PRE-FREEZE DRIED PREPARATION OF AZACITIDINE, FREEZE DRIED PREPARATION OF AZACITIDINE AND METHOD OF MANUFACTURING FOR THE SAME

摘要

PURPOSE: A method for preparing a pre-freeze dried formulation of azacitidine and a freeze dried formulation of azacitidine is provided to improve stability in a solution. CONSTITUTION: A pre-freeze dried formulation of azacitidine is prepared by dissolving azacitidine in a solution containing 40-60%(v/v) of tertiary butanol. The concentration of azacitidine is 0.2-5 mg/ml. The pre-freeze dried formulation is prepared at 5-20 deg.C. A method for preparing a freeze dried formulation of azacitidine comprises: a step of dissolving azacitidine in a solution containing 40-60%(v/v) of tertiary butanol and forming the pre-freeze dried formulation; a step of adding an excipient to the pre-freeze dried formulation; and a step of freeze-drying the formulation. The excipient is polyol including mannitol, sorbitol, or trehalose. [Reference numerals] (AA) Freeze drying cycle; (BB) Temperature(C); (CC) Time(hours)