ファンギゾン®シロップ澱粉ゲル製剤: 服薬時のQOL向上を目指した製剤の調製と評価

The quality of life (QOL) in pharmacotherapy is closely related to improved patient compliance, which remains an important factor guaranteeing proper pharmacotherapy. Fungizone® oral suspension (FOS) containing amphotericin B is generally used for the treatment of candida excrescence in the whole gastrointestinal tract in children. FOS is clinically also used for the prevention of local fungal infections in patients receiving chemotherapy, when the leucocyte level is lower than 500/μL. However, it is difficult for pediatric patients to take FOS three times a day due to the large required dosage, i.e., 0.5mL/kg/day. The aim of the present study is to clarify the dissolution characteristics of amphotericin B in a new dosage form, starch gel, while also evaluating improvements in the QOL regarding such factors as taste, smell, stimulation on the tongue, overall ease in taking the drug, and the ability to keep it in the mouth in comparison to the control FOS preparation in nine healthy adult volunteers. The new starch gel dosage form improved all the above pharmaceutical characteristics both satisfactorily and significantly. These results suggest that the new starch gel dosage form can therefore improve both the compliance of amphotericin B and the QOL of pediatric patients.