Comparitive study on dissolution rates of carbamazepine tablets

Abstract

Background: Carbamazepine is a dibenzazepine derived anti-epileptic drug. It has anti-depression, anti-desperation, sedation of aggressive outbursts, reduce urine output and analgesic properties for neuropathic pain. In the previous study, we selected the appropriate excipients based on the specific properties of the active pharmaceutical ingredient-carbamazepine, developed the technology, and Carbamazepine 200 mg model tablet. Aim: To study the bioequivalence of Carbamazepine 200 mg model by in vitro dissolution method comparision Materials and Methods: The drug release of model tablet was determined in vitro by methodology of USP43–NF38. Therapeutic bioequivalence was compared with 2 comparator products: Tegretol from Novartis, Carbamazepine-Akri, which high market sales in Mongolia. The standard Carbamazepine was supplied from Sigma Aldrich Co.,Ltd. Drug release of the Carbamazepine 200 mg model tablet was determined by dissolution apparatus II, paddles, 75 rpm in 1% sodium lauryl sulfate buffer medium, 900 ml. The difference and similarity factors were calculated by mathematical modeling based on results of drug release. Results: Drug release of tablets was satisfied requirement of USP43-NF38. Carbamazepine 200 mg model tablet and Carbamazepine-Akri were met USP Dissolution Test 2. Tegretol was met USP Dissolution Test 3. The value of similarity and difference factor Carbamazepine 200 mg model tablet were f₂=63.5, f₁=0.81 when in comparison with Carbamazepine-Akri and f₂=36, f₁=16.6 by comparing with Tegretol. Discussion: Dissolution of carbamazepine 200 mg tablets should be 45-75% in 15 minutes and not less than 75% in 60 minutes by Dissolution test 2 according to US pharmacopoeia (USP43 – NF38). And dissolution rate should be 65-85% at 15 minutes, not less 75% at 60 minutes by Dissolution test 3. Carbamazepine 200 mg model tablets met the requirements of Dissolution test 2. As a result of the solubility study, the solubility map is considered to be the same if the similarity factor is f₂=50-100 and the difference factor is f₁=0-15. Conclusion: Drug release of Carbamazepine 200 mg model tablet and Carbamazepine-Akri met the requirements of Dissolution test 2 by USP (USP43 – NF38). Drug release of Tegretol met Dissolution test 3. The solubility mapping curve is the same for Carbamazepine 200 mg model tablets compared to Carbamazepine-Akri 200 mg tablets. The curve was different for Carbamazepine 200 mg model tablets compared to Tegretol tablets.