In vitro evaluation of the quality of essential drugs on the Tanzanian market

We evaluated the in vitro availability and its stability under simulated tropical conditions of variousformulations of four essential drugs marketed in Tanzania. We obtained 22 formulations (containingparacetamol, acetylsalicylic acid, chloroquine or sulphadoxine/pyrimethamine) from wholesalepharmacies in Dar es Salaam and the Medical Stores Department (Tanzania). The drug content, in vitroavailability (dissolution) and its stability under simulated tropical conditions were determined usingmethods specified in the United States Pharmacopoeia (USP) 24 monograph of the respective drugs. Allformulations passed the pharmacopoeia requirements for the drug content. However, sevenformulations (three acetylsalicylic acid, two sulphadoxine/pyrimethamine and two paracetamol) failedto meet the USP 24 tolerance limits for dissolution. Another five formulations (three paracetamol andtwo chloroquine) failed to meet the dissolution tolerance limits after being subjected to an acceleratedstability test under simulated tropical conditions (75% RH/40 ?C) for 6 months. The study hasdemonstrated the presence on the Tanzanian market of essential drug formulations that met potencyrequirements and yet had unsatisfactory in vitro availability as they were not robust enough to withstandstorage under simulated tropical conditions.

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Quality of essential drugs in tropical countries: evaluation of antimalarial drugs in the Brazilian Health System

Revista da Sociedade Brasileira de Medicina Tropical ◽

10.1590/s0037-86822011000500010 ◽

2011 ◽

Vol 44 (5) ◽

pp. 582-586 ◽

Cited By ~ 14

Author(s):

Fernando Henrique Andrade Nogueira ◽

Lígia Maria Moreira-Campos ◽

Roseli La Corte dos Santos ◽

Gerson Antônio Pianetti

Keyword(s):

Storage Conditions ◽

Antimalarial Drugs ◽

Essential Drugs ◽

The North ◽

Weight Variation ◽

Significant Difference ◽

Primaquine Phosphate ◽

Brazilian Health System

INTRODUCTION: The emergence of drug resistance is one of the main problems concerning malaria treatment. The use of counterfeit and/or substandard antimalarial drugs can contribute to the development of parasite resistance. Thus, the aim of this study was to evaluate the quality of antimalarial drugs distributed in Brazil. METHODS: Samples containing chloroquine phosphate, mefloquine hydrochloride, primaquine phosphate, and quinine sulfate tablets were delivered to the Rio de Janeiro central storeroom (CENADI), state storerooms (SS), and Basic Health Units (BHUs) in the north region of Brazil - a total of 10 sample sets. After 5 months of storage, the samples were collected, and in vitro quality control analyses according to official and published methods were performed. RESULTS: Inadequate drug storage conditions were found in two SS and in all BHUs evaluated. There were no quality deviations found in the chloroquine samples. The quinine samples exhibited weight variation above the allowed limits. The primaquine samples were found to have packaging deficiency. The release of mefloquine in samples from some regions showed a statistically significant difference when compared with the CENADI samples. CONCLUSIONS: It is important to periodically evaluate the quality and storage conditions of essential drugs. The quality deviations found with the primaquine and quinine samples are not related to storage conditions and must be addressed urgently. The decreased mefloquine release from tablets is related to formulation problems or influenced by inadequate storage conditions, prompting further investigation. Even with the mentioned problems, the samples would probably not contribute to resistant parasite selection.

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