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|Abstract:||A mixture comprising a poly-ene macrolide and an antioxidant. Preferably, the poly-ene macrolide is rapamycin and the antioxidant is 2,6-di-tert.-butyl-4-methylphenol. The presence of the antioxidant improves the stability of the poly-ene macrolide to oxidation.|
|Inventor(s):||Navarro; Francois (Bruebach, FR), Petit; Samuel (Mont Saint-Aignan, FR), Stone; Guy (Crosshaven Co. Cork, IE)|
|Assignee:||Novartis AG (Basel, CH)|
|Filing Date:||Oct 11, 2007|
|Claims:||1. A pharmaceutical composition comprising a crystalline form of 40-O-(2-hydroxy)ethyl-rapamycin having a crystal lattice a=14.37 .ANG., b=11.24 .ANG., c=18.31 .ANG., the volume being 2805 .ANG..sup.3, together with one or more pharmaceutically acceptable diluents or carriers. |
2. The pharmaceutical composition according to claim 1 for oral administration.
3. A method for preventing or treating acute or chronic allo- or xeno-transplant rejection in a subject in need of such treatment, comprising administering to said subject a therapeutically affective amount of the pharmaceutical composition according to claim 1.
4. A process for preparation of a crystalline form of 40-O-(2-hydroxy)ethyl-rapamycin having a crystal lattice a=14.37 .ANG., b=11.24 .ANG., c=18.31 .ANG., the volume being 2805 .ANG..sup.3, comprising dissolving amorphous 40-O-(2-hydroxy)ethyl-rapamycin in ethyl acetate and adding an aliphatic hydrocarbon CnH2n+2, wherein n=5, 6 or 7, and recovering the crystals thus obtained.
5. A process for purifying a crystalline form of 40-O-(2-hydroxy)ethyl-rapamycin having a crystal lattice a=14.37 .ANG., b=11.24 .ANG., c=18.31 .ANG., the volume being 2805 .ANG..sup.3, comprising crystallizing 40-O-(2-hydroxy)ethyl-rapamycin from a crystal bearing medium comprising ethyl acetate and an aliphatic hydrocarbon, and recovering the crystals thus obtained.
6. The process according to claim 5, wherein the crystal bearing medium comprises 2 parts ethyl acetate and 5 parts aliphatic hydrocarbon C.sub.nH.sub.2n+2, wherein n=5, 6 or 7.
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