Claims for Patent: 6,004,973

Summary for Patent: 6,004,973

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)
Application Number:	08/981,952
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,004,973
Patent Claims:	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 .