Amlodipine maleate and pharmaceutical composition containing amlodipine maleate

摘要

Preparation of amlodipine maleate (I) comprises reacting amlodipine (II) or its acid addition salt with maleic acid (III) in an acidic environment. Independent claims are also included for: (1) a process of purification comprising crystallizing or precipitating (I) from a solution comprising an excess of (II); (2) a method for treatment or prevention of hypertension, angina or heart failure comprising administering a composition containing (I) and excipients which is free from amlodipine aspartate (IV); and (3) amlodipine maleate that is free from amlodipine aspartate (IV).