University of Groningen
ColoPulse tablets in inflammatory bowel disease
Maurer, Marina
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Publication date: 2017
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Maurer, M. (2017). ColoPulse tablets in inflammatory bowel disease: Formulation, potential application and evaluation. Rijksuniversiteit Groningen.
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ColoPulse tablets in
inflammatory bowel disease
Formulation, potential application and evaluation
Publication of this thesis was financially supported by the University of Groningen, and Stichting ter bevordering van Onderzoek in de Ziekenhuisfarmacie te Groningen
Cover design: Jardine Media Layout: Albertjan Tollenaar
Printed by Ridderprint BV, The Netherlands
ISBN 978-94-6299-525-3 © Marina Maurer, 2017
Copyright of the published articles is with the corresponding journal or otherwise with the author. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, without the prior permission in writing from the author or the copyright-owning journal.
ColoPulse tablets in
inflammatory bowel disease
Formulation, potential application and evaluation
Proefschrift
ter verkrijging van de graad van doctor aan de Rijksuniversiteit Groningen
op gezag van de
rector magnificus prof. dr. E. Sterken en volgens besluit van het College voor Promoties.
De openbare verdediging zal plaatsvinden op vrijdag 31 maart 2017 om 16.15 uur
door
Jacoba Maria Maurer geboren op 18 januari 1979
Promotores Prof.dr. J.G.W. Kosterink Prof.dr. H.W. Frijlink Prof.dr. G. Dijkstra Copromotor Dr. H.J. Woerdenbag Beoordelingscommissie Prof.dr. J.H. Beijnen Prof.dr. H. Vroomans Prof.dr. R.K.Weersma
Contents
Chapter 1 General introduction 1
Chapter 2 Influence of critical process parameters on the release characteristics of ColoPulse tablets: a quality by design
approach 13
Chapter 3 Development and potential application of an oral ColoPulse infliximab tablet with colon specific release:
a feasibility study 35
Chapter 4 Population pharmacokinetics of infliximab in patients with inflammatory bowel disease: potential implications for dosing in clincial practice 65 Chapter 5 A non-invasive, low-cost study design to determine
the release profile of colon drug delivery systems:
a feasibility study 87
Chapter 6 Gastrointestinal pH and transit time profiling in healthy volunteers using the IntelliCap system
confirms ileo-colonic release of ColoPulse tablets 105 Chapter 7 ColoPulse tablets perform comparably in healthy
volunteers and crohn’s patients and show no influence
of food and time of food intake on bioavailability 127 Chapter 8 General discussion and future perspectives 151
Summary 161
Samenvatting 169
Dankwoord 177
