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AssigneeDr. Reddy's Laboratories, Inc.
InventorsManne Satyanarayana Reddy, Chakilam Nagaraju, Gudipati Srinivasulu, Mandava Venkata Naga Brahmeshwar Rao, Bojja Ramachandra Reddy, Singamsetty Radhakrishna
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A crystalline Form II of 17β-N-[2,5-bis (trifluoromethyl)phenyl]carbamoyl-4-aza-5-α-androst-1-en-3-one (dutasteride) is provided. The preferred crystalline Form II of dutasteride has an X-ray powder diffraction pattern, expressed in terms of d-spacing (in ° A), with peaks at about 13.42, 6.96, 6.13, 5.27, 4.77, 4.70, 4.58, 4.46 and 3.82. A process for preparation of a crystalline Form II of dutasteride is also provided and includes dissolving a crude form of dutasteride in an alcoholic solvent having from 1 to 5 carbon atoms; removing the alcoholic solvent to obtain a residue; adding an ester solvent to the residue; and filtering the resulting separated solids. The processes of the invention are believed to be simple, eco-friendly, and commercially viable.
A crystalline Form II of 17β-N-[2,5-bis (trifluoromethyl) phenyl]carbamoyl-4-aza-5α-androst-1-en-3-one (dutasteride).
A process for preparation of a crystalline Form II of dutasteride, said process comprising:
A process for the preparation crystalline Form I of dutasteride, said process comprising:
An amorphous form of 17β-N-[2,5-bis (trifluoromethyl) phenyl]carbamoyl-4aza-5-α-androst-1-en-3-one (dutasteride).
A process for preparation of novel amorphous form of dutasteride, said process comprising:
Dependencies are inferred from the claim text.