Crystal forms of pyrrolylheptanoic acid derivatives

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C548S537000

Reexamination Certificate

active

07915302

ABSTRACT:
The present invention provides novel crystalline forms D1and D2of [R—(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemicalcium salt, and hydrates thereof. The crystalline forms D1and D2have X-ray powder diffraction peaks described in FIGS.1and3, 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.

REFERENCES:
patent: 5273995 (1993-12-01), Roth
patent: 5969156 (1999-10-01), Briggs et al.
Morissette et al. Advanced Drug Delivery Reviews 2004, 56, 275-300.
Vippagunta et al., abstract, Vippagunta, Sudha R. “Crystalline Solids.” Advanced Drug Delivery Reviews 48(2001): 3-26.

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