Near-infrared reflection spectroscopy (NIRS) as a successful tool for simultaneous identification and particle size determination of amoxicillin trihydrate

Bittner, L. K.; Heigl, N.; Petter, C.H.; Noisternig, Michael F.; Griesser, Ulrich J.; Bonn, Günther K.; Huck, Christian W.

doi:10.1016/j.jpba.2010.12.019

Cited by 53 publications

(29 citation statements)

References 18 publications

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“…This is concerning the analysis of polymorph mixtures of the pure API as well 0939 as the drug excipient mixtures and solid dosage forms [6,7]. Also, vibrational spectroscopy is frequently and successfully used for qualitative and quantitative analysis of mixtures of polymorphic APIs [8][9][10][11][12]. The applicability of Raman, ATR-IR, and conventional NIR as fast and simple analytical tools for the quantification of ternary mixtures was demonstrated in several studies [13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Comparison of NIR chemical imaging with conventional NIR, Raman and ATR-IR spectroscopy for quantification of furosemide crystal polymorphs in ternary powder mixtures

Schönbichler

Bittner

Weiss³

et al. 2013

European Journal of Pharmaceutics and Biopharmaceutics

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Section: Introductionmentioning

confidence: 99%

Comparison of NIR chemical imaging with conventional NIR, Raman and ATR-IR spectroscopy for quantification of furosemide crystal polymorphs in ternary powder mixtures

Schönbichler

Bittner

Weiss³

et al. 2013

European Journal of Pharmaceutics and Biopharmaceutics

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“…This shows that an increase in particle size results in an increase in scattering intensity at low wavenumbers but not at high wavenumbers. This has been observed before for particles below 20 μm and is due to a decrease in direct backscatter and increase in path length for small particles at larger wavelengths (46). The correlation between baseline offset and the aerodynamic particle size implies that SNV transformation cannot be used since this transformation reduces the baseline offset.…”

Section: Aerodynamic Particle Sizementioning

confidence: 61%

Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Maltesen

Weert

2012

AAPS PharmSciTech

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Abstract. Moisture content and aerodynamic particle size are critical quality attributes for spray-dried protein formulations. In this study, spray-dried insulin powders intended for pulmonary delivery were produced applying design of experiments methodology. Near infrared spectroscopy (NIR) in combination with preprocessing and multivariate analysis in the form of partial least squares projections to latent structures (PLS) were used to correlate the spectral data with moisture content and aerodynamic particle size measured by a time of flight principle. PLS models predicting the moisture content were based on the chemical information of the water molecules in the NIR spectrum. Models yielded prediction errors (RMSEP) between 0.39% and 0.48% with thermal gravimetric analysis used as reference method. The PLS models predicting the aerodynamic particle size were based on baseline offset in the NIR spectra and yielded prediction errors between 0.27 and 0.48 μm. The morphology of the spray-dried particles had a significant impact on the predictive ability of the models. Good predictive models could be obtained for spherical particles with a calibration error (RMSECV) of 0.22 μm, whereas wrinkled particles resulted in much less robust models with a Q 2 of 0.69. Based on the results in this study, NIR is a suitable tool for process analysis of the spray-drying process and for control of moisture content and particle size, in particular for smooth and spherical particles.

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“…Given that the particle size significantly affects physical properties, its adjustment and control after granulation is crucial (Bittner et al 2011). Particle size also affects the characteristics of NIR diffuse reflection spectra.…”

Section: Mean-particle Size Model and Particle Size Distribution Modelmentioning

confidence: 99%

“…This technique has been applied for the determination of the moisture content (Corredor, Bu, and Both 2011;Mantanus et al 2009;Nieuwmeyer et al 2007), monitoring of blending (Blanco et al 2012;El-Hagrasy and Drennen 2006;Moes et al 2008;Sulub, Konigsberger, and Cheney 2011), measurement of the compression force (Gupta et al 2005a;2005b), and determination of the tablet hardness (Tanabe, Otsuka, and Otsuka 2007). NIR has also been used to monitor the particle-size distribution (Bittner et al 2011;Blanco and Peguero 2008;Ša s sić, Yu, and Zhang 2011) and tabletcoating processes (Gendre et al 2011;Moes et al 2008;Moltgen et al 2012). The feasibility of using NIR to monitor these parameters has already been demonstrated.…”

Section: Introductionmentioning

confidence: 99%

Quantitative Analysis of Uncoated Eszopiclone Tablets by Near-Infrared Spectroscopy

Liu¹,

Luo²,

Wang³

et al. 2014

Analytical Letters

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This study employed near-infrared (NIR) spectroscopy to analyze content uniformity, moisture content, compression force, tablet hardness, average particle size, and particle-size distribution. The content uniformity, moisture content, compression force, tablet hardness, and average particle size models yielded high correlation coefficients (R 2 ) of 0.99582, 0.99725, 0.99620, 0.96294, and 0.98421, respectively, whereas the particle size distribution models showed good predictive ability. Conventional criteria such as R 2 , root-mean-square error of calibration, and the root-mean-square error of prediction were used to evaluate the accuracy and precision of the model. To ensure the accuracy and predictability of the content model for low-dose tablets, additional validation and reliability evaluations were performed using 70%, 80%, 100%, 120%, and 130% drug concentrations as well as 90% and 110% active content formulations. Near-infrared spectroscopy with multivariate modeling is a rapid, nondestructive technique for the characterization of the manufacturing process.

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Near-infrared reflection spectroscopy (NIRS) as a successful tool for simultaneous identification and particle size determination of amoxicillin trihydrate

Cited by 53 publications

References 18 publications

Comparison of NIR chemical imaging with conventional NIR, Raman and ATR-IR spectroscopy for quantification of furosemide crystal polymorphs in ternary powder mixtures

Comparison of NIR chemical imaging with conventional NIR, Raman and ATR-IR spectroscopy for quantification of furosemide crystal polymorphs in ternary powder mixtures

Design of Experiments-Based Monitoring of Critical Quality Attributes for the Spray-Drying Process of Insulin by NIR Spectroscopy

Quantitative Analysis of Uncoated Eszopiclone Tablets by Near-Infrared Spectroscopy

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