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.