Highly purified batches of pharmaceutical grade 1-deoxygalactonojirimycin compounds
AssigneeAmicus Therapeutics, Inc.
InventorsKamlesh Sheth, Sergey Tesler, James Cartwright, Clive King, Wendy Cross
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Abstract
Provided are methods of producing Active Pharmaceutical Ingredient (API) grade migalastat hydrochloride, and for purifying intermediate grade migalastat hydrochloride. Further provided are methods of producing [(2R,3S,4R,5S)-1-butyl-2-(hydroxymethyl)piperidine-3,4,5-triol hydrochloride (lucerastat hydrochloride) and other 1-deoxygalactonojirimycin compounds, as well as methods of purifying intermediate grade lucerastat hydrochloride and other 1-deoxygalactonojirimycin compounds.
Claims30
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.
A method of purifying intermediate grade migalastat salt, the method comprising:
- i) performing a first crystallization comprising crystallizing intermediate grade migalastat salt in a first mixture comprising water and a first C1 to C4 alcohol to give a first crystallized migalastat salt;
- ii) isolating the first crystallized migalastat salt from the first mixture to give an isolated first crystallized migalastat salt;
- iii) performing a second crystallization comprising crystallizing the isolated first crystallized migalastat salt in a second mixture comprising water and a second C1 to C4 alcohol to give a second crystallized migalastat salt;
- and
- iv) isolating the second crystallized migalastat salt from the second mixture to give an active pharmaceutical ingredient (API) grade migalastat salt.
Dependencies are inferred from the claim text.