Facultad de Farmacia, Universidad de La Laguna, San Cristóbal de La Laguna, Spain.
Programa de Doctorado Ciencias Médicas y Farmacéuticas, Desarrollo y Calidad de Vida, Universidad de La Laguna, San Cristóbal de La Laguna, Spain.
PLoS One. 2023 Mar 16;18(3):e0282023. doi: 10.1371/journal.pone.0282023. eCollection 2023.
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.
药品质量可能会受到从制造到配药的各个环节的影响，尤其是在像毛里塔尼亚这样高温高湿的环境下。由于缺乏合格的实验室和监测系统，该国未被世界卫生组织列入劣质产品报告中。由于结核病的高发病率、复杂的治疗方案和持续的细菌耐药性，确保药品质量就更加重要。本研究旨在开发一种监测系统，通过基于欧洲和美国药典建议的质量控制标准的不合格检测，来评估抗结核药物产品的质量。除了研究加速储存条件（40 ± 2°C/75 ± 5%相对湿度）对其质量的影响，并比较溶解曲线以对比质量外。从欧洲和毛里塔尼亚采集了 18 种抗结核药物产品，通过外观检查和质量一致性、单位剂量均匀度、溶出度、崩解度和脆碎度等药典测试来研究其质量。此外，还进行了溶出曲线比较以检查质量。进行稳定性研究以评估气候条件对活性药物成分含量和溶解量的影响，通过超高效液相色谱系统进行测定。结果显示，13 种毛里塔尼亚制剂中有 69.3%质量不合格，主要是由于这些药品的脆碎度或含量均匀度试验不符合要求。所有欧洲药品均符合药典规范。此外，储存条件还影响了乙胺丁醇的溶出率和 4 种抗结核组合药物产品的均匀度。
