High purity oritavancin and method of producing same
AssigneesMelinta Therapeutics, Inc., AbbVie Inc.
InventorsAdel Rafai Far, Gopal Krishna, Min Ding, Sanjay R. Chemburkar, Carl M. Knable, James P. Petzel, Julie J. Pruyne, Douglas M. Reamer
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Abstract
Drug substance preparations of oritavancin having high purity are disclosed, along with pharmaceutical compositions comprising such oritavancin drug substance preparations, and drug products or dosage forms comprising such pharmaceutical compositions.
Claims10
A method for preparing a pharmaceutical composition comprising an oritavancin drug substance preparation and one or more pharmaceutically acceptable excipients, wherein the oritavancin drug substance preparation has about 90% purity or greater by peak area relative to impurities 2-16, defined by peaks B-P of FIG. 2, respectively, said method comprising:
- a) dissolving one or more pharmaceutically acceptable excipients in water having a pH of 2.5 to 3.5 to form a solution,
- b) dissolving oritavancin drug substance preparation in the solution of a) and adjusting the pH of the solution to 3.5 to 4.0,
- c) filtering the solution of b), and
- d) lyophilizing the filtered solution of c).
A method of preparing a pharmaceutical composition comprising an oritavancin drug substance preparation and one or more pharmaceutically acceptable excipients, wherein the oritavancin drug substance preparation has a maximum impurity level of not more than 4.8% by peak area of impurity 2 (DEV A) and impurity 10 (oritavancin CR), defined by peaks B and J shown in FIG. 2, respectively, said method comprising:
- a) dissolving one or more pharmaceutically acceptable excipients in water having a pH of 2.5 to 3.5 to form a solution,
- b) dissolving oritavancin drug substance preparation in the solution of a) and adjusting the pH of the solution to 3.5 to 4.0,
- c) filtering the solution of b), and
- d) lyophilizing the filtered solution of c).
Dependencies are inferred from the claim text.