Review evaluates amorphous solid dispersions across non-oral delivery routes, highlighting translational gaps between preclinical physicochemical performance and clinical formulations.
Key Points
Critically examine the mechanisms, limitations, and translational challenges of applying amorphous solid dispersions (ASDs) to non-oral drug delivery routes.
Synthesized mechanistic and formulation evidence across cutaneous, transdermal, pulmonary, ophthalmic, vaginal, rectal, and parenteral drug delivery systems.
Evaluated physicochemical performance factors—including drug–polymer interactions, molecular mobility, crystallization, and supersaturation—against alternative solubility-enhancing technologies.
ASDs demonstrate clear mechanistic capacity to enhance apparent solubility and promote transient supersaturation, but their non-oral application remains fragmented and largely restricted to preclinical stages.
Route-specific biological barriers, manufacturing constraints, and risks of phase separation or crystallization in secondary vehicle bases continue to impede clinical translation across sterile, mucosal, and depot formulations.