Capsugel has announced that it has expanded its micro-dosing services offering for early-phase feasibility work. Capsugel’s offering combines its proprietary Xcelodose® Precision Powder Micro-Dosing Systems with industry-leading powder-in-capsule/powder-in-bottle (PIC/PIB) expertise developed at Xcelience, which Capsugel acquired in January. By replicating the expertise developed at Xcelience’s operations in Tampa, Fla., at Capsugel’s product development and manufacturing facility in Ploërmel, France, the company can now offer its unmatched micro-dosing capabilities in both North America and Europe.
“Today’s announcement builds on Capsugel’s track record of engineering excellence while demonstrating our ability to integrate new capabilities for the benefit of our customers,” said Amit Patel, President, Capsugel Dosage Form Solutions. “By leveraging best practices pioneered by Xcelience, an array of Xcelodose technologies and our high-containment capability, we have further strengthened our speed-to-product toolkit, enabling us to deliver even greater value to our customers.”
Capsugel’s micro-dosing services play a valuable role in pharmaceutical product development by minimizing the cost and time requirements associated with early feasibility work. The company’s Xcelodose technology facilitate rapid, automated and consistent PIC/PIB programs. These programs remove the need for excipient compatibility and stability studies for Phase I evaluations, allow for the rapid screening of API candidates, and reduce early-stage product development time by as much as 45 percent.
With five Xcelodose units in the U.S. and two in Europe – including Capsugel’s recently added isolator capability in Ploërmel – the company can handle highly potent active pharmaceutical ingredients (HPAPIs) up to occupational exposure bands (OEB) 4-5 in both North America and Europe. “This is exactly the type of exciting opportunity we envisioned when we joined forces with Capsugel,” said Derek Hennecke, President, Xcelience, a division of Capsugel Dosage Form Solutions.
“Over the past decade, Xcelience has developed an unrivaled proficiency in micro-dosing, producing more than 600 PIC/PIB batches. As part of Capsugel, we can now extend our expertise to a broader set of customers, while helping to bring Capsugel’s early-phase design and development offerings to a whole new level.” By leveraging its engineering core in the development of proprietary processes and phase-appropriate equipment, Capsugel has positioned itself as a valuable partner in designing and advancing product concepts.
The company’s speed-to-product toolkit, which facilitates rapid feasibility assessments, includes Capsugel’s Xcelodose-based micro-dosing capabilities, in-house micronization/nano-milling expertise for API optimization, additional proprietary bench-scale equipment designed and developed based on science-of-scale studies, and technology selection methodologies based on predictive models that minimize both development time and API requirements.