SEOUL, South Korea, Aug. 14, 2026 /PRNewswire/ -- 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 their enteric capsules - Capsugel® Enprotect® 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. The DGM simulated key physiological factors such as gastric motility, pH changes, digestive secretions, and gastric emptying patterns.
Capsugel® Enprotect® capsules, offer a next-generation enteric delivery solution designed to protect acid-sensitive APIs and enable targeted release in the small intestine. These capsules have been developed using a first-of-its-kind manufacturing process. The bi-layered capsule manufacturing technology allows target delivery of APIs to the distal small intestine without the need for post-filling coating excipients, which accelerates the drug manufacturing and development processes. They avoid exposure to heat and solvents to protect against degradation for some APIs.
To evaluate this performance, researchers filled the capsules with caffeine, a well-characterized model compound, and tested them under three conditions:
- Fasted state
- Light meal (~500 kcal)
- High-fat FDA meal (~900 kcal)
Results showed caffeine‑filled Capsugel® Enprotect® capsules remained intact throughout gastric transit across all tested conditions, with release occurring only after intestinal entry. No caffeine was detected in stomach samples, indicating that the capsules did not prematurely release their contents. The capsules only disintegrated after entering the intestinal compartment, confirming their gastro-resistant properties. The capsules remained in the stomach for approximately 29 minutes in the fasted state, 147 minutes after the light meal, and 243 minutes following the high-fat meal. Despite this prolonged exposure, the capsules maintained their structural integrity.
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. One of the study's most significant findings was that even under the challenging conditions of a high-fat meal, where gastric pH remained elevated for an extended period and stomach emptying was substantially delayed, the capsules still remained intact. The study also indicates that capsule floating behavior and the presence of an acidic "acid pocket" in the stomach may have helped preserve capsule integrity despite the less acidic environment.
Overall, 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.
Join Us at CPHI Korea 2026 and Discover the Future of Targeted Ingredient Delivery
As one of Asia's premier pharmaceutical and nutraceutical industry events, CPHI Korea 2026 connects pharma and nutraceutical leaders across Asia to discover emerging technologies, exchange industry insights, and build partnerships driving innovation in health and nutrition. A key highlight at this year's event will be Capsugel® Enprotect® capsules, our innovative enteric capsule technology designed to provide reliable gastric protection and targeted ingredient delivery without the need for additional enteric coating processes.
Visit us at Booth K15, COEX, Seoul, South Korea, 25-27 August 2026, and discover how Capsugel® Enprotect® capsules and our advanced delivery technologies can help bring your next innovation to market faster and more effectively.
For more information on Capsugel® Enprotect® capsules, please visit us at CPHI Korea.
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New Study Confirms Capsugel® Enprotect® Capsules Deliver Robust Gastric Integrity Under Both Fasted and Fed Conditions
