Capsugel Division of Pfizer

Nov. 5, 2007
Micro-filling System Offers 50% Greater Throughput

Capsugel will unveil the successor to its unique Xcelodose system for micro-dosing of drug powders into capsules and vials in Booth #691 at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting in San Diego (Nov. 11 -15).

The new Xcelodose S system will feature a 50% increase in throughput rate for filled capsules. Additional improvements include an integral high-throughput unit and expanded software functionality.

These enhancements will be available in both the 120 and 600 models, which will replace the existing Xcelodose products. The Xcelodose system, launched in 2002, revolutionized the preparation of drug materials for early stage clinical trials and formulation development. For the first time, pharmaceutical companies could fill pure Active Pharmaceutical Ingredient (API) directly into capsules or other small dose containers with a high level of accuracy and precision.

By automatically dispensing drug substance alone into capsules, pharmaceutical companies can reduce development time by as much as six months. Eliminating the need for formulation for early-stage trials enables companies to more quickly reach the crucial “go/no go” point for continuing development following Phase I clinical studies. In short, the Xcelodose system has made achieving the goal of “Faster Time to First in Man” a reality.

Also at AAPS, Capsugel will feature its CFS1000/1200 capsule filling and sealing machines, which have now been licensed by eight of the top 10 global pharmaceutical companies. An integral part of the Licaps Drug Delivery System, these companies are using the CFS1000/1200 capsule filling and sealing machines in early stage development and manufacturing of Phase 1 clinical trial materials.

Both the CFS1000 and CFS1200 models eliminate the need for banding capsules, while providing a secure and impervious capsule seal.  By filling and sealing in one operation, it helps accelerate the development timeframe and achieve faster time to “First in Man” — the critical Phase 1 "go/no go" decision point for new molecules within the pharmaceutical development process. 

David Edwards, Capsugel’s director of Pharmaceutical Technology, said there is a reason for the increased customer interest: ‘‘We see a growing number of poorly soluble molecules coming through R&D pipelines. The new CFS1200 facilitates rapid and scalable development, thereby cutting R&D timescales and getting drugs into clinical trials as soon as possible. What we are finding now is that the CFS1200 is proving so invaluable that many companies are looking to purchase additional machines in order to capitalize on this unique technology.”

In addition, a number of leading Contract Research Organizations (CROs), both in the United States and the European Union, have acquired CFS1000/1200 machines. These are being used to service pharmaceutical companies that wish to evaluate the Licaps drug delivery technology, as well as to provide additional capacity to those companies who already have the CFS1000/1200 equipment in place.