Preparation of crystalline palonosetron hydrochloride
AssigneeDr. Reddy's Laboratories, Inc.
InventorsSrinivas Katkam, Rajeshwar Reddy Sagyam, Vishnuvardhan Sunkara, Sridhar Munagala, Murali Mohan Muttavarapu
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Abstract
Processes for the preparation of palonosetron hydrochloride and its crystalline forms.
Claims18
A process for preparing palonosetron hydrochloride, comprising:
- (a) hydrogenating a compound of formula IV,
- in the presence of a hydrogenation catalyst and n-propanol;
- (b) providing a suspension of a product of (a) in methanol;
- (c) maintaining the suspension at temperatures about 45° C. to the reflux temperature;
- and
- (d) isolating palonosetron hydrochloride.
A process for preparing crystalline palonosetron hydrochloride crystalline Form A, comprising:
- (a) providing a suspension of palonosetron hydrochloride in n-propyl alcohol or a nitrile solvent;
- (b) maintaining the suspension at temperatures about 50° C. to the boiling point of the solvent;
- and
- (c) isolating crystalline Form A.
A process for preparing palonosetron hydrochloride crystalline Form B, comprising:
- (a) providing a suspension of palonosetron hydrochloride in a ketone solvent, optionally in combination with an alcohol;
- (b) maintaining the suspension at suitable temperature;
- and
- (c) isolating crystalline Form B.
A process for preparation of a mixture of crystalline Forms A and B of palonosetron hydrochloride, comprising:
- (a) providing a suspension or solution of palonosetron hydrochloride in n-propyl alcohol or a nitrile solvent, optionally in combination with a second alcohol or a ketone solvent, or mixtures thereof;
- (b) maintaining the suspension or solution at temperatures about 0° C. to about 40° C.;
- and
- (c) isolating a mixture of crystalline Forms A and B.
A pharmaceutical composition prepared using palonosetron hydrochloride having less than about 0.1% by weight of any individual impurity having structural formula A, B, C, D, E, F, or G.
Dependencies are inferred from the claim text.