Development
Pre-formulation & formulation
API characterisation, excipient compatibility and dosage form design. The upstream work that decides whether a product is feasible, scalable and stable.
The pre-formulation programme
Pre-formulation is where development risk is identified and mitigated before it propagates downstream. Our laboratory characterises the active ingredient against a defined target product profile and runs the studies needed to inform formulation choices and process design.
- API solubility and pH-solubility profiling
- Hygroscopicity and water uptake
- Polymorphism and solid-state characterisation
- Particle size distribution and morphology
- Excipient compatibility studies
- Target product profile co-definition
Formulation focus areas
- Bioavailability enhancement
- Modified-release design
- Taste-masking
- Paediatric formulation
- Low-dose API handling
- Lyophilisation feasibility
Have a tricky API?
We scope formulation work in short, well-defined phases. The first deliverable is a feasibility report, not a quote.