Full Description
This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances.
Contents
Introduction and History of Ophthalmic Product Development.- Ocular Surface Anatomy and Physiology: Impact on Product Development.- Anatomy and Physiology of the Anterior Chamber - Impact on Product Development.- Back of the eye anatomy & physiology - Impact on product development.- Physicochemical and Biological Fundamentals for Drug Delivery to the Eye.- Topical Ophthalmic Dosage Form Development - Key Components and Critical Quality Attributes.- Intra-ocular Injectable Dosage Form Development.- Microbiological Considerations for Ophthalmic Products - Sterility, Endotoxin Limits and Preservatives.- Packaging Development - Multi-dose container closure for preservative free products, extractable/leachables from packaging, new technologies.- Liquid ophthalmic drug products - physicochemical properties, formulations and manufacturing considerations.- Emulsions for topical eye delivery: state of the art and future perspectives.- Emulsions for topical eye delivery: state of the art and future perspectives.- Microparticle Products For The Eye - preformulation, formulation, and manufacturing considerations.- NANOPARTICLE PRODUCTS FOR THE EYE: preformulation, formulation and manufacturing considerations.- Advanced Hydrogel Formulations for the Eye.- Ophthalmic Product Development for Biologics.- Implantable Devices to Treat Ophthalmic Conditions -Drug Delivery Systems.- Development of Artificial Tears Products for Ocular Conditions.- Approval of Topical Ophthalmic Generic Products in the US - Simple to Complex Dosage Forms and Establishing Equivalency.- The development and commercialization of sustained-release ocular drug delivery technologies.- Manufacturing considerations and challenges for AAV Ocular Gene Therapy.- Transcorneal Kinetics of Topical Drugs and Nanoparticles.
