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Preclinical Formulation Development

Gain robust formulation development strategies tailored to the characteristics of each individual API.

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.

Scientists Discussing Test Results in Laboratory
Why SGS?

We are the world’s leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

Wherever you operate in the world, we support you at every step of your product’s development – from raw materials to end product. Whatever your preclinical formulation requirements, we have the expertise to help you deliver safe, effective and compliant products to global markets.

To discuss your preclinical formulation screening requirements, contact us today.

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  • SGS Beograd

Jurija Gagarina 7b,

, 11070,

Belgrade, Serbia