剂型对苯妥英钠片溶出度和生物利用度的影响。
Effect of formulation on dissolution and bioavailability of phenytoin tablets.
作者信息
Chakrabarti S, Belpaire F, Moerman E
出版信息
Pharmazie. 1980;35(10):627-9.
Bioavailability of different phenytoin tablets was calculated from saliva phenytoin levels in healthy human volunteers in a single dose study. Tablets containing different excipients and either phenytoin free acid or sodium phenytoin were chose on the basis of an in vitro dissolution rate study of different tablets. Tablets containing phenytoin precipitated with polysorbate 80 showed faster in vitro dissolution and also higher bioavailability than tablets prepared with phenytoin free acid with different excipients. In vivo studies showed that proper formulation of a tablet containing the free acid form of phenytoin can give rise to the same bioavailability than that of sodium phenytoin. In vitro dissolution of the formulation reflected in vivo bioavailability.
在一项单剂量研究中，通过健康人类志愿者唾液中苯妥英水平计算不同苯妥英片剂的生物利用度。基于不同片剂的体外溶出速率研究，选择了含有不同辅料以及苯妥英游离酸或苯妥英钠的片剂。含聚山梨酯80沉淀的苯妥英片剂在体外溶出更快，并且比用不同辅料的苯妥英游离酸制备的片剂具有更高的生物利用度。体内研究表明，含苯妥英游离酸形式的片剂的合适制剂可产生与苯妥英钠相同的生物利用度。制剂的体外溶出反映了体内生物利用度。
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