Evaluation for Pharmaceutical Characteristics of Nalfurafine Orally Disintegrating Film Agent

Abstract

Nalfurafine is a pharmaceutical agent used in the treatment of cutaneous pruritus. Although its orally disintegrating (OD) film agent is approved, noninferiority of its disintegration and elution to various OD tablet agents has yet to be demonstrated. This study aimed to evaluate the pharmaceutical characteristics of the nalfurafine OD film agent. Disintegration and elution performance were tested for 4 different types of nalfurafine OD pharmaceutical agents including 1 film agent and 3 tablet agents. Visual evaluation was employed for the disintegration test, while measurement of concentration using high performance liquid chromatography with ultraviolet was employed for the elution test. As a result of disintegration evaluation (n = 3), the OD film agent repeatedly exhibited the same complete disintegration time (60 s), while the other three OD tablet agents showed the time variability (120 s - 30 min). After the test start, the OD film agents began disintegration at 20 s while the OD tablet agents began disintegration immediately. As a result of elution evaluation (n = 6), after the test start, the OD film agent was eluted 100.6％ in 5 min, while the OD tablet agents were eluted 95.8％, 75.8％ and 80.5％, respectively. In conclusion, this study indicates that the nalfurafine OD film agent was not inferior to the OD tablet agents in terms of disintegration and elution.