mpformulations

Molecular Profiles can offer expertise to optimise the transformation of drug substance into a stable, reproducible drug product. Our services range from early development studies through to analytical and formulary support during late stage optimisation.

For example, our formulation support packages can include:

• Drug / excipient compatibility assessment
• Formulation viability assessment
• Stability testing / forced degradation
• Research & development for FTIM formulations
• Research & development for Phase 2 formulation
• Analytical method development

For example our advanced characterisation services for formulated products include:

• Drug substance properties within a formulated product
• Optimal coating thickness determination
• Forensic analysis of drug and excipient distribution
• Solid solution vs Solid dispersion
• Optimisation of release performance
• Out of specification analysis for:
  – Batch to batch variability
  – Stability
  – Scale-up

For more information, please contact us.