FORMS I,II AND IV CRYSTALLINE R-(R*,R*)-2-(4-FLUOROPHENYL)-BETA,DELTA-DIHYDROXY-5(1-METHYL-ETHIL)-3-PHENYL-4-(PHENYLAMINO)-CARBONYL-1H-PYRROLE-1-HEPTANOIC ACID HEMI CALCIUM SALT HYDRATE (ATORVASTATIN-HYDRATE), AND PHARMACEUTICAL COMPOSITIONS ...

摘要

The present invention provides [R- (R *, R *)] - 2- (4-fluorophenyl) -β, dihydroxy-5- (1-methylethyl) -3-phenyl-4 - [(phenyl (amino) carbonyl] -1H-pyrrole-1-heptanecarboxylic acid hemicalcium salt designated as Forms I, II and IV, pharmaceutical compositions containing such crystalline forms, and the use of such crystalline forms in the manufacture of a medicament for the treatment of hyperlipidemia and hypercholesterolemia. The advantage of the crystalline forms according to the invention over the previously known amorphous form is that they have greater stability with the same or better bioavailability, but at the same time have more favorable manufacturing properties, such as filterability. ŕ