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AssigneeHetero Drugs Limited
InventorsBandi Parthasaradhi Reddy, Kura Rathnakar Reddy, Rapolu Raji Reddy, Dasari Muralidhara Reddy, Kesireddy Subash Chander Reddy
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The present invention discloses novel and stable polymorphs of rimonabant, its hydrates and solvates, to the processes for their preparation and to pharmaceutical compositions comprising them. The present invention further discloses a novel and stable amorphous form of rimonabant, process for its preparation and a pharmaceutical composition comprising it. The present invention also provides an improved process for the preparation of rimonabant crystalline Form II. Thus, for example, rimonabant is dissolved in methylene dichloride, stirred for 10 minutes at 25-30° C. and then the solvent distilled off under vacuum at 40° C. The resulting residue is stirred with water and the separated solid is collected at 25-30° C. to give a stable crystalline rimonabant hydrate.
A crystalline rimonabant hydrate having a water content in the range of about 3-15% by weight, characterized by peaks in a powder X-ray diffraction pattern having 2θ angle positions at about 9.3, 10.5, 13.5, 14.5, 15.3, 16.1, 17.1, 17.8, 20.8, 21.1, 22.4, 22.9, 23.6 and 27.3±0.1 degrees.
Amorphous rimonabant.
Crystalline rimonabant n-propanol solvate.
Crystalline rimonabant n-butanol solvate.
A process for the preparation of rimonabant crystalline Form II, which comprises:
Dependencies are inferred from the claim text.