Chemical company announces static-reducing functional plastic compounds for use in drug delivery devices
The resins are part of the wider ?medical grade? Mevopur line of colour and additive concentrates and ?ready-to-use? polymer compounds, which includes polymers from PE to PEEK.
Often in drug delivery devices, such as dry powder inhalers where plastics are in contact with powders, the powder sticks to the surface. As a result, this can have a negative effect on the dose reliability and repeatability. Mevopur permanent antistatic compounds are able to reduce the surface resistivity and dissipate charges quickly, eliminating sticking as a result.
In a recent development programme with a European pharmaceutical company, the Mevopur antistatic agent, combined with the chosen polymer, demonstrated antistatic functionality. In other development programmes, antistatic functionality was combined with the chosen colour in one compound product.
As plastics often have direct drug contact, and inhalation is classed as a medium-to-high risk drug administration route, the plastic materials need to be evaluated for biocompatibility and risk of potential leachables.
It is also important to note, that although many resins are now widely available as ?medical grade? products with supporting regulatory declarations and change notification, this usually only covers the resin, and not colours or additives that are introduced by compounding or masterbatch concentrates. It is these colours and additives that present the higher risk of potential leachables that could end up in the drug. The problem is particularly acute as these added materials change routinely over the lifetime of the product.
The Mevopur family significantly reduces this risk by using pre-tested ingredients that support compliance to medical and pharmaceutical standards such as ISO10993 and USP class VI, manufactured in EN- ISO13485:2016 certified production facilities and change control.
Steve Duckworth, global head of marketing and business development- healthcare, said: ?Recently, we introduced the theme of ?The Colour of Innovation? to show how early collaboration with Clariant?s expert team and applying Quality by Design (QbD) principles to material decisions, widen the scope of possibilities.
?This is about bringing new ideas and capabilities to designers, but without sacrificing on regulatory compliance. This is why we say that Mevopur helps make every decision an opportunity.?Tags drug delivery Extractables and leachables Clariant Mevopur Respiratory devices Dry Powder Inhalers