Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1996-10-31
1998-10-20
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424442, 424465, A61K 920
Patent
active
058243364
DESCRIPTION:
BRIEF SUMMARY
CROSS REFERENCE TO RELATED APPLICATIONS
This application is based upon PCT Application Serial No. PCT/EP 95/01801, filed May 12, 1995.
The present invention relates to compositions comprising flubendazole, which are palatable to companion animals, especially dogs. These compositions find utility as palatable anthelmintic compositions for the treatment of helminthiasis.
Flubendazole is an anthelmintically active compound having the formula (1). ##STR2##
Flubendazole is the generic name of methyl described in U.S. Pat. No. 3,657,267. Methods of preparing said compound are also mentioned in said patent. The anthelmintic activity has already been described extensively and the product has been on the market for many years as a veterinary pharmaceutical under the brand names Flubenol.RTM., Biovermin.RTM., Flubenol KH.RTM., Flumoxal.RTM., Flutelmium.RTM..
Over the years, owners of companion animals and veterinarians have continually made the remark that the available tablets, pills or formulated compositions marketed for admixture of flubendazole with feeds are not completely satisfactory. This has resulted in the reluctance of the animals to ingest said tablets, pills or feed containing medication. It would therefore be highly advantageous and most desirable if flubendazole could be rendered palatable without destroying its efficacy. Furthermore, it would be most advantageous if a palatable composition containing flubendazole could be prepared in the form of a chewable tablet, pill, granulated product or the like, especially a chewable tablet
It is therefore an object of this invention to provide palatable, therapeutically effective compositions containing flubendazole, useful for the treatment of helminthiasis in companion animals, especially dogs.
It is also an object of the present invention to provide methods for preparing compositions containing flubendazole which are palatable for companion animals, especially dogs.
Compositions according to the present invention will preferably comprise besides active ingredient pharmaceutically acceptable carriers and excipients, such as fillers e.g. lactose, sucrose, mannitol, maize starch, microcrystalline cellulose or calcium hydrogen phosphate; lubricants e.g. stearic acid, polyethylene glycol, magnesium stearate, talc or silica; disintegrants e.g. rice, potato or maize starch, sodium starch glycollate or croscarmellose sodium (croscarmellose sodium is the British Approved Name for crosslinked carboxymethylcellulose); binding agents e.g. pregelatinised maize starch, polyvinylpyrrolidone or hypromellose (hypromellose is the British Approved Name of hydroxypropyl methylcellulose) and wetting agents.
The compositions of the present invention always contain large amounts of brewer's yeast.
Brewer's yeast throughout this application means in fact the product of the autolysis and hydrolysis of brewer's yeast. Said autolysed and hydrolyzed product can, for instance, be obtained in the following manner. Saccharomyces cerevisiae used in breweries is separated after the brewing process from the residual grain. Said yeast is first heated and pumped into an autolysis tank. During the autolysis the yeast's own enzymes break down the cell wall as well as the yeast proteins. After said autolysis the yeast is again heated to inactivate any remaining enzymes. Following the inactivation the yeast is centrifuged to collect the cell wall material. Said cell wall material is then pasteurized and spray dried, after wich the product is completely hydrolyzed with hydrochloric acid and then neutralized with sodium hydroxide. The remaining product is then again pasteurized and spray dried.
Interesting fillers are lactose, sucrose or microcrystalline cellulose; preferably lactose and microcrystalline cellulose. Interesting lubricants are stearic acid, polyethylene glycol, hydrogenated vegetable oil, sodium stearyl fumarate or magnesium stearate, preferably magnesium stearate. Interesting disintegrants are rice, potato or maize starch, preferably croscarmellose sodium. Preferred binding agent
REFERENCES:
patent: 4578268 (1986-03-01), Quinlan
patent: 5036069 (1991-07-01), Andrews et al.
Gilis Paul Marie Victor
Jans Eugene Maria Jozef
Faulkner D.
Janssen Pharmaceutica N.V.
Metz Charles J.
Page Thurman K.
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