Sustained-Release Injectable Products focuses on the development process for sustained-release versions of drugs and delivery systems and administration routes. From the rationale and basic product development principles to regulatory issues and the approval process, expert contributions address virtually every aspect. They bring together common threads that apply to any sustained-release formulation, such as scale-up, safety, biocompatibility, analytical challenges, and quality assurance.
Rationale for Sustained-Release Products. Product Development Principles. Commercial Sustained-Release Injectable Formulations by Encapsulation. Insoluble Salt Forms & Drug Complexes. Non-aqueous Solutions & Suspensions. Emulsions for Sustained Delivery. Liposomes. Synthetic Polymers, M. Radomsky. Nano/Microspheres from Natural Polymers. In Situ Gelling Formulations. Guidelines for Selection of Sustained-Release Technology. Veterinary Sustained-Release Parenteral Products. Vaccines & Gene Delivery. Microspheres for Proteins & Peptides. Toxicology & Biocompatibility Evaluation of Microsphere & Liposome Sustained-Release Delivery Systems. Scale-up & Technology Transfer. QC Methods & Specifications. Regulatory Perspectives & the Approval Process.