Abstract

Fateh AL Rahman F. Magbool* and Mahmoud ElAoud Ibrahim

ABSTRACT

Quality control (QC) is a process employed to ensure a certain level of quality in a product. Drug analysts play an indirect but very important role in creating the basis for highly efficient drug therapy by giving analytical support to synthetic, biotechnological, pharmacological, pharmaceutical technology, clinical, etc... Much more important is the role of drug analysts in other area, in securing the highest possible safety for drug therapy. Malaria, over the decades, is still one of the most severe infectious diseases globally which is widespread mainly in the tropical and subtropical regions. It kills more people each year than any other infectious diseases except AIDS and tuberculosis. The disease is caused by single-celled protozoan parasites of the genus Plasmodium. Artesunate is a sesquiterpene with an unusual endoperoxide linkage structurally unrelated to other known antimalarials. Artesunate (hemisuccinate ester) its artemisinin derivative is ideal for the treatment of severe malaria, including cerebral malaria. It is also active against chloroquine and mefloquine resistant strains of P. falciparum. ARS was developed as a pro-drug for the treatment of both uncomplicated and severe P. falciparum malaria. It is available in both enteral and parenteral formulations. In this study, the pharmaceutical evaluation and quality assessment of commercial Atesunate tablets that are available in the Sudanese market was performed according to the Pharmacopoeial standard method. The study sought to ascertain the presence or otherwise of counterfeit and substandard artesunate tablets in Sudan. Artesunate tablets were purchased from pharmacies in Khartoum for the study. The mechanical properties of the tablets were evaluated, namely: uniformity of weight, breaking strength, friability, tablet diameter and rate of disintegration in aqueous medium. Titration method was used to determine the presence of artesunate and to assay the tablets. None of the artesunate tablets sampled was found to be a counterfeit or substandard. Most of the brands had acceptable mechanical properties in terms of mass uniformity, hardness, friability, tablet diameter and disintegration time. However, the artesunate content of the tablets was observed (98.18%- 107.18%). Quantitative analysis using titration measurements (standard method) of the studied brands showed all of the tablet brands passing the WHO International Pharmacopoeia requirement which specifies Artesunate tablets to contain not less than 90.0 % and not more than 110.0 % of the amount of artesunate. Accordingly, all Artesunate tablets manufactured in Sudan were of good quality. Fortunately, there is no counterfeit or substandard Artesunate tablets was observed in this studied brands, Because the use of substandard Artesunate tablets in treatment would result in sub-therapeutic levels of the drug in patients, leading to treatment failure and possible development of drug resistance. There is, therefore, the need for drug regulatory bodies in Sudan and other African countries to be vigilant and undertake routine assessment of the quality of Artesunate and other Artemisinin products on the market in order to flush out and to overcome developing of counterfeit and substandard ones.