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Drug delivery systems represent a vast area of research and development within biomaterials and medicine and the demand for sophisticated drug delivery devices continues to drive novel product development. This book illustrates how effective drug delivery can be achieved by means other than tablets. Written by an international team of experts, this book provides a thorough analysis of the fundamentals, applications, and new technologies of drug-device combination products for use throughout the human body. Topics featured include background information, areas of application and the development of drug device combination products.
PART 1 OVERVIEW
Drug-device combination products
Y Wang and J Burgess, University of Connecticut, USA
Introduction. Rationale for drug device combination applications. Drug enhanced device products. Device-based drug delivery systems. Summary. References.
Enabling drug delivery from combination products
A Lewis, Biocompatibles UK Ltd, UK
Introduction. Which drugs and why? Achieving controlled release from a device. Biologic-device combinations. Concluding remarks. References.
Nanomedical drug device combination products
M Bünger, Lux Research Inc., USA
Introduction. Nanomedical combination products (NMCPs). Benefits of nanomedical combination products. Future trends: exploring new principles for designing combination products. References.
PART 2 AREAS OF APPLICATION
Catheter-based drug device combination products: an overview
B Gilmore, T Hamill, S Gorman and D Jones, Queen’s University Belfast, UK
Introduction. Current materials employed in catheter manufacture. Infectious complications associated with the use of indwelling catheters. Complications associated with urological catheters. Complications associated with central venous catheters. Complications associated with peritoneal catheters. Conclusion. References.
Catheter-based drug device combination products: the anti-infective 5-fluorouracil-coated central venous catheter (5-FU CVC)
R Avelar and A Jonker, Angiotech Pharmaceuticals, Inc., Canada
Introduction. Preclinical testing. Clinical Study. Conclusions. References.
Future outlook for drug eluting stents (DES)
K Vedantham, S Chaterji, and J Kitsongsermthon, Purdue University, J Garner, and K Park, Akina Inc, USA
Introduction. Drug eluting stents: Where are we now? Challenges in the use of drug eluting stents. Strategic approaches for future use of drug eluting stents. Summary. Acknowledgements. References.
Drug eluting beads (DEB) in the treatment of liver cancer
A Lewis, Biocompatibles UK Ltd, UK
Introduction. Embolisation therapy. The drug eluting beads (DEB) technology platform. Clinical evaluation of dox drug eluting beads. Interactions of drug eluting beads with irinotecan and comparison with dox. Clinical evaluation of irinotecan drug eluting beads (DEBIRI). Conclusions and future trends. Acknowledgements. References.
Antibiotic-loaded bone cements
D Farrar, R Benson and R Milner, Smith & Nephew Research Centre, UK
Introduction. The need for antibiotics in joint replacement. The development of antibiotic-loaded cements. Choice of antibiotic. Performance characteristics of antibiotic-loaded bone cements. Current products and clinical usage. Regulatory position. Future trends. Conclusions. References.
Glass ionomer cements as drug device combination products
P V Hatton, Sheffield University and G Palmer, UCL Eastman Dental Institute, UK
Introduction. Composition and setting chemistry. Ion release from glass-ionomer cements. Release of antiseptics and related compounds. Conclusions. Acknowledgements. References.
Bone graft substitutes as drug device combination products
G Koller, B Buranawat and L Di Silvio, King’s College London, UK
Introduction. Bone graft substitutes. Bone graft substitutes as combinational drug delivery systems (DDS). Bone substitute combinations with recombinant technology to confer enhanced bioactivity. Future trends of drug delivery systems within the field of bone graft substitution. References.
Anti-bacterial releasing dental restorative materials
A Young, UCL Eastman Dental Institute, UK
Introduction. Dental composites. Glass ionomer cements. Hybrid restorative materials. Resin adhesives. Calcium phosphate-containing resins. Chlorhexidine-containing dental materials. Conclusions and future trends. References.
Collagen-based dressings as therapeutic agents for wound healing
D Silcock, Systagenix Wound Management, UK
Introduction. Biomaterials in wound repair. Collagen-based wound dressings. Collagen composite dressings. Collagen dressings with therapeutic agents. Other therapeutics agents for wound healing. Future trends. References.
Drug device combination products for occular applications
R Willams and V Kearns, University of Liverpool, UK
Introduction. Contact lens. Glaucoma. Cataract and intraocular lens (IOL). Vitreous substitutes. Biological combinational products. Concluding remarks. Sources for further information and advice. References.
PART 3 DEVELOPMENT OF DRUG DEVICE COMBINATION PRODUCTS
Safety and efficacy issues in designing drug device combination products: the case of drug eluting stents (DES)
S Willis and V O’Byrne, Biocompatibles UK Ltd, UK
Introduction. Percutaneous translumal coronary balloon angioplasty. Coronary stenting using bare metal stents (BMS). Combination devices to treat the symptoms of coronary artery disease (CAD). Coronary stenting with drug eluting stents (DES). Acknowledgements. References.
Preclinical testing of drug device combination products
G Clermont, A Alves, X Palazzi and J P Boutrand, Biomatech, a NAMSA Company, France
Introduction. Preclinical safety evaluation of combination products. Preclinical evaluation of performance and bioactivity of combination products. Pathological evaluation of combination products. Conclusion. References.
Sterilisation of drug device combination products
B Parsons, Leeds Metropolitan University, UK
Introduction. Principles of radiation chemistry. Radiation chemistry of aqueous solutions: an overview. Types and yields of water-derived free radicals. Radiation chemistry of components of drug-device products. Sterilisation of proteins and enzymes. Sterilisation of pharmaceutical drugs. Sterilisation of drug delivery systems. Principles of sterilisation of healthcare and related products. Conclusions and future trends. Sources of further information and advice. References.
Innovation and patent issues in the development of drug device combination products: the case of drug eluting stents (DES)
P Baxter, Biocompatibles UK Ltd, UK
Introduction. Drug eluting stent an innovation map. The innovation landscape. Conclusions. References.
Regulation of drug device combination products in Europe
S Leppard, Biocompatibles UK Ltd, UK
Introduction. CE mark jurisdiction. Brief history of medicinal products and medical device legislation. Guidance documents. Mode of action. Device classification. In vitro, in vivo and clinical evaluation of combination products. Submissions for CE approval. Roles of notified bodies vs. competent authorities. Future trends: MDD revisions. Web references.
Regulation of drug device combination products in the US
J Greenbaum, Generic Devices Consulting, Inc., USA
Introduction. What is a combination product? Assignment of designation. Requests for designation. Requests for classification. Drug designations. Device designations. Biologics designations. Investigational device exemption (IDE). Investigational new drug application (IND). 510K pre-market notifications. Pre-market approval applications. New drug applications. Quality system requirements for combination products. Issues at US Food and Drug Administration (FDA) and in industry with the uniqueness presented in combination products. Abbreviations. References.