Because of the slow and costly process of developing new blockbuster drugs, pharmaceutical scientists are increasingly charged with reformulating existing drugs in order to expand a company's market opportunity and to sustain company growth. This presents an opportunity for formulation scientists to innovate and develop novel drug delivery systems to extend the commercial life of existing drugs. Divided into two volumes, this Second Edition describes the anatomical, physiological, pharmaceutical, and technological aspects of oral, colonic and rectal, ocular, oral mucosal, dermal and transdermal, nasal, vaginal, and pulmonary delivery routes, providing insight and critical assessment of the many available and emerging modified release drug delivery systems for their current and future value.
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(t) (RapidMist(t) Technology). Buccal Drug Delivery System. ORAVESCENT(t): A Novel Technology for the Transmucosal Delivery of Drugs. Medichew Technology Platform. DentiPatch. Medicated Chewing Gum. The BEMA(t) 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(t) 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(t) Nasal. Chitosan. Vaginal. Introduction. Intravaginal Ring Systems. Supravail. Vagisite. C-Vad(t) Vaginal Insert. 'Smart' Vaginal Delivery Systems. Pulmonary. Introduction. The AERx(R) 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(R), 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.