Authors: Kayumba, P. C.¹; Risha, P. G.²; Shewiyo, D.³; Msami, A.³; Masuki, G.³; Ameye, D.⁴; Vergote, G.⁴; Ntawukuliryayo, J. D.¹; Remon, J. P.⁴; Vervaet, C.⁴

Source: Journal of Clinical Pharmacy & Therapeutics, Volume 29, Number 4, August 2004 , pp. 331-338(8)

Publisher: Wiley-Blackwell

Abstract:

Summary Objective: 

The quality of 33 formulations of essential antimicrobial and antimalarial drugs (amoxicillin capsules, metronidazole tablets, sulfamethoxazole/trimethoprim tablets, quinine tablets and sulphadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed and the influence of tropical storage conditions on potency and in vitro dissolution investigated. Methods: 

Drug content and in vitro dissolution were determined immediately after purchase and during 6-month storage under simulated tropical conditions (75% relative humidity, 40 °C) using the methods described in the USP 24 monographs on the drugs concerned. Results and discussion: 

At the time of purchase, the drug content of all the formulations was within the limits recommended by the USP 24, but after 6-month storage, the drug content of one sulfamethoxazole/trimethoprim and one quinine formulation were found to be substandard. Immediately after purchase, four formulations (three sulfamethoxazole/trimethoprim and one sulphadoxine/pyrimethamine combination) failed the USP 24 dissolution test. Except for three metronidazole and one quinine formulations, dissolution tests performed after 6 months of storage under simulated tropical conditions showed that drug release remained within the USP 24 recommended values. Conclusion: 

In both countries, essential drug formulations met pharmacopoeial potency requirements, but some had a poor in vitro drug release profiles. Some of the formulations tested were not stable upon storage under simulated tropical conditions.

Keywords: antimalarial drugs; antimicrobial drugs; dissolution; drug quality; essential drugs; stability

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-2710.2004.00568.x

Affiliations: 1: Department of Pharmacy, Faculty of Sciences and Technology, National University of Rwanda, Butare, Rwanda 2: Department of Pharmaceutics, Faculty of Pharmacy, Muhimbili University College of Health Sciences, Dar es Salaam 3: Ministry of Health, Dar es Salaam, Tanzania 4: Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Ghent University, Ghent, Belgium

Publication date: 2004-08-01

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