Patent ID: 9718777
Date: 2017-08-01
CPC Classifications: C07D,C07H

Claim:
1. A process for the preparation of crystalline miglustat of formula (I) comprising the steps of: (1) reacting 2,3,4,6-tetra-O-benzyl-1-deoxynojirimycin hydrochloride of formula (V) with n-butyraldehyde and sodium cyanoborohydride in an organic solvent to prepare 2, 3, 4, 6-tetra-O-benzyl-N-butyl-1-deoxynojirimycin hydrochloride of formula (VI); (2) reacting 2, 3, 4, 6-tetra-O-benzyl-N-butyl-1-deoxynojirimycin hydrochloride of formula (VI) with hydrogen in the presence of 10% Pd/C and HCl to produce miglustat hydrochloric salt; (3) dissolving miglustat hydrochloric salt in a first solvent and adding an organic base; (4) optionally removing the first solvent, and (5) adding a second solvent to crystallize miglustat.