抄録
Beads-Rotatory cell method was investigated as a new release test method for suppositories. A progesterone suppository of Witepsol-W35 and an indomethacin suppository of polyethyleneglycol were employed as model suppositories. After a membrane filter was attached on the bottom of a stainless steel cylindrical cell, a suppository was put into the cell with glass and nylon beads. Release tests were carried out under different conditions on a basis of composite experimental design consisted of two factors: rotation speed of the cell and the glass-to-nylon bead addition ratio. The release parameters of suppositories were predicted by multiple regression analysis.
For the progesterone suppository, a minimum value of area under the dissolution-time curve for 8 hours (ADT0-8) was obtained on the center of the experimental area. It was possible to predict ADT0-8, MDT and T16% using the two factors. For the indomethacin suppository, a tendency was observed for ADT0-8 to vary proportionally to the rotating speed.
The optimum condition producing excellent agreement between the in vitro and in vivo data was then sought for each suppository by multiple regression analysis.
The Beads-Rotatory cell method could be easily executed utilizing the JP dissolution test apparatus and it was possible to establish a condition which correlates well with the in vivo state.
