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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/953

Advisors: Prof. Farghaly Addel-Hamid Omar
Copyright: 2005
Date Added: 24-Apr-2008
Publisher: Addis Ababa University
Abstract: Several literature reports show that up to 30% of epileptic patients may not respond to drug therapy, or inadequate control of their seizures, even if there is increasing prevalence and incidence rates of epilepsy. But why this happens and whether it can be predicted is unknown. Studies show that patients who have many seizures before therapy or who have an inadequate response to initial treatment with antiepileptic drugs are likely to develop refractory epilepsy (resistance epilepsy) of unknown origin. In this investigation, trial has been undertaken for the prediction of the reasons of treatment failures by virtue of controlling the drug quality aspects. Evaluation studies provide a means of identifying quality differences between same products obtained from various manufacturers. Quality analysis and evaluations are the most important tasks to be performed when various reports of therapy indicate problems and failures of treatment. Different products of antiepileptic drugs, carbamazepine and Phenobarbital tablets were evaluated for their in vitro quality so that a base line data was developed to quote the reasons for the therapeutic failures with antiepileptic drugs from the drug quality point of view. Different brands of carbamazepine tablets and different generic products of Phenobarbital tablets marketed in Addis Ababa were analyzed for their identification, hardness and friability, disintegration, dosage form uniformity (weight variation and/or content uniformity), assay (drug content), and in vitro dissolution profiles. In addition, values of t50% and t90% for drug release were determined for all the tablets. Weight variation test was performed for all the tablets analyzed while content uniformity test was performed for two of the Phenobarbital tablets: East Africa Pharmaceutical and Cadila products. With respect to identification, hardness and friability, disintegration test and dosage form uniformity, all the tablets evaluated were in good agreement with the official specification. From the carbamazepine tablets analyzed, Tegral was found to be below the drug ix content specification, while the other brands of carbamazepine and all the Phenobarbital tablets analyzed were in accordance with their respective specifications. The dissolution tests performed indicated that Tegral tablet and two of the Phenobarbital tablets (East Africa Pharmaceutical and Cadila products) did not release the required drug content within the specified time. Taver from the carbamazepine tablets and the Epharm product Phenobarbital had good dissolution profiles, while the other products showed slower dissolution rates as compared to the above two drugs. The study indicated that the tablets analyzed were bioinequivalent to each other with respect to the in vitro quality studies as some were found to be substandard and some were unable to release the required content at the specified time. Therefore, utilization of the substandard ones or interchange use of the bioinequivalent drug products could have contribution to treatment failures. The present study will be of paramount importance provided further in vivo bioavailability evaluation of the indicated brands and generic tablet formulations are performed and correlated with the in vitro findings. Stability studies of the products should be investigated to identify if possible to quantify degraded products, continued quality surveillance of the brand and generic tablet formulations of antiepileptic drugs from different regions of the country should be conducted to ensure quality thereby improve clinical efficacy.
Description: A thesis submitted to the School of Graduate studies of Addis Ababa University in partial fulfillment for the Degree of Master of Science in Pharmaceutical Analysis and Quality Assurance
URI: http://hdl.handle.net/123456789/953
Appears in:Thesis - Pharmaceutical Analysis & Quality Assurance

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