic agent to an animal, said system comprising a volatile and/or water soluble antimethanogenic agent with a cyclodextrin or cyclodextrin-like compound such that sustained release of said agent is provided.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
It has been surprisingly found by the present inventors that cyclodextrin completed with a volatile and/or water soluble antimethanogenic agent delays release of the agent to provide prolonged or sustained release of the agent.
The term “volatile” used herein refers to the tendency of the agent to evaporate and generally refers to fluid substances.
The volatile and/or water soluble antimethanogenic agent may be any antimethanogenic agent which is volatile and/or water soluble. The term refers to any compound not normally in a solid state which is capable of inhibiting methanogenesis in animals with the proviso that the compound is physiologically acceptable to animals. Such agents include bromochloromethane and analogues thereof such as bromochloroethane or bromochloropropane and other compounds such as halothane, 2-bromoethane sulphonate and 2-bromo-2-chloroethane sulphonate.
The cyclodextrin may be selected from &agr;-cyclodextrin, &bgr;-cyclodextrin or &ggr;-cyclodextrin or derivatives thereof which may be naturally and/or synthetically produced. The cyclodextrin-like compound may be any compound capable of slowing or controlling the release of said agent and includes mannose based ring compounds.
The term “such that sustained release of the agent is provided” means that the antimethanogenic agent and cyclodextrin or cyclodextrin-like compound are capable of dissociation whereupon the agent is released at a reduced rate compared to the agent administered on its own.
Accordingly in one aspect the invention provides an antimethanogenic composition for use in animals comprising a volatile and/or water soluble antimethanogenic agent together with a cyclodextrin or a cyclodextrin-like compound such that sustained release of the agent is provided.
The term “animals” used above refers to any animal in which it is desirable to deliver an antimethanogenic compound. Preferably the animals are mammals. The mammals will generally be domestic animals such as ruminants (cattle, sheep, goats, deer, elk, alpacas, llamas), and other animals including horses, pigs, dogs, cats, humans.
The antimethanogenic agent is at least partly enclosed in, confined by, or encapsulated by the cyclodextrin or cyclodextrin-like compound. Once the composition is administered the agent dissociates from the cyclodextrin or cyclodextrin-like compound. Preferably the cyclodextrin forms an inclusion complex with the agent.
Preferably the composition is a pharmaceutical or veterinary composition in order to comply with the various regulatory standards for such compositions in different countries.
The dose of the antimethanogenic agent is in the range from about 1 to 150 mg per kg. More preferably the dose range is from 1 to 120 mg per kg, still more preferably 1 to 50 mg, even more preferably from 1 to 20 mg, even more preferably from 1 to 10 mg per kg of body weight.
Preferably the composition is in a particulate form. More preferably the particles are 50-100 mesh BSM.
Alternatively preferably the composition may be in the form of a capsule such as a gelatin capsule or the capsules described in Australian Patents 520409, 558009 and 555998.
In another aspect the invention provides an animal feed comprising the composition of the invention described above together with a nutrient source. The animal feed may be for a vegetarian animal such as cows, sheep, etc. or for carnivores or omnivores such as pigs and dogs.
In one particularly preferred aspect the composition of the present invention is incorporated into lucerne pasture, hay, cereals, legumes, by-products from food industries and/or polenta in the case of domestic animals such as cattle. In the case of dogs and cats the composition may be incorporated into dried pet or moist pet food. The animal feed or pet food may comprise other active ingredients in addition to the composition of the present invention. S
Edgar John Alexander
May Christopher
Payne Alan Lindsay
Stewart Philip Laurence
Commonwealth Scientific and Industrial Research Organisation
Lee Howard C.
McDermott & Will & Emery
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