Preclinical Formulation Development

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?

We enable you to:

Harness expertise
Benefit from a global network of formulation and material characterization experts.
Access cutting-edge tools
Harness the latest technologies and state-of-the-art testing facilities.
Fast-track formulation
Establish optimal or enabling formulations for efficacy, pharmacokinetic, and toxicological preclinical studies, using minimal API, within just 10 weeks.
Ensure comprehensive analysis
From pKa and log P determination to solubility screening and precipitation inhibition studies.
Tailored formulation approaches
Whether 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 safety
Our considerations around excipient selection prioritize safety across species and prevention of excipient related toxicological events.

Scientist Working in a Chemical Laboratory

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.