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- Title
Evaluation of Specific Administering Devices for Antineoplastic Drugs Compounded in Syringes in Paediatry: Methodology Proposal.
- Authors
Lefebvre, Maximilien; Simon, Nicolas; Vasseur, Michèle; Sidikou, Ousseini; Barthélémy, Christine; Décaudin, Bertrand; Odou, Pascal
- Abstract
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.
- Subjects
DRUG administration; ANALYSIS of variance; ANTINEOPLASTIC agents; GENERIC drug substitution; INFUSION therapy equipment; QUININE; SPECTROPHOTOMETRY; SYRINGES; ACCURACY; EQUIPMENT &; supplies
- Publication
Journal of Oncology Pharmacy Practice, 2019, Vol 25, Issue 2, p309
- ISSN
1078-1552
- Publication type
Article
- DOI
10.1177/1078155217733323