Modified-Release Drug Delivery Technology

MICHAEL J. RATHBONE is Director, Research and Development, and General Manager of InterAg, a Division of DEC International NZ Limited, Hamilton, New Zealand. Dr. Rathbone received his Ph.D. in Pharmaceutical Science from the University of Aston, Birmingham, England, and has innovated many novel modified-release drug delivery systems, several of which have been commercialized. Dr. Rathbone has written over 35 peer-reviewed articles, has licensed five US patents and has edited or co-edited three books and numerous special issues of journals. JONATHAN HADGRAFT is Professor of Biophysical Chemistry, University of London, United Kingdom. Dr. Hadgraft received his D.Phil. in Chemistry and his D.Sc. in Medicine from the University of Oxford, United Kingdom. His major research interests are in the application of physical chemistry to drug delivery, with special reference to the skin. He has been elected to Fellowships of the Royal Society of Chemistry and the American Association of Pharmaceutical Scientists, and has contributed to over 500 publications. He has contributed numerous book chapters and has co-edited several books. He serves on a number of editorial boards of pharmaceutical science journals.MICHAEL S. ROBERTS is Professor, School of Medicine, University of Queensland, Brisbane, Australia; Senior Principal Research Fellow, National Health and Research Council; Director Therapeutics Research Unit, Princess Alexandra Hospital, Queensland Australia; Adjunct Professor, University of Canberra, Australia; and Visiting Professor, University of Lyon, France. Dr. Roberts received his Ph.D. and D.Sc. from the University of Sydney, Australia, and his M.B.A. from the University of Queensland. Dr. Roberts has also written over 280 peer-reviewed articles, 36 chapters, and has edited or co-edited five books. MAJELLA E. LANE is a lecturer in Pharmaceutics in the School of Pharmacy, University of London, United Kingdom. She received her Ph.D. from Trinity College, Dublin, Ireland, and spent a sabbatical period at the University of Michigan, Ann Arbor, where she holds a Visiting Associate Scientist appointment. Her current research interests include development of vaccine dosage forms, formulation of peptides, transdermal drug delivery and mucosal drug delivery, and modeling of absorption processes across epithelial barriers.

• Introduction (The Modified Drug Release Landscape). The Modified Drug Release Landscape: Academic Viewpoint. The Modified Drug Release Landscape: Regulatory Viewpoint. The Modified Drug Release Landscape: Intellectual Property Viewpoint. Using Modified Release Formulations to Maintain and Develop Markets. Maintenance and Development of Markets. Approaches That Satisfy the Patients’ Needs. Approaches That Satisfy the Doctors’ Needs. Approaches That Satisfy the Innovators’ Needs. The Need of the Investor. Oral. Introduction. Osmotic Systems. Qtrol. Qdis. Matrix Systems. SQZgel. Thiolated Polymers for CR. Oradur. IDD Technology. Chronotherapy Technology. Meltrex. Threeform. Floating Capsule. Cast Films for Oral Use. Monolithic and Composite Matrices for Modified Release Drug Delivery in Single or Multiple Drug Therapy. Dissocubes. Dose Sipping Technology. GIPET, GIRES. Micropump. Colonic and Rectal. Introduction. Test Systems for Colonic Devices. Enteric Coating for Colonic Delivery. Biopolymers and Colonic Delivery. Time-dependent Systems for Colonic Delivery. Pulsincap and Hydrophilic Sandwich (HS) Capsules. Egalet Technology. Ocular. Introduction. Ophthalmic Drug Delivery. Ocular Inserts. Intraocular Implants. Ion Exchange Resin Technology for Ophthalmic Applications. I-vation Sustained Release Intravitreal System. Oral Mucosal. Introduction. Oral-lyn™ (RapidMist™ Technology). Buccal Drug Delivery System. ORAVESCENT™: A Novel Technology for the Transmucosal Delivery of Drugs. Medichew Technology Platform. DentiPatch. Medicated Chewing Gum. The BEMA™ Drug Delivery Technology. Oral Transmucosal System (OTS). Dermal and Transdermal. Introduction. ALZA Technologies (E-Trans, D-Trans, Macroflux, etc.). Metered Dose Transdermal Spray Technology. Microneedles for Drug Delivery. Transdermal Delivery. Transfersomes. Recent Advances in Wound Healing. Ultrasound in Transdermal Delivery. SLN and Lipopearls. Iontophoretic Delivery. Radiofrequency Technology. The PassPort™ System. Novel Polymers for Dermal and Transdermal Delivery. Nail Delivery. NanoCyte Technology. Noven Transdermal Technology. Injections and Implants. Introduction. Long Acting Protein Formulations. Duros Implant. Sucrose Acetate Isobutyrate (SAIB) for Parenteral Delivery. Particulate Injectors and Imprinter. ReGel. The Atrigel Drug Delivery System. Depofoam. Medusa. Alzamer. Stealth Technology. Nasal. Introduction. ViaNase Intranasal Device and Controlled Particle Dispersion Technology Platform. Single and Multidose Devices for the Delivery of Liquid and Dry Powder Drug Formulations. DirectHaler™ Nasal. Chitosan. Vaginal. Introduction. Intravaginal Ring Systems. Supravail. Vagisite. C-Vad™ Vaginal Insert. ‘Smart’ Vaginal Delivery Systems. Pulmonary. Introduction. The AERx® Pulmonary Drug Delivery System. Formulation Challenges of Powders for the Delivery of Small Molecular Weight Molecules as Aerosols. AAD—Adaptive Aerosol Delivery Technology. Nebulizer Technologies. MicroDose Propietary Dry Powder Inhaler. Formulation Challenges: Protein Powders for Inhalation. The RESPIMAT®, A New Soft Mist Inhaler for Delivering Drugs to the Lungs. Metered Dose Inhalation Technology. Intellectual Property. US Intellectual Property Issues Relating to Modified Release Products. India Intellectual Property Issues Relating to Modified Release Products. Germany Intellectual Property Issues Relating to Modified Release Products. Japan Intellectual Property Issues Relating to Modified Release Products. Regulatory Issues Relating to Modified Release Drug Formulations. USA (FDA). Japan (PMDA). Australia and New Zealand.