Pravastatin Sodium

CAS 81131-70-6

About the API

Systematic name Sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[[(2S)-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate
Trade name(s) Pravachol, Selektine, Lipostat
Molecular Formula C23H35NaO7
Molecular Weight 446.5 g/mol (anhydrous)
Physical properties White/off-white crystalline powder
Therapeutic category Lipid lowering
Available formulations Oral Solid
Regulations CEP Flag CEP EU DMF Flag EU DMF Japan DMF Flag Japan DMF Korea DMF Flag Korea DMF Other Flag Other US DMF Flag US DMF

General Information

Pravastatin belongs to the family of lipid-lowering compounds known as ‘statins’. Broadly, statins work to reduce the level of low-density lipoprotein (LDL) cholesterol in the blood by inhibiting the liver enzyme responsible for its production.

 

High blood cholesterol levels are associated with cardiovascular diseases such as dyslipidemia (abnormal blood lipid level) and atherosclerosis (narrowing of the artery walls by accumulation of fatty deposits, or ‘plaques’).

 

Statins are thus primarily indicated for the prevention and treatment of such diseases. Pravastatin is typically indicated as an adjunct to a cholesterol-reduced diet.

 

Originally disclosed and claimed in U.S Pat. No. 4.410.629, pravastatin is marketed by Sankyo Pharma Inc. (Japan) and Bristol-Myers-Squibb (outside Japan) under the trade name Pravachol.

 

As of April 2006, Pravas-tatin Sodium is available in several generic formulations. Pravastatin is presently manufactured by large-scale fermentation, a well-established industrial method using microorganisms to convert raw materials to valuable commercial product through chemical transformations. Through careful strain selection and continuous strain improvement, the process has been streamlined for maximum productivity and yield.