RapidFACT
Conventional approaches to optimising dosage forms are expensive both in terms of time and money, taking up to 18 months and costing >£1.0M. Moreover, these approaches are heavily reliant on preclinical animal models to screen and select optimal drug products for human testing.
RapidFACTTM (Rapid Formulation development and Clinical Testing) represents a new paradigm for optimising a drug product. It exploits our integrated formulation development, drug product manufacture, and clinical testing platform. Candidate formulations can be rapidly screened, selected, and validated on the basis of their performance in man – dramatically improving the chances of identifying a drug product that can achieve the target product profile.
RapidFACT significantly reduces development timelines and associated costs. In particular, the quantity of API consumed in a RapidFACT program is reduced to <10% of that required in the conventional process [see table].
| Conventional Process | Integrated Process | |
|---|---|---|
| Timeline Savings | None | 50% Reduction |
| Flexibility | Low | High |
| Precision | Low | High |
| API Consumption | High | Low (<10%) |
| Vendor Management | 7 | 1 |
RapidFACT has been used to bridge between dosage forms (solutions/suspensions to capsules), to optimise drug products to enable transition into later stage development (IR and MR formulation), and in Life Cycle Management projects.
API - Active pharmaceutical ingredient; IR - immediate release; MR - modified release.
For more information on RapidFACT, please download our white paper