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. 

physiochemical properties inform dose selection

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:

Dose Vehicle Development & Evaluation:

  • Excipient Selection
  • Stability (dose vehicle)
  • Artificial Fluids Interactions
  • In Vivo Performance Characterization

In vivo evaluation:

The Absorption Systems Difference

Our approach to physiochemical assays is grounded in a desire to better predict and inform in vivo performace. We have a wide range of in vitro assays that recapitulate the different physiological environments a drug may be exposed to and to understand how these impact its pharmocokinetics. A key strength of our approach is in our ability to connect these studies to in vivo validations of these predictions, such as through ported animal models. We provide a single roadmap to combining in vitro and in vivo studies to inform dose selection.

 
 
 
 

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.

We offer various surgically ported animal models to help with formulation assessment in addition to the standard rodent, canine and non-human primate models for oral and intravenous dosing. These include rats, dogs, and mini-pigs fitted with intestinal cannulas implanted at various sites for dosing solutions or suspensions, as well as dogs fitted with duodenal fistulas for dosing solids, semi-solids, capsules, and tablets directly into the duodenum. Several of these animal models are available routinely and other custom models can be prepared in line with customer needs.

 

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. 

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