|
Addis Ababa University Libraries Electronic Thesis and Dissertations: AAU-ETD! >
School of Pharmacy >
Thesis - Pharmaceutical Analysis & Quality Assurance >
Please use this identifier to cite or link to this item:
http://hdl.handle.net/123456789/953
|
| Title: | COMPARATIVE IN VITRO QUALITY EVALUATION OF TABLETS OF THE COMMONLY PRESCRIBED ANTIEPILEPTIC DRUGS, CARBAMAZEPINE AND PHENOBARBITAL, FROM DRUG RETAIL OUTLETS IN ADDIS ABABA |
| Authors: | SULEMAN, SULTAN |
| 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
|
Items in the AAUL Digital Library are protected by copyright, with all rights reserved, unless otherwise indicated.
|
