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【Research Achievement】 A new research paper has been published in Molecular Pharmaceutics

A new research paper by Keiyo Nakai, et al. has been published in the academic journal “Molecular Pharmaceutics” of the American Chemical Society.

掲載誌: 　   Molecular Pharmaceutics, 2025, 22, 5, 2613–2622

URL: 　　   https://doi.org/10.1021/acs.molpharmaceut.5c00028

DOI: 　　　10.1021/acs.molpharmaceut.5c00028

Title: 　　   Structural Analysis of Active Pharmaceutical Ingredients in Tablets Using 3D ED/MicroED

Authors: 　¹Keiyo Nakai*, ²Takashi Kikuchi, ¹Kuniyoshi Miki, ²Akito Sasaki, ¹Mitsuhisa Yamano

Affiliation:  ¹SPERA PHARMA, Inc.　²Rigaku Corporation

Summary:

Detecting the crystal polymorph information of APIs in pharmaceutical tablets has been considered extremely difficult using conventional analytical techniques. This is because additives contained in tablets interfere with the desired crystal polymorph signals during various analyses. Therefore, it has not been possible to confirm whether the crystal polymorphism of raw materials has changed before and after formulation (tabletting). In this study, we aimed to solve the above problem by using 3D ED/MicroED crystal structure analysis, which has been attracting worldwide attention in recent years. Taking advantage of this analysis, “crystal structure analysis can be performed even on complex mixtures,” we succeeded in directly determining the crystal structures of APIs in three pharmaceutical tablets. Furthermore, by comparing these crystal structures with the 3D ED/MicroED structural information of the before tableting powder, we were able to successfully discuss the changes in crystal polymorphism before and after tableting.

At SERA PHARMA, we are dedicated to pioneering the future of high-quality pharmaceutical formulations through the continuous development of innovative analytical methodologies. By promptly delivering the outcomes of these initiatives to our clients, we strive to provide robust support in addressing their challenges and advancing their goals.

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