Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes
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Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. / Rantanen, Jukka; Wikström, Håkan; Turner, Rebecca; Taylor, Lynne S.
In: Analytical Chemistry, Vol. 77, No. 2, 15.01.2005, p. 556-63.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes
AU - Rantanen, Jukka
AU - Wikström, Håkan
AU - Turner, Rebecca
AU - Taylor, Lynne S
PY - 2005/1/15
Y1 - 2005/1/15
N2 - High shear granulation is a complex unit operation with several interacting process parameters. No generally accepted real-time in-line tools are available to gain insight into this process, and in practice, a highly experienced process formulator and operator are needed to develop a wet granulated solid dosage form. In this study, the use of in-line near-infrared (NIR) spectroscopy as a process analytical tool for high shear granulation was investigated. In combination with principal component-based methods, process analysis of three separate phases of high shear wet granulation (mixing, spraying, and wet massing) was facilitated. Critical information, both chemical and physical, was collected during processing. Chemical information included the homogeneity of the formulation and the amount of water in wet mass. In addition, physical information related to the particle size of granules was extracted. Principal component loadings were fully interpreted to validate the conclusions drawn from scores and predictions. Thus NIR spectroscopy could be used to determine the end points of the three subphases of high shear wet granulation and, as such, provide a fast in-line quality control tool.
AB - High shear granulation is a complex unit operation with several interacting process parameters. No generally accepted real-time in-line tools are available to gain insight into this process, and in practice, a highly experienced process formulator and operator are needed to develop a wet granulated solid dosage form. In this study, the use of in-line near-infrared (NIR) spectroscopy as a process analytical tool for high shear granulation was investigated. In combination with principal component-based methods, process analysis of three separate phases of high shear wet granulation (mixing, spraying, and wet massing) was facilitated. Critical information, both chemical and physical, was collected during processing. Chemical information included the homogeneity of the formulation and the amount of water in wet mass. In addition, physical information related to the particle size of granules was extracted. Principal component loadings were fully interpreted to validate the conclusions drawn from scores and predictions. Thus NIR spectroscopy could be used to determine the end points of the three subphases of high shear wet granulation and, as such, provide a fast in-line quality control tool.
KW - Cellulose
KW - Mannitol
KW - Multivariate Analysis
KW - Particle Size
KW - Quality Control
KW - Spectroscopy, Near-Infrared
KW - Technology, Pharmaceutical
U2 - 10.1021/ac048842u
DO - 10.1021/ac048842u
M3 - Journal article
C2 - 15649053
VL - 77
SP - 556
EP - 563
JO - Industrial And Engineering Chemistry Analytical Edition
JF - Industrial And Engineering Chemistry Analytical Edition
SN - 0003-2700
IS - 2
ER -
ID: 140622477