A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania

• Published in: PloS one Vol. 18; no. 3; p. e0282023
• Main Authors: Cáceres-Pérez, Amor R, El Kory, Mohamed B, Suárez-González, Javier, Soriano, Mabel, Echezarreta, M Magdalena, Santoveña-Estévez, Ana, Fariña, José B
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 16.03.2023; Public Library of Science (PLoS)
• Subjects: Antibiotics; Antitubercular Agents; Chromatography; Climatic conditions; Disintegration; Dissolution; Drug compounding; Engineering and Technology; Ethambutol; Formulations; Friability; Heat resistance; High temperature; Inspection; International organizations; Laboratories; Liquid chromatography; Malaria; Mauritania; Medicine; Medicine and Health Sciences; Monitoring; Monitoring systems; People and Places; Pharmaceutical Preparations; Pharmaceuticals; Pharmacology; Potassium; Quality assessment; Quality Control; Quality management; Relative humidity; Research and Analysis Methods; Stability analysis; Storage conditions; Supply chains; Tablets; Tuberculosis; Mauritania; Belgium; United States > US; China; Africa; Nigeria; Kenya; Germany; Spain
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0282023

The quality of drug products may be affected from manufacture to dispensing, particularly at high temperature and humidity as in Mauritania. This country is not included in the World Health Organization reports on poor quality products due to the lack of a qualified laboratory and monitoring system. Ensuring the quality of medicine is even more relevant in the case of diseases such as Tuberculosis, due to its high prevalence, complex treatment and continuous bacterial resistance. The aim was to develop a monitoring system to assess the quality of antituberculosis drugs products, by the substandard detection based on European and United States Pharmacopeial recommendations regarding quality control. In addition to studying the influence of accelerated storage conditions (40 ± 2°C/75 ± 5% relative humidity) on their qualities and comparing the dissolution profiles to contrast the quality. 18 antituberculosis drug products were taken from Europe and Mauritania, and quality was studied through visual inspection and according to the compliance of the mass uniformity, uniformity of dosage units, dissolution, disintegration and friability pharmacopeial tests. Furthermore, a dissolution profile comparison was carried out to examine quality. A stability study was conducted to assess the influence of climatic conditions on the content and the dissolved amount of the active pharmaceutical ingredients, which were determined by an ultra-performance liquid chromatography system. As result, 69.3% of 13 Mauritanian formulations had a substandard quality mainly due to non-compliance with the test for friability or content uniformity of these medicines. All European drug products complied with pharmacopeia specifications. In addition, storage conditions affected the dissolution rate of ethambutol and the uniformity of the 4 antituberculosis combination drug products.