Abstract
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.
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