World's 10 Largest Pharmaceutical Companies Adopt Novel Approach to Speed Time to Market
Cambridge, UK: Capsugel, the world's leading provider of dosage form solutions to the pharmaceutical and related healthcare industries, announced today that with its latest installation of the Xcelodose® precision powder micro-dosing system, the world's 10 largest pharmaceutical companies have adopted Xcelodose system technology.
The Xcelodose systems installed in these leading pharmaceutical companies offer accurate and reproducible dosing down to as little as 100 g of powder. The Xcelodose system models in use include: the Xcelodose 600S system, a fully automated system for micro-dosing powder into gelatin and HPMC capsules ranging from size 000 to 4; and the Xcelodose 120S system, a semi-automated machine which fills gelatin and HPMC capsules ranging from size 000 to 5, as well as other compact dose containers such as vials, tubes, blisters and cassettes.
The Xcelodose system software is rigorously designed to meet regulatory standards, enabling it to be easily integrated into a 21 CFR Part 11 compliant workflow. Additionally, the installation and validation documentation available for Xcelodose 600S systems are aligned with Good Manufacturing Practice (GMP) standards, enabling customers to rapidly begin operation within their GMP facilities.
The Xcelodose system often serves to eliminate some of the time consuming formulation and stability studies via the direct dosing into capsules of microgram amounts of active pharmaceutical ingredients (APIs). The highly robust machine design can reproducibly dose tiny amounts of API without having to add excipients or bulking agents, realizing a faster route to Phase I trials.
"With the number of competing powder dosing technologies increasing, we are pleased to see the Xcelodose system achieving very favorable reviews. The ease of integration of the system into so many diverse formulation development programs is an excellent endorsement that our stated performance capabilities match expectations," said Keith Hutchison, Vice President of R&D at Capsugel. "The utilization of the Xcelodose systems by these leading companies demonstrates to biotech or pharmaceutical firms wanting to rapidly move compounds to early stage trials that leveraging the unique dosing technology within an Xcelodose precision powder micro-dosing system is a well-validated strategy to adopt, thereby helping them achieve 'faster time to first in human'."
1The top 10 pharma companies referred to are those listed by Contract Pharma magazine and Pharmaceutical Executive.