BASF’s new multi-functional plastic film will raise the bar for purity levels in synthetic excipients, says the firm.
The packaging technology, named PeroXeal, is a combination of different film layers complemented by inert gas flushing and heat-sealing to reduce residual oxygen.
It cuts peroxide levels in polymer-based excipients such as the company’s product Kollidon – made from polyvinylpyrrolidone (PVP) - thereby making it suitable for oxygen-sensitive formulations.
Boris Jenniches, head of global business management PVP at BASF, said: "With our new packaging concept we can significantly reduce peroxide values to a level comparable with that of naturally-based raw materials.
“This makes Kollidon a viable alternative."
The transparency of the PeroXeal also makes the product suitable for NIR (Near-Infrared Spectroscopy) testing.
Upsides of Kollidon
BASF claims that Kollidon – a binder technology used in tablets, capsules and granules – also produces less variability in processing compared to natural materials
In a further bid to out-run its organic counterparts, the company also said the shelf life of the product is extended because the new packaging can remain sealed until the product is used.
Nina Osten, global communications nutrition & HealthToday, told in-PharmaTechnologist.com the firm is still realising the full potential of the product
She said: “There is a Kollidon product perfectly suited for almost any application.
“In the pharmaceutical sector, this versatile excipient can be deployed as a binder, disintegrant, lyophilisation agent, suspension stabilizer and thickener, and new uses keep being discovered all the time.”
PeroXeal will be rolled out to most BASF products in 2012, and is already being used in several products including Kollidon 90F, Kollidon 25, Kollidon CL, Kollidon CL-F, Kollidon CL-SF.
Osten added: “Thanks to PeroXeal packaging, we were able to significantly extend Kollidon’s retest period.
“Worrying about peroxide levels, K values and API degradation is a thing of the past – opening the door for entirely new applications.
“And best of all, PeroXeal is available at no additional cost.”
Eyes on the regulatory prize
Osten added that the US Food and Drug Administration’s (FDA) accelerated focus on peroxide was a driving factor behind the development of the new tech.
She spoke of the FDA’s 2009 alert, for the first time highlighting a certain compendial limit of peroxides.
“One of the industry’s key challenges is the formation of peroxides,” she said.
“The higher the peroxide level, in finished dosage forms the more instable is the formulation and the higher the risk of subpotent finished dosage forms. Therefore, as a manufacturer, we have to ensure a low level of peroxide is maintained.”