Process for the preparation of lenalidomide
AssigneeGenerics [UK] Limited
InventorsVinayak Govind Gore, Vinay Kumar Shukla, Shreyas Shrikant Bhandari, Suresh Hasbe
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Abstract
The present invention relates to improved processes for preparing 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione (I) (lenalidomide) and its intermediate 3-(1-oxo-4-nitro-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione. The present invention further relates to improved processes for preparing lenalidomide crystalline form A, use of said crystalline form A as an active pharmaceutical ingredient or as an intermediate in the preparation of further crystalline or amorphous forms of lenalidomide, compositions comprising lenalidomide crystalline form A and their use in the treatment of disease.
Claims9
A process for the preparation of lenalidomide, comprising the catalytic reduction of 3-(1-oxo-4-nitro-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione, comprising:
- (i) mixing the 3-(1-oxo-4-nitro-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione in a solvent system;
- (ii) contacting the resulting mixture from step (i) with a catalyst;
- and
- (iii) contacting the mixture from step (ii) with hydrogen;
- characterised in that the solvent system comprises a mixture of polar solvents, wherein the mixture of polar solvents comprises a straight or branched chain aliphatic alcohol with 1 to 5 carbon atoms and an aliphatic nitrile with 1 to 3 carbon atoms, wherein the aliphatic nitrile is present at between 40% to 70% of the solvent system.
Dependencies are inferred from the claim text.