药典仪器旋转盘的内在溶出率模型与流道法的比较。

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Amelie M Mattusch, Gerhard Schaldach, Jens Bartsch, Markus Thommes
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引用次数: 0

摘要

为深入了解药物特性,体外测量药物的固有溶解速率非常重要。流体动力学通常被强调为影响溶出的决定性参数。在这项研究中,实验和计算流体动力学(CFD)模拟显示,旋转圆盘装置中的混合行为会导致流场不均匀,并在计算固有溶出率时产生系统误差。该误差受实验时间和速度的影响。由于药典方法中常用的围绕药片中心的旋转运动,流体速度对试样表面单个颗粒的影响存在很大差异。在均匀溢流的情况下,这种差异会明显减小,因此推荐使用流道来研究溶解行为。研究表明,在根据建议的代表性雷诺数和建议的仪器修正系数调整旋转盘的测量数据后,可将旋转盘测量结果与流道测量结果进行比较。此外,还可以使用调整后的列维奇方程来模拟旋转盘仪器中不同温度下与仪器无关的固有溶解速率。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Intrinsic dissolution rate modeling for the pharmacopoeia apparatus rotating disk compared to flow channel method.

For a solid understanding of drug characteristics, in vitro measurement of the intrinsic dissolution rate is important. Hydrodynamics are often emphasized as the decisive parameter influencing the dissolution. In this study, experiments and computational fluid dynamic (CFD) simulations showed that the mixing behavior in the rotating disc apparatus causes an inhomogeneous flow field and a systematic error in the calculation of the intrinsic dissolution rate. This error is affected by both the experimental time and the velocity. Due to the rotational movement around the tablet center, commonly utilized in pharmacopeia methods, a broad variance is present with regard to the impact of fluid velocity on individual particles of the specimen surface. As this is significantly reduced in the case of uniform overflow, the flow channel is recommended for investigating the dissolution behavior. It is shown that rotating disc measurements can be compared with flow channel measurements after adjusting the measured data for the rotating disc based on a proposed, representative Reynolds number and a suggested apparatus-dependent correction factor. Additionally, modeling the apparatus-independent intrinsic dissolution rate for different temperatures in the rotating disc apparatus is possible using the adapted Levich's equation.

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来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
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