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| home > epc > summer 2004 > utrecht university, put controlled parenteral release of pharmaceutical proteins from hydrogels |
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European Pharmaceutical Contractor
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With the 'coming of age' of the biotechnology industry, it is well-recognised that many established and experimental pharmaceutical proteins would greatly benefit from controlled release systems for constant (weeks to months) or pulsed release of the intact protein after a single injection. This article focuses on parenteral delivery systems for proteins based on hydrogels. Controlled release systems for these proteins are used: (a) to produce the desired pharmacokinetic profile, for example, to prevent high initial plasma concentrations (in most cases, 'the flatter, the better'); (b) to reduce the injection frequency and improve patient-friendliness; and (c) to reduce the necessity of involvement of trained medical personnel.
A number of strategies have been developed to control the release of proteins as a function of time (for example (1)). Proteins have been formulated in amorphous form (insulin) or as crystals to ensure release over a short period of one or two days. Secondly, there are pumps with a catheter and a fixed needle to administer drugs for local or systemic purposes. The advantage of these pumps is the control they offer over pump rates and their proven reliability.
However, even the miniaturised devices are rather burdensome for patients using them long-term, and these systems are costly. Thirdly, upon subcutaneous injection, liposomal dispersions have been used, releasing their content over periods up to three weeks. Proteins are intrinsically fragile molecules. Their therapeutic action is highly dependent on proper folding of the amino acid string and rather weak physical interactions; S-S-bonds stabilise this complex three-dimensional structure.
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By Dr Leo de Leede, Managing Director at OctoPlus Technologies, Dr Jeroen Bezemer and Dr Ruud Verrijk, Senior Scientists at OctoPlus Technologies, Dr Gert Bos, Project Manager, Devices, at KEMA Quality bv and Professor Wim Hennink, Head of the Department of Pharmaceutics at Utrecht Institute for Pharmaceutical Sciences at Utrecht University
Dr Leo de Leede is the Managing Director of OctoPlus Technologies. He has over 20 years' experience in the pharmaceutical industry in various R&D roles at respectively Organon (an Akzo-Nobel division), Gist-brocades and Yamanouchi Europe, where he was Director of Pre-Clinical Development for all European activities. He is Chairman of the Committee on Industrial Relations of the European Federation for Pharmaceutical Scientists. He obtained a PhD in Biopharmaceutics - with a focus on pharmacokinetics and drug delivery systems - from the University of Leiden, The Netherlands.
Dr Jeroen Bezemer is Senior Scientist at OctoPlus Technologies. After graduating in Chemical Engineering at the University of Twente, The Netherlands, he obtained a PhD focusing on the application of biodegradable polymers. He joined IsoTis NV in 1999 as Senior Research Scientist, where he was responsible for IsoTis' biodegradable polymers programme, resulting in international patent applications and over 20 peer-reviewed scientific publications.
Dr Ruud Verrijk has over 15 years' experience in the pharmaceutical analysis of drugs, working at the Netherlands Cancer Institute and Solvay Duphar, before becoming Head of the Analytical Chemistry Department at OctoPlus. He is the author of more than 15 papers on pharmaceutical analysis, drug formulation and pharmacology. He is currently Senior Scientist working on protein delivery with hydrogels and non-viral polymeric DNA delivery systems.
Dr Gert Bos is currently Project Manager, Devices, at KEMA Notified Body, where he is a product expert on medical devices, active implantable medical devices and in vitro diagnostics. He is primarily involved in the review and certification of animal tissue based and drug eluting medical devices. Dr Gert Bos holds a master's in Chemical Technology and a PhD in Biomaterial Science from the University of Twente.
Professor Wim Hennink studied Biochemistry at the Agricultural University of Wageningen, and obtained his PhD from the Twente University of Technology. Between 1985 and 1989, he worked as a Research Scientist at the Plastic and Rubber Institute TNO in Delft, and then as a Development Engineer within the R&D Department of Fasson in Leiden. In 1992 he joined Utrecht University, becoming Head of the Department of Pharmaceutics in 1996. He is European Editor of the Journal of Controlled Release.
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Dr Jeroen Bezemer |
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Dr Gert Bos |
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Wim Hennink |
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