Amorphous Solid Dispersions

Overcoming Solubility Limitations Through Amorphous Solid Dispersion Technology

Poor aqueous solubility is the most prevalent physicochemical liability in modern drug pipelines — affecting approximately 40% of marketed drugs and up to 90% of compounds in development (BCS Class II and IV). Addressing it requires choosing the right enabling technology for each molecule. When that technology is ASD, the depth of expertise applied to polymer selection, dispersion manufacturing, and physical stability assessment is what separates a formulation that works from one that fails.

When Is ASD the Right Technology?

ASD is not appropriate for every poorly soluble compound. The technology is most likely to succeed and most worth the development investment when the following conditions are met:

High crystallinity and high melting point

Low intrinsic aqueous solubility (BCS Class II or IV)

Good drug-polymer miscibility

Dose number considerations

For compounds where these criteria are not met, Crystal Pharmatech's formulation scientists will recommend an alternative enabling strategy and explain clearly why ASD is not the right fit before any resources are committed to it.

Our ASD Development Capabilities

Drug-polymer miscibility screening Systematic evaluation to identify miscible polymer candidates and predict physical stability before committing to spray-drying experiments.
Polymer and surfactant selection Screening of polymer type, drug loading, and optional surfactant addition by mini-spray drying or solvent casting; evaluated by XRPD (amorphous confirmation), single Tg by modulated DSC, and in vitro dissolution.
Spray-dried dispersion (SDD) manufacturing Primary ASD manufacturing platform producing homogeneous, amorphous dispersions across scales from milligrams (pre-formulation screening) through kilograms (GMP manufacturing), with full characterization at each stage.
In vitro dissolution and supersaturation assessment Non-sink dissolution testing in biorelevant media to rank-order formulations for in vivo bioavailability enhancement.
Physical stability assessment Accelerated stability testing to confirm amorphous state maintenance and predict shelf life under the intended storage conditions.
Downstream formulation development ASD intermediates processed into the appropriate drug product format for the development stage.
Seamless scale-up to GMP manufacturing /

Achieve Your Success with Our Expertise

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Our capabilities span three specialized platforms:

Small Molecule
Crystal Bio Solutions
Crystal NAX

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