Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

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 journalJournal articleResearchpeer-review

Harvard

Rantanen, J, Wikström, H, Turner, R & Taylor, LS 2005, 'Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes', Analytical Chemistry, vol. 77, no. 2, pp. 556-63. https://doi.org/10.1021/ac048842u

APA

Rantanen, J., Wikström, H., Turner, R., & Taylor, L. S. (2005). Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. Analytical Chemistry, 77(2), 556-63. https://doi.org/10.1021/ac048842u

Vancouver

Rantanen J, Wikström H, Turner R, Taylor LS. Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. Analytical Chemistry. 2005 Jan 15;77(2):556-63. https://doi.org/10.1021/ac048842u

Author

Rantanen, Jukka ; Wikström, Håkan ; Turner, Rebecca ; Taylor, Lynne S. / Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. In: Analytical Chemistry. 2005 ; Vol. 77, No. 2. pp. 556-63.

Bibtex

@article{9e39fe35b2764b7abd372906efa058d3,
title = "Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes",
abstract = "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.",
keywords = "Cellulose, Mannitol, Multivariate Analysis, Particle Size, Quality Control, Spectroscopy, Near-Infrared, Technology, Pharmaceutical",
author = "Jukka Rantanen and H{\aa}kan Wikstr{\"o}m and Rebecca Turner and Taylor, {Lynne S}",
year = "2005",
month = "1",
day = "15",
doi = "10.1021/ac048842u",
language = "English",
volume = "77",
pages = "556--63",
journal = "Analytical Chemistry",
issn = "0003-2700",
publisher = "American Chemical Society",
number = "2",

}

RIS

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 - Analytical Chemistry

JF - Analytical Chemistry

SN - 0003-2700

IS - 2

ER -

ID: 140622477