Long acting injections and implants improve therapy, enhance patient compliance, improve dosing convenience, and are the most appropriate formulation choice for drugs that undergo extensive first pass metabolism or that exhibit poor oral bioavailability. An intriguing variety of technologies have been developed to provide long acting injections and implants. Many considerations need to go into the design of these systems in order to translate a concept from the lab bench to actual therapy for a patient. This book surveys and summarizes the field.
Topics covered in Long Acting Injections and Implants include the historical development of the field, drugs, diseases and clinical applications for long acting injections and implants, anatomy and physiology for these systems, specific injectable technologies (including lipophilic solutions, aqueous suspensions, microspheres, liposomes, in situ forming depots and self-assembling lipid formulations), specific implantable technologies (including osmotic implants, drug eluting stents and microfabricated systems), peptide, protein and vaccine delivery, sterilization, drug release testing and regulatory aspects of long acting injections and implants.
This volume provides essential information for experienced development professionals but was also written to be useful for scientists just beginning work in the field and for others who need an understanding of long acting injections and implants. This book will also be ideal as a graduate textbook.
About the Author
Dr. Jeremy Wright is a Principal Engineer at the DURECT Corporation in Cupertino, California. He has over 30 years of experience in the development of drug delivery systems. He has been a key contributor to the development of implantable osmotic systems for veterinary and human use (DUROS®) and is currently involved in research and development of injectable depot systems. Dr. Wright is the inventor on over 50 patents.
Dr. Diane J. Burgess is Distinguished Professor of Pharmaceutics, at the University of Connecticut. Her research efforts focus on gene and drug delivery and she has over 140 refereed publications. Dr. Burgess was the 2010 President of the Controlled Release Society (CRS), the 2002 President of the American Association of Pharmaceutical Scientists (AAPS) and is a CRS, AAPS and an American Institute for Medical and Biological Engineering (AIMBE) fellow. She is editor of the International Journal of Pharmaceutics.
Table of Contents
An Introduction to Long Acting Injections and Implants.- Historical Overview of Long Acting Injections and Implants.- Host Response to Long Acting Injections and Implants.- Anatomy and Physiology of the Injection Site – Implications for Extended Release Parenteral Systems.- Drugs for Long Acting Injections and Implants.- Diseases and Clinical Applications that Can Benefit from Long Lasting Implants and Injections.- Oily (lipophilic) Solutions and Suspensions.- Aqueous Suspensions.- In Situ Forming Systems (Depots).- Microsphere Technologies.- Liposomes as Carriers for Controlled Drug Delivery.- Micro- and Nanoemulsions (Controlled Release Parenteral Drug Delivery Systems).- Nanosuspensions.- PEGylated Pharmaceutical Nanocarriers.- Protein PEGylation.- Self-Assembling Lipid Formulations.- Implantable Drug Delivery Systems Based on the Principles of Osmosis.- Microtechnologies for Drug Delivery.- Drug Eluting Stents.- Delivery of Peptides and Proteins via Long Acting Injections and Implants.- Injectable PLGA Systems for Delivery of Vaccine Antigens.- Methods of Sterilization for Controlled Release Injectable and Implantable Preparations.- In Vitro Drug Release Testing and In Vivo/In Vitro Correlation for Long Acting Implants and Injections.- Regulatory Issues and Challenges Associated with the Development of Performance Specifications for Modified Release Parenteral Products.