Dry granulation formulation for an HIV protease inhibitor
AssigneeMerck & Co., Inc.
InventorsChung Y. Lui, Drazen Ostovic, Ashok V. Katdare, Christine Stelmach
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Abstract
This invention relates to a dry granulation capsule formulation of the HIV protease inhibitor, indinavir sulfate, which is useful in the treatment of AIDS, ARC or HIV infection. Processes for making the oral formulation are also disclosed.
Claims19
A pharmaceutical composition which comprises about 50 to 90% by weight of an active ingredient which is indinavir sulfate, about 10 to 50% by weight of a low moisture or anhydrous excipient and about 0.5 to 2% by weight of a lubricant.
A process for making a pharmaceutical composition containing an active ingredient of indinavir sulfate, comprising the steps of:
- (a) mixing about 50 to 90% by weight of the active ingredient with about 10 to 50% by weight of a low moisture or anhydrous excipient and about 0.25 to 1% by weight of a first lubricant;
- (b) compacting the mix from step (a) to form compacts;
- (c) milling the compacts from step (b) to form granules;
- (d) lubricating the granules from step (c) with about 0.25 to 1% by weight of a second lubricant;
- and
- (e) forming the lubricated granules from step (d) into a pharmaceutical composition.
Dependencies are inferred from the claim text.