| abstract |
Formula [R- (R * , R * )]-2- (4-fluorophenyl) -β, δ-dihydroxy-5- (1-methylethyl) -3-phenyl-[(phenylamino) carbonyl] -1H-pyrrole- Atorvastatin calcium, also known as 1-heptanoic acid hemi calcium salt, is known as an inhibitor of HMG-CoA reductase and is used to treat hypercholesterolemia. Atorvastatin in commercially available pharmaceutical compositions is usually prepared in the form of calcium salts, as it is convenient for preparing pharmaceutical formulations for oral administration such as tablets, capsules and powders. Atorvastatin calcium can be present in amorphous or at least four known crystalline forms (Form I, Form II, Form III and Form IV). Atorvastatin calcium is a poorly soluble substance with pKa 4.5 in water, and its crystalline form is less soluble than amorphous, which may cause problems in the bioavailability of atorvastatin in the body. The present invention solves the problem of providing therapeutic equivalents of atorvastatin pharmaceutical formulations regardless of the form of atorvastatin calcium (crystalline, amorphous, mixture of the two) used during its manufacture. |