Mo. Oluka et al., A COMPARATIVE BIOAVAILABILITY OF 4 CARBAMAZEPINE TABLET FORMULATIONS AVAILABLE IN THE KENYAN MARKET, East African medical journal, 73(5), 1996, pp. 323-326
The relative bioavailabilities of three carbamazepine tablet formulati
ons available in the Kenyan market (Temporal(R)), Taver(R) and Carbama
zepine Lincoln) compared with the innovator formulation (Tegretol(R))
were evaluated in seven healthy African volunteers (5 males, two femal
es; aged 22-36 years), according to a randomised fourway crossover stu
dy design, following oral administration of single 200mg doses with a
three week washout period, In vitro dissolution profiles of the tablet
s were also evaluated, Relative bioavailabilities ((F)rel) of Temporal
(R), Taver(R) and Carbamazepine Lincoln were 101.2%, 82.2 % and 71.6%
respectively, compared with Tegretol(R), Percent drug content dissolve
d in vitro after 1 hour were 91.3%, 75.9% and 39.3% for Temporal(R), T
aver(R) and Carbamazelpine Lincoln, respectively. It was concluded tha
t Temporal(R) was bioequivalent to Tegretol(R) while Taver(R) and Carb
amazepin Lincoln were bioinequivalent to Tegretol(R). Administration o
f Taver(R) or Carbamazepine Lincoln might lead to poor control of epil
eptic seizures.