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An interlaboratory investigation of intrinsic dissolution rate determination using surface dissolution.
European Journal of Pharmaceutics and Biopharmaceutics ( IF 4.4 ) Pub Date : 2020-02-13 , DOI: 10.1016/j.ejpb.2020.02.005
Kelly Etherson 1 , Claire Dunn 2 , Wayne Matthews 3 , Henrik Pamelund 4 , Camille Barragat 5 , Natalie Sanderson 6 , Toshiko Izumi 7 , Claudia da Costa Mathews 7 , Gavin Halbert 2 , Clive Wilson 2 , Mark McAllister 7 , James Mann 6 , Jesper Østergaard 5 , James Butler 1 , Ibrahim Khadra 2
Affiliation  

The purpose of this study was to conduct an interlaboratory ring-study, with six partners (academic and industrial), investigating the measurement of intrinsic dissolution rate (IDR) using surface dissolution imaging (SDI) equipment. Measurement of IDR is important in pharmaceutical research as it provides characterising information on drugs and their formulations. This work allowed us to assess the SDI's interlaboratory performance for measuring IDR using a defined standard operating procedure (see supporting information) and six drugs assigned as low (tadalafil, bromocriptine mesylate), medium (carvedilol, indomethacin) and high (ibuprofen, valsartan) solubility compounds. Fasted State Simulated Intestinal Fluid (FaSSIF) and blank FaSSIF (without sodium taurocholate and lecithin) (pH 6.5) were used as media. Using the standardised protocol an IDR value was obtained for all compounds and the results show that the overall IDR rank order matched the solubility rank order. Interlaboratory variability was also examined and it was observed that the variability for lower solubility compounds was higher, coefficient of variation >50%, than for intermediate and high solubility compounds, with the exception of indomethacin in FaSSIF medium. Inter laboratory variability is a useful descriptor for understanding the robustness of the protocol and the system variability. On comparison to another published small-scale IDR study the rank ordering with respect to dissolution rate is identical except for the high solubility compounds. This results indicates that the SDI robustly measures IDR however, no recommendation on the use of one small scale method over the other is made.

中文翻译:


使用表面溶解测定内在溶解速率的实验室间研究。



本研究的目的是与六个合作伙​​伴(学术界和工业界)进行实验室间环形研究,研究使用表面溶出成像 (SDI) 设备测量固有溶出率 (IDR)。 IDR 的测量在药物研究中非常重要,因为它提供了药物及其配方的特征信息。这项工作使我们能够使用定义的标准操作程序(参见支持信息)和指定为低(他达拉非、甲磺酸溴隐亭)、中(卡维地洛、吲哚美辛)和高(布洛芬、缬沙坦)的六种药物来评估 SDI 在测量 IDR 方面的性能。可溶性化合物。使用禁食状态模拟肠液 (FaSSIF) 和空白 FaSSIF(不含牛磺胆酸钠和卵磷脂)(pH 6.5)作为介质。使用标准化方案获得了所有化合物的 IDR 值,结果表明总体 IDR 排序与溶解度排序相匹配。还检查了实验室间的变异性,观察到较低溶解度化合物的变异性高于中间和高溶解度化合物的变异性,变异系数>50%,FaSSIF培养基中的吲哚美辛除外。实验室间变异性是了解方案稳健性和系统变异性的有用描述符。与另一项已发表的小规模 IDR 研究相比,除了高​​溶解度化合物外,溶出速率的排序是相同的。这一结果表明,SDI 可以稳健地测量 IDR,但是,并未建议使用一种小规模方法而不是另一种方法。
更新日期:2020-02-20
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