公开(公告)号：EP4043008A1

公开(公告)日：2022-08-17

申请号：EP21460013.2

申请日：2021-02-15

申请人： Warszawskie Zaklady Farmaceutyczne Polfa S.A.

发明人： Kubisiak, Marcin ,  Pietrzak, Tomasz ,  Ratajczak, Tomasz ,  Szendzielorz, Ziemowit ,  Borychowska, Joanna

IPC分类号： A61K9/19 ,  A61K9/00 ,  A61K9/10 ,  A61K31/496 ,  A61P25/18

摘要： It relates to a process for the preparation of an extended-release pharmaceutical composition comprising aripiprazole and a pharmaceutically acceptable vehicle, wherein the process comprises: a) providing aripiprazole; b) providing a vehicle which is an aqueous solution, wherein the vehicle comprises a suspending agent which comprises a cellulose, and wherein the vehicle has been submitted to a thermal treatment; c) combining a) and b) to form a primary suspension comprising aripiprazole in the form of particles; and d) reducing the size of the aripiprazole particles to obtain a secondary suspension, wherein the aripiprazole particles in the secondary suspension have a volume moment mean diameter D[4,3] from 1 to 10 microns. The obtained suspension may be freeze-dried and stored and can be conveniently reconstituted as a suspension before administration.