Following the completion of a feasibility study the concept formulations are evaluated and further optimised.
Phase 1
Prototype evaluation
The concept formulations that result from the feasibility study are evaluated for in vitro efficacy, in vivo efficacy, physical and chemical stability. This evaluation stage concludes with an optimisation plan developed in collaboration with the client to create a clinic ready formulation that meets a target requirements
Phase 2
Formulation optimization
The formulation can be optimised along a series of dimensions depending on the requirements of the client including drug load, physical and chemical stability, capsule compatibility and excipient preferences. The optimized formulation will be produced in larger batches in house for final in vivo studies.
Additional information
- We keep close communication lines at every phase of the feasibility study
- Time to complete: 4-8 weeks
- Deliverable: A fully evaluated formulation that can confidently move into GMP manufacturing and subsequent clinical studies.