Polymorph of a Pharmaceutical
AssigneeAbbott Laboratories
InventorsJohn F. Bauer, Azita Saleki-Gerhardt, Bikshandarkoil A. Narayanan, Sanjay R. Chemburkar, Ketan M. Patel, Harry O. Spiwek, Philip E. Bauer, Kimberly A. Allen
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Abstract
A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed.
Claims10
A process for preparing a composition comprising ritonavir, said process comprising dissolving Form II and Form I crystalline ritonavir in a solvent, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.88°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.71°±0.1° and 25.38°±0.1°, and said Form I crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 3.33°±0.1°, 6.76°±0.1°, 8.33°±0.1°, 14.61°±0.1°, 16.33°±0.1°, 16.76°±0.1°, 17.03°±0.1°, 18.02°±0.1°, 18.62°±0.1°, 19.47°±0.1°, 19.86°±0.1°, 20.25°±0.1°, 21.46°±0.1°, 23.46°±0.1° and 24.36°±0.1°.
A composition comprising ritonavir, wherein said composition is prepared by a process which comprises dissolving Form II crystalline ritonavir in a solvent, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67°±0.1°, 9.88°±0.1°, 16.11°±0.1°, 16.70°±0.1°, 17.36°±0.1°, 17.78°±0.1°, 18.40°±0.1°, 18.93°±0.1°, 20.07°±0.1°, 20.65°±0.1°, 21.71°±0.1° and 25.38°±0.1°.
A process of making ritonavir Form I, comprising mixing ritonavir dissolved in ethyl acetate with seed crystals of ritonavir Form I in heptane.
Dependencies are inferred from the claim text.