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|Title:||Crystalline anhydrous mycophenolate mofetil and intravenous formulation thereof|
|Abstract:||The crystalline anhydrous salt formed by complexing mycophenolate mofetil with an anion selected from the group chloride, sulfate, phosphate and acetate (in particular the hydrochloride salt), and pharmaceutical compositions, intravenous formulations and a kit thereof, and associated methods of treatment.|
|Inventor(s):||Fu; Roger C. (Saratoga, CA), Leung; De-Mei (Los Altos, CA), Fleitman; Jeffrey S. (Sunnyvale, CA), Rizzolio; Michele C. (Durham, NC), Miksztal; Andrew R. (Menlo Park, CA)|
|Assignee:||Syntex (U.S.A.) Inc. (Palo Alto, CA)|
1. A crystalline anhydrous salt consisting essentially of mycophenolate mofetil complexed with an anion selected from the group consisting of chloride, sulfate, phosphate and
2. The crystalline anhydrous salt of claim 1 wherein said anion is chloride.
3. The crystalline anhydrous salt of claim 2 characterized by having a melting point of about 145.degree. to about 155.degree. C.
4. The crystalline anhydrous salt of claim 3 further characterized by having the Differential Scanning Calorimetry thermogram as shown in FIG. 3B.
5. The crystalline anhydrous salt of claim 4 further characterized by having the powder X-ray diffraction pattern as shown in FIG. 1B.
6. A pharmaceutical composition suitable for preparing an aqueous intravenous formulation, said composition comprising a crystalline anhydrous salt of claim 1 and a pharmaceutically acceptable excipient.
7. The pharmaceutical composition of claim 6 wherein said anion is chloride.
8. The pharmaceutical composition of claim 6 wherein said pharmaceutically acceptable excipient consists of polysorbate 80.
9. The pharmaceutical composition of claim 6 wherein said pharmaceutically acceptable excipient consists of polysorbate 80 and citric acid.
10. The pharmaceutical composition of claim 7 wherein said pharmaceutically acceptable excipient consists of polysorbate 80.
11. The composition of claim 10 characterized by having the powder X-ray diffraction pattern shown in FIG. 2B.
12. A kit useful for preparing an intravenous formulation comprising in separate containers:
a) the pharmaceutical composition of claim 6; and
b) a liquid medium selected from water for injection or a dextrose solution .
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