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US 5,916,594 AGranted
Process of making solid ribavirin dosage forms
AssigneeSchering Corporation
InventorsStephen M. Liebowitz, Elliot I. Stupak, Imtiaz A. Chaudry, Winston A. Vadino, Frank E. Bowen
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Abstract
A process of making an orally administrable solid dosage form containing a compacted ribavirin composition having an advantageously high tap density of at least 0.6 g/mL as well as surprisingly rapid disintegration and dissolution rates and wherein the ribavirin is substantially free of polymorphic forms of ribavirin as determined is disclosed.
Claims11
A method of producing a rapidly dissolving compacted ribavirin composition which comprises the steps of:
- (a) admixing an antivirally effective amount of ribavirin, an effective amount of a pharmaceutically acceptable disintegrant, and an effective amount of at least one filler for a time sufficient and at a temperature wherein the heat produced is insufficient;
- and to form a homogeneous mixture;
- b) compacting the homogeneous mixture of Step (a) at a compressing force in the range of about 50 to about 75 kN for a time sufficient to produce an acceptable compact wherein the ribavirin is substantially free of polymorphic forms of ribavirin;
- c) admixing the acceptable compact of Step (b) with an effective amount of a lubricant for a time sufficient to produce a uniform, rapidly dissolving compacted ribavirin composition having a uniformly high tap density of at least about 0.60 glmL and wherein 80% of the rapidly dissolving compacted ribavirin composition dissolves in water in about 30 minutes.
1 more element
Dependencies are inferred from the claim text.