Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1996-09-27
1999-07-20
Weddington, Kevin E.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
514393, 514394, 514395, 514396, A61K 970
Patent
active
059253746
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to a method of preparing an anthelmintic composition and/or an anthelmintic composition (including a preparation so prepared) and/or a method of using such a composition.
BACKGROUND ART
Benzimidazole anthelmintics are widely used orally in aqueous suspension formulations for the control of parasitic helminths, namely round worms (nematodes), tapeworms (cestodes), or flukes (trematode). This anthelmintic group has been used in a variety of animal species including sheep, cattle, goats, deer, horses, cats, dogs, llama buffalo and poultry. Injectable preparations of benzimidazole anthelmintics are also known. Benzimidazole anthelmintic compounds are widely used in veterinary medicine. Common forms include oxfendazole, mebendazole, fenbendazole, albendazole and the probenzimidazoles febantel and netobimin, which are metabolised to benzimidazoles within the animal.
In general, these compounds are sparingly soluble in aqueous solutions although the solubility can be improved by heating the aqueous solution.
Bayer AG British Patent Specification No. 1527584, the full content of which is hereby included by way of reference, refers to the advantages of pour-on application in veterinary practice over oral treatments and additionally discloses a pour-on formulation characterised in that the active compound is dissolved, emulsified or suspended in a suitable solvent or solvent mixture which is tolerable by the skin (optionally with addition of further auxiliaries) and applied with the aid of a suitable device, eg. measuring cup or spray bottle to the skin of the animal to be treated. The active ingredients disclosed are Tetramisole and Levamisole.
Reference should also be had to the paper "Seasonal Variation and Anthelmintic Response by Cattle to dermally applied Levamisole", B. A. Forsyth et al. Australian Veterinary Journal, Vol. 60 No.5, May 1983 and "Pharmacokinetics of ivermectin after oral or percutaneous administration to adult milking goats", E. W. Scott et al., Journal Veterinary Pharmacology, Volume 13, pages 432-435, 1990.
E. R. Squibb & Sons Inc, U.S. Pat. No.4,145,433 discloses the option of topical or parenteral administration to mammalian hosts of benzimidazole dispersed in a non-toxic, non-pyrogenic acceptable carrier. In particular it discloses a solution for cutaneous administration being prepared by acid, methyl ester in a solution of about 4 cc xylene and 1 cc dimethyl sulfoxide. Such administrations are stated as being useful in treating infection caused by Haemonchus, Ostertagia, Trichostrongylus, Cooperia, Dictyocaulus, Nematodirus, Bunostomum, Strongyloides, Oesphagostomum, Trichuris and liver flukes at a recommended dosage of from 2.5-25 mg/kg body weight.
DISCLOSURE OF INVENTION
Nevertheless the sparing solubility of anthelmintics restricts their use as pour-ons.
The present invention relates to improved methods of formulating compositions of anthelmintics (preferably benzimidazoles) for topical or transdermal administration to provide a substantially stable composition despite any solubility difficulties with the (benzimidazole) active ingredient(s).
It is an object of the present invention to provide a method of preparing an alternative anthelmintic composition and/or an anthelmintic composition and/or a method of using an anthelmintic composition which will obviate or minimise the foregoing disadvantages in a simple yet effective manner or which will at least provide the public with a useful choice. More specifically, it is an object of the present invention to provide alternative veterinary preparations, and/or methods of preparation and/or of use of veterinary preparations, whereby preferably benzimidazole anthelmintics may be applied externally to animals so as to pass into tissue! of the animal, providing a simple and quick administration method which is effective in achieving the necessary dose response.
In addition it may provide a simple more prolonged method of administering the anthelmintic, increasing the anthelmintics effectiveness.
REFERENCES:
patent: 3852336 (1974-12-01), Harfenist
patent: 4018932 (1977-04-01), Spicer et al.
patent: 4145433 (1979-03-01), Haugwitz et al.
patent: 4672072 (1987-06-01), Hackney et al.
patent: 5169846 (1992-12-01), Crooks
patent: 5324521 (1994-06-01), Gertner et al.
IVS Annual, p. 284 (Dec. 1993).
The Merck Index, Ed. 11, (1989,) Entry Nos. 201, 1091, 1733, 3888, 3904, 4050, 5647, 6390, 6890, 6891, 6985, 9217 and 9282.
Leech Wayne Frederick
McLaren Donald George
Bomac Laboratories Limited
Weddington Kevin E.
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