Design of experiments-based monitoring of critical quality attributes for the spray-drying process of insulin by NIR spectroscopy.

AAPS PharmSciTech
Morten Jonas MaltesenHolger Grohganz

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...Continue Reading

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Citations

Dec 25, 2012·AAPS PharmSciTech·Otto ScheibelhoferJohannes G Khinast
Aug 21, 2013·Chemical & Pharmaceutical Bulletin·Mio TangeTakahiro Uchida
Dec 27, 2015·Advanced Drug Delivery Reviews·Abhishek Singh, Guy Van den Mooter
Apr 11, 2015·Protein Science : a Publication of the Protein Society·Wei Wang
Mar 20, 2015·Pharmaceutical Research·Karin BeckerAndreas Zimmer
Jun 1, 2018·The Journal of Pharmacy and Pharmacology·Petra A PriemelHanne Mørck Nielsen

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