Preservatives are necessary evils in the conventional multi dose eye droppers, as the ambient non-sterile as well as the left over drop exposed to
ambience gains entry in the container from the same path as that of the drug flow path contaminating the liquid inside.
Preservatives are added, as mandated, to prevent the growth of microbial contaminants and biodegradation. Thus, preservatives have become a key component in ophthalmic formulations, common among them are:
Benzalkonium chloride (BAC/BAK),
Stabilized Oxychloro Complex (SOC)
Though preservatives help keep the containers sterile over the course of multiple uses, various studies have proved that preservatives induce ocular toxicity particularly in long term therapy, multiple applications, aged patients and in pre existing ocular surface diseases, such as :
‘Novelia ®’, a technology from France, brought in India for the first time by Eyekare Kilitch Ltd., is the solution that provides the benefit of the medication
without the ill effects of any preservatives.
The state of art technology prevents bacterial contamination and avoids the need of preservatives over treatment duration Benefits of Preservative-free multi dose formulations are as under :
FUNCTIONING: On squeezing the liquid flows out of the bottle
through a defined path dispensing uniform dosage. ( )
Contaminated air ( ) or contaminated liquid from atmosphere cannot flow back into the bottle due to the presence of Non return valve in the nozzle. ( )
Air compensation happens by entry of ambient air or liquid from ambient atmosphere through the aperture provided on the side of the bottle, through the homogenous silicon membrane which allows only gases to flow through, arresting the microbes. ( )
Hydroxypropylmethylcellulose IP 0.3% w/v, Glycerin IP 0.2% w/v, Dextran 70 USP 0.1% w/v.
Sodium Hyaluronate BP 0.1% w/v, L-proline, L-lysine HCI, L-Ieucine, L- glycine.
Dorzolamide Hydrochloride IP 2.0% w/v & Timolol Maleate IP 0.5% w/v.
Travoprost IP 0.004% w/v +
Timolol Maleate IP 0.5% w/v.
Preservatives are added to formulations to prevent decomposition of drug content due to microbial growth. In traditional eye dropper bottle, as external ambient non sterile air comes in contact with the drug, inducing microbial growth, preservatives are added. It is myth to say that preservatives help to keep the drop efficacy.
In Novelia® technology, ambiant non sterile air passes through the homogenous silicone membrane, blocking any potential bacteria and only allowing gasses to flow through, hence the product remains sterile and efficient all throughout its shelf life even after opening. Preservatives have no effect on efficacy of drug, so drops even after one month will be sterile and as efficient as first drop.
In Novelia® technology during instillation even if there is a residual drop remaining on the tip of the bottle, it does not get wasted for the following reasons:
The air venting system is made up of homogeneous silicone membrane. This patented PureFlow™ Technology relies on the air permeability characteristic of the silicone in order to allow air flow through the membrane. As there is no pore in the Novelia® system, the silicone membrane cannot be wet on the external surface, so there is no risk of biofilm creation affecting the functions of filter.