title: Development and potential application of an oral ColoPulse infliximab tablet with colon specific release: A feasibility study.
abstract: The monoclonal antibody infliximab is one of the cornerstones in the treatment of Crohn's disease. Local delivery of infliximab would be an alternative to overcome the inherent disadvantages of intravenous therapy. For this purpose 5mg infliximab tablets were developed. To stabilize the antibody during production and storage it was incorporated in a sugar glass containing the oligosaccharide inulin. To obtain colon-specific release a ColoPulse coating was applied. The tablets were stored for 16 months under different conditions based on ICH climatic zone I.
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. Electronic address: m.maurer@umcg.nl.
authors.forename: Jacoba M
authors.initials: JM
authors.lastname: Maurer
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. Electronic address: s.hofman@umcg.nl.
authors.forename: Susan
authors.initials: S
authors.lastname: Hofman
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands. Electronic address: reinout.schellekens@kpnplanet.nl.
authors.forename: Reinout C A
authors.initials: RC
authors.lastname: Schellekens
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: w.tonnis@gmail.com.
authors.forename: Wouter F
authors.initials: WF
authors.lastname: Tonnis
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: a.o.t.dubois@gmail.com.
authors.forename: Annelien O T
authors.initials: AO
authors.lastname: Dubois
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: h.j.woerdenbag@rug.nl.
authors.forename: Herman J
authors.initials: HJ
authors.lastname: Woerdenbag
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: w.l.j.hinrichs@rug.nl.
authors.forename: Wouter L J
authors.initials: WL
authors.lastname: Hinrichs
authors.affiliation: Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands; Department of Pharmacotherapy and Pharmaceutical Care, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: j.g.w.kosterink@umcg.nl.
authors.forename: Jos G W
authors.initials: JG
authors.lastname: Kosterink
authors.affiliation: Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands. Electronic address: h.w.frijlink@rug.nl.
authors.forename: Henderik W
authors.initials: HW
authors.lastname: Frijlink
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D003106:Colon / Q000378:metabolism; D003424:Crohn Disease / Q000188:drug therapy; D003692:Delayed-Action Preparations; D016503:Drug Delivery Systems; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D005240:Feasibility Studies; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000737:chemistry; D000069285:Infliximab / Q000008:administration & dosage* / Q000737:chemistry; D007444:Inulin / Q000737:chemistry; D013607:Tablets; D013997:Time Factors
chemical_list: D003692:Delayed-Action Preparations; D005079:Excipients; D005765:Gastrointestinal Agents; D013607:Tablets; D007444:Inulin; D000069285:Infliximab
keywords: ColoPulse; Colon specific delivery; Crohn’s disease; Formulation; Infliximab; Oral delivery; Protein stability