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由超崩解剂组成的片剂压缩物的 2D 立体变焦图像的轴向和径向同时溶胀研究。

Simultaneous axial and radial swelling studies from 2D stereozoom images of tablet compacts composed of superdisintegrants.

机构信息

Post-Graduate Institute of Pharmaceutical Sciences (formerly College of Pharmacy), University of Health Sciences, Rohtak, Haryana, 124001, India.

Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, Haryana, 124001, India.

出版信息

J Microsc. 2022 Oct;288(1):16-27. doi: 10.1111/jmi.13138. Epub 2022 Sep 6.

Abstract

Swelling-based disintegration is considered important for drug release from tablets and can be modified with excipients called tablet disintegrants. Swelling of tablets occurs axially and radially, and most researchers have observed both these events separately using 2D images. In the current work, we have studied these events simultaneously instead of separately under a stereozoom microscope for tablet compacts composed of high proportions of disintegrants (sodium starch glycolate, SSG and croscarmellose sodium, CCS), using water as the disintegrating medium. A hypothesis is proposed for the measurements of radial and axial swellings from a single 2D image, as horizontal lengths based on trigonometric functions for a right-angle triangle. All predicted axial and radial lengths (as per proposed hypothesis) are found validated with respect to vernier calliper measurements for dry-tablet compacts with a minute error of 3.809%. The axial swelling is approximately fivefolds more than that of radial swelling on the basis of normalised lengths. No particular trend can be spotted exclusively in favour of a superdisintegrant; however, the CCS-based tablets have shown higher swelling as compared to SSG-based tablets. From the current studies, it is evident that both axial and radial dimensions are obtainable from single 2D stereozoom images and can be successfully implemented for swelling studies of tablets.

摘要

基于溶胀的崩解被认为对片剂中药物的释放很重要,可以通过称为片剂崩解剂的赋形剂来进行修饰。片剂的溶胀是轴向和径向的,大多数研究人员已经使用二维图像分别观察到这两个事件。在当前的工作中,我们使用立体显微镜研究了由高比例崩解剂(交联羧甲基纤维素钠(交联羧甲基纤维素钠)和交联聚维酮(交联聚维酮))组成的片剂压片在水作为崩解介质的情况下,同时而不是分别研究这些事件。提出了一个从单个二维图像测量径向和轴向溶胀的假设,作为基于直角三角形的三角函数的水平长度。对于干片剂压片,所有预测的轴向和径向长度(根据提出的假设)都通过游标卡尺测量得到验证,误差仅为 3.809%。根据归一化长度,轴向溶胀约为径向溶胀的五倍。没有特别的趋势可以专门支持超级崩解剂;然而,基于交联羧甲基纤维素钠的片剂的溶胀比基于交联聚维酮的片剂更高。从当前的研究中可以明显看出,单个二维立体图像可以获得轴向和径向尺寸,并且可以成功地用于片剂溶胀研究。

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