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|Title:||Pharmaceutical compositions comprising rafamycin coprecipitates|
|Abstract:||Disclosed are pharmaceutical compositions containing solid dispersions in the form of co-precipitates, which solid dispersions contain rapamycin and a carrier medium, and methods of treatment utilizing such pharmaceutical compositions.|
|Inventor(s):||Guitard; Patrice (Hegenheim, FR), Haeberlin; Barbara (Riehen, CH), Link; Rainer (Staufen, DE), Richter; Friedrich (Grenzach-Wyhlen, DE)|
|Assignee:||Novartis AG (Basel, CH)|
1. A pharmaceutical composition, comprising: a solid dispersion in the form of a co-precipitate, said solid dispersion comprising a rapamycin and a carrier medium.
2. A pharmaceutical composition as claimed in claim 1 wherein the carrier medium comprises a water-soluble polymer or a cyclodextrin.
3. A pharmaceutical composition as claimed in claim 1 wherein the rapamycin is selected from 40-O-(2-hydroxy)ethyl rapamycin, 32-deoxorapamycin or 16-pent-2ynyloxy-32(S)-dihydrorapamycin.
4. A pharmaceutical composition as claimed in claim 2 wherein the polymer is hydroxypropylmethylcellulose or polyvinylpyrrolidone.
5. A pharmaceutical composition as claimed in claim 1 comprising up to 30% by weight rapamycin.
6. A pharmaceutical composition as claimed in claim 2 wherein the water-soluble polymer is hydroxypropylmethylcellulose which is present in an amount by weight of up to about 95%.
7. A pharmaceutical composition as claimed in claim 2, wherein the weight ratio of rapamycin to polymer is less than 1:4.
8. A pharmaceutical composition as claimed in claim 1 which is surfactant free.
9. A method of treatment of organ or tissue allo- or xeno-transplant rejection, autoimmune disease, inflammatory conditions, or multi-drug resistance, the method comprising: orally administering to a subject suffering from or at risk of such condition or rejection a pharmaceutically effective amount of the pharmaceutical composition as claimed in claim 1.
10. The pharmaceutical composition of claim 1 wherein the rapamycin is in amorphous or substantially amorphous form.
11. The pharmaceutical composition of claim 1 further comprising an enteric coating.
12. The pharmaceutical composition of claim 1 wherein the rapamycin is rapamycin.
13. The pharmaceutical composition of claim 1 wherein the rapamycin is 40-O-(2-hydroxy)ethyl rapamycin.
14. The pharmaceutical composition of claim 1 further comprising an antioxidant.
15. The pharmaceutical composition of claim 14 wherein the antioxidant is selected from the group consisting of butylated hydroxytoluene, DL-.alpha.-tocopherol, propyl gallate, ascorbyl palmitate and fumaric acid .
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