Comparative quality assessment of selected fluconazole brands in Ibadan, Nigeria Évaluation comparative de la qualité de certaines marques de fluconazole à Ibadan, au Nigéria
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Abstract
ENGLISH
Background: Drug therapeutic failure is a significant challenge currently ravaging the healthcare system of developing countries like Nigeria. This is often linked to the variable quality of generic drug brands. Fluconazole, a triazole antifungal agent, is of clinical importance due to its excellent penetrability in the CSF.
Objective: To evaluate the quality and pharmaceutical equivalence between generic brands of fluconazole and the innovator brand that might affect its performance and interchangeability within Ibadan, Nigeria.
Methods: Seventeen brands of fluconazole including the innovator brand were evaluated for their physicochemical properties (weight uniformity), mechanical properties (crushing strength and friability), release properties (disintegration and dissolution time tests), content assay, and antifungal activity. Statistical analysis was conducted using ANOVA (p < 0.05) to assess significant differences.
Results: All brands passed the weight uniformity test, but only three passed the friability test. One brand from the tablets and the capsules failed the disintegration time test. Notably, only one brand passed the content assay test. The tablets released > 80 % of fluconazole within 30 min while all the capsules including the innovator brand exhibited a burst release. Two brands showed no activity against Candida albicans. The innovator brand had a significantly higher antifungal activity (p < 0.05) than the generics.
Conclusion: The differences in quality among the brands suggest that none would adequately substitute the innovator brand.
FRENCH
Contexte: L'échec thérapeutique des médicaments est un défi important qui ravage actuellement le système de santé des pays en développement comme le Nigéria. Ce problème est souvent lié à la qualité variable des marques de médicaments génériques. Le fluconazole, un agent antifongique triazole, est d'une importance clinique en raison de son excellente pénétration dans le LCR.
Objectif: Évaluer la qualité et l'équivalence pharmaceutique entre les marques génériques de fluconazole et la marque innovante qui pourraient affecter ses performances et son interchangeabilité à Ibadan, au Nigéria.
Méthodes: Dix-sept marques de fluconazole, dont la marque innovante, ont été évaluées pour leurs propriétés physicochimiques (uniformité du poids), leurs propriétés mécaniques (résistance à l'écrasement et friabilité), leurs propriétés de libération (tests de désintégration et de temps de dissolution), leur dosage et leur activité antifongique. Une analyse statistique a été réalisée à l'aide de l'ANOVA (p < 0,05) pour évaluer les différences significatives.
Résultats: Toutes les marques ont passé avec succès le test d'uniformité du poids, mais seulement trois ont réussi le test de friabilité. Une marque de comprimés et de gélules a échoué au test de temps de désintégration. Il convient de noter qu'une seule marque a réussi au test d'analyse du contenu. Les comprimés ont libéré plus de 80% de fluconazole en 30 minutes, tandis que toutes les gélules, y compris la marque innovante, ont présenté une libération en rafale. Deux marques n'ont montré aucune activité contre Candida albicans. La marque innovante avait une activité antifongique significativement plus élevée (p < 0,05) que les génériques.
Conclusion: Les différences de qualité entre les marques suggèrent qu'aucune ne pourrait remplacer adéquatement la marque innovante.
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