Rapid solid-state analysis of freeze-dried protein formulations using NIR and raman spectroscopies

Holger Grohganz; Delphine Gildemyn; Erik Skibsted; James M. Flink; Jukka Tapio Rantanen

doi:10.1002/jps.22490

Rapid solid-state analysis of freeze-dried protein formulations using NIR and raman spectroscopies

Holger Grohganz, Delphine Gildemyn, Erik Skibsted, James M. Flink, Jukka Tapio Rantanen

16 Citations (Scopus)

Abstract

Noninvasive near-infrared (NIR) and Raman spectroscopies were applied to provide a fast and efficient insight into the formation of different mannitol solid forms occurring in freeze-dried formulations. Multivariate data analysis clearly showed the formation of δ-mannitol in the presence of protein, whereas β-mannitol was observed in the absence of protein.The multivariate analysis of the NIR spectra also gave an indication for the formation of mannitol hemihydrate in the absence of protein. Spectroscopic techniques in combination with multivariate analysis can be applied for fast screening and identification of excipient solid-state properties in pharmaceutical formulations.

Original language	English
Journal	Journal of Pharmaceutical Sciences
Volume	100
Issue number	7
ISSN	0022-3549
DOIs	https://doi.org/10.1002/jps.22490
Publication status	Published - Jul 2011

Keywords

Former Faculty of Pharmaceutical Sciences

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10.1002/jps.22490

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abstract = "Noninvasive near-infrared (NIR) and Raman spectroscopies were applied to provide a fast and efficient insight into the formation of different mannitol solid forms occurring in freeze-dried formulations. Multivariate data analysis clearly showed the formation of δ-mannitol in the presence of protein, whereas β-mannitol was observed in the absence of protein.The multivariate analysis of the NIR spectra also gave an indication for the formation of mannitol hemihydrate in the absence of protein. Spectroscopic techniques in combination with multivariate analysis can be applied for fast screening and identification of excipient solid-state properties in pharmaceutical formulations.",

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AU - Gildemyn, Delphine

AU - Skibsted, Erik

AU - Flink, James M.

AU - Rantanen, Jukka Tapio

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N2 - Noninvasive near-infrared (NIR) and Raman spectroscopies were applied to provide a fast and efficient insight into the formation of different mannitol solid forms occurring in freeze-dried formulations. Multivariate data analysis clearly showed the formation of δ-mannitol in the presence of protein, whereas β-mannitol was observed in the absence of protein.The multivariate analysis of the NIR spectra also gave an indication for the formation of mannitol hemihydrate in the absence of protein. Spectroscopic techniques in combination with multivariate analysis can be applied for fast screening and identification of excipient solid-state properties in pharmaceutical formulations.

AB - Noninvasive near-infrared (NIR) and Raman spectroscopies were applied to provide a fast and efficient insight into the formation of different mannitol solid forms occurring in freeze-dried formulations. Multivariate data analysis clearly showed the formation of δ-mannitol in the presence of protein, whereas β-mannitol was observed in the absence of protein.The multivariate analysis of the NIR spectra also gave an indication for the formation of mannitol hemihydrate in the absence of protein. Spectroscopic techniques in combination with multivariate analysis can be applied for fast screening and identification of excipient solid-state properties in pharmaceutical formulations.

KW - Former Faculty of Pharmaceutical Sciences

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Rapid solid-state analysis of freeze-dried protein formulations using NIR and raman spectroscopies

Abstract

Keywords

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