Case study: Fast-track formulation development

- From early feasibility to process-ready material in two days

During a visit to a potential partner, the objective was to rapidly assess the feasibility of formulating a poorly soluble compound using Formulite^®— and generate material for downstream development without entering a lengthy formulation program.

Approach
A 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.