Development of film coated orally disintegrating tablets “REMITCH^® OD TABLETS 2.5µg

Abstract

The orally disintegrating tablets REMITCH^® OD TABLETS 2.5µg composing Nalfurafine hydrochloride was launched. The composition rate of the active ingredient is extremely low and the Nalfurafine is unstable for temperature, humidity and light. To overcome these difficulties, the original film coating technology for OD tablets “RADIFIL^®” was developed and applied to “REMITCH^® OD TABLETS 2.5µg”. The key technology of RADIFIL^® and the bioequivalence study between REMITCH^® CAPSULES 2.5μg and REMITCH® OD TABLETS 2.5µg was summarized in this report.