Near-Infrared Imaging for High-Throughput Screening of Moisture-Induced Changes in Freeze-Dried Formulations
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Near-Infrared Imaging for High-Throughput Screening of Moisture-Induced Changes in Freeze-Dried Formulations. / Trnka, Hjalte; Palou, Anna; Panouillot, Pierre Emanuel; Kauppinen, Ari; Toiviainen, Maunu; Grohganz, Holger; Alcalà, Manel; Juuti, Mikko; Ketolainen, Jarkko; Rantanen, Jukka.
In: Journal of Pharmaceutical Sciences, Vol. 103, No. 9, 24.03.2014, p. 2839–2846.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Near-Infrared Imaging for High-Throughput Screening of Moisture-Induced Changes in Freeze-Dried Formulations
AU - Trnka, Hjalte
AU - Palou, Anna
AU - Panouillot, Pierre Emanuel
AU - Kauppinen, Ari
AU - Toiviainen, Maunu
AU - Grohganz, Holger
AU - Alcalà, Manel
AU - Juuti, Mikko
AU - Ketolainen, Jarkko
AU - Rantanen, Jukka
N1 - © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.
PY - 2014/3/24
Y1 - 2014/3/24
N2 - Evaluation of freeze-dried biopharmaceutical formulations requires careful analysis of multiple quality attributes. The aim of this study was to evaluate the use of near-infrared (NIR) imaging for fast analysis of water content and related physical properties in freeze-dried formulations. Model formulations were freeze-dried in well plates. Samples were imaged with a NIR hyperspectral camera after freeze-drying and upon storage. On the basis of Karl Fischer titration reference values, a univariate quantification model was constructed and used to visualize the distribution of water within freeze-dried samples. Differences observed between samples stored at 11% and 43% relative humidity (RH) were found to be related to the amount of amorphous component in the sample. When stored at 43% RH, the moisture content in samples with high sucrose content increased within 2 days and some degree of localized drying was observed within the samples after 3 days of storage. Further investigations with X-ray powder diffraction confirmed this local drying to be related to crystallization of sucrose. The combination of fast analysis of water content and spatial solid-state information makes NIR imaging a powerful tool for formulation development of freeze-dried samples. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
AB - Evaluation of freeze-dried biopharmaceutical formulations requires careful analysis of multiple quality attributes. The aim of this study was to evaluate the use of near-infrared (NIR) imaging for fast analysis of water content and related physical properties in freeze-dried formulations. Model formulations were freeze-dried in well plates. Samples were imaged with a NIR hyperspectral camera after freeze-drying and upon storage. On the basis of Karl Fischer titration reference values, a univariate quantification model was constructed and used to visualize the distribution of water within freeze-dried samples. Differences observed between samples stored at 11% and 43% relative humidity (RH) were found to be related to the amount of amorphous component in the sample. When stored at 43% RH, the moisture content in samples with high sucrose content increased within 2 days and some degree of localized drying was observed within the samples after 3 days of storage. Further investigations with X-ray powder diffraction confirmed this local drying to be related to crystallization of sucrose. The combination of fast analysis of water content and spatial solid-state information makes NIR imaging a powerful tool for formulation development of freeze-dried samples. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci.
U2 - 10.1002/jps.23948
DO - 10.1002/jps.23948
M3 - Journal article
C2 - 24665039
VL - 103
SP - 2839
EP - 2846
JO - Journal of Pharmaceutical Sciences
JF - Journal of Pharmaceutical Sciences
SN - 0022-3549
IS - 9
ER -
ID: 113037218