Pharmaceutical formulations comprising high purity cangrelor and methods for preparing and using the same

  • US 9,295,687 B1
  • Filed: 07/10/2015
  • Issued: 03/29/2016
  • Est. Priority Date: 01/14/2015
  • Status: Active Grant
First Claim
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1. A pharmaceutical formulation comprising high purity cangrelor, or a salt thereof, as an active ingredient and one or more pharmaceutically acceptable excipients prepared by a method comprising:

  • (a) dissolving cangrelor or a salt thereof in a solvent to form a first solution;

    (b) mixing a pH-adjusting agent with the first solution to form a second solution, wherein the pH of the second solution is between about 7.0 and 9.5; and

    (c) removing the solvent from the second solution to produce high purity cangrelor or a salt thereof under conditions wherein a level of moisture of less than about 2.0% by weight is achieved,wherein one or more pharmaceutically acceptable excipients is added to the first solution, or to the second solution, or to both,wherein the high purity cangrelor or salt thereof has a combined total of selected hydrolysis and oxidation degradants of cangrelor not exceeding about 1.5% by weight of the high purity cangrelor, andwherein the selected hydrolysis and oxidation degradants are one or more members selected from the group consisting of;

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