Evaluation of Specific Administering Devices ...
Document type :
Article dans une revue scientifique
DOI :
PMID :
Permalink :
Title :
Evaluation of Specific Administering Devices for Antineoplastic Drugs Compounded in Syringes in Paediatry: Methodology Proposal.
Author(s) :
Lefebvre, Maximilien [Auteur]
Simon, Nicolas [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Vasseur, Michele [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Sidikou, Ousseini [Auteur]
Barthelemy, Christine [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Décaudin, Bertrand [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Odou, Pascal [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Simon, Nicolas [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Vasseur, Michele [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Sidikou, Ousseini [Auteur]
Barthelemy, Christine [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Décaudin, Bertrand [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Odou, Pascal [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Journal title :
Journal of oncology pharmacy practice
Abbreviated title :
J. Oncol. Pharm. Pract.
Pages :
178155217733323
Publication date :
2017
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
Purpose The aims of this study were to propose a simple methodology to assess the rinsing volume of syringe extension sets and to compare several marketed devices. Methods A UV-spectrophotometry assay using quinine ...
Show more >Purpose The aims of this study were to propose a simple methodology to assess the rinsing volume of syringe extension sets and to compare several marketed devices. Methods A UV-spectrophotometry assay using quinine hydrochloride as drug substitute was developed. Quinine concentration ranged from 20 to 200 µg/ml. The assay was validated with the accuracy profile method and tested on five different assemblies (device+extension sets) with different dead-space volumes (1.28-2.80 ml) and at two different quinine concentrations (0.3 and 8.0 mg/ml). Rinsing was performed stepwise with water for injection until reaching an undetectable quinine concentration. After fitting the data with a Weibull model, assemblies were compared with an ANOVA performed on ranks (GraphPad, La Jolla, USA). Results The within-day and between-day precision ranges were 0.39-0.81 and 0.48-0.84%, respectively. The lower limit of quantification was 4.26 µg/ml. The volume required to completely rinse the infusion line was different according to the initial drug concentration and to the device assessed: from 6 to 10 ml for a low quinine concentration and from 7 to 17 ml for a high quinine concentration. Conclusion This study shows that a simple, cheap and easy-to-use methodology may be used to assess the rinsing volume of syringe extension sets. The rinsing volume is different according to the tested device.Show less >
Show more >Purpose The aims of this study were to propose a simple methodology to assess the rinsing volume of syringe extension sets and to compare several marketed devices. Methods A UV-spectrophotometry assay using quinine hydrochloride as drug substitute was developed. Quinine concentration ranged from 20 to 200 µg/ml. The assay was validated with the accuracy profile method and tested on five different assemblies (device+extension sets) with different dead-space volumes (1.28-2.80 ml) and at two different quinine concentrations (0.3 and 8.0 mg/ml). Rinsing was performed stepwise with water for injection until reaching an undetectable quinine concentration. After fitting the data with a Weibull model, assemblies were compared with an ANOVA performed on ranks (GraphPad, La Jolla, USA). Results The within-day and between-day precision ranges were 0.39-0.81 and 0.48-0.84%, respectively. The lower limit of quantification was 4.26 µg/ml. The volume required to completely rinse the infusion line was different according to the initial drug concentration and to the device assessed: from 6 to 10 ml for a low quinine concentration and from 7 to 17 ml for a high quinine concentration. Conclusion This study shows that a simple, cheap and easy-to-use methodology may be used to assess the rinsing volume of syringe extension sets. The rinsing volume is different according to the tested device.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Research team(s) :
Innovation/évaluation des médicaments injectables
Modélisation biopharmaceutique et pharmacocinétique
Innovation/évaluation des dispositifs médicaux de perfusion
Modélisation biopharmaceutique et pharmacocinétique
Innovation/évaluation des dispositifs médicaux de perfusion
Submission date :
2019-02-26T17:07:05Z
2019-07-05T12:31:29Z
2019-07-05T12:31:29Z