On 30 October 2024, the Orapuh Journal published a groundbreaking study led by Rachel Ndezu Angirio of the University of Kisangani, Makiso, Kisangani, Democratic Republic of the Congo. This study analysed the bioequivalence profile of generic Penicillin V tablets compared to an originator brand available in Kisangani. With the prevalence of counterfeit products and the growing use of generics in sub-Saharan Africa, this research provides critical insights into drug quality and therapeutic effectiveness in the region.
Phenoxymethylpenicillin, or Penicillin V, is a widely used antibiotic that is essential for treating bacterial infections. However, it is primarily available in generic forms in sub-Saharan Africa, making quality assurance crucial. The study highlights the importance of testing generic medications for bioequivalence to ensure they can serve as safe and effective alternatives to originator drugs. Angirio’s research focused on two types of Penicillin V tablets: a generic 250 mg formulation and an originator 600 mg product, comparing their dissolution profiles and assay results under European Medicines Agency (EMA) and USP Pharmacopoeia (USP 43-NF 38, 2013) guidelines.
Study Methodology and Findings
The research team at the University of Kisangani used advanced laboratory techniques to test the dissolution and absorption profiles of the two tablet types. Using a UV-visible spectrophotometer, the team identified and measured the concentration of the active ingredient in each tablet. They also conducted dissolution tests at various pH levels—1.2, 4.5, and 6.8—to simulate the human digestive environment, as pH levels vary from the acidic conditions in the stomach to the more basic environment of the intestines.
Key findings from the study included:
- Mass and Ingredient Consistency:
Despite a noticeable difference in tablet weight—the generic weighed 340 mg compared to the 770 mg originator—both tablet types contained close to the intended 250 mg of active Penicillin V. This finding is significant as it confirms that the generics meet dosage accuracy standards, a key factor in bioequivalence. - Dissolution Profile Results:
The team employed the fit factor method to analyse how the tablets dissolved over time in different pH environments. Both the difference factor (f1) and similarity factor (f2) fell within EMA bioequivalence standards (f1 < 15 and f2 > 50). In acidic environments (pH 1.2 and 4.5), both the generic and originator tablets achieved full dissolution within 15 minutes, suggesting rapid absorption when taken orally. - Performance in Basic pH Conditions:
At pH 6.8, which reflects the basic environment of the intestines, both types of tablets showed a slower release, with approximately 80% of the active ingredient released. While these dissolution profiles were comparable between the two formulations, the study notes that potential differences could emerge during in vivo testing in actual patients.
Public Health Implications for Sub-Saharan Africa
The findings from this study have critical implications for public health in sub-Saharan Africa. With generic drugs becoming increasingly prevalent in the region, it is essential to ensure they meet quality and bioequivalence standards. This research confirms that the tested generic Penicillin V tablets can serve as effective alternatives to originator brands, offering more accessible treatment options for patients without compromising therapeutic quality.
Moreover, in a region where counterfeit and substandard drugs present a significant threat to health, this study underscores the need for ongoing monitoring of generic drug quality. The team at the University of Kisangani has set a valuable precedent, demonstrating that laboratory-based studies can effectively assess and ensure drug quality. However, the study also points out the importance of conducting further in vivo research to validate these results in human subjects.
Angirio’s research provides critical support for using generic antibiotics, helping to reduce healthcare costs and improve access to essential medications in low-resource settings. By ensuring that generics meet rigorous bioequivalence standards, Kisangani and similar regions can benefit from safer and more affordable treatment options.
Conclusion
This study, published in the Orapuh Journal, represents a significant advance in understanding the effectiveness of generic drugs in sub-Saharan Africa. As healthcare systems across the region continue to rely on generics to expand access to essential medicines, rigorous bioequivalence testing remains essential. The work by Rachel Ndezu Angirio and her team at the University of Kisangani offers hope that affordable generic medications can reliably serve as effective alternatives to originator brands, improving public health outcomes across the Democratic Republic of the Congo and beyond.