Acetate salt of buprenorphine and methods for preparing buprenorphine
AssigneeRhodes Technologies
InventorsC. Frederick M. HUNTLEY, Erik Wayne KATAISTO, Helge Alfred REISCH, Archana SHARMA
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Abstract
The present disclosure provides acetate salts of buprenorphine, and its anhydrates, solvates, hydrates, and crystalline forms thereof, where the acetate salts of buprenorphine are essentially free of impurities. The disclosure further provides method of preparing the acetate salts, buprenorphine free base prepared from the acetate salts, other salts prepared from the free base, and pharmaceutical compositions thereof essentially free of impurities.
Claims21
1-160. (canceled)
A method for preparing buprenorphine free base comprising:
- (a) agitating an admixture comprising an acetate salt of buprenorphine, a solution, and a basic material at a temperature of from about 20° C. to about 90° C. to provide buprenorphine free base;
- and
- (b) isolating the buprenorphine free base from the admixture.
A method for preparing buprenorphine free base comprising:
- (a) agitating an admixture comprising an acetate salt of buprenorphine, a solution comprising from about 30 wt % to about 70 wt % of an alcohol in water, and ammonium hydroxide at a temperature of from about 20° C. to about 90° C., to provide buprenorphine free base;
- and (b) isolating the buprenorphine free base of (a).
A method for preparing buprenorphine free base comprising:
- (a) converting an acetate salt of buprenorphine to a buprenorphine free base product in the presence of a basic material;
- and
- (b) isolating the buprenorphine free base product of (a) without chromatography, wherein the buprenorphine free base product comprises about 0.05 wt % to about 0.10 wt % of a compound of formula (12)
- and about 0.05 wt % or less of a compound of formula (13)
Dependencies are inferred from the claim text.