Bicalutamide polymorphs
AssigneeHetero Drugs Limited
InventorsReddy Parthasaradhi, Reddy Rathnakar, Reddy Raji, Reddy Narasa, Reddy Narasa
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Abstract
The invention provides crystalline form of bicalutamide and amorphous bicalutamide. The invention also provides methods for their preparation and pharmaceutical compositions containing the new forms of bicalutamide.
Claims12
1) Bicalutamide crystalline form characterized by a powder x-ray diffraction pattern having characteristic interplanar spacings shown in table 1.
2) Bicalutamide crystalline form characterized by an x-ray powder diffraction pattern of FIG. 1.
3) A method of preparing bicalutamide crystalline form which comprises:
- i) dissolving bicalutamide obtained by known method in a suitable solvent,
- ii) maintaining the solution obtained in step(i) at 0-40° C. for about 5 to 36 hours, optionally seeded with bicalutamide crystalline form,
- iii) filtering and drying the crystals formed to give bicalutamide crystalline form,
- wherein suitable solvents include C1-C3 alcohol, C1-C6 ketone.
8) Amorphous bicalutamide.
9) Amorphous bicalutamide characterized by a broad x-ray diffraction maxima at about 10.0 to 35.0 degree 2θ.
10) Amorphous bicalutamide having characteristic x-ray powder diffraction of FIG. 2.
11) A pharmaceutical composition comprising bicalutamide crystalline form and a pharmaceutically acceptable carrier.
12) A pharmaceutical composition comprising amorphous bicalutamide and a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.