Organic compounds -- part of the class 532-570 series – Organic compounds – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
1995-04-17
2001-01-30
Badio, Barbara (Department: 1616)
Organic compounds -- part of the class 532-570 series
Organic compounds
Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
active
06180781
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a novel composition of matter, 9&agr;, 21-dichloro-16&agr;-methyl-1,4-pregnadiens-11&bgr;, 17&agr;-diol-3,20-dione-17-(2′-furoate) monohydrate, also designated mometasone furoate monohydrate, process for its preparation, and pharmaceutical preparation thereof.
Mometasone furoate is known to be useful in the treatment of inflammatory conditions. The compound is prepared by procedures disclosed in U.S. Pat. No. 4,472,393, which patent is hereby incorporated by reference.
When aqueous pharmaceutical compositions, e.g. suspensions, containing anhydrous mometasone furoate were subjected to stability testing by rotating for four weeks at room temperature and 35° C., formation of a crystalline material which is different from the anhydrous mometasone furoate crystal was observed in suspension. Experiments were designed to determine the nature of the crystalline material. It was postulated that formulation of mometasone furoate compositions with the stable crystalline form would reduce the probability of crystal growth during long term storage of the suspension leading to a more stable product.
SUMMARY OF THE INVENTION
The present invention provides mometasone furoate monohydrate of formula I
a process for preparing said compound by crystallization from a saturated aqueous water miscible organic solution. The present invention also provides aqueous stable pharmaceutical compositions of mometasone furoate monohydrate.
REFERENCES:
patent: 4472393 (1984-09-01), Shapiro
patent: 4775529 (1988-10-01), Sequeira et al.
patent: 4783444 (1988-11-01), Watkins et al.
patent: 0262681 (1988-04-01), None
patent: 9204365 (1992-03-01), None
Bristol-Myers Co. v. US Int'l Trade Commission, 15USPQ2d 1258 (1989).
In re Certain Crystalline Cefadioxil Monohydrate, 15USPQ2d 1263 (1990).
Eckhart Charles
Etlinger Teresa
Levine Nancy
Yuen Pui-Ho
Badio Barbara
Battle Carl W.
Franks Robert A.
Maitner John J.
Schering Corporation
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