Enteric-Coated Capsules Providing Reliable Site-Specific Drug Delivery to the Distal Ileum.

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 caff

SUBMITTER: Grimm M 

PROVIDER: S-EPMC11151196 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature