A comparative evaluation of pharmacokinetics of conventional and slow-release carbamazepine formulation in newly treated patients of epilepsy: a random evaluation.

Study was conducted to compare the pharmacokinetic profile of conventional and slow-release carbamazepine formulations in Indian epileptic patients. Twenty consecutive untreated patients of partial seizures were randomly assigned to receive either conventional carbamazepine (200 mg thrice a day) or slow-release carbamazepine formulation (200 mg thrice a day), 10 patients in each group. The serum carbamazepine concentrations were measured on 10th day and 20th day of treatment. The blood samples were collected before the morning dose. In the conventional treatment group five patients experienced side effects as compared to two in the slow-release group. On 10th day mean serum carbamazepine levels were significantly higher in conventional group (8.27 +/- 1.39 micrograms/ml) in comparison to slow release group (4.28 +/- 3.89 micrograms/ml). The difference was statistically significant (p < 0.05). On 20th day carbamazepine levels fell significantly in conventional group only (8.27 +/- 1.39 micrograms/ml to 5.76 +/- 2.32 micrograms/ml, p < 0.05). At this stage the difference in mean carbamazepine levels of two groups became insignificant (p < 0.05). In conclusion, controlled release formulations provide more steady serum concentrations of carbamazepine along with better tolerability.