Innovative TiO2 free film coating designed to mitigate the challenges of moisture sensitive actives
HARLEYSVILLE, Pa., Sept. 5, 2023 /PRNewswire/ — Colorcon, a world leader in the development and supply of film coating systems, speciality excipients and functional packaging for the healthcare industries, announces the launch of a new Opadry® film coating system to address the moisture management needs for pharmaceutical tablets, without the use of titanium dioxide (TiO2).
Annabel Bordmann, Film Coatings General Manager, explains, “With uncertainty around the future of TiO2 use in pharmaceutical products marketed in the European Union, global pharmaceutical manufacturers are now formulating their products without the inclusion of TiO2. Many pharmaceutical active ingredients are moisture sensitive and require a protective coating. This new Opadry® formulation delivers the TiO2 free claim and provides functional moisture protection while upholding productivity levels and overall cost effectiveness.”
Dr Ali Rajabi-Siahboomi, VP & Chief Innovation Officer, adds: “Moisture management is a critical aspect of pharmaceutical formulations and manufacturing, especially when it comes to tablets. Exposure of active pharmaceutical ingredients (APIs) in tablets to the environmental moisture, reduces product stability. With Colorcon’s in-depth knowledge of materials, coating technology and regulatory needs, we have developed this new Opadry TiO2 free formulation that is specifically designed to deliver protection from environmental moisture on storage and during use by patients. The coating is easy to apply and efficient for manufacturers.”
Through its extensive portfolio of Opadry® complete film coating systems, Colorcon provides scope for customers to reduce complexity and time-to-market by delivering high-quality products, with ingredients carefully selected to meet local pharmaceutical regulatory requirements. This is all backed by Colorcon’s superior and dedicated technical support, along with regulatory expertise.