Accelerating Drug Development With Precision Micro-Dosing Technology

In early-stage drug development, the amount of active pharmaceutical ingredient available for formulation development is usually very limited. Aggressive timelines for initiating phase I clinical studies to evaluate safety, pharmacokinetics of the drug, and proof of concept often favors the selection of capsule dosage form. Direct encapsulation of API provides an expedited strategy to First-In-Man clinical studies and can be substantially more efficient than development efforts that result in a full formulation. The ability to deliver micro-dose amount of API eliminates the need for preformulation and excipients compatibility studies.

In early 2005, Xcelience became the first North American CRO to adopt Xcelodose 600™ powder micro-dosing technology, placing it at the cutting edge of contract service providers in its ability to offer strategies that enable clients to accelerate the drug development process.