Process for the preparation of vilazodone hydrochloride and its amorphous form
AssigneeAlembic Pharmaceuticals Limited
InventorsVenkat Raman Jayaraman, Dhiraj Rathod, Irfan Vohra, Vinayak Bhujade, Viral Modi, Mayur Budh, Ojas Gandhi
Life of this patent
Estimating the term…
Abstract
The present invention relates to an improved process for the preparation of vilazodone Hydrochloride and a process for preparation of novel pure amorphous form of vilazodone hydrochloride.
Claims21
-32. (canceled)
A process for preparation of Vilazodone a compound of formula (I) or a salt thereof, comprising a step of reacting compound of formula (II) with source of ammonia to get a compound of formula (I).
A process for preparation of a thermodynamically stable and substantially pure amorphous form of Vilazodone hydrochloride, which comprises:
- a) providing a solution of Vilazodone hydrochloride in a first solvent or a mixture of solvents;
- b) optionally, filtering said solvent solution to remove any extraneous matter;
- and
- c) substantially removing said solvent from said solvent solution to afford amorphous form of Vilazodone hydrochloride.
A process for the preparation of Vilazodone or a salt thereof and its amorphous form, comprising:
- a. reacting 5-nitro salicaldehyde of formula (III) with 2-bromo diethyl malonate of formula (IV) to get compound of formula (V);
- b. reducing compound of formula (V) to get compound of formula (VI);
- c. converting compound of formula (VI) to compound of formula (VII);
- d. Condensing compound of formula (VII) or salt thereof with compound of formula (VIII) to get compound of formula (II) or salt thereof;
- e. reacting compound of formula (II) with source of ammonia to get compound of formula (I);
- and
- f. converting Vilazodone base of formula (I) into amorphous form of Vilazodone hydrochloride.
Dependencies are inferred from the claim text.