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US 11,299,558 B2Granted
Process for the preparation of low molecular weight heparin
AssigneeBiological E Limited
InventorsManohar Sarma Vedula, Sreedhar Kosgi, Narender Dev Mantena, Ratnakar Aryasomayajula
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Abstract
The present invention provides an improved process for the preparation of Enoxaparin sodium. The process is simple, commercially viable and industrially advantageous.
Claims13
A process for the preparation of Enoxaparin sodium, comprising the steps of:
- a) salifying heparin sodium with benzethonium chloride to form benzethonium heparinate,
- b) reacting the benzethonium heparinate obtained in step (a) with benzyl chloride in an inert solvent to form a crude heparin benzyl ester,
- c) adding water to the reaction mixture containing the crude heparin benzyl ester obtained in step (b) at a temperature of 0° C. to room temperature to obtain a precipitate of heparin benzyl ester,
- d) adding an alcoholic solution of sodium acetate to the reaction mixture containing the precipitate of heparin benzyl ester obtained in step (c) to isolate the heparin benzyl ester sodium salt,
- e) depolymerizing the heparin benzyl ester sodium salt obtained in step (d) with sodium hydroxide to produce crude Enoxaparin sodium,
- f) bleaching the crude Enoxaparin sodium obtained in step (e) at a pH of about 9-10 to obtain a decolorized Enoxaparin sodium, and
- g) purifying the decolorized Enoxaparin sodium.
4 more elements
Dependencies are inferred from the claim text.