Patent ID: 9211336
Filing Date: 2015-12-15
Classification: A61K,A61L

Abstract:
1. A pharmaceutical formulation, prepared by a process comprising the steps of: (a) dissolving at least one excipient and at least one buffer into an aqueous diluent to form an acidic solution, wherein the temperature of the aqueous diluent is in the range of 16 to 24° C. before addition of the excipient and buffer; (b) dissolving a stabilizer either into the solution of step (a) or into the aqueous diluent of step (b) before addition of the excipient and buffer; and (c) dissolving an antineoplastic compound having a cyclic or non-cyclic hydrazine, triazine, or tetrazine group, or a pharmaceutically acceptable salt thereof, into the solution of step (b) at a temperature in the range of 16 to 24° C.; and (d) lyophilizing the solution of step (c) to yield a lyophilized powder that contains less than 0.6 wt % of total impurities, based on the total weight of the lyophilized powder, after storage for 3 months at 40° C./75% RH; wherein the stabilizer is an antioxidant and/or more susceptible to nucleophilic attack than the antineoplastic compound.