Details for Patent: 7,981,911
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Title: | Pharmaceutical formulations |
Abstract: | Improved pharmaceutical compositions are provided comprising one or more solubilized HIV protease inhibiting compounds having improved solubility properties in a medium and/or long chain fatty acid, or mixtures thereof, a pharmaceutically acceptable alcohol, and water. |
Inventor(s): | Alani; Laman (Foster City, CA), Ghosh; Soumojeet (Lansdale, PA) |
Assignee: | Abbott Laboratories (Abbott Park, IL) |
Filing Date: | Jul 31, 2008 |
Application Number: | 12/183,507 |
Claims: | 1. A process of preparing a pharmaceutical composition which includes a solution, said process comprising filling said solution into a capsule, wherein said solution comprises: (a) ritonavir; (b) a pharmaceutically acceptable medium and/or long chain fatty acid, or a mixture of pharmaceutically acceptable medium and/or long chain fatty acids, in an amount of from 30% to 75% by weight of said solution; (c) water in an amount of from 0.4% to 3.5% by weight of said solution; and, optionally, (d) a pharmaceutically acceptable surfactant. 2. The process according to claim 1, wherein said solution further comprise a pharmaceutically acceptable alcohol. 3. The process according to claim 1, wherein said solution further comprises ethanol or propylene glycol in an amount of from 1% to 15% by weight of said solution. 4. The process according to claim 3, wherein said solution comprises said pharmaceutically acceptable surfactant in an amount of from 2% to 20% by weight of said solution. 5. The process according to claim 3, wherein said pharmaceutically acceptable medium or long chain fatty acid is a mono-unsaturated C.sub.16-C.sub.20 fatty acid which is liquid at room temperature, and said mixture of pharmaceutically acceptable medium and/or long chain fatty acids is a mixture of mono-unsaturated C.sub.16-C.sub.20 fatty acids which are liquids at room temperature. 6. The process according to claim 3, wherein said pharmaceutically acceptable medium and/or long chain fatty acid, and said mixture of pharmaceutically acceptable medium and/or long chain fatty acids, comprise oleic acid. 7. The process according to claim 1, wherein said solution comprises: (a) ritonavir in an amount of from 1% to 30% by weight of said solution; (b) oleic acid in an amount of from 30% to 75% by weight of said solution; and (c) polyoxyl 35 castor oil in an amount of from 0% to 20% by weight of said solution. 8. The process according to claim 7, wherein said solution further comprises ethanol in an amount of from 1% to 15% by weight of said solution. 9. The process of according to claim 8, wherein said solution comprises polyoxyl 35 castor oil in an amount of from 2.5% to 10% by weight of said solution. 10. The process according to claim 1, wherein said solution comprises: (a) ritonavir and (2S ,3S ,5S)-2-(2,6-dimethylphenoxyacetyl) -amino-3-hydroxy-5-(2S-(1-tetrahydropyrimid-2-onyl)-3-methyl-butanoyl)ami- no-1,6 -diphenylhexane in an amount from 1% to 45% by weight of said solution; (b) oleic acid in an amount of from 30% to 75% by weight of said solution; and (c) polyoxyl 35 castor oil in an amount of from 0% to 20% by weight of said solution. 11. The process according to claim 10, wherein said solution comprises propylene glycol in an amount of from 1% to 15% by weight of said solution. 12. The process according to claim 11, wherein said solution comprises polyoxyl 35 castor oil in an amount of from 2.5% to 10% by weight of said solution. 13. The process according to claim 1, wherein said capsule is a hard gelatin capsule or a soft gelatin capsule. 14. A process of preparing a pharmaceutical composition which includes a solution, said process comprising filling said solution into a capsule, wherein said solution comprises: (a) ritonavir in an amount of 10% by weight of said solution; (b) oleic acid in an amount of from 70% to 75% by weight of said solution; (c) ethanol in an amount of from 3% to 12% by weight of said solution; (d) water in an amount of from 0.4% to 1.5% by weight of said solution; and (e) polyoxyl 35 castor oil in an amount of 6% by weight of said solution. |