4.6 Article

Semisolid Pharmaceutical Product Characterization Using Non-invasive X-ray Microscopy and AI-Based Image Analytics

期刊

AAPS JOURNAL
卷 24, 期 3, 页码 -

出版社

SPRINGER
DOI: 10.1208/s12248-022-00696-z

关键词

X-ray microscopy; semisolid formulation; microstructure; globule size; imaging

资金

  1. Pfizer Inc.

向作者/读者索取更多资源

This study investigates the use of X-ray microscopy (XRM) imaging to characterize the microstructure of semisolid formulations containing multiple immiscible phases. The results show that XRM imaging combined with artificial intelligence-based image processing can provide advanced characterization of semisolid formulation microstructure and offer richer details.
This work reports the use of X-ray microscopy (XRM) imaging to characterize the microstructure of semisolid formulations containing multiple immiscible phases. For emulsion-based semisolid formulations, the disperse phase globule size and its distribution can be critical quality attributes of the product. Optical microscopy and light diffraction techniques are traditionally used to characterize globule size distribution. These techniques are subjected to sample preparation bias and present challenges from matrix interference and data processing. XRM imaging is an emergent technique that when combined with intelligent data processing has been used to characterize microstructures of pharmaceutical dosage forms including oral solid formulations, controlled release microspheres, and lyophilized products. This work described our first attempt to use XRM imaging to characterize two complex emulsion-based semisolid formulations, a petrolatum-based ointment with a dispersed phase comprising a hydrophilic liquid, and an oil-in-water cream. This initial assessment of technology showed that microstructure details such as globule size distribution, volume fraction, spatial distribution uniformity, inter-globule spacing, and globule sphericity could be obtained and parameterized. It was concluded that XRM imaging, combined with artificial intelligence-based image processing is feasible to generate advanced characterization of semisolid formulation microstructure through 3D visualization and parameterization of globule attributes. This technique holds promise to provide significantly richer microstructure details of semisolid formulations. When fully developed and validated, it is potentially useful for quantitative comparison of microstructure equivalence of semisolid formulations.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

4.6
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据