Solid-form selection is a development strategy, not an experiment count
Most active pharmaceutical ingredients can exist in multiple crystalline or non-crystalline forms. The preferred form must balance crystallinity, stability, solubility, hygroscopicity, manufacturability, control strategy, regulatory needs, and intellectual-property objectives rather than simply being the first form isolated.
What the resource covers
- Polymorphs, hydrates, solvates, pharmaceutical salts, cocrystals, and amorphous materials.
- How form properties can affect dissolution, bioavailability, stability, filtration, flow, processing, and product performance.
- How screening scope and timing change across preclinical development, clinical supply, manufacturing, regulatory, and lifecycle stages.
Key scientific takeaways
Screen against the development decision
The study design should reflect available material, development stage, dosage-form needs, process risks, and the consequences of discovering a new form later.
Rank forms with relevant evidence
Structural identity, thermodynamic relationships, humidity and temperature response, solubility, and manufacturability all contribute to form selection.
Plan for control and intellectual property
A useful program identifies form-conversion risks, defines monitoring tools, supports CMC documentation, and evaluates opportunities for differentiated solid-form protection.
Document details
| Document type | Application Note |
|---|---|
| Title | A Comprehensive Approach for Solid Form Selection in Preclinical Development and Beyond |
| Author | Melanie Bevill, Chris Seadeek, Nico Setiawan, Shawn Comella, Blaise Mibeck, and Steef Boerrigter |
| Publication date | November 2023 |
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