Contained Xcelodose® Technology
Traditional product development of a formulated solid oral drug for Phase I clinical trials involves a range of activities, this process can take considerable time to complete and at a significant cost for product development alone.
Filling an Active Pharmaceutical Ingredient (API) directly into a capsule is potentially the quickest and most cost-effective option for entering early phase clinical trials by minimizing the formulation and analytical development requirements.
Using Xcelodose® removes the need for initial formulation development and the associated stability testing enabling PCI to achieve fast times to first-in-man studies on behalf of its clients. The fully programmable system provides exceptional levels of accuracy and precision. Waste of drug substance is minimized and batch records allow traceability of individual capsules that meet GMP requirements.
At PCI we utilize both Xcelodose® 120S and 600S instruments which can be used for formulation development, pre-clinical and clinical trial batch manufacturing. Both technologies offer full containment solutions enabling the safe early stage development of highly potent molecules.
Features of Xcelodose® Technology
- Programmable and precise dispensing of dose weights from 100 micrograms to 100 milligrams and beyond
- Weight of each capsule content is recorded, allowing traceability of samples that meet GMP requirements
- Simplifies analytical development and stability requirements, reducing development time
- Reduces waste and eliminates the need for a “powder blend”
- Ability to handle moisture-sensitive compounds
- Xcelodose® 120S system is able to fill capsules and a variety of small dose containers including; vials, tubes, blisters and cassettes
- Precision closing of capsules
- Compensates for variability in drug powder properties
- Simplification of method development
- Improved data transfer
- Can be used for formulation development, pre-clinical and clinical trial batch manufacturing for both potent and non-potent molecules