Phenytoin sodium pharmaceutical compositions
AssigneeMylan Pharmaceuticals Inc.
InventorsWilliam J. Addicks, Joseph P. Duda, Daniel A. Snider, Kerry R. Benson
Life of this patent
Estimating the term…
Abstract
A pharmaceutical composition is provided containing an admixture of phenytoin sodium and an erodible matrix which extends the release of the phenytoin sodium over about a two hour period. The erodible matrix comprises binder(s) and diluent(s) which control the release of drug from the pharmaceutical composition. The erodible matrix can further comprise an alkaline pH modifier.
Claims18
A pharmaceutical composition comprising one or more tablets in a capsule, wherein each of said tablets comprises an admixture of phenytoin sodium and an erodible matrix, wherein said matrix comprises a pharmaceutically acceptable binder(s), diluent(s), or combination thereof, and wherein said matrix releases said phenytoin initially and after storage for 12 months at 25 degrees centrigrade/60% relative humidity over two hours when measured in-vitro by dissolution testing and wherein said capsule comprises from 100-300 mg of said phenytoin sodium.
A pharmaceutical composition comprising one or more tablets in a capsule, said tablets compressed from an admixture formed from mixing:
- (a) about 10% to about 75% by weight phenytoin sodium and
- (b) about 25% to about 90% by weight of a combination of erodible matrix components, said components comprising:
- i) about 1% to about 5% by weight hydroxyethyl cellulose,
- ii) about 66% to about 86% by weight microcrystalline cellulose,
- iii) about 5% to about 12% by weight povidone, and
- iv) about 1% to about 7% by weight magnesium oxide,
- wherein said composition comprises from 200-300 mg in total of phenytoin sodium, and wherein said composition has the following in-vitro dissolution profile initially and after storage for 12 months at 25 degrees centigrade/60% relative humidity when measured in-vitro by dissolution testing:
- (a) not more than 45 percent in 30 minutes,
- (b) between 30 to 85 percent in 60 minutes,
- (c) not less than 70 percent in 120 minutes.
Dependencies are inferred from the claim text.