Details for Patent: 9,255,092
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Title: | Polymorph of a pharmaceutical |
Abstract: | A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed. |
Inventor(s): | Bauer; John F. (Georgetown, KY), Saleki-Gerhardt; Azita (Mettawa, IL), Narayanan; Bikshandarkoil A. (Newton, CT), Chemburkar; Sanjay R. (Gurnee, IL), Patel; Ketan M. (Wheeling, IL), Spiwek; Harry O. (Kenosha, WI), Bauer; Philip E. (Chester Springs, PA), Allen; Kimberly A. (Trevor, WI) |
Assignee: | AbbVie Inc. (North Chicago, IL) |
Filing Date: | Oct 14, 2013 |
Application Number: | 14/053,311 |
Claims: | 1. A composition comprising one or more of amorphous ritonavir and Form II crystalline ritonavir, wherein said composition is prepared by dissolving one or more of Form II crystalline ritonavir 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.degree..+-.0.1.degree., 9.88.degree..+-.0.1.degree., 16.11.degree..+-.0.1.degree., 16.70.degree..+-.0.1.degree., 17.36.degree..+-.0.1.degree., 17.78.degree..+-.0.1.degree., 18.40.degree..+-.0.1.degree., 18.93.degree..+-.0.1.degree., 20.07.degree..+-.0.1.degree., 20.65.degree..+-.0.1.degree., 21.71.degree..+-.0.1.degree. and 25.38.degree..+-.0.1.degree., and wherein said Form I crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 3.33.degree..+-.0.1.degree., 6.76.degree..+-.0.1.degree., 8.33.degree..+-.0.1.degree., 14.61.degree..+-.0.1.degree., 16.33.degree..+-.0.1.degree., 16.76.degree..+-.0.1.degree., 17.03.degree..+-.0.1.degree., 18.02.degree..+-.0.1.degree., 18.62.degree..+-.0.1.degree., 19.47.degree..+-.0.1.degree., 19.86.degree..+-.0.1.degree., 20.25.degree..+-.0.1.degree., 21.46.degree..+-.0.1.degree., 23.46.degree..+-.0.1.degree. and 24.36.degree..+-.0.1.degree.. 2. The composition of claim 1, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67.degree..+-.0.1.degree., 9.51.degree..+-.0.1.degree., 9.88.degree..+-.0.1.degree., 10.97.degree..+-.0.1.degree., 13.74.degree..+-.0.1.degree., 16.11.degree..+-.0.1.degree., 16.70.degree..+-.0.1.degree., 17.36.degree..+-.0.1.degree., 17.78.degree..+-.0.1.degree., 18.40.degree..+-.0.1.degree., 18.93.degree..+-.0.1.degree., 19.52.degree..+-.0.1.degree., 19.80.degree..+-.0.1.degree., 20.07.degree..+-.0.1.degree., 20.65.degree..+-.0.1.degree., 21.49.degree..+-.0.1.degree., 21.71.degree..+-.0.1.degree., 22.23.degree..+-.0.1.degree., 25.38.degree..+-.0.1.degree., 26.15.degree..+-.0.1.degree. and 28.62.degree..+-.0.1.degree.. 3. A composition comprising one or more of amorphous ritonavir and Form II crystalline 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.degree..+-.0.1.degree., 9.88.degree..+-.0.1.degree., 16.11.degree..+-.0.1.degree., 16.70.degree..+-.0.1.degree., 17.36.degree..+-.0.1.degree., 17.78.degree..+-.0.1.degree., 18.40.degree..+-.0.1.degree., 18.93.degree..+-.0.1.degree., 20.07.degree..+-.0.1.degree., 20.65.degree..+-.0.1.degree., 21.71.degree..+-.0.1.degree. and 25.38.degree..+-.0.1.degree.. 4. The composition of claim 3, wherein said Form II crystalline ritonavir has characteristic peaks in a powder X-ray diffraction pattern at values of two theta of 8.67.degree..+-.0.1.degree., 9.51.degree..+-.0.1.degree., 9.88.degree..+-.0.1.degree., 10.97.degree..+-.0.1.degree., 13.74.degree..+-.0.1.degree., 16.11.degree..+-.0.1.degree., 16.70.degree..+-.0.1.degree., 17.36.degree..+-.0.1.degree., 17.78.degree..+-.0.1.degree., 18.40.degree..+-.0.1.degree., 18.93.degree..+-.0.1.degree., 19.52.degree..+-.0.1.degree., 19.80.degree..+-.0.1.degree., 20.07.degree..+-.0.1.degree., 20.65.degree..+-.0.1.degree., 21.49.degree..+-.0.1.degree., 21.71.degree..+-.0.1.degree., 22.23.degree..+-.0.1.degree., 25.38.degree..+-.0.1.degree., 26.15.degree..+-.0.1.degree. and 28.62.degree..+-.0.1.degree.. |