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15 Jun 2020

Lonza enhances product line to tackle concerns around bias during blinded clinical trials

Image: courtesy of Lonza.

The cost-effective capsules incorporate anti-tampering measures to ensure they comply with blinding regulations.

Capsugel DBcaps double-blinded capsules are designed to be used as an over-encapsulation tool during clinical phases to overcome the main hurdles during double-blinded clinical trials.

This opaque product has an extended capsule length and dual locking rings to allow for 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.

These 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.

The company has broadened its portfolio by adding an HPMC version to the standard gelatin one, thus making them suitable for use with multiple formulation properties. The capsules are available 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.

Stephen Rode, Business Development Manager at Lonza said, “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.“

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