Stable pharmaceutical composition for atherosclerosis

A - Human Necessities – 61 – K

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Details

A61K 38/05 (2006.01) A61K 31/165 (2006.01) A61K 31/366 (2006.01) A61K 31/549 (2006.01) A61K 31/616 (2006.01) A61P 9/10 (2006.01) A61K 9/20 (2006.01) A61K 9/48 (2006.01)

Patent

CA 2754134

The present invention relates to a stable solid oral pharmaceutical multi- component composition comprising combination of blood pressure lowering drugs with lipid lowering agent/s and optionally a platelet aggregation inhibitor in a single dosage form. The blood pressure lowering agents are selected from .beta.- adrenergic receptor blocking agent, ACE inhibitor and diuretic. The lipid lowering agent is selected from HMG Co-enzyme-A reductase inhibitor. The pharmaceutical composition made as per present invention a) overcomes any drug-drug interactions, b) exhibits pharmacokinetic and pharmacodynamic profile of individual therapeutic agent, c) has minimal side effects. The invention provides multi-component composition (MCC) to increase adherences to therapy. The MCC as per present invention provides compositions that maintain activity of all active ingredients without significant increase in adverse event profile. The present invention further relates to a method of preparing the said pharmaceutical composition.

La présente invention concerne une composition multi-composant pharmaceutique orale solide stable, comprenant une combinaison de médicaments abaissant la pression artérielle avec un ou des hypolipidémiants et éventuellement un inhibiteur d'agrégation plaquettaire, dans une forme pharmaceutique unique. Lesdits hypolipidémiants sont sélectionnés parmi un agent bloquant le récepteur ß-adrénergique, un inhibiteur ACE et un diurétique. Ledit hypolypidémiant est sélectionné à partir de l'inhibiteur de réductase de la HMG CoA-réductase. La composition pharmaceutique réalisée selon la présente invention a) surmonte toute interaction médicament-médicament, b) présente un profil pharmacocinétique et pharmacodynamique de l'agent thérapeutique individuel, et c) possède des effets secondaires minimes. L'invention porte en outre sur une composition multi-composant (MCC) destinée à accroître l'adhésion à la thérapie. Le MCC selon la présente invention concerne des compositions qui maintiennent l'activité de tous les ingrédients actifs sans diminution significative, dans des profils d'événement anormal. La présente invention concerne en outre un procédé de préparation de ladite composition pharmaceutique.

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