Pharmaceutical composition useful for making amlodipine tablets, comprising amlodipine free base and excipients, leaves only a small residue in the tabletting press

摘要

Pharmaceutical tablet composition comprising amlodipine free base (I) and excipients leaves only a small residue in the tabletting press. Independent claims are also included for: (1) crystalline form II of (I); (2) treating or preventing hypertension, angina or congestive heart failure by administering (I); (3) process comprising deprotecting an N-protected amlodipine derivative to form (I), precipitating (I) from solution and isolating the precipitated (I) in solid form; (4) purification of (I) by crystallization from a non aqueous solvent; (5) particles of (I) with an average particle size of at least 100 micro m.