Aptar Stelmi to feature PremiumCoat at CPHI India

Coated stoppers for sensitive and high-value injectables.

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% 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 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 India in December 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.