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Details for Patent: 8,674,112

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Details for Patent: 8,674,112

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. (Lake Bluff, IL), Saleki-Gerhardt; Azita (Libertyville, 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:May 25, 2012
Application Number:13/480,882
Claims:1. 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.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 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 process 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. The process of claim 1, wherein said solvent is ethyl acetate.

4. The process of claim 1, wherein said solvent is isopropyl acetate.

5. The process of claim 1, wherein said solvent comprises ethanol and oleic acid.

6. A process of making ritonavir Form I, comprising mixing ritonavir dissolved in ethyl acetate with seed crystals of ritonavir Form I in heptane.
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