They are designed for sensitive and high-value injectables
Aptar Stelmi, providing premium elastomeric closure systems for injectables, announces a new addition to its broad portfolio of products with the introduction of a novel range of coated stoppers called PremiumCoat, designed for the protection of sensitive and high-value drugs, including biopharmaceuticals.
Sensitive and high-value injectables, a dynamic market
Sensitive and high-value injectables encompass complex and potent drugs manufactured by chemical synthesis and biological agents engineered in a living system such as a microorganism, plant or animal cell. They include cytotoxic drugs used in cancer therapies, novel vaccines, blood derivatives, hormones and many compounds used to treat auto-immune diseases, including monoclonal antibodies. The market for biologics represents 20 per cent of the global drug market with growth at a CAGR of 10 per cent in 2010-2015, twice that of the global drug market.
Sensitive and high-value injectables require premium components
Sensitive and high-value injectables are fragile by nature. Therefore maintaining the integrity of the container closure while minimising interaction between the drug compound(s) and the component constituents is a challenge.
Conventional elastomeric closure systems may not be an optimal solution for these fragile drugs.
PremiumCoat is a novel range of elastomeric stoppers developed by Aptar Stelmi. The surface of the elastomer is coated during manufacturing with a thin fluoropolymer film. This coating acts as an effective barrier to many of the extractables and leachables that can be released from the elastomer and contaminate the drug. As a result, compatibility of the drug and the closure is significantly superior with PremiumCoat stoppers.
“Aptar Stelmi is looking forward to unveiling PremiumCoat at the upcoming Pharmapack Europe in February 2015. The past three years we have spent developing the technology and then preparing for this new product launch have been very exciting. PremiumCoat is the first product in our range of innovative solutions for high-value injectable drugs,” said Ghislain Fournier, Industrial & Technical Director, Aptar Stelmi.
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