STABLE FORMULATION OF AMORPHOUS PERINDOPRIL SALTS, A PROCESS FOR THE PREPARATION THEREOF ON INDUSTRIAL SCALE AND USE THEREOF IN THE TREATMENT OF HYPERTENSION

摘要

The present invention discloses a preparation of a stable formulation of alkali and alkaline earth salts of perindopril in an amorphous form, wherein perindopril in the form of a free acid, dissolved in alcohol, is neutralized with an aqueous solution of alkali or alkaline earth base, this solution is thereafter sprayed onto inert substances for the preparation of a granulate and dried in a stream of warm air at 30-50 °C or in vacuum. Substances to facilitate tabletting or additional active substances, such as diuretics, preferably indapamide, are added to this granulate to be tabletted.