Near-infrared imaging for high-throughput screening of moisture-induced changes in freeze-dried formulations

Hjalte Trnka, Anna Palou, Pierre-Emmanuel Panouillot, Ari Kauppinen, Maunu Toiviainen, Holger Grohganz, Manel Alcalà, Mikko Juuti, Jarkko Ketolainen, Jukka Rantanen (Corresponding Author)

Research output: Contribution to journalArticleScientificpeer-review

8 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)2839-2846
JournalJournal of Pharmaceutical Sciences
Volume103
Issue number9
DOIs
Publication statusPublished - 2014
MoE publication typeA1 Journal article-refereed

Fingerprint

Humidity
Sucrose
Water
Powder Diffraction
Freeze Drying
Crystallization
X-Ray Diffraction
Reference Values

Keywords

  • Formulation screening
  • freeze-drying
  • moisture
  • NIR imaging
  • solid state
  • sucrose crystallization
  • water-solid interactions

Cite this

Trnka, H., Palou, A., Panouillot, P-E., Kauppinen, A., Toiviainen, M., Grohganz, H., ... Rantanen, J. (2014). Near-infrared imaging for high-throughput screening of moisture-induced changes in freeze-dried formulations. Journal of Pharmaceutical Sciences, 103(9), 2839-2846. https://doi.org/10.1002/jps.23948
Trnka, Hjalte ; Palou, Anna ; Panouillot, Pierre-Emmanuel ; Kauppinen, Ari ; Toiviainen, Maunu ; Grohganz, Holger ; Alcalà, Manel ; Juuti, Mikko ; Ketolainen, Jarkko ; Rantanen, Jukka. / Near-infrared imaging for high-throughput screening of moisture-induced changes in freeze-dried formulations. In: Journal of Pharmaceutical Sciences. 2014 ; Vol. 103, No. 9. pp. 2839-2846.
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abstract = "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.",
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Trnka, H, Palou, A, Panouillot, P-E, Kauppinen, A, Toiviainen, M, Grohganz, H, Alcalà, M, Juuti, M, Ketolainen, J & Rantanen, J 2014, 'Near-infrared imaging for high-throughput screening of moisture-induced changes in freeze-dried formulations', Journal of Pharmaceutical Sciences, vol. 103, no. 9, pp. 2839-2846. https://doi.org/10.1002/jps.23948

Near-infrared imaging for high-throughput screening of moisture-induced changes in freeze-dried formulations. / Trnka, Hjalte; Palou, Anna; Panouillot, Pierre-Emmanuel; Kauppinen, Ari; Toiviainen, Maunu; Grohganz, Holger; Alcalà, Manel; Juuti, Mikko; Ketolainen, Jarkko; Rantanen, Jukka (Corresponding Author).

In: Journal of Pharmaceutical Sciences, Vol. 103, No. 9, 2014, p. 2839-2846.

Research output: Contribution to journalArticleScientificpeer-review

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