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 Citationer (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.

Originalsprog	Engelsk
Tidsskrift	Journal of Pharmaceutical Sciences
Vol/bind	100
Udgave nummer	7
ISSN	0022-3549
DOI	https://doi.org/10.1002/jps.22490
Status	Udgivet - jul. 2011

Emneord

Det tidligere Farmaceutiske Fakultet

Adgang til dokumentet

10.1002/jps.22490

Citationsformater

@article{82ef4fc404cd4fba9c080685ee0db16f,

title = "Rapid solid-state analysis of freeze-dried protein formulations using NIR and raman spectroscopies",

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.",

keywords = "Former Faculty of Pharmaceutical Sciences",

author = "Holger Grohganz and Delphine Gildemyn and Erik Skibsted and Flink, {James M.} and Rantanen, {Jukka Tapio}",

year = "2011",

month = jul,

doi = "10.1002/jps.22490",

language = "English",

volume = "100",

journal = "Journal of Pharmaceutical Sciences",

issn = "0022-3549",

publisher = "Elsevier",

number = "7",

}

TY - JOUR

T1 - Rapid solid-state analysis of freeze-dried protein formulations using NIR and raman spectroscopies

AU - Grohganz, Holger

AU - Gildemyn, Delphine

AU - Skibsted, Erik

AU - Flink, James M.

AU - Rantanen, Jukka Tapio

PY - 2011/7

Y1 - 2011/7

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

U2 - 10.1002/jps.22490

DO - 10.1002/jps.22490

M3 - Journal article

C2 - 21259241

SN - 0022-3549

VL - 100

JO - Journal of Pharmaceutical Sciences

JF - Journal of Pharmaceutical Sciences

IS - 7

ER -

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

Abstract

Emneord

Adgang til dokumentet

Fingeraftryk

Citationsformater