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In situ nondestructive sediment characterization and resuspendability evaluation of concentrated aqueous paliperidone palmitate suspensions in prefilled syringes by low-field one-dimensional pulsed-field gradient NMR profilometry

Wuxin Zhu UGent, Lien Vermeir UGent, Ruxandra Govoreanu, Katrien Verbruggen, Tina Ariën, Arne Verliefde UGent and Paul Van Der Meeren UGent (2012) PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY. 17(3). p.259-267
abstract
This work aims to demonstrate the usefulness of a low-field one-dimensional pulsed-field gradient NMR (1D pfg NMR) profilometry technique to enable in situ nondestructive sediment characterization and resuspendability quantification of concentrated prefilled injectable suspensions. Aqueous paliperidone palmitate suspensions were used as model samples and low-intensity centrifugation was evaluated as a long-term gravity simulation approach. The low-field 1D pfg NMR technique allowed a detection zone of 2.5 cm in height for water content measurement of syringe samples using a Teflon syringe holder. Thus, the sediment compactness could be deduced from its water content. Quantitative evaluation of resuspendability was realized by front tracking of the NMR profile signals, which yielded the exponential sediment volume decay constant as a resuspendability quantification parameter. The study shows that both active ingredient particle size distribution and storage temperature had significant effects on the sedimentation rate and the resuspendability of the suspensions. The centrifugation method proved to be useful as a long-term gravity simulation and screening method, although the results should be interpreted with caution due to its higher acceleration and compression force imposed on the active ingredient particles.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
MRI, DISPERSIONS, syringe, DOSE UNIFORMITY, BEHAVIOR, REDISPERSIBILITY, Sedimentation, resuspendability, paliperidone palmitate, suspension, NMR
journal title
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
Pharm. Dev. Technol.
volume
17
issue
3
pages
259 - 267
Web of Science type
Article
Web of Science id
000302916500001
JCR category
PHARMACOLOGY & PHARMACY
JCR impact factor
1.333 (2012)
JCR rank
188/259 (2012)
JCR quartile
3 (2012)
ISSN
1083-7450
DOI
10.3109/10837450.2012.672990
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
2917900
handle
http://hdl.handle.net/1854/LU-2917900
date created
2012-06-25 12:34:56
date last changed
2013-06-20 13:27:07
@article{2917900,
  abstract     = {This work aims to demonstrate the usefulness of a low-field one-dimensional pulsed-field gradient NMR (1D pfg NMR) profilometry technique to enable in situ nondestructive sediment characterization and resuspendability quantification of concentrated prefilled injectable suspensions. Aqueous paliperidone palmitate suspensions were used as model samples and low-intensity centrifugation was evaluated as a long-term gravity simulation approach. The low-field 1D pfg NMR technique allowed a detection zone of 2.5 cm in height for water content measurement of syringe samples using a Teflon syringe holder. Thus, the sediment compactness could be deduced from its water content. Quantitative evaluation of resuspendability was realized by front tracking of the NMR profile signals, which yielded the exponential sediment volume decay constant as a resuspendability quantification parameter. The study shows that both active ingredient particle size distribution and storage temperature had significant effects on the sedimentation rate and the resuspendability of the suspensions. The centrifugation method proved to be useful as a long-term gravity simulation and screening method, although the results should be interpreted with caution due to its higher acceleration and compression force imposed on the active ingredient particles.},
  author       = {Zhu, Wuxin and Vermeir, Lien and Govoreanu, Ruxandra and Verbruggen, Katrien and Ari{\"e}n, Tina and Verliefde, Arne and Van Der Meeren, Paul},
  issn         = {1083-7450},
  journal      = {PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY},
  keyword      = {MRI,DISPERSIONS,syringe,DOSE UNIFORMITY,BEHAVIOR,REDISPERSIBILITY,Sedimentation,resuspendability,paliperidone palmitate,suspension,NMR},
  language     = {eng},
  number       = {3},
  pages        = {259--267},
  title        = {In situ nondestructive sediment characterization and resuspendability evaluation of concentrated aqueous paliperidone palmitate suspensions in prefilled syringes by low-field one-dimensional pulsed-field gradient NMR profilometry},
  url          = {http://dx.doi.org/10.3109/10837450.2012.672990},
  volume       = {17},
  year         = {2012},
}

Chicago
Zhu, Wuxin, Lien Vermeir, Ruxandra Govoreanu, Katrien Verbruggen, Tina Ariën, Arne Verliefde, and Paul Van Der Meeren. 2012. “In Situ Nondestructive Sediment Characterization and Resuspendability Evaluation of Concentrated Aqueous Paliperidone Palmitate Suspensions in Prefilled Syringes by Low-field One-dimensional Pulsed-field Gradient NMR Profilometry.” Pharmaceutical Development and Technology 17 (3): 259–267.
APA
Zhu, W., Vermeir, L., Govoreanu, R., Verbruggen, K., Ariën, T., Verliefde, A., & Van Der Meeren, P. (2012). In situ nondestructive sediment characterization and resuspendability evaluation of concentrated aqueous paliperidone palmitate suspensions in prefilled syringes by low-field one-dimensional pulsed-field gradient NMR profilometry. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, 17(3), 259–267.
Vancouver
1.
Zhu W, Vermeir L, Govoreanu R, Verbruggen K, Ariën T, Verliefde A, et al. In situ nondestructive sediment characterization and resuspendability evaluation of concentrated aqueous paliperidone palmitate suspensions in prefilled syringes by low-field one-dimensional pulsed-field gradient NMR profilometry. PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY. 2012;17(3):259–67.
MLA
Zhu, Wuxin, Lien Vermeir, Ruxandra Govoreanu, et al. “In Situ Nondestructive Sediment Characterization and Resuspendability Evaluation of Concentrated Aqueous Paliperidone Palmitate Suspensions in Prefilled Syringes by Low-field One-dimensional Pulsed-field Gradient NMR Profilometry.” PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 17.3 (2012): 259–267. Print.