Journal of Pharmaceutical Investigation

The Korean Society of Pharmaceutical Sciences and Technology (한국약제학회)
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In-line Monitoring of Fluid-Bed Blending Process for Pharmaceutical Powders using Fiber Optics Probe and NIR Spectroscopy

광섬유-탐침과 근적외선(NIR) 분광기를 이용한 약제분말 유동층 혼합공정의 인라인 모니터링 연구

  • 박초롱 (인제대학교 식의약생명공학과) ;
  • 김아영 (인제대학교 식의약생명공학과) ;
  • 이민정 (인제대학교 식의약생명공학과) ;
  • 이혜은 (인제대학교 제약공학과) ;
  • 서다영 (인제대학교 식의약생명공학과) ;
  • 신상문 (인제대학교 시스템경영공학과) ;
  • 최용선 (인제대학교 시스템경영공학과) ;
  • 권병수 (코오롱제약(주) 기술연구소) ;
  • 방규호 (코오롱제약(주) 기술연구소) ;
  • 강호경 ((주)바이오써포트) ;
  • 김종국 (인제대학교 제약공학과) ;
  • 이상길 (인제대학교 제약공학과) ;
  • 최광진 (인제대학교 제약공학과)
  • Published : 2009.02.20
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Abstract

Since the quality of final products is significantly affected by the homogeneity of powder mixture, the powder blending process has been regarded as one of the critical pharmaceutical unit processes, especially for solid dosage forms. Accordingly, the monitoring to determine a blending process' end-point based on a faster and more accurate in-line/on-line analysis has attracted enormous attentions recently. Among various analytical tools, NIR (near-infrared) spectroscopy has been extensively studied for PAT (process analytical technology) system due to its many advantages. In this study, NIR spectroscopy was employed with an optical fiber probe for the in-line monitoring of fluid-bed blending process. The position of the probe, the ratio of binary powder mixture, the powder size differential and the back-flush period of the shaking bag were examined as principal process parameters. During the blending process of lactose and mannitol powders, NIR spectra were collected, corrected, calibrated and analyzed using MSC and PLS method, respectively. The probe position was optimized. A reasonable end-point was predicted as 1,500 seconds based on 5% RSD value. As a consequence, it was demonstrated that the blending process using a fluid-bed processor has several advantages over other methods, and the application of NIRS with an optical fiber probe as PAT system for a fluid-bed blending process could be high feasible.

Keywords

References

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