Phenytoin sodium pharmaceutical compositions
AssigneeMylan Pharmaceuticals Inc.
InventorsWilliam J Addicks, Joseph P Duda, Daniel A. Snider, Kerry R Benson
Life of this patent
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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.
Claims44
A pharmaceutical composition comprising an admixture of phenytoin sodium and an erodible matrix, wherein said matrix comprises a pharmaceutcally 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 centigrade/60% relative humidity over two hours when measured in-vitro by dissolution testing.
A pharmaceutical composition comprising a tablet in a capsule, wherein said tablet is compressed from an admixture of phenytoin sodium and an erodible matrix, wherein said matrix comprises a pharmaceutically acceptable binder(s), diluent(s), and optionally, alkaline pH modifier(s), 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:
- not more than 45 percent released in 30 minutes,
- between 40 and 80 percent released in 60 minutes,
- not less than 70 percent released in 120 minutes.
A pharmaceutical composition comprising a tablet in a capsule, said tablet 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,
- 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 40 to 80 percent in 60 minutes,
- (c.) not less than 70 percent in 120 minutes.
A pharmaceutical composition comprising a phenytoin species in an erodible matrix, wherein the species has the Raman Shift as set out in FIG. 2 and the matrix comprises a pharmaceutically acceptable binder(s), diluent(s), or combination thereof.
A pharmaceutical composition comprising a tablet in a capsule, wherein said tablet comprises a phenytoin species having the Raman shift as is set out in FIG. 2 in an erodible matrix 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 released in 30 minutes,
- (b.) between 40 and 80 percent released in 60 minutes,
- (c.) not less than 70 percent released in 120 minutes.
A phenytoin species having the Raman Shift as set out in FIG. 2.
Dependencies are inferred from the claim text.