速崩壊性錠剤の口腔内崩壊時間とＩｎ Ｖｉｔｒｏ崩壊試験法の評価

Abstract

The purpose of this study was to evaluate the oral (in vivo) disintegration time of commercially available rapidly disintegrating tablets (RDTs), and to establish an in vitro disintegration test that may be used to predict in vivo disintegration times.The in vivo disintegration time for the tablets tested ranged from a minimum of 8.32 sec to a maximum of 44.27 sec, information that will be useful for medication counseling and in the selection of products that will maintain high patient compliance. The in vitro disintegration times were determined using the JP XIV disintegration test apparatus in which the attached Distopper® electronic sensor automatically determines in vitro disintegration time. The results were well correlated with the in vivo disintegration times (r2=0.88), and the slope was close to 1 for the majority of RDTs (30 of 43 products tested). In the case of the RDTs that showed poor correlation, the in vitro disintegration time became virtually equal to in vivo disintegration time when the Distopper® sensor was modified so that the mechanical stress generated by the tongue could be simulated. Thus the optimization of the Distopper® to more closely simulate the disintegration mechanism in the mouth enabled the in vitro testing apparatus to be applied to a greater number of RDTs. This testing method should be useful in evaluating RDT quality at the sites of manufacturing, development and medical treatment.