Abstract
The beads-thimble filter (B-TF) method was investigated in an effort to develop a useful release test method applicable via suppository in vitro. The progesterone suppository which is used for replacement therapy for sterility and infertility resulting from luteal defect was chosen as the model suppository. The time required for a 16% release for the B-TF method was half of that for the rotatory cell method and a quarter of that for the Muranishi method.When the suppositories were administered to rectum of rabbit, the profile of drug concentration in plasma was similar to the drug release profiles in vitro. The influence of two factors, number of beads and rotating speed, on the release pattern was examined in line with the composite experimental design. The release parameters were predicted by second-order polynomial regression equation.The results suggest the usefulness of the B-TF method as in vitro suppository release test method.
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