Optimize drug efficacy and safety with our preclinical formulation development platform.
Navigating the early stages of drug development often presents a dilemma. With limited available data on the active pharmaceutical ingredient (API) and small quantities at hand for studies, formulating the right approach for drug delivery can be challenging.
We provide a structured pre-formulation pathway to ensure the efficient screening of lead candidates, maximizing the dose that can be administered and is available for absorption.
Why choose preclinical formulation screening from SGS?
- Harness expertiseBenefit from a global network of formulation and material characterization experts.
- Access cutting-edge toolsHarness the latest technologies and state-of-the-art testing facilities.
- Fast-track formulationEstablish optimal or enabling formulations for efficacy, pharmacokinetic, and toxicological preclinical studies, using minimal API, within just 10 weeks.
- Ensure comprehensive analysisFrom pKa and log P determination to solubility screening and precipitation inhibition studies.
- Tailored formulation approachesWhether it's solution-based formulations, solid dispersions, or nanoparticles, we customize based on the API’s characteristics the intended pre-clinical species and the route of administration.
- Focus on safetyOur considerations around excipient selection prioritize safety across species and prevention of excipient related toxicological events.
Comprehensive pre-clinical, pre-formulation services
Where limited data is available, API characterization services may be employed such as:
- pKa,and log P determination
- Thermal analysis, Melting Point/DSC/TGA
- Hygroscopicity, TGA
- Particle size determination
- Permeation using Caco-2 cell lines
- Particle size determination (laser diffraction)
Establishing the most effective formulation approach
Typically to establish the formulation approach, we undertake the following studies:
- Analytical method transfer
- Solubility screening and precipitation inhibition studies
Approaches to formulation may include:
- Solution-based formulations. using solvents/co-solvents and surfactants where appropriate. This would be the primary approach before investigating more complex formulations (which may expand development timelines)
- Solid dispersions
- Nanoparticles
Prototype development studies may include:
- Compatibility assessment
- Dose optimization
- Precipitation evaluation
- Delivery route specific formulation characterization
- Short term stability evaluation
- Toxicology batch/PK batch production
We aim to establish prototype formulations suitable for evaluation in non-clinical PK or toxicological studies, within 6 to10 weeks of receipt of the API, subject to formulation complexity.
