ANTI-HYPERTENSIVE AND CHOLESTEROL-LOWERING FIXED-DOSE COMBINATION AND METHOD OF MANUFACTURE

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...

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Bibliographic Details
Main Authors GREGORY, JR., Dr. Daniel Tyree, WHITTINGHAM, Wayne L, STIMITS, Roy A, GLENN, Dr. Stephan Dale, HAUSE, David P
Format Patent
LanguageEnglish
French
German
Published 14.12.2022
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Summary: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.
Bibliography:Application Number: EP20190924674