Evaluation of Specific Administering Devices for Antineoplastic Drugs Compounded in Syringes in Paediatry: Methodology Proposal

by | Sep 3, 2017 | Studies | 0 comments

Maximilien Lefebvre, Nicolas Simon, Michèle Vasseur, Ousseini Sidikou, Christine Barthélémy, Bertrand Décaudin and Pascal Odou




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 mg/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 mg/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 10ml for a low quinine concentration and from 7 to 17ml 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.

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