A Safer, Faster Route to Early Phase Trials for Poorly Water Soluble and Potent Compounds

Capsugel, the world’s leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, is delighted to announce its new automated CFS 1500 C (Containment) Capsule Filling and Sealing system is now available to provide rapid and safe filling and sealing of capsules containing lipid-based formulations or potent compounds for use in early phase clinical trials.

The new CFS 1500 C system, which utilises Capsugel’s patented and proprietary Licaps® Drug Delivery System technology, offers many of the same time saving benefits as Capsugel’s established CFS 1200 Capsule Filling and Sealing system, has been developed to enable easy movement and integration into suitable containment equipment. Additionally, the CFS 1500 C system has been designed to facilitate ease of cleaning and also to ensure that compounds remain within the working area. It has readily accessible moving parts which can be removed for manual or auto washer cleaning. This combination of useful features is designed to help ensure scientists can safely work with lipid-based formulations or potent compounds confident that these won’t contaminate their equipment or different capsule batches.

The CFS 1500 C system has an increased throughput of 1,500 filled and sealed capsules per hour and is scalable to commercial manufacturing using the LEMS® 70 Liquid Encapsulation Micro-spray Sealing system, which is capable of sealing up to 70, 000 capsules per hour. Using the LEMS® 70 Liquid Encapsulation Micro-spray Sealing system’s unique micro-spraying technology in conjunction with Capsugel’s Licaps® capsules, the CFS 1500 C system can fill and seal capsules with a robust, impervious seal. One of the key factors in getting the best seal for a liquid-filled capsule is a clean precise dosing system; to enable this, the CFS 1500C system features Capsugel’s unique new liquid dosing technology which allows precision dosing and prevents the occurrence of drips. In addition, the completely new software design provides much greater functionality and, in combination with a new weigh cell feature, measures the weight of each filled capsule to ensure compliance with 21 CFR part 11 requirements.

David Edwards, Director, Pharmaceutical Technology Group at Capsugel, explained: “We have developed the CFS 1500 C system in response to requests from our customers for an improved and faster system which is easier to clean and could be used in a suitable containment system, particularly for more potent compounds. The resulting CFS 1500 C system provides an excellent solution for formulation scientists who want high integrity filled capsules of these challenging formulations without compromising safety in manufacturing or the supply chain.”

Edwards added: “Throughout the development process, our engineers have consulted with our customers at several stages, to ensure we produce the equipment according to market needs. The CFS 1500 C system is a very useful addition to our range of liquid filling and sealing equipment and will be of considerable benefit to companies working with not only early stage lipid-based compounds, but also generic and OTC companies seeking a differentiating delivery system for their products and for companies looking to extend their product life cycles .”