Quality demonstration of prednisolone tablet manufacture using personalized manufacturing equipment

Abstract

In recent years, increasing attention has been paid to personalized medicine that can flexibly vary dosage forms, dose, and drug delivery system characteristics such as drug-release patterns for individual patients. The development of manufacturing equipment is particularly important for achieving personalized medicine. In this context, some of the authors of this study developed tabletop [1200 mm (length) × 600 mm (width) × 900 mm (height)] equipment for personalized tablet manufacturing with a quality control mechanism.

Highlights

A personalized tablet manufacturing equipment named TABMED was assessed.
400 over tablets were manufactured using TABMED.
The manufactured tablets met quality standards related to physical properties.
The checking system of prednisolone concentrations had a high accuracy.

This compact equipment can manufacture tablets from active pharmaceutical ingredient particles and excipient granules on demand. In this study, we produced prednisolone tablets using this equipment and investigated various aspects regarding quality. We found that the operating parameters of each manufacturing unit comprising the equipment affect the physical properties of tablets. Based on the physical properties of the tablets, the quality of the prednisolone tablets produced was equivalent to that of a commercial product and met dissolution testing of USP standards.

Moreover, compared with previous studies, the accuracy of the prednisolone concentration prediction system was satisfactory. We anticipate that this manufacturing system for pharmaceutical solids will advance the future capacity to produce personalized medicine on demand in the form of ready-to-use pharmaceuticals.

Materials

Prednisolone tablets 1 mg (Asahi Kasei Pharma, Tokyo, Japan) and 5 mg (Shionogi Pharma, Osaka, Japan) were the reference medications. Prednisolone (Mwt 360.45) for the API was purchased from Tokyo Chemical Industry (Tokyo, Japan). The following were kindly provided by the companies mentioned. PEARLITOL FLASH and PEARLITOL CR-H were provided by Roquette Japan (Tokyo, Japan). GRANFILLER-D GNF-D215 and HiSORAD were provided by Daicel Corporation (Tokyo, Japan).

Kazuya Tanabe, Ko Matsui, Yusuke Hayashi, Hirokazu Sugiyama, Kohei Tahara, Quality demonstration of prednisolone tablet manufacture using personalized manufacturing equipment, Journal of Drug Delivery Science and Technology, Volume 115, Part 2, 2026, 107793, ISSN 1773-2247, https://doi.org/10.1016/j.jddst.2025.107793.