STABLE PHARMACEUTICAL COMPOSITION CONTAINING DOCETAXEL AND METHOD OF MANUFACTURING THE SAME

摘要

An injection composition comprising docetaxel is provided to show excellent storage stability and increased solubility by stabilizing the docetaxel in a water-soluble polymer and distilled water. And a method for preparing the same is also provided. An injection composition comprising docetaxel and cyclodextrin is characterized in that at least one water-soluble polymer selected from the group consisting of hydroxypropylmethyl cellulose(HPMC), polyethyleneglycol(PEG) and polyvinylpyrrolidone(PVP) is contained. Regarding 1 part by weight of the docetaxel, 5-400 parts by weight of the cyclodextrin and 0.1-100 parts by weight of the water-soluble polymer are added. A method for preparing the composition comprises the steps of: (a) dissolving docetaxel, cyclodextrin and a water-soluble polymer such as HPMC, PEG or PVP in distilled water; (b) freeze-drying the mixture solution to prepare a freeze-dried composition; and (c) diluting the freeze-dried composition in distilled water, a dextrose solution or a saline solution.