Kit for preparing stable paclitaxel formulation for use as anticancer agent, comprising separately stored drug, solution of anhydrous citric acid in ethanol and solution of polyethoxylated castor oil in ethanol

摘要

A kit for preparing a stable paclitaxel (I) formulation comprises three sealed sterile vials, respectively containing: (i) a defined amount of (I); (ii) a defined solution (A) of anhydrous citric acid in ethanol; and (iii) a defined solution (B) of Cremophor EL (RTM; polyethoxylated castor oil) or Cremophor ELP (RTM; polyethoxylated castor oil) in ethanol. Independent claims are also included for: (a) a method for preparing a (I) formulation, by dissolving a specific amount of (I) in a specific amount of solution (A), adding a specific amount of solution (B) and shaking the mixture until homogeneous; and (b) the formulation obtained by method (a).