{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T13:23:39Z","timestamp":1789565019128,"version":"build-2803163510"},"reference-count":12,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2022,9,21]],"date-time":"2022-09-21T00:00:00Z","timestamp":1663718400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Lonza Capsules &amp; Health Ingredients"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first place and the potential degradation of fragile APIs during the coating process. Ready-to-use enteric hard capsules would be an easily available alternative to test and develop APIs in enteric formulations, while decreasing the time and cost of process development. In this regard, Lonza Capsugel\u00ae Next Generation Enteric capsules offer a promising approach as functional capsules. The in vivo performance of these capsules was observed with two independent techniques (MRI and caffeine in saliva) in eight human volunteers. No disintegration or content release in the stomach was observed, even after highly variable individual gastric residence times (range 7.5 to 82.5 min), indicating the reliable enteric properties of these capsules. Seven capsules disintegrated in the distal part of the small intestine; one capsule showed an uncommonly fast intestinal transit (15 min) and disintegrated in the colon. The results for this latter capsule by MRI and caffeine appearance differed dramatically, whereas for all other capsules disintegrating in the small intestine, the results were very comparable, which highlights the necessity for reliable and complementary measurement methods. No correlation could be found between the gastric residence time and disintegration after gastric emptying, which confirms the robust enteric formulation of those capsules.<\/jats:p>","DOI":"10.3390\/pharmaceutics14101999","type":"journal-article","created":{"date-parts":[[2022,9,22]],"date-time":"2022-09-22T05:33:14Z","timestamp":1663824794000},"page":"1999","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["In Vivo Evaluation of a Gastro-Resistant HPMC-Based \u201cNext Generation Enteric\u201d Capsule"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1335-2809","authenticated-orcid":false,"given":"Adrian","family":"Rump","sequence":"first","affiliation":[{"name":"Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, 17489 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0420-7303","authenticated-orcid":false,"given":"Marie-Luise","family":"Kromrey","sequence":"additional","affiliation":[{"name":"Department of Diagnostic Radiology and Neuroradiology, University Hospital Greifswald, 17475 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eberhard","family":"Scheuch","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, University Hospital Greifswald, 17487 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1630-2807","authenticated-orcid":false,"given":"Vincent","family":"Jannin","sequence":"additional","affiliation":[{"name":"Lonza Capsules & Health Ingredients, 68000 Colmar, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Rehenbrock","sequence":"additional","affiliation":[{"name":"Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, 17489 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mladen Vassilev","family":"Tzvetkov","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, University Hospital Greifswald, 17487 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3492-7747","authenticated-orcid":false,"given":"Werner","family":"Weitschies","sequence":"additional","affiliation":[{"name":"Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, 17489 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1310-7435","authenticated-orcid":false,"given":"Michael","family":"Grimm","sequence":"additional","affiliation":[{"name":"Department of Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, 17489 Greifswald, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,9,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"966","DOI":"10.1021\/mp500809f","article-title":"Toward Oral Delivery of Biopharmaceuticals: An Assessment of the Gastrointestinal Stability of 17 Peptide Drugs","volume":"12","author":"Wang","year":"2015","journal-title":"Mol. Pharm."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1016\/j.addr.2021.02.001","article-title":"Current Challenges and Future Perspectives in Oral Absorption Research: An Opinion of the UNGAP Network","volume":"171","author":"Vinarov","year":"2021","journal-title":"Adv. Drug Deliv. Rev."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1016\/j.ejps.2019.03.027","article-title":"Oral Delivery of Non-Viral Nucleic Acid-Based Therapeutics\u2014Do We Have the Guts for This?","volume":"133","author":"Friedl","year":"2019","journal-title":"Eur. J. Pharm. Sci."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Fu, M., Al-gousous, J., Blechar, J.A., and Langguth, P. (2020). Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between in Vitro Disintegration and Dissolution Times. 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Pharmaceutics, 14.","DOI":"10.3390\/pharmaceutics14020270"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1007\/BF00609587","article-title":"Plasma and Salivary Pharmacokinetics of Caffeine in Man","volume":"21","author":"Newton","year":"1981","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1782","DOI":"10.1021\/acs.molpharmaceut.8b01320","article-title":"Combined Application of MRI and the Salivary Tracer Technique to Determine the in Vivo Disintegration Time of Immediate Release Formulation Administered to Healthy, Fasted Subjects","volume":"16","author":"Sager","year":"2019","journal-title":"Mol. Pharm."},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Sager, M., Schick, P., Mischek, M., Schulze, C., Hasan, M., Kromrey, M.L., Benameur, H., Wendler, M., Tzvetkov, M.V., and Weitschies, W. (2019). Comparison of in Vitro and in Vivo Results Using the Gastroduo and the Salivary Tracer Technique: Immediate Release Dosage Forms under Fasting Conditions. Pharmaceutics, 11.","DOI":"10.3390\/pharmaceutics11120659"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"99","DOI":"10.1540\/jsmr.49.99","article-title":"Interdigestive Migrating Motor Complex -Its Mechanism and Clinical Importance","volume":"49","author":"Takahashi","year":"2013","journal-title":"J. Smooth Muscle Res."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1016\/j.ejpb.2016.09.009","article-title":"Resolving the Physiological Conditions in Bioavailability and Bioequivalence Studies: Comparison of Fasted and Fed State","volume":"108","author":"Schneider","year":"2016","journal-title":"Eur. J. Pharm. 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