Dissolution and relative bioavailability of two carbamazepine preparations for children with epilepsy.
The in-vitro dissolution profiles of two carbamazepine formulations (Tegretol and a generic carbamazepine) have been assessed and the bioavailability of carbamazepine compared in 12 epileptic children at steady-state. Dissolution from the generic formulation (100 and 200 mg tablets) tended to be greater than for the proprietary tablets. However, the bioavailability and pharmacokinetics of carbamazepine when assessed at steady-state were similar for the two formulations. It appears, therefore, that the breakthrough seizures and higher incidence of neurological side-effects observed when children were given generic carbamazepine in place of the proprietary formulation cannot be accounted for by differences in bioavailability or pharmacokinetics.
Hartley
R
R
Paediatric Research Unit, Leeds General Infirmary, UK.
Aleksandrowicz
J
J
Bowmer
C J
CJ
Cawood
A
A
Forsythe
W I
WI
D000293:Adolescent; D001682:Biological Availability; D002220:Carbamazepine / Q000031:analogs & derivatives / Q000097:blood / Q000378:metabolism / Q000493:pharmacokinetics*; D002648:Child; D004827:Epilepsy / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D006801:Humans; D008297:Male; D011897:Random Allocation; D013810:Therapeutic Equivalency
D002220:Carbamazepine; C012227:carbamazepine epoxide