C - Chemistry – Metallurgy – 07 – D
Patent
C - Chemistry, Metallurgy
07
D
C07D 207/34 (2006.01) A61P 3/06 (2006.01)
Patent
CA 2679317
The present invention provides novel crystalline forms D1 and D2 of [R-(R*,R* )]-2-(4- fluorophenyl)-.beta.,.delta.-dihydroxy-5-(l-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H- pyrrole- 1-heptanoic acid hemicalcium salt, and hydrates thereof. The crystalline forms D1 and D2 have X-ray powder diffraction peaks described in Figs. 1 and 3, respectively. Further, the present invention provides processes for preparing the crystalline forms and pharmaceutical compositions comprising the crystalline forms. The crystalline forms can be produced on a commercial scale and exhibit excellent stability.
La présente invention concerne des nouvelles formes cristallines D1 et D2 de sel d'hémicalcium d'acide [R-(R*,R* )]-2-(4- fluorophényl)-.beta.,.delta.-dihydroxy-5-(l-méthyléthyl)-3-phényl-4-[(phénylamino)carbonyl]-1H- pyrrole- 1-heptanoïque, et des hydrates de celles-ci. Les formes cristallines D1 et D2 présentent des pics de diffraction de rayons X sur poudres décrits dans les figures 1 et 3, respectivement. La présente invention concerne également des procédés de préparation desdites formes cristallines ainsi que des compositions pharmaceutiques comprenant lesdites formes cristallines. Les formes cristallines de l'invention peuvent être produites à l'échelle commerciale et présentent une excellente stabilité.
Cha Dae Won
Choi Jun Ho
Kim Moon Sung
Kim Yong Jik
Lim Hong Gyu
Cassan Maclean
Dong-A Pharm. Co. Ltd.
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