ABSTRACT
Bioavailability of carbamazepine (CBZ) tablet in Thai subject has never been reported before. Owing to the big difference of the drug cost and the National Drug Policy to promote the use of generic drugs, it is therefore essential to compare the bioavailability of tablets available in Thai market. Two brands of CBZ tablets that are commonly used in various hospitals were included in the present study in 17 healthy Thai volunteers. The drugs were given in randomized crossover fashion. Vanes blood samples were grown at 0,1,2,3,4,6,8,10,24,4,8,72,96,120, and 144 hours prior to and after ingestion of 2x 200 mg CBZ tablets A washout period of 4 weeks was allowed because of its autoinduction of hepatic enzymes. Plasma samples were separated and the amount of CBZ contained in each samples were analyzed by HPLC. The present results indicate a significantly slower rate of absorption of drug A nut the extent of absorption appears to be equal to that of drug B.
ABSTRACT
Three brands of carbamazepine tablets available in Thailand were assessed for their pharmaceutical properties according to the requirement of pharmacopoeia. The present study demonstrated that the dissolution profile of CBZ tablets varied markedly to the hardness of the tablet. All brands of CBZ tablet tested fulfill most of the pharmacopoeial requirements, (e.g. weight variation, content uniformity, disintegration tie, etc.), except the dissolution and the friability limit. The present results indicate the problem of dissolution of CBZ tablet. However, Thai FDA has not yet required the dissolution limit for CBZ tablet. The present study, therefore, provide the evidence for addition of CBZ tablet to the list of drugs that are subjected to the dissolution testing.