coated stabilized ramipril particles, ramipril coating process, solid oral pharmaceutical composition, methods for preventing and treating cardiovascular disorders, and process for manufacturing a pharmaceutical composition

摘要

COATED STABILIZED RAMIPRIL PARTICULARS, RAMIPRIL COATING PROCESS, SOLID ORAL PHARMACEUTICAL COMPOSITION, METHODS FOR AVOIDING AND TREATING CARDIOVASCULAR DISORDERS, AND PROCESS TO MANUFACTURE A COMPULSORY. The present invention relates to novel crystalline ramipril particles with improved stability and bioavailability. More particularly, the present invention is directed to single coated single ramipril crystalline particles for pharmaceutical and biopharmaceutical applications in oral therapies which are stabilized against decomposition in degradation products, ie ramipril - DKP and diacid ramipril during formulations. and storage conditions. The present invention also relates to stabilized ramipril pharmaceutical compositions, novel pharmaceutical anhydrous ramipril powders, methods for improving the bioavailability of ramipril, and method of manufacturing and stabilizing ramipril formulations. The novel pharmaceutical-type anhydrous ramipril powders and ramipril compositions and dosage forms formed therein are usable in the treatment of cardiovascular disorders and have the advantage that they provide greater stability against decomposition in ramipril - DKPs, and ramipril - diacids under storage and formulation conditions. In addition, they maintain the potency of ramipril consistent with the label over a prolonged half-life and provide reduced in vivo variability in ranupril bioavailability among individuals when administered orally.