Capsugel has announced that 10 large pharmaceutical companies have adopted its Xcelodose precision powder micro-dosing system technology.
The Xcelodose systems installed at these pharmaceutical companies offer accurate and reproducible dosing down to as little as 100mg of powder.
The 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 that 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 designed to meet regulatory standards, enabling it to be integrated into a 21 CFR Part 11-compliant workflow.
The installation and validation documentation available for Xcelodose 600S systems are aligned with good manufacturing practice (GMP) standards, enabling customers to quickly 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 machine design can reproducibly dose tiny amounts of API without having to add excipients or bulking agents, realising a faster route to Phase I trials.
