Pharmaceutical Quality and Syringeabilityof Pre-filled Syringes : An explorative study on the effect of different syringe barrel andplunger combinations on a proteinaceous pharmaceutical.

Sammanfattning: 4AbstractA pre-filled syringe consists of a number of different components and materials e.g. glass, polymer and silicone oil, which will, in various degrees, interact with the pharmaceutical protein and excipients contained within. In addition to soluble protein loss due to adsorption to silicone droplets, silicone oil (SO) have also been reported to form complexes with pharmaceutical proteins that potentially provoke early and late-stage immune responses. The objective of this project was to investigate the impact of 10 different syringe barrel and plunger combination on the quality on pharmaceutical X and the performance of the syringe (syringeability). This is an explorative study and the purpose of this study was to investigate what options there were rather than to make firm recommendations. pH measurements indicated all chosen combinations were within acceptance criteria. Similarly, subvisible particle with reference standards and USP <788> tests indicated that all chosen combinations were within acceptance criteria. Analysis of visible particles without reference standards indicated that all combinations except 1B and 1C were within acceptance criteria. In terms of syringeability, functional testing revealed that combination 8A was a very poor choice and combination 1B a very good choice. In all of the tests, the currently used combination 1A was within the acceptance criteria. With respect to both the pharmaceutical quality and syringeability, it was considered to be equally preferred as many other combinations. Therefore, there is no real urgency to exchange the currently used syringe. Further investigation of plunger B, and possible other plunger combinations is recommended as they might play a bigger role than the syringe barrel with regard to the syringeability. Additionally, placebo suspension can only be used as a representative alternative for testing pH.