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

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 paliperid...

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Veröffentlicht in:Pharmaceutical development and technology 2012-05, Vol.17 (3), p.259-267
Hauptverfasser: Zhu, Wuxin, Vermeir, Lien, Govoreanu, Ruxandra, Verbruggen, Katrien, Ariën, Tina, Verliefde, Arne, Van der Meeren, Paul
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container_end_page 267
container_issue 3
container_start_page 259
container_title Pharmaceutical development and technology
container_volume 17
creator Zhu, Wuxin
Vermeir, Lien
Govoreanu, Ruxandra
Verbruggen, Katrien
Ariën, Tina
Verliefde, Arne
Van der Meeren, Paul
description 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.
doi_str_mv 10.3109/10837450.2012.672990
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subjects Antipsychotic Agents - administration & dosage
Antipsychotic Agents - chemistry
Centrifugation - methods
Drug Storage
Gravitation
Isoxazoles - administration & dosage
Isoxazoles - chemistry
Magnetic Resonance Spectroscopy - methods
NMR
Paliperidone Palmitate
Palmitates - administration & dosage
Palmitates - chemistry
Particle Size
resuspendability
Sedimentation
suspension
Suspensions
syringe
Syringes
Temperature
Water - chemistry
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
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