The rebranded drug-delivery manufacturer Nemera headquartered in France, formerly Rexam Healthcare, anticipates its preservative-free multidose eyedropper Novelia to have an impact at Pharmapack North America on June 9 and June 10 after gaining traction in Europe and Latin America since its debut. Located at booth #4007, Novelia is touted as the only preservative-free multidose system on the U.S. market, and it is already used in more than 15 countries with drug products and medical devices.
Novelia is the key patient-oriented innovation for Nemera, following the sale of Rexam Healthcare in 2014 and the renaming of the devices business unit. Novelia has been promoted for several years on the market since 2012, according to Fanny Sellier, global category manager for Nemera’s ophthalmic products. Developments have been made to the product since then.
Sellier tells PMP News there is already a U.S. company commercializing Novelia but cannot yet reveal the name. In Europe, Novelia has been branded on products for Hyprosan, Clinitas Soothe and Xiloial Zero, to name a few. The device is being commercialized in many over-the-counter brands worldwide as well, Sellier added, and as a packaging of drug product in six European countries.
To avoid bacteria contamination, Sellier said preservatives are required and contained in about two-thirds of multidose eyedroppers in the ophthalmic packaging market.
"The most common preservative is benzalkonium chloride (which can have variable consequences for patients, from allergy to cornea damage when used in chronic treatments, such as glaucoma and dry eyes)," Sellier said. "Novelia was designed to provide a convenient and affordable way to avoid drugs with preservatives."
Nemera credits Novelia’s “100 percent controlled and safe” claim to its patented PureFlow technology, used for both air filtration and flow control, to dispense one drop at a time. The soft, easy-to-squeeze bottles come in five size ranges from 5 milliliters (standard) up through 20 milliliters.
“Basically Novelia is a self-preserved system,” Sellier said. “In a nutshell, Novelia functions with a non-return valve that avoids any potential contaminated liquid to come back into the bottle, and [it has] a patented venting system that allows air compensation and blocks bacteria. The fact that Novelia doesn’t use any filter is a key advantage to the product; indeed filtered devices cannot be controlled at 100 percent whereas our silicone-based venting system allows us to control each device on the assembly line to prove its efficacy and safety.”
When asked how the multi-dose closing tip system prevents bacterial contamination over the duration of the treatment, Sellier said it continues functioning to prevent bacterial contamination.
“As there are no preservatives in the formulation, the system itself needs to ensure that no contamination can enter the product and the content of the bottle remains sterile during treatment duration,” Benjamin Quaglia, senior design engineer, said. “In order to make sure Novelia works as a preservative-free system, Nemera has designed and conducted numerous microbiology challenge tests, in normal patient use as well as in patient misuse, up to 90 days.”
Quaglia noted that 4800 products have been tested from November 2009 to assess Novelia’s sterility performance.
During Novelia’s production, the Innovation Center and Nemera’s La Verpillière plant worked in a close collaboration to industrialize the device, Sellier said. It began with a pilot experiment to assess the design robustness and reduce risks to the industrial process.
Drop sizes are also addressed with the Novelia system, aiming to produce consistent drops for better patient compliance.
“The drops are calibrated in order to achieve a precise and consistent dose for a better adherence to the medication,” Sellier said. “The calibration is created by the valve’s design and, more precisely, the diameter of the valve’s head.”
The current drop size is 40 microliters (+/- 15 percent) with water. Drops can vary due to its viscosities and surface tensions, and Nemera notes it is developing new drop sizes in order to accommodate more formulations.
A draw to the eyedropper is that it uses up all the liquid supplied within, adding to its sustainability reference. Nemera conducted a comparison analysis of a one-month treatment of one drop per eye twice a day between the Novelia device and other monodoses.
“It is easier and less bulky to carry one multidose bottle needed for a month treatment than a full box of unit doses,” Sellier said. “On top of the convenience, it is also more economical and sustainable to use a multidose eyedropper than unit doses as it consumes up to eight times less plastic, 25 times less liquid, and nine times less energy needed for transportation. Furthermore, with Novelia, we can use the liquid until the very last drop, so there is no waste.”
In addition, Nemera claims the Novelia bottle is compatible with most existing screw cap filling lines, eliminating investment for new filling lines and requiring some modifications for existing equipment. The filling process is simplified, too, due to the preassembled cap and nozzle, making it two components instead of three.
The cap’s dark blue tip was the chosen color following a user study comparing it to a transparent tip.
“A patient suggested to color the tip in order to add some contrast between the tip and the main part of the nozzle for a better precision when targeting the eye,” Sellier said.
For more company and product details, visit http://www.nemera.net.