Lonza has introduced an enhanced product line aimed at tackling concerns around bias during blinded clinical trials.
Capsugel® DBcaps® double-blinded capsules are designed to be used as an over-encapsulation tool during clinical phases to overcome the challenges of blinding products during trials.
“Capsugel® DBcaps® capsules have been specifically created to combat the main hurdles during double-blinded clinical trials. This opaque product has an extended capsule length and dual locking rings which mean that they are not only allowing a high visual coverage of the form that is placed inside, but also extremely hard to open without damaging the capsules and breaking the blind,” Julien Lamps, Product Manager at Lonza said. "We have broadened our portfolio by adding an HPMC version to the standard gelatin one. This makes them suitable for use with multiple formulation properties, like for example hygroscopicity or prone to promote cross-linking phenomena. The capsules are available also in a range of sizes and colors, making them suitable for a variety of products in all shapes and sizes. In addition, their shorter length makes them easier for patients to swallow, helping to improve patient compliance.“
Capsugel® DBcaps® capsules can be used with medical devices, as well as for over-encapsulation of uniquely shaped dosage forms and comparator products. They offer a faster, more cost-efficient solution for companies who would otherwise have to produce placebo forms identical in shape and size to the candidate product.
“During clinical trials it is imperative that sponsor companies and contract research companies alike can have peace of mind that they are complying sufficiently with blinding regulations to ensure a smooth journey to market. By combining anti-tampering measures with a flexible and robust product, we have been able to develop a solution that will meet the needs of our customers globally,” Stephen Rode, Business Development Manager at Lonza said.