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Details for Patent: 7,081,445

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Details for Patent: 7,081,445

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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