Whitepaper
Predicting Physical Stability of Amorphous Solid Dispersions (ASD)
12 Feb 2026
en
Moving Beyond "Fit-for-Purpose"
Many fit-for-purpose formulations fail because one-size-fits-all approaches simply don't work. Our 3-STEP approach begins at the lead optimization stage to set the foundation for clinical success.
The 'Fit-for-Purpose' Trap
Traditional rapid-development strategies often fail to account for key API physicochemical properties, solid-state behavior, and manufacturability considerations.
As a result, many programs encounter formulation failures in the clinic, requiring significant reformulation efforts and additional PK bridging studies.
The Mol2Med™ First-Time-Right Solution
At Crystal Pharmatech, we address these challenges through an integrated strategy designed to guide small molecule drug development from early evaluation through Phase I readiness.
By evaluating molecular properties, material behavior, and clinical requirements together, this approach enables informed decision-making for progression toward FIH studies.
The 3-Step Framework
Developability Assessment
Our approach determines the physicochemical properties of lead candidates against industry standards to find the most "developable" lead. For a given preclinical candidate, this determines whether a free form or salt, and a conventional or enabling formulation, should be selected.
Solid Form & Pre-Formulation
This stage begins with comprehensive screening and selection of the optimal crystalline form for the API. Subsequently, we develop an optimal preclinical formulation specifically designed to support robust PK/PD and GLP Tox animal studies.
Formulation Dev & CTM Manufacturing
We execute an API-specific strategy that yields the best formulation for Phase I and clinical studies. This allows late-stage development to focus strictly on process optimization without needing significant re-formulation or human PK bridging studies.
Set the Foundation for Clinical Success
Guarantees a robust API form for poorly soluble compounds, ensuring your formulation performs in vivo exactly as intended.
Streamlining the transition from Phase I through commercialization without major formulation changes or bridging studies.
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Our capabilities span three specialized platforms:
Small Molecule
Crystal Bio Solutions
Crystal NAX
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