Pharmaceutical formulation containing phenytoin sodium and magnesium stearate
AssigneeTaro Pharmaceuticals North America, Inc.
InventorsTamar Blumberg, Orit Brodzsky, Nataly Zissman, Avraham Yacobi
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Abstract
The present invention relates to a novel pharmaceutical formulation comprising phenytoin sodium, a high amount of magnesium stearate, and a low level of a hydrophilic polymer such as a methocel, and a method of preparing the same by blending.
Claims20
A pharmaceutical formulation of phenytoin sodium comprising from about 10% (w/w) to about 90% (w/w) phenytoin sodium, from about 6% (w/w) to about 20% (w/w) magnesium stearate and from about 1% (w/w) to about 7% (w/w) of a hydrophilic polymer.
A pharmaceutical formulation of phenytoin sodium comprising about 42% (w/w) phenytoin sodium, about 9% (w/w) magnesium stearate and, about 4% (w/w) hydroxypropyl methylcellulose, about 20% lactose and 10% talc.
A process for preparing a pharmaceutical phenytoin sodium formulation comprising the steps of:
- (a) screening a mixture of phenytoin sodium and a hydrophilic polymer through a 30 mesh sieve;
- (b) screening magnesium stearate through a 60 mesh screen;
- and,
- (c) mixing the phenytoin sodium, hydrophilic polymer from step (a) and magenisum stearate from step (b) together to form a dry blended powder.
Dependencies are inferred from the claim text.