Forms of dutasteride and methods for preparation thereof

Details Forms of dutasteride and methods for preparation thereof Forms of dutasteride and methods for preparation thereof

2006-04-04

2006-04-04

Aulakh, Charanjit S. (Department: 1625)

Organic compounds -- part of the class 532-570 series

Organic compounds

Heterocyclic carbon compounds containing a hetero ring...

C546S061000, C514S284000

Reexamination Certificate

active

07022854

ABSTRACT:
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.

REFERENCES:
patent: 5565467 (1996-10-01), Batchelor et al.

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