PROBLEM TO BE SOLVED: To achieve a lyophilized formulation production method in which the process window for preliminary freezing is wider than conventional lyophilization techniques and which can carry out successful pre-freezing.SOLUTION: The method comprises a pre-freezing step of freezing a sample containing a pharmaceutical agent, and a dehydration step of dehydrating the frozen sample under reduced pressure. The pre-freezing step comprises a first freezing step of cooling the sample to a target temperature while applying an electric field, and a second cooling step of cooling and freezing the sample after the first cooling step without applying an electric field.SELECTED DRAWING: None【課題】従来の凍結乾燥技術よりも予備凍結のプロセスウィンドウが広く、予備凍結を首尾よく行うことができる凍結乾燥製剤の製造方法を実現する。【解決手段】医薬品を含有している試料を凍結させる予備凍結工程と、凍結させた上記試料を減圧下で乾燥させる乾燥工程とを含み、上記予備凍結工程は、上記試料を、電界を印加しながら品温が目標温度になるまで冷却する第1の冷却工程と、第1の冷却工程後の上記試料を、電界を印加せずに冷却して凍結させる第2の冷却工程と、を含む。【選択図】なし
