Abstract: Disclosed is a method of manufacturing a cardiovascular fixed-dose combination pharmaceutical dosage form that includes an anti-hypertensive active agent, a cholesterol-lowering active agent, and optionally, an enteric-coated aspirin or platelet inhibitor. The fixed-dose combination is prepared with at least two granulation solutions that are free of citric acid and enhance the aqueous solubility of the cholesterol-lowering agent in fixed-dose combination. The active agents in the resulting dosage form, which is also free of citric acid, have the same strength and release profiles as the same active agents prepared as a single formulation.
Type:
Grant
Filed:
April 17, 2019
Date of Patent:
August 29, 2023
Assignee:
CardioPharma, Inc.
Inventors:
Roy A. Stimits, Daniel Tyree Gregory, Jr., Wayne L. Whittingham, Stephan Dale Glenn, David P. Hause