• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The Open Drug Delivery Journal >Comparative Dissolution of Diltiazem Immediate and Extended Release Products Using Conventional USP and Innovative Dissolution Paddles
【24h】

Comparative Dissolution of Diltiazem Immediate and Extended Release Products Using Conventional USP and Innovative Dissolution Paddles

机译：使用常规USP和创新溶出桨比较地尔硫卓即时和延长释放产品的溶出度

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Drug dissolution studies are commonly conducted using compendial methods employing USP Paddle andBasket apparatuses. In many cases, dissolution studies can be of limited benefit especially for product-dependent dissolutionprocedures like in extended release (ER) formulations. The high variability in dissolution testing, that is not productrelated,emphasizes the need for developing new methods for dissolution testing that can address the artifacts foundwith the current USP dissolution methods. A crescent shaped spindle was suggested as a solution to overcome drawbacksassociated with conventional dissolution methods. Diltiazem immediate- and extended-release tablets and capsules wereused to evaluate the crescent-shaped spindle and compare it to the USP paddle system. Appropriate dissolution rates wereobtained using crescent-shaped spindle at 25 rpm compared to higher rotation speeds of 75/100 rpm with the USP Paddle.Similarity factor (F2) and dissolution efficiency (DE) parameters were used to evaluate dissolution profiles. Statisticalanalysis using student t-test and P-value was used to compare the results under various test conditions. For the immediaterelease (IR) products, only one product out of four had similar dissolution profile in the USP paddle and Crescent shapedspindles. Two products out of five ER products were found similar based on the F2 value. In general, Crescent shapedspindle provided better evaluation for the dissolution of IR and ER products without any evidence of harsh stirringenvironment or crushing.
机译：药物溶解研究通常是使用USP Paddle和Basket装置的药典方法进行的。在许多情况下，溶出度研究的益处有限，特别是对于依赖产品的溶出过程，例如在缓释（ER）制剂中。溶出度测试的高度可变性（与产品无关）强调需要开发新的溶出度测试方法，以解决当前USP溶出度方法发现的假象。建议采用月牙形纺锤作为克服常规溶解方法相关缺点的解决方案。地尔硫卓的速释和缓释片剂和胶囊用于评估新月形锭子并将其与USP桨叶系统进行比较。与USP Paddle的75/100 rpm更高的转速相比，使用月牙形主轴以25 rpm可获得适当的溶出速率。使用相似因子（F2）和溶出效率（DE）参数评估溶出曲线。使用学生t检验和P值进行统计分析，以比较各种测试条件下的结果。对于速释（IR）产品，只有四分之一的产品在USP桨叶和新月形心轴中具有相似的溶出曲线。根据F2值，发现五种ER产品中有两种产品相似。一般而言，新月形锭子可提供更好的IR和ER产品溶解度评估，而没有任何恶劣的搅拌环境或压碎迹象。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号