Gelation Film Coatings Applied to Mini-Tablets for Bitterness Masking and Improved Swallowability
Abstract
Gelation film-coating (GFC) technology has attracted attention as a strategy to improve the swallowability and taste masking of oral solid dosage forms; however, its application to mini-tablets remains challenging because of their high specific surface area and manufacturing limitations. This study aimed to develop a simple and scalable GFC formulation for mini-tablets using standard film-coating equipment. A poly(vinyl alcohol)/polyethylene glycol graft copolymer (PVAPEG) was used as the base polymer, and various thickening agents were screened to optimize the gel formation, disintegration behavior, and surface adhesion. The formulations were evaluated in terms of maximum extrusion stress, disintegration time, dissolution performance, pharmacokinetics, sensory characteristics, and stability. Among the tested formulations, xanthan gum (XG) provided an optimal balance between reduced adhesion and controlled disintegration. GFC mini-tablets containing PVAPEG and XG significantly improved swallowability and bitterness masking compared to uncoated formulations, while maintaining rapid drug dissolution comparable to that of the reference product. Bioequivalence with the marketed product was confirmed, and accelerated stability studies demonstrated excellent stability of the formulation. These findings indicate that GFC mini-tablets based on PVAPEG and XG represent a robust and scalable formulation strategy that enhances patient acceptability without compromising the pharmaceutical performance.
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BibTeX
@article{nakamichi2026gelation,
title = {{Gelation Film Coatings Applied to Mini-Tablets for Bitterness Masking and Improved Swallowability}},
author = {Katsuki Nakamichi and Hiromasa Uchiyama and Yoshiyuki Ogawa and Wataru Izui and Takuya Matsukawa and Ryoma Tanaka and Kazunori Kadota and Yuichi Tozuka},
journal = {Chemical and Pharmaceutical Bulletin},
year = {2026},
month = oct,
doi = {10.1248/cpb.c26-00290},
url = {https://www.jstage.jst.go.jp/article/cpb/74/10/74_c26-00290/_article},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Gelation Film Coatings Applied to Mini-Tablets for Bitterness Masking and Improved Swallowability
AU - Katsuki Nakamichi
AU - Hiromasa Uchiyama
AU - Yoshiyuki Ogawa
AU - Wataru Izui
AU - Takuya Matsukawa
AU - Ryoma Tanaka
AU - Kazunori Kadota
AU - Yuichi Tozuka
PY - 2026
DA - 2026/10/22
JO - Chemical and Pharmaceutical Bulletin
DO - 10.1248/cpb.c26-00290
UR - https://www.jstage.jst.go.jp/article/cpb/74/10/74_c26-00290/_article
AB - Gelation film-coating (GFC) technology has attracted attention as a strategy to improve the swallowability and taste masking of oral solid dosage forms; however, its application to mini-tablets remains challenging because of their high specific surface area and manufacturing limitations. This study aimed to develop a simple and scalable GFC formulation for mini-tablets using standard film-coating equipment. A poly(vinyl alcohol)/polyethylene glycol graft copolymer (PVAPEG) was used as the base polymer, and various thickening agents were screened to optimize the gel formation, disintegration behavior, and surface adhesion. The formulations were evaluated in terms of maximum extrusion stress, disintegration time, dissolution performance, pharmacokinetics, sensory characteristics, and stability. Among the tested formulations, xanthan gum (XG) provided an optimal balance between reduced adhesion and controlled disintegration. GFC mini-tablets containing PVAPEG and XG significantly improved swallowability and bitterness masking compared to uncoated formulations, while maintaining rapid drug dissolution comparable to that of the reference product. Bioequivalence with the marketed product was confirmed, and accelerated stability studies demonstrated excellent stability of the formulation. These findings indicate that GFC mini-tablets based on PVAPEG and XG represent a robust and scalable formulation strategy that enhances patient acceptability without compromising the pharmaceutical performance.
SN - 1347-5223
SN - 0009-2363
ER -