Selection criterions for packaging of single-dose injectable solutions in ready-to-use syringes
Unité Préparation et Contrôle du Médicament - Lyon, France
Packaging materials (e.g. single-dose syringe) might affect (i) the solute stability, (ii) the pharmaceutical controls (e.g. visual inspection) and (iii) the delivery device ergonomics. The purpose of the study is to compare physico-chemical and ergonomic properties of polycarbonate syringes (PC-S) and polypropylene syringes (PP-S).
Materials and methods
Water permeability of PC-S and PP-S, filled at 1 ml (n=5) and stored at room temperature, were determined by gravimetric measuring, after checking the watertightness of blocked syringes (luer lock). The leak test was done by syringes filled (1 ml) with methylene blue solution followed by an immersion in to water. Otherwise, the syringe transparency was appreciated by visual inspection under standardized lighting. Syringes hardness and ergonomics were evaluated by a healthcare stall in “Plan Blanc” context.
Results and discussion
Syringes water loss profile (WL) over time was adjusted to the model WL = Japp x tn (Japp : apparent water steady stat flow, t: time and n: constant). WL profile of PC-S was higher than PP-S (Japp: 2.14•10-5 vs. 6.01•10-7 g.cm-2.h-1; p<0.01). Water permeability of PC-S and PP-S were both characteristic of diffusive transport (0.5 < n ¡Ü 1). After 6 months of storage, WL of PC-S and PP-S were respectively around 20% and 10%. Then, PC-S and PP-S use-by-date do not exceed 2 and 6 months, respectively. PC-S present a better transparency, a greater hardness and better ergonomics than PP-S.
The choice of the material of ready-to-use syringes implies to accurate a knowledge physico-chemical properties and future conditions of use.
 Stability Testing of New Drug Substances and Products (Q1A (R2)), ICH Harmonised Tripartite Guideline Geneva, 2003.