Physicochemical Properties and Dose Selection
Understanding the physiochemical properties of your drug are prerequisites to accurate assessments of dose selection. We specialise in using robust, established assays, combined with our expertise, to help you understand how fundamental properties of drugs impact their in vivo performance.
The physiochemical properties of a drug describe how its chemical characteristics can inform us about how it will behave in vivo. These properties can range from basic information like molecular weight to more complex interactions with solvents.
We have particular expertise in understanding the relationship between physiochemical properties of drugs and key pharmacokinetic properties such as dissolution, solubility and stability. This knowledge can support regulatory waivers and streamline development.
Physicochemical Property Testing:
- Formulation Assessment (bio-buffers and formulation excipients)
- Dissolution Testing
- Chemical Stability
- LogD Assessment
Dose Vehicle Development & Evaluation:
- Excipient Selection
- Stability (dose vehicle)
- Artificial Fluids Interactions
- In Vivo Performance Characterization
In vivo evaluation:
- Surgically ported animal models
- Formulation assessment
- Oral and intravenous dosing
- Can be combined with disease state models (e.g. diabetes)
FREQUENTLY ASKED QUESTIONS
What are surgically ported animals and how can they help with dosing assessments?
Ported animal models use a surgical procedure on model organisms (e.g. rodent, dog) to assess key pharmocokinetic properties of a drug in vivo. When used correctly, they can be critical in supporting in vitro data and help inform clinical trials.
Where do physicochemical studies fit in the drug development pipeline?
Physicochemical properties of a compound are key in determining in vivo pharmacokinetics. High-level drug properties such as toxicology, bioavailability and clearance need to be optimised for a drug to be clinically effective. Ensuring the fundamental physical properties of your compound support this is essenetial to ensure time and money are not wasted on compounds that cannot function effectively further down the pipeline.