Preclinical Formulation Screening
Fast identification of excipients to enhance bioavailability – enabling reliable toxicology and safety studies.
Introduction
- Preclinical safety studies require rapid formulation decisions.
- The goal is not always the final market product, but a robust formulation ensuring high bioavailability for tox and dose-finding studies.
Benefits
- Fast turnaround: From screening to tox-ready formulation within days.
- Bioavailability focus: Maximize exposure for reliable PK/PD readouts.
- Cost-efficient: Targeted validation, minimal experimental loops.
- Flexible: Solutions, suspensions, or ASD prototypes – depending on need.
Objectives
- Develop a formulation for preclinical tox studies quickly.
- Ensure high API bioavailability during the studies.
- Tailor the optimal formulation for each specific API.
- Find alternatives to co-solvents or other undesired excipients.
Approach
Grounded in established practice, we combine in-silico predictions (e.g., PC-SAFT) with a systematic decision tree. This reduces iterations and reliably leads to the right preclinical formulation.
Scope of Services
- Structured screening of relevant excipient classes (polymers, lipids, small molecules).
- Optional co-solvent strategies or replacement of traditional solvents.
- Formulation options: solution, suspension, ASD prototypes.
- Targeted lab validation of the shortlisted options.
- Documentation & tech transfer for preclinical studies.
Preclinical Drug Formulation in Just 1 Day
In the preclinical phase, formulation work is often standardized, time-boxed and guided by rules of thumb. amofor’s digital design approach offers a proven alternative: by combining in-silico modeling with a systematic decision tree, we can develop potent, tox-ready formulations within a single day—supporting faster transitions to first-in-human studies.
Achieving High Bioavailability for Toxicology
Preclinical tox studies aim for very high exposure so that potential side effects—and their dose levels—are observed reliably. The challenge is to prevent the API from passing through the body without sufficient absorption. By selecting the right platform technique based on the API’s physicochemical profile, we ensure a robust release and exposure in animal models.
Formulation Constraints
Subcutaneous, mostly liquid tox formulations must remain physically stable only for days to a week—quite different from later clinical requirements. Questions such as the right vehicle, the role of co-solvents and the stabilizing effect of polymers must be answered quickly and conservatively.
Digital Drug Formulation Helps
Our in-silico methodology rapidly evaluates excipient classes and their interactions with the API. It accelerates decisions on co-solvents, reduces conventional trial-and-error and saves material—so studies can start sooner with clear, data-driven formulation recommendations.
Key Benefits
- Rapid prototyping: Ready-to-test formulations within one day.
- High bioavailability: Maximizes exposure for sound efficacy and safety assessment.
- Cost efficiency: Fewer experiments and lower material use.
- Precision: Tailored to the API’s specific intermolecular interaction profile.
Key Takeaways
Early stages are marked by uncertainty; an in-silico approach creates an enduring backbone from the first experiments through later development phases, ensuring continuity and informed decisions throughout.
Read the full article: Preclinical Drug Formulation in Just 1 Day
Our stepwise, model-driven selection—rooted in long-standing formulation practice—leads reliably to the optimal preclinical option.
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