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公开(公告)号:EP3616688A1
公开(公告)日:2020-03-04
申请号:EP18306138.1
申请日:2018-08-27
申请人: Centre National de la Recherche Scientifique - CNRS , UNIVERSITE PARIS DESCARTES , INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) , Ecole Nationale Superieure de Chimie de Paris
IPC分类号: A61K9/14 , A61K9/51 , A61K31/365 , A61K31/7048 , A61P35/00
摘要: The invention relates to a method for manufacturing a nanostructured powder comprising nanocrystalline agglomerates containing active pharmaceutical ingredient (API) in its crystalline form, said method comprising (i) Preparing a first solution comprising API and an API solvent; (ii) Mixing the first solution with a second solution comprising an API antisolvent and optionally a stabilizing agent P1 to obtain a third mixture; (iii) Evaporating the third mixture until both the API solvent and the API antisolvent are evaporated, advantageously under vacuum; characterized in that when the stabilizing agent P1 is present, the third mixture has a stabilizing agent P1 to API weight ratio equal or less than 5, preferably less than 2. The invention also concerns a nanostructured powder and a nanosuspension.