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US 2009/0023955 A1Published application
Novel process for the preparation of sertraline hydrochloride form II
AssigneeApotex Pharmachem Inc.
InventorsDaqing Che, Fan Wang, Shahid Rabbani
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Abstract
The present invention relates to novel processes to produce sertraline hydrochloride Form II comprising the steps of forming a solution of sertraline hydrochloride in a polar organic solvent and adding this solution to a less polar organic solvent.
Claims18
A process to prepare sertraline hydrochloride Form II comprising:
- (a) forming a solution of sertraline hydrochloride by dissolving said sertraline hydrochloride in a first organic solvent, wherein said first organic solvent is a polar organic solvent or mixture thereof;
- and
- (b) adding the solution formed in step (a) to a second organic solvent to form sertraline hydrochloride Form II, wherein said second organic solvent is selected from a C3 to C8 ester, C4 to C8 ether, C3 to C8 ketone, C5 to C10 hydrocarbon, C3 to C6 alcohol and a mixture thereof.
A process to prepare sertraline hydrochloride Form II comprising:
- (a) forming a solution of sertraline free base in a first organic solvent, wherein said first organic solvent is a polar organic solvent or mixture thereof, by the process of either:
- i. adding a base to a solution comprising sertraline mandelate and a first organic solvent;
- or
- ii. adding a base to a solution comprising sertraline mandelate and an organic solvent, removing said organic solvent to isolate sertraline free base and dissolving said isolated sertraline free base in a first organic solvent;
- (b) adding hydrogen chloride, in the form of a gas or a solution, to the solution formed in step (a) to form a sertraline hydrochloride solution;
- and
- (c) adding the solution formed in step (b) to a second organic solvent to form sertraline hydrochloride Form II, wherein said second organic solvent is selected from a C3 to C8 ester, C4 to C8 ether, C3 to C8 ketone, C5 to C10 hydrocarbon, C3 to C6 alcohol and a mixture thereof.
4 more elements
A process to prepare sertraline hydrochloride Form II comprising:
- (a) forming a solution of sertraline hydrochloride in n-butanol;
- (b) adding the solution formed in step (a) to ethyl acetate, MTBE, MIBK or heptanes to form sertraline hydrochloride Form II;
- (c) isolating sertraline hydrochloride Form II;
- and
- (d) drying said sertraline hydrochloride Form II.
2 more elements
A process to prepare sertraline hydrochloride Form II comprising:
- (a) forming a solution of sertraline hydrochloride in DMF;
- (b) adding the solution formed in step (a) to ethyl acetate to form sertraline hydrochloride Form II;
- (c) isolating sertraline hydrochloride Form II;
- and
- (d) drying said sertraline hydrochloride Form II.
2 more elements
Dependencies are inferred from the claim text.