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Application of In Vivo MRI Imaging to Track a Coated Capsule and Its Disintegration in the Gastrointestinal Tract in Human Volunteers

Sulaiman, Sarah; Gershkovich, Pavel; Hoad, Caroline L.; Calladine, Matthew; Spiller, Robin C.; Stolnik, Snow; Marciani, Luca

Application of In Vivo MRI Imaging to Track a Coated Capsule and Its Disintegration in the Gastrointestinal Tract in Human Volunteers Thumbnail


Authors

Sarah Sulaiman

CAROLINE HOAD CAROLINE.L.HOAD@NOTTINGHAM.AC.UK
Senior Research Fellow

Matthew Calladine

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ROBIN SPILLER ROBIN.SPILLER@NOTTINGHAM.AC.UK
Professor of Gastroenterology

Snow Stolnik

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LUCA MARCIANI LUCA.MARCIANI@NOTTINGHAM.AC.UK
Professor of Gastrointestinal Imaging



Abstract

Oral specially coated formulations have the potential to improve treatment outcomes of a range of diseases in distal intestinal tract whilst limiting systemic drug absorption and adverse effects. Their development is challenging, partly because of limited knowledge of the physiological and pathological distal gastrointestinal factors, including colonic chyme fluid distribution and motor function. Recently, non-invasive techniques such as magnetic resonance imaging (MRI) have started to provide novel important insights. In this feasibility study, we formulated a coated capsule consisting of a hydroxypropyl methylcellulose (HPMC) shell, coated with a synthetic polymer based on polymethacrylate-based copolymer (Eudragit®) that can withstand the upper gastrointestinal tract conditions. The capsule was filled with olive oil as MRI-visible marker fluid. This allowed us to test the ability of MRI to track such a coated capsule in the gastrointestinal tract and to assess whether it is possible to image its loss of integrity by exploiting the ability of MRI to image fat and water separately and in combination. Ten healthy participants were administered capsules with varying amounts of coating and underwent MRI imaging of the gastrointestinal tract at 45 min intervals. The results indicate that it is feasible to track the capsules present in the gastrointestinal tract at different locations, as they were detected in all 10 participants. By the 360 min endpoint of the study, in nine participants the capsules were imaged in the small bowel, in eight participants in the terminal ileum, and in four in the colon. Loss of capsule integrity was observed in eight participants, occurring predominantly in distal intestinal regions. The data indicate that the described approach could be applied to assess performance of oral formulations in undisturbed distal gastrointestinal regions, without the need for ionizing radiation or contrast agents.

Journal Article Type Article
Acceptance Date Jan 19, 2022
Online Publication Date Jan 24, 2022
Publication Date Feb 1, 2022
Deposit Date Feb 18, 2022
Publicly Available Date Feb 18, 2022
Journal Pharmaceutics
Electronic ISSN 1999-4923
Publisher MDPI AG
Peer Reviewed Peer Reviewed
Volume 14
Issue 2
Article Number 270
DOI https://doi.org/10.3390/pharmaceutics14020270
Keywords Pharmaceutical Science
Public URL https://nottingham-repository.worktribe.com/output/7355560
Publisher URL https://www.mdpi.com/1999-4923/14/2/270

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