Inline Real-Time Near-Infrared Granule Moisture Measurements of a Continuous Granulation-Drying-Milling Process

被引:69
|
作者
Chablani, Lipika [1 ,2 ]
Taylor, Michael K. [3 ]
Mehrotra, Amit [4 ]
Rameas, Patrick [5 ]
Stagner, William C. [1 ]
机构
[1] Campbell Univ, Dept Pharmaceut Sci, Coll Pharm & Hlth Sci, Buies Creek, NC 27506 USA
[2] Mercer Univ, Grad Program, Coll Pharm & Hlth Sci, Atlanta, GA USA
[3] BioDelivery Sci, Raleigh, NC USA
[4] GlaxoSmithKline Inc, Pharma Launch & Global Supply, Zebulon, NC USA
[5] GlaxoSmithKline Inc, Pharmaceut Dev, Res Triangle Pk, NC USA
来源
AAPS PHARMSCITECH | 2011年 / 12卷 / 04期
关键词
continuous granulation-drying-milling; near-infrared (NIR) spectroscopy; process analytical technology (PAT); real-time moisture determination; NIR SPECTROSCOPY; POWDER; QUALITY; MONITOR; DESIGN;
D O I
10.1208/s12249-011-9669-z
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The purpose of this research was to use inline real-time near-infrared (NIR) to measure the moisture content of granules manufactured using a commercial production scale continuous twin-screw granulator fluid-bed dryer milling process. A central composite response surface statistical design was used to study the effect of inlet air temperature and dew point on granule moisture content. The NIR moisture content was compared to Karl Fischer (KF) and loss on drying (LOD) moisture determinations. Using multivariate analysis, the data showed a statistically significant correlation between the conventional methods and NIR. The R (2) values for predicted moisture content by NIR versus KF and predicted moisture values by NIR versus LOD were 0.94 (p < 0.00001) and 0.85 (p < 0.0002), respectively. The adjusted R (2) for KF versus LOD correlation was 0.85 (p < 0.0001). Analysis of the response surface design data showed that inlet air temperature over a range of 35-55A degrees C had a significant linear impact on granule moisture content as measured by predicted NIR (adjusted R (2) = 0.84, p < 0.02), KF (adjusted R (2) = 0.91, p < 0.0001), and LOD (adjusted R (2) = 0.85, p < 0.0006). The inlet air dew point range of 10-20A degrees C did not have a significant impact on any of the moisture measurements.
引用
收藏
页码:1050 / 1055
页数:6
相关论文
共 50 条
  • [31] Real-time monitoring of the tablet-coating process by near-infrared spectroscopy - Effects of coating polymer concentrations on pharmaceutical properties of tablets
    Hattori, Yusuke
    Sugata, Misuzu
    Kamata, Hitoshi
    Nagata, Makoto
    Nagato, Takuya
    Hasegawa, Kouji
    Otsuka, Makoto
    JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, 2018, 46 : 111 - 121
  • [32] Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and Young's modulus of roller compacted powder blends
    Gupta, A
    Peck, GE
    Miller, RW
    Morris, KR
    JOURNAL OF PHARMACEUTICAL SCIENCES, 2005, 94 (07) : 1589 - 1597
  • [33] Near-infrared control and real-time detection of osteogenic differentiation in mesenchymal stem cells by multifunctional upconversion nanoparticles
    Wang, Kaipeng
    Wu, Qian
    Wang, Xichao
    Liang, Guohai
    Yang, Anli
    Li, Jinming
    NANOSCALE, 2020, 12 (18) : 10106 - 10116
  • [34] On-Line Real-Time Monitoring of a Rapid Enzymatic Oil Degumming Process: A Feasibility Study Using Free-Run Near-Infrared Spectroscopy
    Forsberg, Jakob
    Nielsen, Per Munk
    Engelsen, Soren Balling
    Sorensen, Klavs Martin
    FOODS, 2021, 10 (10)
  • [35] A mitochondria-targeted near-infrared fluorescent probe with a large Stokes shift for real-time detection of hypochlorous acid
    Jiao, Xiaojie
    Huang, Kun
    He, Song
    Liu, Chang
    Zhao, Liancheng
    Zeng, Xianshun
    ORGANIC & BIOMOLECULAR CHEMISTRY, 2019, 17 (01) : 108 - 114
  • [36] Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits
    Shi, Guolin
    Xu, Bing
    Wang, Xin
    Xue, Zhong
    Shi, Xinyuan
    Qiao, Yanjiang
    JOURNAL OF SPECTROSCOPY, 2019, 2019
  • [37] An approach combining real-time release testing with near-infrared spectroscopy to improve quality control efficiency of Rhizoma paridis
    Li, Yerui
    Liu, Bowen
    Geng, Shu
    Kim, Sungchan
    Jin, Ye
    Liu, Xuesong
    Luan, Lianjun
    Wu, Yongjiang
    Chen, Yong
    SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY, 2016, 157 : 186 - 191
  • [38] Real-time breath gas analysis of methane using a multipass cell-based near-infrared gas sensor
    Kong, Rong
    Huang, Jie
    Liu, Peng
    Zhou, Xin
    BIOMEDICAL OPTICS EXPRESS, 2024, 15 (07): : 4207 - 4219
  • [39] A Study of the Reliability and Accuracy of the Real-Time Detection of Forage Maize Quality Using a Home-Built Near-Infrared Spectrometer
    Gao, Fei
    Zhang, Yuejing
    Liu, Xian
    FOODS, 2022, 11 (21)
  • [40] Application of the quantitative detection of a change in concentration of magnesium stearate in a feeder tube of tableting manufacture by real-time near-infrared spectroscopy
    Sasakura, D.
    Nakayama, K.
    Chikuma, T.
    PHARMAZIE, 2015, 70 (10): : 636 - 639