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oa Central African Journal of Medicine - A comparative bioavailability of 2 oral solid phenytoin dosage forms

Volume 35, Issue 4
  • ISSN : 0008-9176

 

Abstract

The comparative bioavailability of two phenytoin products, Phenytoin Sodium (CAPS (Pvt) Ltd) and Epanutin (Parke - Davis (Pty) Ltd) was studied. Single dose studies carried out in eight healthy volunteers showed that CAPS Phenytoin exhibited a small but significantly higher bioavailability (P.<0.05). The AUC (0-72hr) for CAPS Phenytoin was 50.61 ug/ml/hr compared to 45.09au/ml/hr for Epanutin. The time to peak concentrations, Tmax, was significantly longer in CAPS Phenytoin when compared to Epanutin being 3.75hr and 3.25hr respectively (P.<0.05) and the peak concentrations Cmax, achieved after single dose administration showed that CAPS Phenytoin exhibited higher levels than Spanutin (1.76au/m1 and 1.58au/ml respectively) although these differences were not statistically significant. Multiple dose studies carried out in four healthy volunteers and two epileptic patients showed that changes from one product to the other did not produce any significant differences in the steady state phenytoin levels.

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/content/CAJM/35/4/AJA00089176_513
1989-04-01
2019-12-09

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