Process for production of glycopyrronium tosylate
AssigneeJourney Medical Corporation
InventorsAnthony Adrian Shaw, Enrico Vigano, Renato Molteni
Life of this patent
Estimating the term…
Abstract
Provided herein are methods for the production of glycopyrronium tosylate and glycopyrronium tosylate compositions. Also provided herein are compositions useful in the production of glycopyrronium tosylate. Additionally provided herein are glycopyrronium tosylate compositions. Glycopyrronium tosylate is useful for the treatment of, among other conditions, hyperhidrosis.
Claims12
A glycopyrrolate base composition comprising threo-glycopyrrolate base and erythro-glycopyrrolate base, wherein the threo-glycopyrrolate base is at least 95% of the total glycopyrrolate base content of the composition and the erythro-glycopyrrolate base is less than 5% of the total glycopyrrolate base content of the composition.
A glycopyrrolate base composition comprising threo-glycopyrrolate base and erythro-glycopyrrolate base, wherein the composition is produced by:
- (i) contacting cyclopentylmandelic acid with 1-methylpyrrolidin-3-ol to form glycopyrrolate base:
- (ii) contacting the glycopyrrolate base with 5-nitroisophthalic acid to form glycopyrrolate base, 5-nitroisophthalate salt:
- and
- (iii) contacting the glycopyrrolate base, 5-nitroisophthalate salt with an inorganic base to form glycopyrrolate base:
- (iv) purifying the glycopyrrolate base obtained in step (iii) by contacting it with an organic solvent to obtain a purified glycopyrrolate base;
- wherein the organic solvent is a water-immiscible organic solvent.
Dependencies are inferred from the claim text.