US 11,685,718 B2
Highly purified batches of pharmaceutical grade 1-deoxygalactonojirimycin compounds
Kamlesh Sheth, North Brunswick, NJ (US); Sergey Tesler, Monroe, NJ (US); James Cartwright, Middlesex (GB); Clive King, Middlesex (GB); and Wendy Cross, Middlesex (GB)
Assigned to Amicus Therapeutics, inc., Philadelphia, PA (US)
Filed by Amicus Therapeutics, Inc., Philadelphia, PA (US)
Filed on Dec. 15, 2021, as Appl. No. 17/551,806.
Application 17/551,806 is a continuation in part of application No. 17/148,817, filed on Jan. 14, 2021.
Claims priority of provisional application 63/126,264, filed on Dec. 16, 2020.
Prior Publication US 2022/0194899 A1, Jun. 23, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. C07D 211/46 (2006.01)
CPC C07D 211/46 (2013.01) [C07B 2200/13 (2013.01)] 30 Claims
 
1. A method of purifying an intermediate grade 1-deoxygalactonojirimycin compound, the method comprising:
i) performing a first crystallization comprising crystallizing intermediate grade 1-deoxygalactonojirimycin compound in a first mixture comprising water and a first C1 to C4 alcohol to give a first crystallized 1-deoxygalactonojirimycin compound;
ii) isolating the first crystallized 1-deoxygalactonojirimycin compound from the first mixture to give an isolated first crystallized 1-deoxygalactonojirimycin compound;
iii) performing a second crystallization comprising crystallizing the isolated first crystallized 1-deoxygalactonojirimycin compound in a second mixture comprising water and a second C1 to C4 alcohol to give a second crystallized 1-deoxygalactonojirimycin compound; and
iv) isolating the second crystallized 1-deoxygalactonojirimycin compound from the second mixture to give an active pharmaceutical ingredient (API) grade 1-deoxygalactonojirimycin compound.