Crystalline forms of Fentanyl Alkaloid
AssigneeMallinckrodt Inc.
InventorGary A. Nichols
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Abstract
The present invention provides crystalline forms of fentanyl alkaloid and methods for preparing crystalline forms of fentanyl alkaloid.
Claims23
A crystalline form of fentanyl alkaloid, N-[1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide, the crystalline form being Form II.
A pharmaceutical composition, the composition comprising crystalline Form II of fentanyl alkaloid, N-[1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide, and at least one pharmaceutically acceptable excipient.
A process for preparing a substantially pure crystalline form of fentanyl alkaloid, N-[1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide, the process comprising:
- a) contacting fentanyl alkaloid with a solvent to form a saturated or near saturated solution;
- and
- b) evaporating the solvent in the solution to form a mass of crystals of the substantially pure crystalline form.
A process for converting a crystalline Form I of fentanyl alkaloid into a crystalline Form II of fentanyl alkaloid, the process comprising:
- a) melting the crystalline Form I of fentanyl alkaloid;
- b) cooling the fentanyl alkaloid from step a);
- and
- c) heating the fentanyl alkaloid from step b) to form the crystalline Form II of fentanyl alkaloid.
Dependencies are inferred from the claim text.