Lonza Capsules and Health Ingredients introduces HPMC double-blinded capsules for clinical trials
- Capsugel® DBcaps® (double-blinded capsules) are designed to be used as an over-encapsulation solution with a tamper-evident design addressing the clinical trial challenge of testing without bias
- These opaque products have an extended cap length and dual locking rings which makes them extremely hard to open without damaging the capsules and breaking the blind
- The portfolio now includes a wide size range and both gelatin and HPMC variations. This makes them suitable for use with multiple formulations properties and multiple oral dosage forms sizes to be over-encapsulated
Quote from Julien Lamps, Product Manager, Lonza:
“Capsugel® DBcaps® capsules have been specifically created to combat the main hurdles during double-blinded clinical trials. This opaque product has an extended cap length and dual locking rings which means 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. We have just broadened our portfolio by adding an HPMC version to the standard gelatin one. This makes them suitable for use with multiple formulations 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.“
Quote from Steve Rode, Business Development Manager, Lonza:
“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.“
Basel, Switzerland, 12 June 2020 – A global capsule and equipment developer and manufacturer, 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 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.
Lonza is a global capsule and equipment developer and manufacturer which designs and produces innovative products for a wide range of oral dosage forms across the pharmaceutical and consumer health and nutrition market. By combining science, engineering and expertise with innovation and flexibility the company provides quality products to more than 4,000 customers in over 100 countries and can offer advice on how to achieve customized solutions that optimize formulations and align with project and consumer requirements.