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|Title:||Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin|
|Abstract:||A synergistic combination of an IL-2 transcription inhibitor (e.g., cyclosporin A or FK506) and 40-O-(2-hydroxyethyl)-rapamycin is provided, which is useful in the treatment and prevention of transplant rejection and also certain autoimmune and inflammatory diseases, together with novel pharmaceutical compositions comprising an IL-2 transcription inhibitor in combination with a rapamycin, e.g., 40-O-(2-hydroxyethyl)-rapamycin.|
|Inventor(s):||Zenke; Gerhard (Rheinfelden, DE), Schuurman; Hendrik (Basel, CH), Haeberlin; Barbara (Riehen, CH), Meinzer; Armin (Buggingen, DE)|
|Assignee:||Novartis AG (Basel, CH)|
1. A pharmaceutical composition comprising (I) cyclosporin A and (II) 40-O-(2-hydroxyethyl)-rapamycin, wherein the weight ratio I:II is 2:1 to 180:1, in combination or
association with a pharmaceutically acceptable diluent of carrier.
2. A composition of claim 1 in the form of a microemulsion or a microemulsion preconcentrate or a solid dispersion.
3. A composition of claim 2 which is a microemulsion preconcentrate formulation.
4. A composition of claim 2 which is a solid dispersion formulation.
5. A composition of claim 1 wherein I and II are present in an oil-in-water microemulsion preconcentrate comprising a hydrophilic phase, a lipophilic phase, and a surfactant.
6. Cyclosporin A and 40-O-(2-hydroxyethyl)-rapamycin as a combined pharamceutical preparation in the weight ratio 2:1 to 180:1 for simultaneous, separate, or sequential use in synergistically effective amounts.
7. A method of treating or preventing an autoimmune or inflammatory condition or transplant rejection in a subject suffering from or at risk for such condition or rejection, comprising co-administering synergistically effective amounts of (I) cyclosporin A and (II) 40-O-(2-hydroxyethyl)-rapamycin in the weight ratio 2:1 to 180:1.
8. The method of claim 7 wherein the ratio is 5:1 to 60:1.
9. The method of claim 7 wherein the ratio is 10:1 to 20:1.
10. The method of claim 9 wherein the ratio is 16:1.
11. A method of treating or preventing chronic rejection of a heart or kidney transplant in a subject suffering from or at risk for such rejection, comprising co-administering together or at substantially the same time synergistically effective amounts of (I) cyclosporin A and (II) 40-O-)2-hydroxyethyl)-rapamycin.
12. The method of claim 11 wherein the compounds are administered as a fixed combination.
13. The method of claim 11 wherein the weight ratio 1:11 is 5:1 to 50:1.
14. The method of claim 11 wherein the weight ratio is 10:1 to 20:1.
15. The method of claim 11 wherein the weight ratio is 16:1.
16. The method of claim 11 wherein compounds I and II are co-administered in combination or association with a pharmaceutically acceptable diluent or carrier.
17. The method of claim 16 wherein compounds I and II are co-administered in the form of a microemulsion, a microemulsion preconcentrate, or a solid dispersion.
18. A kit comprising (I) cyclosporin A and (II) 40-O-(2-hydroxyethyl)-rapamycin in separate unit dosage forms, wherein said unit dosage forms are suitable for administrating I and II in synergistically effective amounts, wherein the weight ratio I:II is 2:1 to 180:1.
19. The method of using cyclosporin A in the manufacture of a pharmaceutical kit of claim 18.
20. The method of using 40-O-(2-hydroxyethyl)-rapamycin in the manufacture of a pharmaceutical kit of claim 18.
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