Capsugel Expands Micro-Dosing Services

Capsugel announced on May 16, 2016, that it is expanding its micro-dosing services offering for early-phase feasibility work, combining the company’s proprietary Xcelodose Precision Powder Micro-Dosing Systems with powder-in-capsule/powder-in-bottle (PIC/PIB) expertise developed at Xcelience. Capsugel acquired Xcelience in January 2016.

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 micro-dosing capabilities in both North America and Europe, the company reports.

Capsugel's micro-dosing services can minimize the cost and time requirements associated with early feasibility work, and the Xcelodose technology facilitates rapid, automated and consistent PIC/PIB programs, the company reports.  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%.

With five Xcelodose units in the United States 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.

The company's speed-to-product toolkit 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.

Source: Capsugel