< 0.0001). A partial rupture-resealing phenomenon characterized by transient fissuring and formation of a persistent hydrated pellicle was observed in certain products. Lot-to-lot variability was identified among selected formulations. These findings indicate that fill composition, shell material, and manufacturing variables contribute to disruption variability in dietary supplement softgels. Evaluation under physiologically informed testing conditions may reveal performance differences not evident under conventional water-based methods and may be particularly relevant for essential oil-containing formulations.
Gurley et al. (Mon,) studied this question.