Toxicology Formulation Development

• Particle morphology (SEM optical microscopy)
• Particle size distribution (laser diffraction)
• Hygroscopicity profiling (10-90% RH, DVS)
• XRPD
• Thermal analysis (DSC, TGA)

• Aqueous and biorelevant media across the pH range.
• Solubility in excipients for enhanced bioavailability and stability.

• Leverage existing drug substance methods for cost savings and accelerated timelines.
• Data collected during toxicology formulation serves as a strategic asset, streamlining and informing method development for clinical phases.

• Rapid in-vitro assays enable precise evaluation the formulation solubility and precipitation dynamics across varying pH and biorelevant media.
• Phase appropriate analytical method qualification focused on efficacy, quality, and reproducibility.

• Evaluation of the chemical and physical stability of the formulation, including amorphous forms.
• Compatibility and stability testing with potential dosing vehicles to support selection of the final vehicle.
• Biorelevant dissolution testing in dosing vehicles to assess precipitation risks.

• ‘In-use’ stability testing under simulated dosing conditions provides critical insights into precipitation and chemical degradation risks.
• Dose recovery studies to ensure delivery accuracy and consistency.

• Design and coordination of pharmacokinetic (PK) and toxicokinetic (TK) studies aligned with formulation objectives.
• Interpretation of systemic exposure data to inform formulation suitability, dose selection, and safety margins.
• PK/TK insights are strategically integrated into the iterative formulation development to optimise performance and accelerate decision-making.

• Final dosing formulation provided as a ready-to-reconstitute format.
• Clearly defined preparation instructions and documented stability data to guide scheduling of dosing preparation.