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Claims for Patent: 7,125,560

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Claims for Patent: 7,125,560

Title:Pharmaceutical composition of topiramate
Abstract:The invention is directed to a pharmaceutical composition of topiramate, an anticonvulsant which is useful for treating epilepsy. More specifically, the present invention provides a solid dosage formulation of topiramate intended primarily for use by pediatric patients, or for patients who have difficulty swallowing tablets. Processes for preparing the pharmaceutical composition are also described.
Inventor(s): Thakur; Madhav S. (North Wales, PA), Kotwal; Pramod M. (Blue Bell, PA), Gibbs; Irwin S. (Huntington Valley, PA)
Assignee: Ortho-McNeil Pharmaceutical, Inc. (Raritan, NJ)
Application Number:10/748,764
Patent Claims: 1. A method of treating convulsions in a mammal in need thereof which comprises administering to the mammal a therapeutically effective amount of a pharmaceutical composition comprising (a) core particles containing an active agent of topiramate, a binder and a diluent wherein the diluent is sugar spheres and wherein the core particles have an initial particle size between about 0.710 mm and 1.18 mm; and (b) a taste mask coating, wherein the taste mask coating comprises between about 9% by weight and about 13% by weight of the pharmaceutical composition and wherein the coated particles of the pharmaceutical composition have a final particle size between about 0.850 mm and 1.18 mm; and wherein the coated particles are sprinkled onto soft food and swallowed.

2. The method of claim 1, wherein the taste mask coating comprises about 11% by weight of the pharmaceutical composition.

3. The method of claim 1, wherein the binder is selected from povidone, HPMC, sodium alginate, panwar gum, acacia gum, gelatin, sugar, molasses, starch, pregelatinized starch, methycellulose, ethylcellulose or caroboxymethylcellulose; and the taste mask coating comprises a taste masking agent and a disintegrant, wherein the taste masking agent is selected from cellulose acetate, methylcellulose, ethylcellulose, a Eudragit or cellulose acetate butyrate; and the disintegrant is selected from povidone, cellulose, carboxymethylcellulose, croscarmellose sodium, magnesium aluminate silicate, starch, sodium starch glycolate, pregelatinized starch, alginic acid or guar gum.

4. The method of claim 3, wherein the binder is povidone, the taste masking agent is cellulose acetate and the disintegrant is povidone.

5. The method of claim 4, wherein the coated particles of the pharmaceutical composition are encapsulated.
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