Aptar Stelmi, which provides premium elastomeric closure systems for injectables, have announced 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 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 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.
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