インドメタシンカプセルの溶出試験とバイオアベイラビリティ

概要

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The dissolution and bioavailability of indomethacin in the commercially available capsules were studied, and the correlation between in vitro and in vivo findings was investigated. Dissolution profiles of two brands of indomethacin capsules (Preparations A and B) and sustained-release capules (Preparations C and D) were recorded according to JP X and USP XX methods. A significant difference in the amount and the rate of dissolution was observed between C and D, but not between A and B. Then, 5 healthy adult subjects received a single dose of 25 mg indomethacin (A, C and D) orally, and the drug level in the serum was determined with high-performance liquid chromatography. The dissolution behavior of the preparations was related to some bioavailability parameters (peak level, time to peak level, and AUC). Particularly, in preparations C and D, the amount of indomethacin dissolved in 2hr was well correlated with the AUC from 0 to 8hr and the peak level.
1982-10-20