Abstract
Purpose :
About 80% of the ophthalmic packaging market is taken by multidose eyedroppers requiring preservatives to avoid bacterial contamination.The use of preservatives can cause allergies or ocular irritation, damaging patients’ eyes.
Patients needed a convenient and affordable way to avoid drugs with preservatives that jeopardize compliance. More than half of the commercially available bottles designed for multi-dose preservative-free eye drops rely on a filtering system to filter both the solution and air to stop the entry of bacteria.
0.22 μm sterile filters are industry standards, and a lot of research has been carried out that challenge their effectiveness as bacterial filters.
Nemera’s objective was to come up with a safe preservative-free multidose system without using any sterile filters, Novelia®
Methods :
Nemera developed a patented venting technology (PureFlow®) that filters the intake of air using a very fine membrane manufactured from silicone polymer.
The silicone membrane is a solid material and doesn’t contain any holes unlike the mesh filters. The principle of PureFlow® technology is that air diffuses through the membrane in order to enter the bottle and to compensate the negative pressure inside the bottle.
The diffusion of gas molecules in the silicone membrane is a slow process in which the gas molecules migrate from free volume to free volume (permeability process). Therefore PureFlow® technology isolates the solution from the environment and maintains its sterility
Results :
The preservative-free multidose system passed with success difficult challenge tests simulating 28 days, 90 days and up to 1-year of treatments in normal or misuse conditions and with different bulks.
Other specific tests have also been designed and conducted on this new venting technology to prove that the air venting system functions well and protects the content from potential contamination
Conclusions :
A non-return valve combined with a silicone membrane venting system demonstrates how intelligent design can be used to prevent the entry of bacteria into a bottle, making it possible to deliver safe, preservative-free eye drops.
Thanks to the PureFlow® technology, Novelia® is the only preservative-free multidose eyedropper for which all the critical components linked to the sterility of the device are 100% controlled on line by air testing, ensuring that each single device released is safe to use by patients.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.