Isolation and recovery of simvastatin in lactone form or in the form of an acid salt from the harvested fermentation broth
AssigneeThemis Medicare Limited
InventorsDinesh Shantilal PATEL, Sachin Dinesh Patel, Shashikant Prabhudas Kurani, Tapas Barui, Rajneesh Anand, T. Damodar Reddy
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Abstract
The present invention relates to a novel process for isolation and recovery of compounds such as biosynthetically produced simvastatin in either lactone form or in the form of its acid salt in high yield and purity, from microbial fermentation broth and isolating the said statin from harvested microbial broth.
Claims29
A process for isolation and recovery of biosynthetically produced simvastatin from microbial broth comprising the steps of:
- a) adjusting the pH of the broth to acidic;
- b) separating the biomass from the aqueous layer by using standard methods of separation of solid from aqueous layer;
- c) extracting simvastatin from the biomass into an organic solvent;
- d) adjusting the pH of the extracting solvent layer to alkaline pH;
- e) isolating the crystals of simvastatin.
A novel process for isolation and recovery of biosynthetically produced simvastatin in either lactone form or in the form of its acid salt from microbial broth comprising the steps of:
- a) adjusting the pH of the broth the basic;
- b) separating the biomass from the aqueous layer by using standard methods of separation of solid from aqueous layer;
- c) treating the aqueous layer with an acid to acidic pH;
- d) extracting the aqueous layer with an organic solvent;
- e) treating the organic layer with a base to basic pH;
- f) isolating the crystals of simvastatin;
A novel process for isolation and recovery of biosynthetically produced simvastatin in lactone form from microbial broth comprising the steps of:
- a) providing an organic solvent to the broth;
- b) separating the biomass from the layers by using standard methods of separation of solid from aqueous layer;
- c) concentrating the organic layer to get a concentrated mass;
- d) treating the concentrated mass with a hydrophilic solvent;
- e) filtering the precipitated simvastatin lactone;
- f) optinally purifying simvastatin to make it pharmaceutically acceptable grade.
A novel process for isolation and recovery of biosynthetically produced simvastatin in lactone form from microbial broth comprising the steps of:
- a) providing an organic solvent to the broth;
- b) separating the biomass from the layers by using standard methods of separation of solid from aqueous layer;
- c) concentrating the organic layer to get a concentrated mass;
- d) treating the concentrated mass with a hydrophobic solvent;
- e) isolating simvastatin from the hydrophobic solvent by adding less polar hydrocarbon solvent;
- f) optionally purifying simvastatin to make it pharmaceutically acceptable grade
A novel process for isolation and recovery of biosynthetically produced simvastatin in selective form of lactone and an acid salt from microbial broth comprising:
- a) subjecting the whole broth to multiple stage continuous extractor wherein the broth is extracted by an organic solvent;
- b) isolating simvastatin from the organic layer by concentrating the organic layer;
- and anti solvent is added.
- c) optionally purifying simvastatin to make it pharmaceutically acceptable grade.
Dependencies are inferred from the claim text.