PROCESS FOR THE PREPARATION OF STABLE AND HIGHLY PURE CRYSTALLINE FORM 2 OF BILASTINE

Disclosed herein is a consistently reproducible process for the production of highly pure and stable crystalline Form 2 of Bilastine essentially free of other polymorphic forms. Provided also herein is a pharmaceutical composition comprising the highly pure crystalline Form 2 of Bilastine essentiall...

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Bibliographische Detailangaben
Hauptverfasser:	VENUGOPAL, Bingi, MOHAN RAO, Dodda
Format:	Patent
Sprache:	eng ; fre
Schlagworte:	CHEMISTRY HETEROCYCLIC COMPOUNDS HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE METALLURGY ORGANIC CHEMISTRY PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Beschreibung
Zusammenfassung:	Disclosed herein is a consistently reproducible process for the production of highly pure and stable crystalline Form 2 of Bilastine essentially free of other polymorphic forms. Provided also herein is a pharmaceutical composition comprising the highly pure crystalline Form 2 of Bilastine essentially free from other crystalline forms made by the process disclosed herein, and one or more pharmaceutically acceptable excipients. L'invention concerne un procédé reproductible de manière constante pour la production de la forme cristalline 2 hautement pure et stable de bilastine essentiellement exempte d'autres formes polymorphes. L'invention concerne également une composition pharmaceutique comprenant la forme cristalline 2 de grande pureté de bilastine sensiblement exempte d'autres formes cristallines fabriquée par le procédé de l'invention, et un ou plusieurs excipients pharmaceutiquement acceptables.