Stability of amorphous indomethacin in a solid dispersion using crospovidone prepared by a twin-screw kneader or extruder and application of aqueous film-coating to solid dispersion tablets

摘要

A powder solid dispersion system (SD) of indomethacin (IM) with crospovidone prepared by a twin-screw kneader or twin-screw extruder possessed good fluidity and was suitable for tablet formulation. Tablets of SD prepared by direct compression possessed favorable pharmaceutical characteristics. A thousand tablets could be manufactured without problems such as sticking or capping when 1% magnesium stearate and 50% microcrystalline cellulose were added to the SD containing 25% IM. Aqueous film-coated SD tablets coated with Opadry OY7300 were obtained without recrystallizing during the coating process. The properties of SD powder, tablets and aqueous film-coated tablets were influenced by humidity during storage at 40degC and 75% relative humidity (RH) under open conditions. IM in SD powder, tablets in all formulations and aqueous film-coated SD tablets maintained an amorphous state during storage at 40degC and 75% RH in closed glass bottles for at least three months and solubility and tablet properties did not change during storage.