Pravastatin Production Technology

Introduction

Romanian company, through its Germany and Italy based associates, offers the technology for production of Pravastatin. The technology offered does not conflict with any existing patent. The technical details and product specifications are: Name: 1-Napthalene-heptanoic acid, 1,2,6,7,8,8a-hexahydro-b,d,6-trihydroxy-2-methyl-8-(2-methyl-1-pxpbutoxy)-monosodium salt Empirical formula: C23 H34 NaO7 Molecular weight: 446.5 Sodium Description: White to off-white granular powder Identification by IR: Complies with test Solubility: Soluble in water and glacial acetic acid, insoluble in acetone, dichloroethane, hexane, and acetonitrile Water by Karl Fisher (% w/w): NMT 6.0 Assay: (% w/w): NLT98.0 HPLC on dried basis Strain classification: Pravastatin is produced by microbial hydroxylation of Compactin (ML-236B Na) using Streptomyces carbophilis, in this case a mutant selected for high productivity. Pharmaceutical use: Coronary artery disease is an exceptionally important problem in industrial society and is often associated with arteriosclerosis, a condition in which esterified and free cholesterol is deposited in thinner walls of coronary arteries. Extensive epidemiological studies have established a link between abnormally high level of low density lipoprotein cholesterol and the incidence of coronary arteriosclerosis. Pravastatin is a potent inhibitor of 3-hydroxy-3methylglutaryl coenzyme A (HMG CoA) reductase. This enzyme catalyzes the conversion of hydroxymethylglutarate to mevanolate, which is an early and rate limiting step in biosynthesis of cholesterol.

The effectiveness of Pravastatin in lowering cholesterol has been confirmed clinically and it is approved for the treatment of primary hypercholesterolemia. Process description: Streptomyces carbophilus is grown on agar medium for 7-8 days. Flasks are inoculated with a piece of well grown agar culture and cultivated on a shaker. After 48 hours cultivation time the culture is completely transferred to the production fermenter. The productive fermenter is fed with sterile solution of Glucose to maintain the optimal concentration of Carbon source and pH. During the fermentation samples are taken to check the conversion of compactin to pravastatin. The fermentation broth is transferred to the recovery section where the product is extracted by solvents, lactonised and then converted to Sodium salt of Pravastatin. It is re-crystallised to get the pharma grade material

Area of Application

Pharmaceutical industry, medicine, biotechnology: Pravastatin treats hypercholesterolemia

For further information please contact

Asian and Pacific Centre for Transfer of Technology
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