|
KMID : 0369820090390010029
|
|
Jorunal of Korean Pharmaceutical Sciences
2009 Volume.39 No. 1 p.29 ~ p.36
|
|
|
In-Line Monitoring of Fluid-Bed Blending Process for Pharmaceutical Powders using Fiber Optics Probe and NIR Spectroscopy
|
|
Park Cho-Rong
Kang Ho-Kyung
Kwon Byung-Soo
Kim Ah-Young
Kim Chong-Kook
Bang Kyu-Ho
Seo Da-Young
Shin Sang-Mun
Lee Min-Jeong
Lee Sang-Kil
Lee Hea-Eun
Choi Guang-Jin
Choi Yong-Sun
|
|
|
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.
|
|
|
KEYWORD
|
|
|
PAT, process analytical technology, Powder blending, In-Line monitoring, NIR, Fluid bed process
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|