title: Polymer-coated gelatin capsules as oral delivery devices and their gastrointestinal tract behaviour in humans.
abstract: In oral delivery of protein and peptide drugs there is a great need for suitable devices for delivering the therapeutic agent-incorporated microspheres selectively in the intestine. It is essential that the drug-loaded multiple unit carrier system should be protected from the harsh environment of the stomach and deliver the carrier system in the large intestine where drug action or absorption is desired. Gelatin capsules were coated with various concentrations of sodium alginate and cross-linked with appropriate concentrations of calcium chloride and tested in vitro for resistance to gastric and intestinal medium. Gelatin capsules coated with 20% w/v of the polymer which gave the most promising result in vitro were evaluated in human volunteers for their in vivo gastro intestinal tract behaviour. The radiographical studies show that while the uncoated gelatin capsules disintegrated in the stomach within 15 min of ingestion, the alginate coated gelatin capsules remained intact as long as they were retained in the stomach (up to 3 h) and then migrated to the ileocecal region of the intestine and disintegrated.
authors.affiliation: Biomaterials Department, Central Leather Research Institute, Adyar, Madras, India.
authors.forename: R
authors.initials: R
authors.lastname: Narayani
authors.forename: K P
authors.initials: KP
authors.lastname: Rao
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000464:Alginates / Q000737:chemistry* / Q000378:metabolism; D001466:Barium Sulfate / Q000008:administration & dosage* / Q000493:pharmacokinetics; D001672:Biocompatible Materials / Q000378:metabolism; D002122:Calcium Chloride / Q000737:chemistry; D002214:Capsules / Q000592:standards; D003432:Cross-Linking Reagents; D003692:Delayed-Action Preparations; D004064:Digestive System / Q000378:metabolism*; D004337:Drug Carriers; D016503:Drug Delivery Systems; D005780:Gelatin / Q000737:chemistry*; D020723:Glucuronic Acid; D006603:Hexuronic Acids; D006801:Humans; D007408:Intestinal Absorption / Q000502:physiology; D007420:Intestine, Large / Q000000981:diagnostic imaging / Q000378:metabolism; D008297:Male; D008863:Microspheres; D010455:Peptides / Q000008:administration & dosage; D011506:Proteins / Q000008:administration & dosage; D011859:Radiography
chemical_list: D000464:Alginates; D001672:Biocompatible Materials; D002214:Capsules; D003432:Cross-Linking Reagents; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D006603:Hexuronic Acids; D010455:Peptides; D011506:Proteins; D001466:Barium Sulfate; D020723:Glucuronic Acid; D005780:Gelatin; D002122:Calcium Chloride