Abstract
Purpose :
Two elements of the Microliter Dosing Syringe (MDS) performance are highlighted in this paper – a) Accurate, precise microliter dosing, and b) Ability to inject viscous drug formulations currently in clinical and pre-clinical development.
This paper outlines how the accurate dosing MDS can help reduce clinical trials costs by i) reducing vial overfill requirements, and by ii) Minimizing drug material costs during dose sensitivity studies.
The MDS attenuates injection force felt by the user to ensure stable injection. This is relevant to the administration of several high viscous formulations currently being developed.
Methods :
In order to demonstrate the accuracy of the Microliter Dosing Syringe, in vivo dose volume measurements for injections performed by 40 retina specialists are reported. One cohort injected a 20 microliter dose and the other injected a 50 microliter dose. They also injected using standard syringes for a comparison.
Dose volumes from MDS configurations to deliver 5, 10, 15, 20, 25 and 50 microliters (n=10 each) were measured using a validated gravimetric test method.
Ability of the MDS to accurately draw an injectable fluid from a vial was test by drawing different amount of fluid and measuring gravimetrically.
Injection forces measurements to dispense variation viscosity standards using the MDS are reported. Viscosities as high as 832cP were tested and reported in this paper.
Results :
The Microliter Dosing Syringe (MDS) is reported to be accurate and precise in the 5 through 50 microliter range (see attached figure). The accuracy and precision of the MDS was validated with user data involving retina specialists.
The MDS was able to draw accurately from a vial upto 180 microliters with accuracy of within 2.3% and a co-efficient of variation of 1.7%.
Controlling for syringe diameter, the MDS had significantly lower injection forces than conventional BD syringe populalry used for eye injections.
Conclusions :
The ability of the MDS can help reduce clinical trials costs by redesigning dose sensitivitty studies to inject different volumes of the same drug concentration as opposed to the current approach injecting same volume of different drug strength. The proposed approach can enale savings of millions of dollars in reduced drug and quality control costs.
Commercialization of viscous formulations is now possible with the MDS.
This is a 2020 ARVO Annual Meeting abstract.