Lovastatin,
pravastatin,
simvastatin, mevastatin,
atorvastatin,
fluvastatin and cervastatin and derivatives and analogs thereof are known as HMG-CoA
reductase inhibitors and are used as antihypercholesterolemic agents. The majority of them are produced by
fermentation using microorganisms of different species identified as species belonging to
Aspergillus,
Monascus,
Nocardia,
Amycolatopsis,
Mucor or
Penicillium genus, some are obtained by treating the
fermentation products using the methods of
chemical synthesis (
simvastatin) or they are the products of total
chemical synthesis (
fluvastatin,
atorvastatin and cervastatin). The present invention relates to a crystalline form of the
sodium salt of
pravastatin, which is known by the chemical name 1-naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-β,δ,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, mono
sodium salt, which is useful as a pharmaceutical substance. The present invention further relates to the method for its preparation and isolation, to a
pharmaceutical formulation containing the
sodium salt of
pravastatin in the crystalline form and a pharmaceutically acceptable carrier, and to a pharmaceutical method of treatment. The novel crystalline form of the
sodium salt of pravastatin is useful in the treatment of hypercholesterolemia and
hyperlipidemia.