Snabbare formuleringsutveckling
Vid ett besök hos en potentiell partner var målet att snabbt utvärdera möjligheten att formulera en svårlöslig läkemedelssubstans med Formulite® – och samtidigt ta fram material för fortsatt utveckling, utan att behöva genomföra ett omfattande formuleringsprogram.
Läs mer på engelska nedan:
Approach
focused, on-site development sprint was conducted over two days,
combining feasibility screening with immediate scale-up:
Day
1 – Feasibility screening
Multiple
small-scale trials (gram scale) were performed to assess amorphicity
and identify suitable processing conditions.
Day
2 – Rapid scale-up
The
selected method was directly scaled to a ~300 g batch to generate
material for formulation development and tableting trials.
Process
The scale-up followed the standard Formulite® process:
- API dissolved in a suitable solvent system
- Mixed with Formulite® matrix (minutes)
- Integrated mixing and drying in a single-pot-solution (minutes)
The process was performed using standard equipment, enabling a fast and reproducible transition from screening to scale.
Outcome
- Fully amorphous formulation achieved
- Free-flowing powder ready for downstream processing
- Material generated for formulation development and tableting
- Direct transition from feasibility to process-relevant scale
Impact
- This case illustrates how early formulation work can be streamlined:
- Fast feasibility assessment – early confirmation of technical viability
- Direct scale-up – from grams to hundreds of grams within days
- Manufacturing readiness – compatible with standard solid oral dosage processes
Conclusion
Formulite® enables a simplified path from early screening to process-ready material, supporting faster, more informed development decisions without extended iteration cycles.