Aldosari Basmah N, Al-Mutairi Areej M, Almurshedi Alanood S, M Alfagih Iman, Al Quadeib Bushra T, Eltahir Eram, Almarshidy Salma S, Ibrahim Mohamed A, El Sayeh F Abou El Ela Amal
Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11495, Saudi Arabia.
Saudi Pharm J. 2024 Aug;32(8):102134. doi: 10.1016/j.jsps.2024.102134. Epub 2024 Jun 12.
This study aimed to investigate the impact of storage conditions on the dissolution performance of commercial metronidazole (MTZ) tablets available in Saudi Arabia; these were coded as the reference and Test A, Test B, and Test C products. Moreover, the hardness and the disintegration time were measured. The UV spectrophotometrically analytical technique was utilized to quantify MTZ. All the control tablets, which were tested upon receipt, met the USP requirement as not less than 85 % of the labeled amount of MTZ was dissolved in 60 min. The MTZ reference released 91.79 % ± 1.23 after 60 min, while the products A, B, and C released 87.96 % ± 2.60, 93.26 % ± 2.01, and 88.61 % ± 2.04, respectively. The different dissolution parameters calculated for all the control tablets showed that the MTZ products A and B had optimal dissolution performances and were considered similar to the reference product. The product C showed a significantly reduced dissolution performance and was considered different from the reference. The in vitro dissolution of the MTZ tablets stored at 40oC ± 2 oC/75 % RH ± 5 % for 6 months indicated that the tablets maintained compliance with the USP requirement. The MTZ reference released 89.36 % ± 3.64 after 60 min, while the products A, B, and C released 95.79 % ± 3.91, 88.52 % ± 2.52, and 87.79 % ± 5.04, respectively. However, a slight reduction in the percentage released after 30 min (% DE30) and a slight increase in the mean dissolution time (MDT) were observed during the first 3 months of storage under stressed conditions. These changes were more obvious after 6 months of storage under the same conditions. Furthermore, in vitro dissolution of the product C stored at 40oC ± 2 oC/75 % RH ± 5 % for 3 months with further protection against high humidity revealed an improvement in the dissolution parameters due to the similar protective effects exerted by the two packaging forms. Furthermore, the study shows that storage conditions such as humidity and temperature affect in vitro dissolution of MTZ marketed tablets which may have an impact on efficiency and patient safety.
本研究旨在调查储存条件对沙特阿拉伯市售甲硝唑（MTZ）片剂溶出性能的影响；这些片剂被编码为参比产品以及试验A、试验B和试验C产品。此外，还测量了硬度和崩解时间。采用紫外分光光度分析技术对MTZ进行定量。所有收到时进行检测的对照片剂均符合美国药典要求，即在60分钟内溶解的MTZ量不少于标示量的85%。MTZ参比产品在60分钟后释放了91.79%±1.23%，而产品A、B和C分别释放了87.96%±2.60%、93.26%±2.01%和88.61%±2.04%。为所有对照片剂计算的不同溶出参数表明，MTZ产品A和B具有最佳溶出性能，被认为与参比产品相似。产品C的溶出性能显著降低，被认为与参比产品不同。在40℃±2℃/75%相对湿度±5%条件下储存6个月的MTZ片剂的体外溶出试验表明，这些片剂仍符合美国药典要求。MTZ参比产品在60分钟后释放了89.36%±3.64%，而产品A、B和C分别释放了95.79%±3.91%、'88.52%±2.52%和87.79%±5.04%。然而，在加速条件下储存的前3个月内，观察到30分钟后释放百分比（%DE30）略有降低，平均溶出时间（MDT）略有增加。在相同条件下储存6个月后，这些变化更为明显。此外，产品C在40℃±2℃/75%相对湿度±5%条件下储存3个月，并进一步采取防潮措施，结果显示由于两种包装形式发挥的类似保护作用，溶出参数有所改善。此外，该研究表明，湿度和温度等储存条件会影响市售MTZ片剂的体外溶出，这可能会对疗效和患者安全产生影响。
