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Pre-formulation is the systematic characterization of an API's physicochemical, biopharmaceutical, and solid-state properties before formulation development begins. The data generated in pre-formulation directly drives every downstream decision — from dosage form selection and excipient choice to enabling formulation strategy and the design of preclinical in vivo studies. At Crystal Pharmatech, pre-formulation is not a standalone service but an integrated scientific foundation, built in close collaboration with our solid-state research and formulation development teams.
Inadequate pre-formulation data is one of the most common and costly root causes of late-stage formulation failures. When the physicochemical landscape of an API is not fully understood early, the consequences compound through every subsequent stage:
Incorrect solid form selection leads to stability failures, polymorphic conversion during processing, or unexpected changes in dissolution behavior
Uncharacterized solubility limitations result in formulation approaches that cannot achieve adequate oral bioavailability or dose-proportional exposure in preclinical studies
Undetected API–excipient incompatibilities cause chemical degradation or physical instability that only emerges during stability studies — triggering costly reformulation
Poorly designed preclinical dosing formulations generate variable or uninterpretable PK and Tox data, leading to flawed development decisions and potential study repeats
A rigorous, integrated pre-formulation program identifies and resolves these risks before they become failures — protecting your program timeline, data quality, and development budget.
BCS classification, aqueous and biorelevant solubility profiling, pH-solubility relationships, and intrinsic dissolution rate — defining whether an enabling formulation strategy is needed and which technology is most appropriate.
Susceptibility to polymorphic conversion, hydrate formation, amorphous crystallization, and chemical degradation under temperature, humidity, light, and mechanical stress — identifying conditions that must be controlled in manufacturing and storage.
API–excipient chemical and physical compatibility — identifying degradation pathways and incompatible combinations before prototype development begins, preventing downstream stability failures.
Crystal Pharmatech's pre-formulation scientists work alongside our solid-state and crystallization teams — not in a separate silo. This means that API form selection, physicochemical characterization, and formulation strategy are developed concurrently, eliminating the handoffs and delays that occur when these activities are outsourced separately.
We deliver more than raw data. Every pre-formulation report includes scientific interpretation, risk assessment, and a clear recommended path forward — translating physicochemical measurements into actionable formulation and development decisions. Our goal is to answer 'What should we do next?' — not just 'What did we measure?'
Pre-formulation studies are designed with material efficiency in mind. With our Mol2Med approach, we generate comprehensive characterization data from as little as 50–500 mg of API and turnaround times as fast as 2 weeks. This enables informed decisions even at the earliest stages of drug discovery, when API supply is tightly constrained.
Pre-formulation data generated at Crystal Pharmatech is documented to support IND, CTA, and NDA/MAA submissions. Study designs align with ICH Q6A (solid form specifications), ICH Q1 (stability), ICH Q8 (pharmaceutical development), and FDA/EMA pharmaceutical development guidance — ensuring pre-formulation outputs are scientifically sound and submission-ready.
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