Lenalidomide solvates and processes
AssigneeDr. Reddy's Laboratories, Inc.
InventorsSrinivasulu Rangineni, Nagakiran Duggirala, Vamsi Krishna Mudapaka, Rajasekhar Kadaboina, Veerender Murki, Amarendhar Manda, Venkata Rao Badisa, Naresh Vemula, Rama Seshagiri Rao Pulla
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Abstract
The present application relates to lenalidomide salts and solvates, and processes for the preparation thereof.
Claims21
1-20. (canceled)
A process for preparing a N,N-dimethylformamide solvate of Lenalidomide, comprising:
- a) reducing 3-(4-nitro-1-oxo 1,3-dihydroisoindol-2-yl)piperidine-2,6-dione of formula II,
- with a catalyst in the presence of an acid to give an acid addition salt of lenalidomide of formula III,
- wherein HX is an acid;
- and
- b) reacting the acid addition salt of lenalidomide of formula III with a base in the presence of N,N-dimethylformamide to provide a N,N-dimethylformamide solvate of lenalidomide.
A process for preparing a N,N-dimethylformamide solvate of lenalidomide, comprising:
- a) providing a solution of an acid addition salt of lenalidomide of formula III in a solvent comprising N,N-dimethylformamide;
- b) combining a base with the solution of step a);
- c) optionally, adding an anti-solvent;
- and
- d) isolating an N,N-dimethylformamide solvate of lenalidomide.
A process for preparing a N,N-dimethylformamide solvate of lenalidomide, comprising:
- a) providing a solution or suspension of lenalidomide in a solvent comprising N,N-dimethylformamide;
- b) optionally, adding a solvent selected from an alcohol or a hydrocarbon;
- c) maintaining the solution or suspension at a temperature below 40° C.;
- d) isolating an N,N-dimethylformamide solvate of lenalidomide.
A N,N-dimethylformamide solvate of lenalidomide characterized by an X-ray powder diffraction pattern having peaks at 17.0, 23.3 and 25.4±0.2 degrees 2-theta.
Dependencies are inferred from the claim text.