PDF(Pubmed)
Abstract：
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.
摘要：
本研究旨在研究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；这些被编码为参考和测试A，试验B,和测试C产品。此外，测量硬度和崩解时间。利用UV分光光度分析技术来定量MTZ。所有的控制片，收到后进行了测试，满足USP要求,因为在60分钟内溶解了不少于85%的标记量的MTZ。MTZ参考在60分钟后释放91.79%±1.23，而产品A,B,C释放率分别为87.96%±2.60、93.26%±2.01和88.61%±2.04。对所有对照片剂计算的不同溶出参数表明,MTZ产品A和B具有最佳溶出性能并且被认为与参考产品相似。产物C显示出显著降低的溶出性能,并且被认为与参照不同。在40℃±2℃/75%RH±5%下储存6个月的MTZ片剂的体外溶出表明片剂保持符合USP要求。MTZ参考在60分钟后释放89.36%±3.64，而产品A,B,C释放率分别为95.79%±3.91、88.52%±2.52和87.79%±5.04。然而,在应激条件下储存的前3个月期间观察到30分钟后释放的百分比(%DE30)的轻微降低和平均溶解时间(MDT)的轻微增加。在相同条件下储存6个月后，这些变化更加明显。此外，在40°C±2°C/75%RH±5%下储存3个月并进一步防止高湿度的产品C的体外溶出表明,由于两种包装形式所发挥的类似保护作用,溶出参数有所改善。此外，研究表明，储存条件如湿度和温度会影响MTZ上市片剂的体外溶出度，这可能会影响效率和患者安全。
