EP4183450A1 — Method for preparing a hydrated form of perindopril l-arginine

USPTO Abstract

The present invention relates to a novel process for preparing a hydrated form of perindopril L-arginine with improved process properties.In the process for the production of a hydrated form of perindopril L-arginine according to the invention, by precisely controlling and regulating the amount of water in the crystallisation solution comprising perindopril L-arginine, the isolation properties of the suspension of the hydrated form of perindopril L-arginine formed in the process are improved, i.e. the stability time of the resulting suspension is prolonged, the filtration time of the suspension is shortened and the amount of solvent and antisolvent in the final product - an isolated wet filter cake of the hydrated form of perindopril L-arginine - is reduced, wherein the wet filter cake has a high dry residue value after drying. The process according to the invention has a high molar yield and the resulting hydrated form of perindopril L-arginine has high chromatographic purity and adequate stability under storage conditions at room temperature.The process according to the invention is suitable for use on an industrial scale and provides an efficient, economical and reproducible process for the production of a hydrated form of perindopril L-arginine using materials that can be regenerated with a minimal environmental footprint.