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US 11,111,228 B2Granted
Process for the preparation of pomalidomide and its purification
AssigneeNatco Pharma Limited
InventorsDurga Prasad Konakanchi, Buchappa Gongalla, Dharmendher Ragidi, Uma Naresh Babu Kotra, Kali Satya Bhujanga Rao Adibhatla, Venkaiah Chowdary Nannapaneni
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Abstract
The present invention is related to an improved process for the preparation of Pomalidomide with higher yields and high purity. Particularly the present invention relates to form A preparation of Pomalidomide and its purification. wherein the present process doesn't involve use of dioxane solvent and avoids higher temperatures.
Claims4
A process for the preparation of pomalidomide form A comprising the steps of:
- a) reacting 3-nitrophthalic acid with acetic anhydride in presence of toluene to get 3-nitrophthalic anhydride,
- b) reacting 3-nitrophthalic anhydride with 3-aminoglutarimide hydrochloride in presence of tri ethylamine and acetic acid solvent to get 2-(2, 6-dioxo-3-piperidyl)-4-nitro-isoindoline-1, 3-dione,
- c) reducing the 2-(2, 6-dioxo-3-piperidyl)-4-nitro-isoindoline-1, 3-dione in the presence of Pd/C, dimethyl formamide solvent, and nitrogen, with hydrogen gas bubbled into the reaction mass, at 15° C. to 20° C. to get pomalidomide form A.
Dependencies are inferred from the claim text.