Abstract: Methods for the manufacture of Mycophenolate are disclosed. Mycophenblate mofetil is biochemically synthesized using Mycophenolic Acid and 2-morpholino ethanol with the help of an enzyme. Mycophenolate mofetil is also chemically synthesized non-catalytically by refluxing mycophenolic acid with 2-morpholino ethanol in the absence of a third solvent or a catalyst.

Abstract: The present invention provides an improved solid state fermentation device that combines all of the operations of microorganism cultivation (sterilization, inoculation, cultivation, extraction, and post extraction treatment). This solid state fermentation device is modular in nature and operates in a contained manner so that the live microorganisms from the reactor cannot come into contact with the environment and pollute the environment and also so that the environment inside the bioreactor is aseptic. Another aspect of this invention allows fermentation of microorganisms without inhibiting the growth of the microorganism. Specifically, the bioreactor is designed to remove heat that accumulates inside the bioreactor during fermentation by conduction. Additionally, there is a mechanism to add fluid to the interior of the bioreactor that permits equal distribution and precise control of a variety of environmental parameters.

Abstract: The present invention provides a novel process for the synthesis of Simvastatin of formula II. The process comprises converting Lovastatin to the corresponding amide intermediate using a secondary amine. The C-8 2-methylbutyrate side chain of the amide intermediate is subsequently methylated by reaction with a suitable base, followed by treatment with a methylating agent. The 2,2-dimethylbutyrate intermediate is further transformed to the final product, Simvastatin, by hydrolysis, followed by lactonization. In another aspect, the present invention provides intermediates of formula IIb and IIc useful for the preparation of Simvastatin: wherein R1 and R2 are as defined herein.

Abstract: This invention describes the synthesis of simvastatin from lovastatin by converting the lovastatin to lova amide using a secondary amine and subsequent reaction with a metal amide base generated from n-butyl lithium and pyrrolidine and followed by treatment with methyl iodide to give desired C-methylated intermediate. This intermediate was further transformed to the final product, simvastatin. This method of production consumes lesser quantities of metal amide, gives fewer side reactions and a lowered overall cost of manufacture of simvastatin than other procedures reported.

Abstract: The present invention provides intermediates of formula IIb and IIc useful for the preparation of Simvastatin: wherein R1 and R2 are each independently an alkyl, heteroalkyl, aryl or heteroaryl moiety, or R1 and R2, taken together, form a heterocyclic moiety containing 5-8 atoms; wherein each of the foregoing alkyl and heteroalkyl moieties may be linear or branched, substituted or unsubstituted, cyclic or acyclic or saturated or unsaturated, and each of the foregoing heterocyclic, aryl and heteroaryl moieties may be substituted or unsubstituted.

Abstract: The present invention provides an improved solid state fermentation device that combines all of the operations of microorganism cultivation (sterilization, inoculation, cultivation, extraction, and post extraction treatment). This solid state fermentation device is modular in nature and operates in a contained manner so that the live microorganisms from the reactor cannot come into contact with the environment and pollute the environment and also so that the environment inside the bioreactor is aseptic. Another aspect of this invention allows fermentation of microorganisms without inhibiting the growth of the microorganism. Specifically, the bioreactor is designed to remove heat that accumulates inside the bioreactor during fermentation by conduction. Additionally, there is a mechanism to add fluid to the interior of the bioreactor that permits equal distribution and precise control of a variety of environmental parameters.