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US 5,635,208 AGranted
Granulation process for producing an acetaminophen and diphenhydramine hydrochloride composition and composition produced by same
AssigneeMcNeil-PPC, Inc.
InventorsKishor B. Parekh, Peter F. Eisenhardt, Robert Hitchner
Life of this patent
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Abstract
A granulation process for preparing a solid dosage form containing acetaminophen and diphenhydramine hydrochloride, as active agents is disclosed. In addition, the solid dosage form produced by the process is described.
Claims11
A process for preparing a medicament comprising acetaminophen and diphenhydramine hydrochloride for use in forming a suitable dosage form, wherein the process comprises:
- (a) blending together acetaminophen, a filler and a disintegrant to form a dry blend;
- (b) spraying a binder into a granulator containing the dry blend formed in step (a) while the dry blend is being mixed so as to form a wet granulation;
- (c) partially drying the wet granulation of step (b);
- (d) spraying a solution of diphenhydramine hydrochloride into the granulator containing the partially dried granulation of step (c) while the partially dried granulation is being mixed;
- (e) spraying a binder selected from the group consisting of hydroxypropyl methylcellulose, polyvinyl pyrrolidone and pregelatinized starch into the granulator containing the granulation of step (d);
- (f) drying the granulation of step (e) so as to form the granulated medicament.
3 more elements
Dependencies are inferred from the claim text.