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US 7,465,831 B2Granted
Levalbuterol hydrochloride Polymorph A
AssigneeTeva Pharmaceutical Fine Chemicals S.r.l.
InventorsValeriano Merli, Silvia Mantovani, Stefano Bianchi, Paola Daverio, Angelo Spreafico, Judith Aronhime, Adrienne Kovacsne-Mezei
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Abstract
The invention is directed to processes for making levalbuterol HCl Polymorph A from by suspending or forming a first slurry of (R)-SLB(D)-DBTA in at least a first organic solvent, adding HCl to the suspension or slurry of the solid (R)-SLB.D-DBTA until the (R)-SLB.D-DBTA forms levalbuterol HCl Polymorph A, and isolating the levalbuterol HCl Polymorph A.
Claims12
A process for making levalbuterol HCl Polymorph A comprising:
- suspending or forming a first slurry of the R enantiomer of albuterol D-dibenzoyl tartrate complex in at least a first organic solvent;
- adding HCl to the suspension or slurry of the solid R enantiomer of albuterol D-dibenzoyl tartrate complex until the pure levalbuterol HCl Polymorph A is formed;
- and
- isolating the pure levalbuterol HCl Polymorph A;
- wherein said levalbuterol HCl Polymorph A is characterized by an X-ray diffraction pattern containing peaks at 10.7, 15.3, 15.6, 19.1 and 23.9 degree two-theta±0.2 degree two-theta.
2 more elements
Dependencies are inferred from the claim text.