Safety and efficacy of sodium caprate in promoting oral drug absorption : from in vitro to the clinic

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dc.contributor.author Maher, Sam
dc.contributor.author Leonard, Thomas W
dc.contributor.author Jacobson, Jette
dc.contributor.author Brayden, David James
dc.date.accessioned 2011-04-28T13:41:41Z
dc.date.available 2011-04-28T13:41:41Z
dc.date.copyright 2009 Elsevier B.V. en
dc.date.issued 2009-12-17
dc.identifier.citation Advanced Drug Delivery Reviews en
dc.identifier.issn 0169-409X
dc.identifier.uri http://hdl.handle.net/10197/2908
dc.description.abstract A major challenge in oral drug delivery is the development of novel dosage forms to promote absorption of poorly permeable Class III drugs across the intestinal epithelium. To date, no absorption promoter has been approved in a formulation specifically designed for oral delivery of Class III molecules. Promoters that are designated safe for human consumption have been licensed for use in a recently approved buccal insulin spray delivery system and also for many years as part of an ampicillin rectal suppository. Unlike buccal and rectal delivery, oral formulations containing absorption promoters have the additional technical hurdle whereby the promoter and payload must be co-released in high concentrations at the small intestinal epithelium in order to generate significant but rapidly reversible increases in permeability. The most advanced promoter in the clinic is the medium chain fatty acid (MCFA), sodium caprate (C10) , a compound already approved as a direct food additive. We discuss how it has evolved to a matrix tablet format suitable for administration to humans under the headings of mechanism of action at the cellular and tissue level and in vitro and in vivo efficacy and safety studies. In specific clinical examples, we review how C10-based formulations are being tested for oral delivery of bisphosphonates using Gastro Intestinal Permeation Enhancement Technology, GIPET (Merrion Pharmaceuticals, Ireland) and in a related solid dose format for anti-sense oligonucleotides (ISIS Pharmaceuticals, USA). en
dc.description.sponsorship Science Foundation Ireland en
dc.format.extent 1088717 bytes
dc.format.mimetype application/pdf
dc.language.iso en en
dc.publisher Elsevier en
dc.rights All rights reserved. en
dc.subject Sodium caprate en
dc.subject Absorption promoter en
dc.subject Oral drug delivery en
dc.subject Drug delivery platforms en
dc.subject Clinical trials en
dc.subject Oral formulation en
dc.subject Drug delivery systems en
dc.subject.lcsh Drug delivery systems en
dc.subject.lcsh Fatty acids en
dc.subject.lcsh Intestinal absorption en
dc.subject.lcsh Oral medication en
dc.subject.mesh Drug Delivery Systems en
dc.subject.mesh Decanoic Acids en
dc.subject.mesh Intestinal Absorption en
dc.subject.mesh Administration, Oral en
dc.title Safety and efficacy of sodium caprate in promoting oral drug absorption : from in vitro to the clinic en
dc.type Journal Article en
dc.internal.availability Full text available en
dc.internal.webversions Publisher's version en
dc.internal.webversions http://dx.doi.org/10.1016/j.addr.2009.09.006 en
dc.status Peer reviewed en
dc.identifier.volume 61 en
dc.identifier.issue 15 en
dc.identifier.startpage 1427 en
dc.identifier.endpage 1449 en
dc.identifier.doi 10.1016/j.addr.2009.09.006
dc.neeo.contributor Maher|Sam|aut| en
dc.neeo.contributor Leonard|Thomas W|aut| en
dc.neeo.contributor Jacobson|Jette|aut| en
dc.neeo.contributor Brayden|David James|aut| en


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