Formulation and Quality – Biomolecular
2019 PharmSci 360
Intravitreal (IVT) injection is currently the state of the art for drug delivery to the back of the eye.
In our syringe in-use study, we compared three IVT transfer injection syringes (including a non-siliconized syringe). In a set of experiments, we assessed multiple potential impact factors such as protein concentration, needle gauge, injection speed, surfactant type and the impact of an in-use hold time step on the generation of SvPs and injection force. Extended characterization methods were applied to measure, dead space volume by weight (ISO 7886-1:2017) and micro CT imaging as well as FTIR for total silicone oil content quantification.
Significant differences between the syringes and upon changing the potential impact factors were observed in total SvP counts and injection force measurements. In addition, the syringes showed significant differences in total silicone oil content and dead volume.