Capsugel® Enprotect® capsules show robust gastric integrity under fasted and fed conditions using a dynamic gastrointestinal model

Enteric capsules are widely used to protect acid‑sensitive compounds and to delay drug release until intestinal entry. However, evidence supporting their gastric integrity under physiologically relevant fed‑state conditions remains limited, as most data rely on conventional static in vitro dissolution tests. In this study, the authors from Bioneer A/S, the University of Copenhagen, and Lonza Capsugel evaluated the gastric integrity of enteric capsules using the Dynamic Gastrointestinal Model (DGM), which simulates the physical, hydrodynamic, and biochemical conditions of the human gastrointestinal tract under fasted and fed states.

Caffeine‑filled Capsugel® Enprotect® capsules remained intact throughout gastric transit across all tested conditions, with release occurring only after intestinal entry. Importantly, DGM‑based predictions of gastric residence time, capsule disintegration, and pharmacokinetic profiles closely aligned with previously published human MRI and salivary tracer data in the fasted state and after a light meal. These findings confirm the robust gastro‑resistant performance of Capsugel® Enprotect® capsules and highlight the value of biorelevant in vitro tools to predict oral dosage form behavior beyond standard dissolution testing.

Reference:

Knopp, Jannin, Gonzalez & Müllertz, Utilizing the dynamic gastrointestinal model (DGM) to evaluate the gastric integrity of Capsugel® Enprotect® capsules in fasted and fed states, European Journal of Pharmaceutics and Biopharmaceutics, 2026, https://doi.org/10.1016/j.ejpb.2025.114962

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