新生児特定集中治療室での使用を目的としたシルデナフィル錠に対する粉砕調剤の最適化

抄録

The aim of the present study was to develop a method for grinding sildenafil tablets (Revatio^® tablets 20 mg) to prepare 0.2 g of powder containing 0.5 mg sildenafil. A method for grinding tablets and a formulation with additives was examined using Allegra^® 60 mg tablets as a model preparation. The optimal method and formulation for the sildenafil tablets were clarified. A sildenafil tablet was ground with 400 mg of calcium monohydrogen phosphate by mortar and pestle. Then, 117 mg of the ground powder was withdrawn and added to a clean mortar. After 630 mg of calcium monohydrogen phosphate, 603 mg of microcrystalline cellulose, 225 mg lactose monohydrate, and 225 mg of glucose were added to the mortar, the ground powder and additives were mixed. A 0.2-g sample of the mixed powder had 0.5 mg of sildenafil. A decrease in or scattering of drug content was not observed. A suspension of 0.2 g of the mixed powder in 1 mL water indicated 225 mOsmol, which was lower than that of 0.9% NaCl solution.