Leon Shargel

Effect of stannous fluoride and sodium fluoride on hepatic mixed-function oxidase activities in the rat

Abstract Alterations in rat hepatic mixed-function oxidase activities were measured in vivo and in vitro 20 hr after pretreatment with a single dose of stannous fluoride or sodium fluoride. SnF 2 pretreatment significantly decreased the N-demethylation of aminopyrine and O -demethylation of p -nitroanisole; whereas, NaF in an equimolar dose did not affect N-demethylation but did decrease O -demethylation. Hexobarbital sleeping time was significantly prolonged by SnF 2 but not by NaF. Furthermore, the elimination half-life of antipyrine was increased by SnF 2 but not by NaF. These results demonstrate that the inhibition by SnF 2 of hepatic mixed-function oxidase activities in the rat is primarily due to the stannous ion and that fluoride ion has very little affect on these enzyme activities.

Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests

As part of its evaluation of the performance verification tests used periodically to affirm the integrity of the USP Performance test when General Chapter Dissolution is relied upon, the Biopharmaceutics Expert Committee of the Council of Experts, working with staff, decided to change the form of the accept/reject decision from one based on the result for each tablet to one based on the mean and coefficient of variation of results from a set of tablets. This paper describes the new approach. The paper also describes an implementation period for the approach, coupled with a period during which USP will discontinue use of the Salicylic Acid tablet in a performance verification test.