Journal Africain de Technologie Pharmaceutique et Biopharmacie

REVISION OF APPROVAL PROCEDURES FOR HUMAN MEDICINES USE WITHIN WAEMU: WHAT EVOLUTION?

2025-12-08T05:43:41+00:00

The harmonization of pharmaceutical regulations has made it possible to provide UEMOA Member States with a corpus of texts, which has been revised. The objective of this study was to describe the new UEMOA regulations relating to approval procedures for medicines for human use in order to highlight the developments changes. The study material consisted of the harmonized legal texts of UEMOA, in particular the regulations relating to approval procedures. The method used consisted of analyzing the new harmonized texts from 2020 to 2022, in particular, regulation n°04/2020/CM/UEMOA with regard to the old regulations; and comparing the procedures and contents of the files. The organs involved in the approval procedure have been maintained. The National Pharmaceutical Regulatory Authority acts in place of the Minister responsible for health for applications and the issuance of Market Authorization. The new regulation defines Improved Traditional Medicines without providing for a specific approval procedure. The content of the approval application file is more detailed. In addition to the approval fees introduced in 2010, regulation No. 04/2020/CM/UEMOA introduces penalties and changes several minor variations into major variations. The processing time for market authorization applications is extended from 120 days to a range of 120 to 360 days. Finally, the new regulation n°04/2020/CM/UEMOA improves the approval procedure for medicines for human use in UEMOA Member States, which must continue harmonization efforts by showing diligence in assessing applications for approval.

Development of an antibacterial lotion based on hydroethanolic extract from the leaves of Feretia apodanthera Delile (Rubiaceae) indicated for skin conditions caused by Staphylococcus aureus and Staphylococcus epidermidis.

2026-03-19T02:14:06+00:00

Introduction : La quête perpétuelle des nouvelles molécules pour lutter contre les germes ayant développé une résistance face aux médicaments disponibles sur le marché, suscite une exploration continue des ressources naturelles. De ce fait, la thérapie à base de plantes demeure l’une des voies utilisées par les populations pour se soigner. Le but de cette étude était d’évaluer l’efficacité des lotions antibactériennes formulées à base d’extrait hydroéthanolique des feuilles de Feretia apodanthera Delile (Rubiaceae). Matériel et méthodes : Le test de sensibilité microbiologique sur gélose a été évalué sur Staphylococcus aureus, Staphylococcus epidermidis, Salmonella typhi, Escherichia coli, Pseudomonas aeruginosa et Streptococcus pyogènes aux concentrations d’extraits allant de 100 à 12,5 mg/mL. Trois lotions F1, F2 et F3 ont été formulées et leurs paramètres physico-chimiques, organoleptiques et biologiques ont été contrôlés. Résultats : Les diamètres d’inhibitions de l’infusé hydroéthanolique retenu comme substance active était de 15,50±0,86, 12,50±1,03 et 9,50±4,76 mm pour Staphylococcus aureus, 18±1,70, 15±1,60 et 12,50±6,25 mm pour Staphylococcus epidermidis et 16±1,54, 10±5,02 et 13,50±1,73 mm pour Pseudomonas aeruginosa aux concentrations respectives de 100, 50 et 25 mg/mL. Les diamètres d’inhibitions des trois lotions formulées allaient de 12,50±0,51 à 14,50±0,51 mm sur Staphylococcus aureus et Staphylococcus epidermidis respectivement. Conclusion : Les lotions formulées à bases d’extrait hydroéthanolique de Feretia apodanthera Delile (Rubiaceae) ont démontré une activité antibactérienne vis-à-vis de Staphylococcus aureus et de Staphylococcus epidermidis. Ceci justifierait l’utilisation traditionnelle de Feretia apodanthera dans la prise en charge des infections cutanées au Burkina-Faso.

Formulation and evaluation of rapidly désintégration furosémide tablet

2026-04-16T06:45:02+00:00

Oral liquid forms of furosemide are very rarely available on the market. Custom-made preparations produced in hospital settings for the management of paediatric patients are prone to instability. The aim of this study was to develop rapid-dispersing furosemide tablets for paediatric patients.

Rapid-dispersing tablets were formulated. They contained a diluent inspired by the Pharmaburst C1, 20% w/w microcrystalline cellulose, 1 to 4% w/w croscarmellose sodium, 0.5% w/w magnesium stearate, 2.5% w/w sodium benzoate, and 0.1% w/w sodium saccharinate. The rheological characteristics of the powder mixtures were determined prior to direct compression. The appearance, average mass, hardness, friability, assay and dissolution of the tablets were determined according to European and British pharmacopeia

Two formulations, named F1 and F2, were produced. The average mass and friability were in accordance with pharmacopoeia standards. The disintegration time was 126s and 158s for F1 and F2, respectively. The furosemide content in the tablets was 96.76 ±1.22 and 100.14 ±1.93 for F1 and F2, respectively. The percentage of in vitro release of furosemide was 87.45% and 62.93% m/m in 3 minutes for tablets F1 and F2, respectively, and 100% after 10 minutes.

Formulation F1 showed the best characteristics. It could be further optimized before scale-up.