...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Journal of pharmaceutical sciences. >Dissolution of prednisone tablets in the presence of an arch-shaped fiber optic probe in a USP dissolution testing apparatus 2
【24h】

Dissolution of prednisone tablets in the presence of an arch-shaped fiber optic probe in a USP dissolution testing apparatus 2

机译：在USP溶出度测试仪中，在存在弧形光纤探头的情况下，泼尼松片的溶出度2

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

During dissolution testing of solid dosage forms in the United States Pharmacopoeia (USP) Apparatus 2, samples are manually withdrawn from the medium in the vessel prior to the analysis. Probes permanently inserted in the medium can automate the sampling process but can also alter the system's hydrodynamics, possibly resulting in different dissolution-testing results. In this work, dissolution tests were conducted in a USP Apparatus 2 with and without an arch-shaped fiber optic probe using prednisone tablets fixed at nine different locations on the vessel bottom. The resulting dissolution profiles were compared using statistical tools. Dissolution rates obtained with the probe were typically higher than those obtained without the probe. The magnitude of the difference between dissolution profiles depended on the tablet location: Larger differences were observed with tablets located immediately downstream of the probe. The differences in dissolution profiles were generally small enough to satisfy the US Food and Drug Administration criteria (f1 and f2 values), although a paired t-test [P(t-test)] indicated that most of the profiles were statistically different [P(t-test) 0.05]. The hydrodynamic effects generated by the arch-shaped fiber optic probe resulted in detectable differences in the dissolution profiles, which, although limited, were clearly measurable and could introduce variations in test results.
机译：在美国药典（USP）装置2中对固体剂型进行溶出度测试期间，在分析之前从容器中的介质中手动取出样品。永久插入介质中的探针可以使采样过程自动化，但也可以改变系统的流体力学，可能会导致不同的溶出度测试结果。在这项工作中，使用固定在容器底部九个不同位置的泼尼松片剂，在有或没有弓形光纤探头的USP仪器2中进行了溶出度测试。使用统计工具比较所得的溶出曲线。用探针获得的溶解速率通常高于不使用探针获得的溶解速率。溶出曲线之间差异的大小取决于片剂的位置：对于紧邻探针下游的片剂，观察到更大的差异。溶出曲线的差异通常很小，足以满足美国食品药品监督管理局的标准（f1和f2值），尽管配对t检验[P（t-test）]表明大多数曲线在统计学上是不同的[P （t检验）<0.05]。拱形光纤探头产生的流体动力学效应导致溶出曲线的可检测差异，尽管有限，但可以明显测量，并可能导致测试结果变化。

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