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|Title:||Solid pharmaceutical dosage form|
|Abstract:||A solid pharmaceutical dosage form providing improved oral bioavailability is disclosed for inhibitors of HIV protease. In particular, the dosage form comprises a solid dispersion of at least one HIV protease inhibitor and at least one pharmaceutically acceptable water-soluble polymer and at least one pharmaceutically acceptable surfactant, said pharmaceutically acceptable water-soluble polymer having a Tg of at least about 50.degree. C. Preferably, the pharmaceutically acceptable surfactant has an HLB value of from about 4 to about 10.|
|Inventor(s):||Rosenberg; Joerg (Ellerstadt, DE), Reinhold; Ulrich (Heidelberg, DE), Liepold; Bernd (Dossenheim, DE), Berndl; Gunther (Herxheim, DE), Breitenbach; Joerg (Mannheim, DE), Alani; Laman (Foster City, CA), Ghosh; Soumojeet (Gurnee, IL)|
|Assignee:||Abbott Laboratories (Abbott Park, IL)|
1. A solid pharmaceutical dosage form comprising a solid dispersion, wherein said solid dispersion comprises (1) sorbitan monolaurate, (2) at least one pharmaceutically
acceptable water-soluble polymer having a Tg of at least 50.degree. C., (3) colloidal silica (4) at least one HIV protease inhibitor, and wherein said at least one HIV protease inhibitor comprises ritonavir, and said dosage form comprises from 50 to 85%
by weight of the total dosage form of said at least one pharmaceutically acceptable water-soluble polymer.
2. The dosage form of claim 1, wherein said at least one pharmaceutically acceptable water-soluble polymer comprises copovidone.
3. The dosage form of claim 1, wherein said dosage form comprises from 2 to 20% by weight of the total dosage form of sorbitan monolaurate, and wherein said at least one pharmaceutically acceptable water-soluble polymer is copovidone.
4. The dosage form of claim 1, wherein said solid dispersion is a solid solution.
5. The dosage form of claim 3, wherein said solid dispersion is a solid solution.
6. The dosage form of claim 1, wherein said dosage form is prepared by a process comprising solidifying a melt, said melt comprising sorbitan monolaurate, said at least one pharmaceutically acceptable water-soluble polymer, and ritonavir.
7. The dosage form of claim 1, wherein said solid dispersion is prepared by melt-extrusion, spray-drying or solution-evaporation.
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