• Formulation Study of HPMC-based Hot-melt Extruded Rebamipide Solid Dispersions for Solubility Enhancement and Sustained Release

  • Won Kyung Kim*,# , Giwon Lee*,#, Sunjae Park*, and Gilson Khang*, **, ***,†

  • *Department of PolymerNano Science & Technology, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea
    **Department of Bionanotechnology and Bio-Convergence Engineering, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea
    ***Polymer Materials Fusion Research Center, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea

  • 용해도 개선 및 서방형 약물 방출 달성을 위한 HPMC 기반 열용융 압출 레바미피드 고체분산체의 제형 설계

  • 김원경*,# · 이기원*,# · 박선재* · 강길선*, **, ***,†

  • *전북대학교 고분자나노공학과, **전북대학교 바이오나노융합공학과, ***전북대학교 고분자융합소재연구소

  • Reproduction, stored in a retrieval system, or transmitted in any form of any part of this publication is permitted only by written permission from the Polymer Society of Korea.


Abstract

This study proposes a Hot Melt Extrusion method-based solid dispersion using HPMC to improve the solubility and achieve sustained release of rebamipide. The rebamipide solid dispersions show a 19-fold increase in water solubility compared with the pure rebamipide by combining pH adjustment and various surfactants. Fourier transform infrared spectroscopy (FTIR), X-ray diffractometer (XRD), and differential scanning calorimetry (DSC) analyses confirmed the amorphous transformation of rebamipide and its stable dispersion in the polymer matrix. Sustained-release tablet, prepared with rebamipide solid dispersion, showed first-order dissolution pattern over 14 hours, consistently with a diffusion-controlled mechanism. As a result, this study demonstrates the potential of combining solid dispersion and sustained-release technologies based on hot-melt extrusion method as an effective formulation platform for simultaneous solubility enhancement and controlled drug release.


본 연구에서는 난용성 위점막 보호제인 레바미피드에 열용융 압출을 적용하여 용해도를 개선하고, 동시에 서방화 용출을 달성할 수 있는 HPMC 기반 고체분산체를 제안하고자 하였다. pH 조절제와 다양한 계면활성제를 조합하여 열용융 압출을 통해 제조된 레바미피드 고체분산체는 원료 약물 대비 최대 19배까지 용해도가 증가하였다. Fourier transform infrared spectroscopy(FTIR), X-ray diffractometer(XRD) 및 differential scanning calorimetry(DSC) 분석을 통해 레바미피드의 무정형화 및 고분자 내 안정한 분산을 확인하였다. 레바미피드와 수용성고분자로 제조한 서방정은 약 14시간 동안 완만한 용출 패턴을 나타냈으며, 이는 서방정의 겔층 형성에 따른 확산 지연 기전과 일치하였다. 본 연구는 열용융 압출 기반 고체분산체와 서방화 기술을 결합하여 용해도 및 방출 제어를 동시에 구현할 수 있는 제형 플랫폼의 가능성을 제시한다.


Keywords: rebamipide, solid dispersion, solubilization, hot-melt extrusion, sustained release.

  • Polymer(Korea) 폴리머
  • Frequency : Bimonthly(odd)
    ISSN 2234-8077(Online)
    Abbr. Polym. Korea
  • 2024 Impact Factor : 0.6
  • Indexed in SCIE

This Article

  • 2026; 50(2): 348-355

    Published online Mar 25, 2026

  • 10.7317/pk.2026.50.2.348
  • Received on Dec 10, 2025
  • Revised on Jan 26, 2026
  • Accepted on Jan 28, 2026

Correspondence to

  • Gilson Khang

  • *Department of PolymerNano Science & Technology, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea
    **Department of Bionanotechnology and Bio-Convergence Engineering, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea
    ***Polymer Materials Fusion Research Center, Jeonbuk National University, 567 Baekje-daero, Deokjin-gu, Jeonju-si, Jeollabuk-do 54896, Korea

  • E-mail: gskhang@jbnu.ac.kr