Non-compliant antibiotics pose problems of therapeutic efficacy at the level of the individual, but also a serious public health problem. The objective of our study was to evaluate the quality of generic amoxicillin (42 samples) by analytical methods in Dakar/Senegal. At 100% visual inspection of compliance; 100% compliance uniformity test; at the dissolution test all > 80% (86.8% to 108.8%). The presence of amoxicillin with the following contents: Tablets (95.2% to 104.1%); Capsules (91.5% to 113.9%) and Suspensions drinkable (96.9% - 118.7%). All the samples in our study are 100% compliant according to the European and American pharmacopoeias (90% - 120%). Other studies should therefore be oriented in the direction of stability as well as the dosage of degradation products.
References
[1]
Roth, G.A., Abate, D., Abate, K.H., Abay, S.M., Abbafati, C., Abbasi, N., et al. (2018) Global, Regional, and National Age-Sex-Specific Mortality for 282 Causes of Death in 195 Countries and Territories, 1980-2017: A Systematic Analysis for the Global Burden of Disease Study 2017. The Lancet, 392, 1736-1788.
[2]
Hierink, F., Okiro, E.A., Flahault, A. and Ray, N. (2021) The Winding Road to Health: A Systematic Scoping Review on the Effect of Geographical Accessibility to Health Care on Infectious Diseases in Low- and Middle-Income Countries. PLOS ONE, 16, e0244921. https://doi.org/10.1371/journal.pone.0244921
[3]
OMS (1987) Rapport du comité regional de l’Afrique de la trente septième session du 09-16 septembre 1987. https://www.afro.who.int/sites/default/files/sessions/final-reports/afr_rc37_rapport_final_fr_0.pdf
[4]
Hubschweren, C. (2017) Beta-Lactam. In: Triggle, D.J. andTaylor, J.B., Eds., Comprehensive Medicinal Chemistry II, Elsevier, Amsterdam, 479-518.
[5]
Silhavy, T., Kahne, D. and Walker, S. (2010) The Bacterial Cell Envelope. Cold Spring Harbor Perspectives in Biology, 2, 414-417. https://doi.org/10.1101/cshperspect.a000414
[6]
Thakuria, B. and Lahon, K. (2013) The Beta Lactam Antibiotics as an Empirical Therapy in a Developing Country: An Update on Their Current Status and Recommendations to Counter the Resistance against Them. Journal of Clinical and Diagnostic Research, 7, 1207-1214. https://doi.org/10.7860/JCDR/2013/5239.3052
[7]
OMS (2010) Rapport du groupe spécial régional sur la lutte contre les produits médicaux de qualité inférieure, faux/faussement étiquetés/falsifiés/contrefaits dans la région africaine de l’OMS. Rapport n°AFR/RC60/16; Comité régional de l’Afrique. 60ème Session, OMS, Malabo. https://apps.who.int/iris/handle/10665/1671
[8]
Tshilumba, P.M., Amuri, S.B., Kaghowa, E.R., Mbikay, D.M., Impele, A.B., Duez, P. and Ndoumba, J.B.K. (2015) Enquête sur la contrefaçon de quelques anti-infectieux administrés per os commercialisés dans la ville de Lubumbashi [Survey of Counterfeit Oral Antiinfectives Medecine Sold in Lubumbashi]. Pan African Medical Journal, 22, Article 318. https://doi.org/10.11604/pamj.2015.22.318.7302
[9]
Barbereau, S. (2006) La contrefaçon des médicaments: Un phénomène en pleine expansion. Médecine Tropicale, 66, 529-532.
[10]
USP (2013) United States Pharmacopeia 36 NF 31. Vol. 2, U.S. Pharmacopeial Convention, Inc., Rockville.
[11]
Diop, A., Sarr, S.O., Diop, Y.M., Ndiaye, B., Fall, M. and Mbaye, G. (2009) Contrôle de la qualité de quelques molécules antibiotiques utilisées au Sénégal. Médecine Tropicale, 69, 251-254.
[12]
Gueye, A.K. (2007) Contrôle de la qualité des antibiotiques vendus au Sénégal. Thèse de pharmacie. Université Cheikh Anta Diop, Dakar.
[13]
(2011) Pharmacopee Européenne. 7.0 tome 1. 265-1161.
[14]
Koech, L.C., Irungu, B.N., Ng’ang’a, M.M., Ondicho, J.M. and Keter, L.K. (2020) Quality and Brands of Amoxicillin Formulations in Nairobi, Kenya. BioMed Research International, 2020, Article ID: 7091278. https://doi.org/10.1155/2020/7091278
[15]
Fadeyi, I., Lalani, M., Mailk, N., Van Wyk, A. and Kaur, H. (2015) Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom. American Journal of Tropical Medicine and Hygiene, 92, 87-94. https://doi.org/10.4269/ajtmh.14-0539
[16]
(2008) Pharmacopee Européenne. 6ème édition, tome 1. 649-759.
[17]
Goyffon, M. (2004) Commentaires d’un toxicologue. Ethnologie Française, 34, 495-498. https://doi.org/10.3917/ethn.043.0495
[18]
Robertson, S.G., Hehonah, N.T., Mayaune, R.D. and Glass, B.D. (2021) Prevalence of Substandard Amoxicillin Oral Dosage Forms in the National Capital District of Papua New Guinea. American Journal of Tropical Medicine and Hygiene, 105, 238-244. https://doi.org/10.4269/ajtmh.20-1570
[19]
Wycliffe, N. (2010) Tests volontaires de la qualité de médicaments fournis par les institutions membres de l’EPN. Pharmalink, 10, 12-13.
