Crystalline glycopyrrolate tosylate
AssigneeDermira, Inc.
InventorsJohn Allan Statler, Anthony Adrian Shaw, Delphine Caroline Imbert, Jennifer Leigh Nelson, Patricia Andres, Lisa Lynn McQueen, Stephan Xander Mattheus Boerrigter
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Abstract
Salts of glycopyrrolate, including solid forms thereof are herein disclosed. Methods of making glycopyrrolate salts and methods of treating hyperhidrosis with salts of glycopyrrolate are disclosed.
Claims18
Form D crystalline glycopyrrolate tosylate monohydrate characterized by an x-ray powder diffraction pattern comprising one or more peaks at about 6.9°2θ and about 12.6°2θ, prepared by treating glycopyrrolate bromide with a metal salt in a suitable solvent to form a glycopyrrolate salt slurry;
- removing the solids in the slurry to form a solution;
- lyophilizing the solution to form a solid;
- dissolving the solid in a crystallization solvent;
- and removing the crystallization solvent to form Form D.
Form D crystalline glycopyrrolate tosylate monohydrate characterized by an x-ray powder diffraction pattern comprising one or more peaks at about 6.9°2θ and about 12.6°2θ , prepared by treating glycopyrrolate-Y and p-toluenesulfonic acid in a suitable solvent;
- removing the solvent to form a solid;
- re-dissolving the solid in a crystallization solvent to form a solution;
- and removing the crystallization solvent to form Form D glycopyrrolate tosylate.
Dependencies are inferred from the claim text.