ArticleMolecular pharmaceutics2024
Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum.
Article in Molecular pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- In vivo comparison of enteric capsule shells composed of different HPMCAS grades after simultaneous intake by dual MRI labeling and pharmacokinetics.International journal of pharmaceutics: X · 2026Article
- Evaluation of Targeted-Release Capsule Formulations for Protection of the Acid-Sensitive Enzyme Pancreatin Under Fasted and Fed Intestinal Conditions In Vitro.Pharmaceutics · 2026Article
- Efficacy and safety of Nefecon, glucocorticoids, or supportive therapyadded to RASi+SGLT2i in IgA nephropathy.Frontiers in pharmacology · 2026Article
- Engineering Small Extracellular Vesicles for Colon-Targeted Delivery: Microenvironment-Responsive Design, Therapeutic Mechanisms, and Clinical Translation.International journal of nanomedicine · 2026Review
- Novel Use of Manganese Gluconate as a Marker for Visualization of Tablet Dissolution in the Fed Human Stomach Using Magnetic Resonance Imaging.Molecular pharmaceutics · 2025Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nefecon, a targeted-release capsule formulation of budesonide approved for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy, targets overproduction of galactose-deficient immunoglobulin A type 1 in the Peyer's patches at the gut mucosal level. To investigate whether the commercial formulation of Nefecon capsules reliably releases budesonide to the distal ileum, a human study was conducted with test capsules reproducing the delayed-release function of Nefecon capsules. Caffeine was included in the test capsules as a marker for capsule opening in the gut since it appears rapidly in saliva after release from orally administered dosage forms. Magnetic resonance imaging with black iron oxide was used to determine the capsule's position in the gut at the time caffeine was first measured in saliva and additionally to directly visualize dispersion of the capsule contents in the gut. In vitro dissolution results confirmed that the test capsules had the same delayed-release characteristics as Nefecon capsules. In 10 of 12 human volunteers, the capsule was demonstrated to open in the distal ileum; in the other two subjects, it opened just past the ileocecal junction. These results compared favorably with the high degree of variability seen in other published imaging studies of delayed-release formulations targeting the gut. The test capsules were shown to reliably deliver their contents to the distal ileum, the region with the highest concentration of Peyer's patches.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.