Case Study 5
Clinical Proof of Concept Study with an Accelerated Time Frame

A specialty pharmaceutical company needed help with a clinical protocol intended to determine the doses in a fixed-dose combination product. This project had very short timelines imposed by regulatory filing commitments as well as a lean budget.

The Xcelodose encapsulation machine was used to put the API directly into a hard gelatin capsules. This eliminated the need to formulate with excipients and greatly decreased the time needed to produce clinical supplies.

Capsules were manufactured at strengths down to 100 ug while meeting the dose uniformity specifications set for the clinical trial materials

The timeline and cost requirements were met by Xcelience.