STABILIZED SINGLE-LIQUID PHARMACEUTICAL COMPOSITION CONTAINING DOCETAXEL

摘要

THIS INVENTION RELATES TO A SINGLE-LIQUID PHARMACEUTICAL COMPOSITION FOR INJECTION CONTAINING DOCETAXEL. THE COMPOSITION INCLUDES (A) DOCETAXEL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, (B) A SURFACTANT SELECTED FROM THE GROUP CONSISTING OF POLYSORBATE, POLYOXYETHYLENE GLYCOL ESTER AND POLYOXYETHYLENE CASTOR OIL DERIVATIVES, (C) A SOLVENT COMPRISING ANHYDROUS ETHANOL IN A CONCENTRATION RANGE OF 100 TO 800MG/ML IN AN INJECTABLE SOLUTION, AND (D) A PH ADJUSTER OF AN AMOUNT SUITABLE FOR ADJUSTING THE PH OF THE LIQUID COMPOSITION TO 5 OR LESS. THE COMPOSITION MAY BE DIRECTLY DILUTED IN A PERFUSION LIQUID EVEN WITHOUT THE USE OF AN INTERMEDIARY DILUTE SOLUTION IN CASE THE COMPOSITION IS USED FOR INJECTABLE PREPARATIONS SINCE THE COMPOSITION IS IN A SINGLE LIQUID PHASE. FURTHERMORE, THE COMPOSITION IS SUITABLE FOR EFFECTIVE ADMINISTRATION OF DOCETAXEL SINCE THE PHARMACEUTICAL STABILITY OF THE COMPOSITION IS SIGNIFICANTLY IMPROVED.