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.

SEOUL, South Korea, Aug. 5, 2026 /PRNewswire/ -- Lonza Capsugel has released new peer-reviewed research showing that its Licaps^® DUOCAP^® capsule-in-capsule technology can significantly improve the protection and targeted delivery of acid-sensitive enzymes in the gastrointestinal (GI) tract. Conducted in collaboration with ProDigest (Belgium), leading experts in preclinical gastrointestinal tract models, the study highlights the impact of dual-release capsule technologies in unlocking advanced product development opportunities and reinforces the importance of delivery choice for nutraceutical products

Published in Pharmaceutics, the study used the Simulator of the Human Intestinal Microbial Ecosystem (SHIME)^® in vitro model to compare multiple capsule polymers and formulations under realistic fed and fasted digestive conditions. To assess dissolution behavior, capsules contained caffeine as a marker of capsule dissolution, as well as pancreatin, an acid-sensitive digestive enzyme that is converted from tributyrin to butyrate when it reaches the upper small intestine. Five capsule formulations, including two single capsule types and three Licaps^® DUOCAP^® capsule-in-capsule configurations, were assessed for dissolution timing, ingredient protection and enzyme activity throughout the upper gastrointestinal tract, with particular focus on the upper small intestine where digestive enzymes are most effective.

When taken with food, the Licaps^® DUOCAP^® capsule-in-capsule formulations demonstrated superior protection and targeted release profiles, with caffeine released at the end of the duodenum and/or jejunum and a high butyrate recovery, ranging from 53% to 87%. Enzyme activity was up to four times higher in the upper small intestine compared to standard immediate-release capsules. In contrast, the immediate-release single capsule format released a high level of its contents in the stomach, as shown by low butyrate recovery in the upper small intestine (16–21%). This suggests gastric degradation of the unprotected enzyme, meaning that the intended delivery was significantly impaired when compared to the Licaps^® DUOCAP^® capsule-in-capsule technology.

Dr. Elnaz Karimian Azari, Senior Manager R&D, Lonza Capsugel and lead author of the study, said:

"This study further reinforces the robustness and reliability of our Licaps^® DUOCAP^® capsule-in-capsule technology, providing independent, peer-reviewed validation of its ability to deliver sensitive ingredients to targeted regions of the gastrointestinal tract. While this work focused on release in the upper small intestine, it builds on a growing body of evidence demonstrating that Licaps^® DUOCAP^® capsules can protect and transport ingredients like live probiotics all the way to the colon, where they are needed to achieve optimal performance. It also highlights just how important capsule selection is to the success and effectiveness of nutraceutical products – and why delivery really does matter."

Experience the Future of Oral Delivery at CPHI Korea 2026

As one of Asia's premier pharmaceutical and nutraceutical industry events, CPHI Korea 2026 brings together innovators, formulators, manufacturers, and industry leaders to explore the latest advancements shaping the future of healthcare and nutrition. The event serves as a key platform for networking, knowledge exchange, and discovering breakthrough technologies that enable next-generation product development

Join our experts at Booth K15, COEX, Seoul, South Korea, from 25-27 August 2026, to explore the latest scientific advancements in targeted ingredient delivery, discuss your formulation challenges, and learn how innovative capsule technologies can accelerate your next product innovation. Whether you are developing digestive health solutions, probiotics, oral biologics, or next-generation nutraceutical products, our team will be available to share insights and collaborate on tailored delivery strategies.

For more information on Licaps® DUOCAP® capsule-in-capsule technology, please visit us at CPHI Korea or contact us at solutions.apac@lonza.com.