A comparative bioavailability of four carbamazepine tablet formulations available in the Kenyan market

Abstract

The relative bioavailabilities of three carbamazepine tablet formulations available in the Kenyan market (Temporal", Taver" and Carbamazepine Lincoln) compared with the innovator formulation (Tegretol") were evaluated in seven healthy African volunteers (5 males, two females; aged 22-36 years), according to a randomised fourway crossover study design, following oral administration of single 200mg doses with a three week washout period. In vitro dissolution profiles ofthe tablets were also evaluated. Relative bioavailabilities (Frel) of Temporals, TaverR and Carbamazepine Linocoln were 101.2%, 82.2% and 71.6% respectively, compared with Tegretol''. Percent drug content dissolved ill vitro after I hour were 91.3%, 75.9% and 39.3% for Temporals, Taverf and Carbamazepine Lincoln, respectively. It was concluded that Temporalf was bioequivalent to Tegretol while Taver and Carbamazepin Lincoln were bioinequivalent to TegretoI. Administration of TaverR or Carbamazeplne Lincoln might lead to poor control of epileptic seizures.