A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in bohle bin-blender

Nhat Hang Duong; Paulo Arratia; Fernando Muzzio; Andrew Lange; Joep Timmermans; Scott Reynolds

doi:10.1081/DDC-120021317

A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in bohle bin-blender

Nhat Hang Duong, Paulo Arratia, Fernando Muzzio, Andrew Lange, Joep Timmermans, Scott Reynolds

School of Engineering, Chemical & Biochemical Engineering

Research output: Contribution to journal › Article › peer-review

54 Scopus citations

Abstract

A method was developed for studying mixing of cohesive pharmaceutical mixtures. A combination of accurate sampling and NIR spectroscopic analysis was developed as a suitable method to determine homogenization of magnesium stearate as a function of blending variables. A typical pharmaceutical blend containing a ratio 35:64:1 lactose, avicel, and magnesium stearate was used as a model system. The method accounted for variability of the concentration of magnesium stearate as well as variability of the excipients. Levels of magnesium stearate as low as 0.05% could be resolved by the method, and showed a predicting confidence interval above 98%.

Original language	English (US)
Pages (from-to)	679-687
Number of pages	9
Journal	Drug Development and Industrial Pharmacy
Volume	29
Issue number	6
DOIs	https://doi.org/10.1081/DDC-120021317
State	Published - 2003

All Science Journal Classification (ASJC) codes

Pharmacology
Pharmaceutical Science
Drug Discovery
Organic Chemistry

Keywords

Homogeneity
Infrared
Lubrication
Magnesium stearate
NIR spectroscopy
Near-infrared
Pharmaceutical blends
Powder blending

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10.1081/DDC-120021317

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abstract = "A method was developed for studying mixing of cohesive pharmaceutical mixtures. A combination of accurate sampling and NIR spectroscopic analysis was developed as a suitable method to determine homogenization of magnesium stearate as a function of blending variables. A typical pharmaceutical blend containing a ratio 35:64:1 lactose, avicel, and magnesium stearate was used as a model system. The method accounted for variability of the concentration of magnesium stearate as well as variability of the excipients. Levels of magnesium stearate as low as 0.05% could be resolved by the method, and showed a predicting confidence interval above 98%.",

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AU - Duong, Nhat Hang

AU - Arratia, Paulo

AU - Muzzio, Fernando

AU - Lange, Andrew

AU - Timmermans, Joep

AU - Reynolds, Scott

PY - 2003

Y1 - 2003

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AB - A method was developed for studying mixing of cohesive pharmaceutical mixtures. A combination of accurate sampling and NIR spectroscopic analysis was developed as a suitable method to determine homogenization of magnesium stearate as a function of blending variables. A typical pharmaceutical blend containing a ratio 35:64:1 lactose, avicel, and magnesium stearate was used as a model system. The method accounted for variability of the concentration of magnesium stearate as well as variability of the excipients. Levels of magnesium stearate as low as 0.05% could be resolved by the method, and showed a predicting confidence interval above 98%.

KW - Homogeneity

KW - Infrared

KW - Lubrication

KW - Magnesium stearate

KW - NIR spectroscopy

KW - Near-infrared

KW - Pharmaceutical blends

KW - Powder blending

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A homogeneity study using NIR spectroscopy: Tracking magnesium stearate in bohle bin-blender

Abstract

All Science Journal Classification (ASJC) codes

Keywords

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