Polymorphic forms of (R)-oxybutynin hydrochloride
AssigneeApnimed, Inc. (Delaware)
InventorsDennis Molnar, Sean Johnston
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Abstract
Polymorphic forms of (R)-oxybutynin HCl, including three crystalline forms, are prepared and characterized. Uses of the various polymorphic forms of (R)-oxybutynin HCl for Obstructive Sleep Apnea (OSA) treatment are also disclosed.
Claims38
A solid crystalline form of (R)-oxybutynin HCl, designated as Form C.
A solid crystalline form of (R)-oxybutynin HCl, having a combination of the Form B and Form C polymorphs as shown in FIG. 9.
A solid crystalline form of (R)-oxybutynin HCl, designated as Form A.
A solid crystalline form of (R)-oxybutynin HCl, designated as Form B.
A solid crystalline form of (R)-oxybutynin citrate.
A process for producing crystalline R-oxybutynin HCl of Form C, the process comprising:
- isolating (R)-oxybutynin from racemic oxybutynin via chiral resolution with D-malic acid;
- and
- adding HCl to the isolated (R)-oxybutynin to produce crystalline (R)-oxybutynin HCl of Form C.
Dependencies are inferred from the claim text.