This item is in: Materials > Biomaterials > Applications

Drug-device combination products: Delivery technologies and applications

Edited by A Lewis, Biocompatibles UK Ltd, UK

Woodhead Publishing Series in Biomaterials No. 22

 - illustrates how effective drug delivery can be achieved by means other than tablets providing readers with a comprehensive introduction and background to the field
 - provides a thorough analysis of the fundamentals, applications and new technologies of drug device combination products
 - discusses areas of application such as catheter based products and reviews the development of drug device combination products including pre-clinical testing and sterilisation

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. Advanced drug delivery devices can offer significant advantages over conventional drugs and devices alone, such as increased efficiency, improved performance and convenience. The purpose of this book is to illustrate how effective drug delivery can be achieved by means other than tablets. The book will provide a thorough analysis of the fundamentals, applications and new technologies of drug-device combination products for use throughout the human body.

Part one provides readers with an introduction and background to the field. Chapters in Part two discuss areas of application such as catheter based products, drug eluting stents and beads and anti-biotic loaded cements. Part three covers the development of drug device combination products with chapters on such topics as pre-clinical testing, sterilisation, patent issues and regulation of drug device combination products.

With its distinguished editor and team of international contributors, Drug-device combination products: delivery technologies and applications is an invaluable reference for product development specialists, materials scientists and engineers in the biomedical industry and academia as well as those concerned with drug delivery.

ISBN 1 84569 470 8
ISBN-13: 978 1 84569 470 8
December 2009
560 pages  234 x 156mm  hardback  
£165.00 / US$280.00 / €200.00

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About the editor

Andrew Lewis is Research & Technology Director for Biocompatibles UK Ltd and Visiting Professor of Biomaterials & Drug Delivery at the University of Brighton.

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Contents

PART 1 OVERVIEW
PART 2 AREAS OF APPLICATION
PART 3 DEVELOPMENT OF DRUG-DEVICE COMBINATION PRODUCTS

PART 1 OVERVIEW

Drug-device combination products
Y Wang and D 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 L 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 (NMCPs)
 - 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 P Gorman and D S 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 (CVCs)
 - Complications associated with peritoneal catheters
 - Conclusion
 - References

Catheter-based drug-device combination products: the anti-infective 5-fluorouracil-coated central venous catheter
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, Purdue University, USA
 - Introduction
 - Drug eluting stents (DES): Where are we now?
 - Challenges in the use of drug eluting stents (DES)
 - Strategic approaches for future use of drug eluting stents (DES)
 - Summary
 - Acknowledgements
 - References

Drug eluting beads in the treatment of liver cancer
A L Lewis, Biocompatibles UK Ltd, UK
 - Introduction
 - Embolisation therapy
 - The drug eluting beads (DEB) technology platform
 - Clinical evaluation of Dox drug eluting beads (DEB)
 - 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, The University of Sheffield 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 (DDS) within the field of bone graft substitution
 - References and further reading

Antibacterial releasing dental restorative materials
A M 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 L Willams and V R 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
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 and further reading

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 (DES): an innovation map
 - The innovation landscape
 - Conclusions
 - Sources of further information and advice
 - References

Regulation of drug-device combination products in Europe
S Leppard, Biocompatibles UK Ltd, UK
 - Introduction
 - Conformite European (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 (NBs) vs
 - competent authorities (CAs)
 - Future trends: MDD revisions
 - Web references

Regulation of drug-device combination products in the USA
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 (IND) application
 - 510K premarket notifications
 - Premarket 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 and nomenclature
 - References