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Generated: July 20, 2017
| Title: | Cyclosporin galenic forms |
| Abstract: | Pharmaceutical compositions comprising a cyclosporin as active ingredient, a fatty acid triglyceride, a glycerol fatty acid partial ester or propylene glycol or sorbitol complete or partial ester, preferably, and a tenside having an HLB of at least 10. |
| Inventor(s): | Cavanak; Thomas (Biel-Benken, CH), Posanski; Ulrich (Freiburg, DE) |
| Assignee: | Novartis AG (Basel, CH) |
| Filing Date: | Mar 01, 2004 |
| Application Number: | 10/790,543 |
| Claims: | 1. A pharmaceutical composition for oral administration comprising: a) a cyclosporin as active ingredient in a carrier medium consisting essentially of b+c) a transesterification product of a hydrogenated vegetable oil with glycerol or propylene glycol. 2. A composition according to claim 1 comprising b+c) a transesterification product of a hydrogenated vegetable oil and glycerol. 3. A composition according to claim 2, wherein (a) is selected from the group consisting of Ciclosporin, (Dihydro-MeBmt).sup.1-(Val).sup.2-Ciclosporin and (Nva).sup.2-Ciclosporin. 4. A composition according to claim 2, wherein (b+c) is a corn oil, almond oil, ground-nut oil, olive oil or palm oil trans-esterification product. 5. A composition according to claim 4, wherein (b+c) is a corn oil trans-esterification product. 6. A composition according to claim 2, wherein the amount of free glycerol plus any other free mono-or poly-ol present in (b+c) is less than 10% by weight. 7. A composition according to claim 2, wherein the amount of mono-glyceride present in (b+c) is Ca. 25 50% by weight. 8. A composition according to claim 2, wherein the amount of free glycerol present in (b+c) is less than 10%. 9. A composition according to claim 2, wherein the amount of mono-glyceride present in (b+c) is 35 50% by weight. 10. A composition according to claim 2, wherein the amount of di-glyceride present in (b+c) is less than 40% and the amount of tri-glyceride present is less than 10% by weight. 11. A composition according to claim 2, wherein the amount of mono-glyceride present in (b+c) is 30 to 40% by weight. 12. A composition according to claim 2 additionally comprising: d) a pharmaceutically acceptable solvent or diluent miscible with (b+c) and reducing, or capable of reducing, the viscosity of (b+c). 13. A composition according to claim 12, wherein (d) comprises a trans-esterification product of a natural vegetable oil triglyceride and a polyalkylene poly-ol. 14. A composition according to claim 12, wherein (d) comprises ethanol. 15. A composition according to claim 12, wherein (d) comprises an esterification product of caprylic acid and caproic acid with glycerol. 16. A composition according to claim 12, additionally comprising: e) a pharmaceutically acceptable emulsifying agent. 17. A composition according to claim 16, wherein (d) comprises a reaction product of a natural or hydrogenated castor oil and ethylene oxide. 18. A composition according to claim 2, in admixture with a pharmaceutically acceptable base material, the admixture being formed as, or capable of being formed into, a solid unit dosage. 19. A composition according to claim 18 wherein the pharmaceutically acceptable base material comprises a natural fat. 20. A composition according to claim 18, wherein the pharmaceutically acceptable base material comprises a chocolate base. 21. A composition according to claim 2 wherein the amount of free glycerol plus any other free mono-or poly-ol present in (b+c) is less than 5% by weight. 22. A composition according to claim 2 wherein the amount of mono-glyceride present in (b+c) is 30 45% by weight. 23. A composition according to claim 2, wherein the amount of free glycerol present in (b+c) is less than 5%. 24. The composition of claim 23 wherein the amount of free glycerol present in (b+c) is ca. 4% by weight. 25. A composition according to claim 2, wherein the amount of mono-glyceride present in (b+c) is 40 45% by weight. 26. A composition according to claim 11, wherein the amount of mono-glyceride present in (b+c) is 35% by weight. 27. A composition according to claim 8, 23 or 24, wherein (b+c) is corn-oil trans-esterification product. 28. A composition according to claim 19 wherein the natural fat is a natural vegetable fat. 29. A composition according to claim 28 wherein the natural vegetable fat is cacao fat or butter. 30. The composition of claim 20 wherein the chocolate base is couverture chocolate. |
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