Pharmaceutical compositions of amlodipine and atorvastatin

A - Human Necessities – 61 – K

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Details

A61K 31/4422 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 31/40 (2006.01) A61P 3/10 (2006.01) A61P 9/00 (2006.01)

Patent

CA 2444554

A pharmaceutical composition comprising two components: (a) one component comprising a granulation of atorvastatin or pharmaceutically acceptable salts thereof and a carrier including an alkalizing agent that forms a pH greater than 5; and (b) a second component comprising amlodipine or pharmaceutically acceptable salts thereof and a carrier excluding an alkalizing agent that forms a pH greater than 5, wherein the two components are combined to form a final composition for a solid dosage form is described as well as methods to prepare the compositions, kits for containing such compositions, and a method of treating angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and/or hypercholesterolemia, and symptoms of cardiac risk using a therapeutically effective amount of the pharmaceutical composition.

Une composition pharmaceutique comprend deux constituants: (a) un constituant comprenant une granulation d'atorvastatine ou des sels pharmaceutiquement acceptables de cette dernière et un support comprenant un agent alcalifiant qui produit un pH supérieur à 5; et (b) un deuxième constituant comprenant de l'amlodipine ou des sels pharmaceutiquement acceptables de cette dernière et un support ne comprenant pas un agent alcalifiant qui produit un pH supérieur à 5; les deux constituants étant combinés pour former une composition finale destinée à une forme posologique solide. Cette invention concerne également des procédés de préparation desdites compositions, des trousses prévues pour renfermer ces compositions ainsi qu'une méthode de traitement de l'angine de poitrine, de l'athérosclérose, de l'hypertension et de l'hyperlipidémie et/ou de l'hypercholestérolémie combinées, et des symptômes de risque cardiaque au moyen d'une quantité thérapeutiquement efficace de ladite composition pharmaceutique.

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