■药物过期的问题是一个明显的障碍,造成相当大的经济损失。然而,目前有限的数据表明,某些药物在失效后的有效性没有显著下降.因此,这项研究的目的是评估过期的氟喹诺酮类抗生素的理化质量。
■氟喹诺酮类抗生素的过期样本是有目的地从奥罗米亚州金马区的公立医院收集的,埃塞俄比亚。采用了世界卫生组织质量评估抽样策略。然后,使用简单的随机抽样技术来选择用于实验室质量控制测试的片剂。化验,identification,和溶出按照美国药典(USP)指南进行,以及失效模式和效应分析(FMEA)技术。
■发现表明,约100%(7/7)过期样品通过了药典质量规范,用于身份和测定测试。然而,在七个过期的品牌中,约14.3%(1/7)的样本(Code-002)无法在30分钟的USP标准内释放其API含量.基于风险的质量评估表明,分析是环丙沙星片剂最关键的质量(RPN=189),其次是同一性(RPN=100)。测定也是最关键的质量属性(RPN=378),其次是诺氟沙星片剂的同一性(RPN=100)。基于风险的合意函数方法表明,75%(3/4)的环丙沙星产品质量良好,25%(1)的质量合格,而诺氟沙星片剂的理想功能是优异的1(33.3%),良好1(33.3%),和可接受的1(33.3%)。
■该研究表明,药物可以在标记的有效期后保持其质量。通过将药典标准与基于风险的方法(如失效模式和效果分析(FMEA))相结合,该研究提供了一个全面的评估框架。这种方法不仅证实了过期的氟喹诺酮类抗生素的持续有效性,而且强调了潜在的减少废物和节省成本的好处。这可以大大有助于解决低资源环境中的医疗保健挑战,促进更有效的医药资源利用。
UNASSIGNED: The problem of medicine expiration presents a notable obstacle, resulting in considerable financial losses. Nevertheless, there is currently limited data indicating that certain medications do not experience a significant decrease in effectiveness after their expiration date. Therefore, the aim of the study was to assess the physico-chemical quality of expired fluoroquinolone antibiotics.
UNASSIGNED: The expired samples of fluoroquinolone antibiotics were purposively collected from public hospitals in the Jimma zone of the Oromia regional state, Ethiopia. A World Health Organization quality evaluation sampling strategy was employed. Then, simple random sampling techniques were utilized for the selection of tablets for the laboratory quality control test. The assay, identification, and dissolution were performed in accordance with the United States Pharmacopeia (USP) guidelines, as well as failure mode and effect analysis (FMEA) techniques.
UNASSIGNED: The finding revealed that about 100% (7/7) expired samples passed pharmacopeia quality specifications for
identity and assay tests. However, of the seven expired brands, about 14.3% (1/7) of the sample (Code-002) was unable to release its API content within the USP criteria of 30 min. The risk-based quality evaluation revealed that assay was the most critical quality attributed to ciprofloxacin tablets (RPN = 189), followed by
identity (RPN = 100). Assay was also the most critical quality attribute (RPN = 378), followed by
identity (RPN = 100) for Norfloxacin tablets. The risk-based desirability function approach showed that 75% (3/4) of ciprofloxacin products were of good quality, and 25% (1) were found to be of acceptable quality, while the desirability function of norfloxacin tablets was found to be excellent 1 (33.3%), good 1 (33.3%), and acceptable 1 (33.3%).
UNASSIGNED: The study revealed that medications can maintain their quality beyond their labeled expiration date. By combining pharmacopeial standards with risk-based approaches like failure mode and effect analysis (FMEA), the study provides a comprehensive evaluation framework. This approach not only confirms the continued effectiveness of expired fluoroquinolone antibiotics but also underscores the potential waste reduction and cost-saving benefits. This could significantly contribute to addressing healthcare challenges in low-resource settings, promoting more efficient pharmaceutical resource utilization.