Process for making amlodipine maleate, the amlodipine maleate prepared, the pharmaceutical composition and the use thereof

Process for making amlodipine maleate, the amlodipine maleate prepared, the pharmaceutical composition and the use thereof

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 exce...

Ausführliche Beschreibung

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Bibliographische Detailangaben
Hauptverfasser: FRANTISEK PICHA, FRANCISCUS BERNARDUS GEMMA BENNEKER, PAVEL SLANINA
Format: Patent
Sprache:eng
Schlagworte:
CHEMISTRY
HETEROCYCLIC COMPOUNDS
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
METALLURGY
ORGANIC CHEMISTRY
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung: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).