Invention Grant
- Patent Title: Process for the preparation of polymorph form B of treprostinil diethanolamine salt
-
Application No.: US16978391Application Date: 2019-03-07
-
Publication No.: US11319274B2Publication Date: 2022-05-03
- Inventor: Irén Hortobágyi , István Lászlófi , Zoltán Varga , Imre Juhász , Imola Ritz , Zsuzsanna Kardos
- Applicant: CHINOIN GYÓGYSZER ÉS VEGYÉSZETI TERMÉKEK GYÁRA ZRT.
- Applicant Address: HU Budapest
- Assignee: CHINOIN GYÓGYSZER ÉS VEGYÉSZETI TERMÉKEK GYÁRA ZRT.
- Current Assignee: CHINOIN GYÓGYSZER ÉS VEGYÉSZETI TERMÉKEK GYÁRA ZRT.
- Current Assignee Address: HU Budapest
- Agency: Birch, Stewart, Kolasch & Birch, LLP
- Priority: HUP1800089 20180309
- International Application: PCT/HU2019/050007 WO 20190307
- International Announcement: WO2019/171093 WO 20190912
- Main IPC: C07C51/43
- IPC: C07C51/43 ; C07C59/72 ; C07C215/10

Abstract:
The invention relates to a robust and reproducible process for the preparation of polymorph form B of treprostinil diethanolamine salt, comprising the following steps: a. treprostinil is dissolved in methanol, b. to the solution of step a) diethanolamine or its methanol solution is added, c. the reaction mixture of step b) is agitated till dissolution, d. when salt formation is completed in step c), first portion of an aprotic solvent is added to the solution, e. the solution of step d) is filtered to remove insoluble impurities, f. the filtrate of step e) is seeded with polymorph form B of treprostinil diethanolamine salt, g. to the crystal suspension obtained in step f) a second portion of the aprotic solvent is added, h. the suspension of step g) is agitated until crystallisation is completed, i. the crystals are separated, washed and dried.
Public/Granted literature
- US20210053901A1 PROCESS FOR THE PREPARATION OF POLYMORPH FORM B OF TREPROSTINIL DIETHANOLAMINE SALT Public/Granted day:2021-02-25
Information query