by Judy Senior
and Michael Radomsky

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.

Contents

1. Rationale for Sustained-Release Products
2. Product Development Principles
3. Commercial Sustained-Release Injectable Formulations by Encapsulation
4. Insoluble Salt Forms & Drug Complexes
5. Non-aqueous Solutions & Suspensions
6. Emulsions for Sustained Delivery
7. Liposomes
8. Synthetic Polymers
9. Nano/Microspheres from Natural Polymers
10. In Situ Gelling Formulations
11. Guidelines for Selection of Sustained-Release Technology
12. Veterinary Sustained-Release Parenteral Products
13. Vaccines & Gene Delivery
14. Microspheres for Proteins & Peptides
15. Toxicology & Biocompatibility Evaluation of Microsphere & Liposome Sustained-Release Delivery Systems
16. Scale-up & Technology Transfer
17. QC Methods & Specifications
18. Regulatory Perspectives & the Approval Process

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