Utilizing the dynamic gastrointestinal model (DGM) to evaluate the gastric integrity of Capsugel® Enprotect® capsules in fasted and fed states

Abstract

This study aimed to evaluate if the Dynamic Gastrointestinal Model (DGM) is able to simulate the gastro-resistant behavior of Capsugel® Enprotect® capsules under physiologically relevant fasted and fed states. Enprotect® capsules were filled with a caffeine powder blend and tested under three conditions: fasted state, a light meal (∼500 kcal), and a high-fat meal (∼900 kcal).

Results showed that the capsules remained intact in the stomach across all conditions and released their contents only after intestinal entry. Dissolution and pharmacokinetic predictions closely aligned with published clinical data for the fasted state and light meal.

The extended gastric residence and elevated pH of the high-fat meal did not compromise capsule integrity possibly due to a combination of capsule floating and acid pocket formation on the top of the digesting meal. These findings confirm the robustness of Enprotect® capsules and demonstrate the utility of the DGM in predicting oral dosage form behavior and performance under physiologically relevant gastrointestinal conditions.

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Materials

Enprotect® size 0 capsules were provided by Capsugel France SAS (Colmar, France). Caffeine (anhydrous), sodium chloride, potassium chloride, acetic acid glacial, calcium chloride, trifluoroacetic acid, sodium dihydrogen phosphate, hydrochloric acid, sodium hydroxide, pepsin from porcine pancreas, pancreatin from porcine pancreas and lipase R Oryzae were sourced by Sigma-Aldrich (St. Louis, MO, USA). Instant SIF (simulated intestinal fluid) powder was purchased from Biorelevant (London, United Kingdeom).

Matthias Manne Knopp, Vincent Jannin, Vanessa Gonzalez, Anette 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, Volume 219, 2026, 114962, ISSN 0939-6411, https://doi.org/10.1016/j.ejpb.2025.114962.

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