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Details for Patent: 7,183,416

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Details for Patent: 7,183,416

Title:Polymorph of a pharmaceutical
Abstract: A new crystalline polymorph of ritonavir and methods for its use and preparation are disclosed.
Inventor(s): Chemburkar; Sanjay R. (Gurnee, IL), Patel; Ketan (Arlington Heights, IL), Spiwek; Harry O. (Kenosha, WI)
Assignee: Abbott Laboratories (Abbott Park, IL)
Filing Date:Jul 29, 2004
Application Number:10/901,818
Claims:1. A process for preparing amorphous ritonavir, comprising adding a solution of ritonavir to a sufficient amount of an anti-solvent, thereby producing solid amorphous ritonavir, wherein said solution comprises a solvent selected from the group consisting of methylene chloride and methanol.

2. The process of claim 1, wherein said solution comprises methylene chloride as a solvent, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 60 110 mL of anti-solvent per gram of ritonavir.

3. The process of claim 1, wherein said solution comprises methylene chloride as a solvent, and said anti-solvent is hexane, and wherein the concentration of ritonavir in said solution is about 1 gram of ritonavir per about 1.5 mL of methylene chloride, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 85 90 mL of anti-solvent per gram of ritonavir.

4. The process of claim 1, wherein said solution comprises methanol as a solvent, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 60 150 mL of anti-solvent per gram of ritonavir.

5. The process of claim 1, wherein said solution comprises methanol as a solvent, and said anti-solvent is methyl t-butyl ether, and wherein the concentration of ritonavir in said solution is about 1 g of ritonavir per 1.5 mL of methanol, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 90 110 mL of anti-solvent per gram of ritonavir.

6. The process of claim 1, wherein said solution comprises methanol as a solvent, and said anti-solvent is methyl t-butyl ether, and wherein the concentration of ritonavir in said solution is about 1 g of ritonavir per 1.5 mL of methanol, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 100 mL of anti-solvent per gram of ritonavir.

7. A process for preparing substantially pure amorphous ritonavir, comprising adding a solution of ritonavir to a sufficient amount of an anti-solvent, thereby producing substantially pure solid amorphous ritonavir, wherein said solution comprises methylene chloride as a solvent, and said anti-solvent is selected from the group consisting of hexane and heptane, and wherein the concentration of ritonavir in said solution is about 1 gram of ritonavir per about 1.5 2.0 mL of methylene chloride, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 60 110 mL of anti-solvent per gram of ritonavir.

8. A process for preparing substantially pure amorphous ritonavir, comprising adding a solution of ritonavir to a sufficient amount of an anti-solvent, thereby producing substantially pure solid amorphous ritonavir, wherein said solution comprises methanol as a solvent, and said anti-solvent is methyl t-butyl ether.

9. The process of claim 8, wherein the concentration of ritonavir in said solution is about 1 gram of ritonavir per about 1.5 2.0 mL of methanol, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 60 150 mL of anti-solvent per gram of ritonavir.

10. The process of claim 8, wherein the concentration of ritonavir in said solution is about 1 gram of ritonavir per about 1.5 mL of methanol, and the relative amount of said anti-solvent as compared to ritonavir in said solution is about 90 110 mL of anti-solvent per gram of ritonavir.
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