Patent ID: 8871227

Claim:
A pharmaceutical formulation for parenteral administration as a solution of an epothilone analog to a patient, the epothilone analog having the formula: wherein the formulation comprises 1) an infusion fluid selected from the group consisting of saline and dextrose, and excluding Lactated Ringer's Solution, having an infusion fluid pH, wherein the epothilone analog has a pH of maximum stability different from the infusion fluid pH to define a pH differential; and 2) a pharmaceutical preparation comprising said epothilones analog, and a reconstitution vehicle comprising (a) a nonionic surfactant, (b) a solvent which comprises an alcohol, (c) a buffer, and (d) a pH-adjusting ingredient, wherein the buffer and the pH-adjusting ingredient are selected so that when the pharmaceutical preparation is mixed with the infusion fluid to provide the solution formulation for parenteral administration said formulation has a pH within the range from 6 to 9, wherein the buffer is sodium lactate and is present in the pharmaceutical formulation in a concentration between about 10 to about 20 mg/mL, wherein the pH-adjusting ingredient is a base, sodium hydroxide and is present at a concentration of from about 0.01 mg/mL to about 1 mg/mL, and wherein the compound of formula above is present in the formulation for administration in a concentration between about 0.1 mg/mL and about 0.9 mg/mL, said formulation for parenteral administration being free of Lactated Ringer's Solution and having an enhanced stability of about 25% or greater determined over a period for 0 to 24 hours as compared to a formulation having the same ingredients except without buffer and pH-adjusting ingredient.