Coated stoppers for sensitive and high-value injectablesAptar Stelmi, the industry’s trusted global partner, 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 calledPremiumCoat™, designed for the protection of sensitive and high-value drugs, including biopharmaceuticals.
Sensitive and high-value injectables, a dynamic marketSensitive 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% of the global drug market with growth at a CAGR of 10% in 2010-2015, twice that of the global drug market.Sensitive and high-value injectables require premium componentsSensitive and high-value injectables are fragile by nature. Therefore maintaining the integrity of the container closure while minimizing 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 presenting PremiumCoat™ at the upcoming CPhI/InnoPack 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.