The present invention relates to novel
ramipril crystalline particles with improved stability and
bioavailability. More particularly, the present invention is directed to individually coated, single
ramipril crystalline particles for pharmaceutical and
biopharmaceutical applications in oral therapies that are stabilized against
decomposition into degradation products, namely,
ramipril-DKP and ramipril-diacid, during formulation and storage conditions. The present invention also relates to stabilized ramipril pharmaceutical compositions, novel
anhydrous pharmaceutical grade ramipril powders, methods for improving ramipril
bioavailability, and methods of manufacture and stabilization of ramipril formulations. The novel,
anhydrous pharmaceutical grade ramipril powders and ramipril compositions and dosage forms formed therewith are useful in the treatment of cardiovascular disorders and have the
advantage that they provide greater stability against
decomposition into ramipril-DKPs and ramipril-diacids under formulation and storage conditions. In addition, they maintain consistent
label ramipril
potency over extended shelf-life and provide reduced
in vivo variability in the
bioavailability of ramipril among subjects when administered orally.