Ophthalmic Drug Delivery: Advancement, Industrialization Prospect and Applications delves into the complexities and potential of scaling up and commercializing pharmaceutical innovations within ophthalmology. This book serves as a complete guide through research findings, industry insights, and regulatory guidelines, offering a thorough roadmap for the future of drug delivery systems targeting the eye. The importance of understanding the eye's physiology and anatomy is emphasized, laying the foundational knowledge necessary for developing effective treatments. The book continues by exploring various aspects such as novel formulations, fixed-dose combinations, and microbiological considerations.
It also discusses cutting-edge research in reverse engineering approaches, the significance of Quality by Design (QbD), and the treatment of eye-related diseases like glaucoma, age-related macular degeneration, uveal melanoma, cataracts, and fungal keratitis. Corporate researchers will find the manufacturing insights particularly beneficial, making this an essential resource for professionals in the field of ophthalmic drug delivery.
1. Introduction to Ocular Drug Delivery: Core Principles and Fundamental Concepts 2. Complex ophthalmic Drug delivery Approaches 3. Excipients and polymers in complex ophthalmic products: Formulation science and engineering perspectives 4. Fixed-Dose Combination technique in ophthalmic products 5. Emerging trends in ophthalmic products: Microneedles, hydrogels, and ocular inserts 6. Reverse Engineering strategy in Complex Ophthalmic Product 7. Quality by design and Design of Experiments (DOE) in Ophthalmic Product Development: Statistical Approaches and Optimization Strategies 8. Translational roadmap for complex ophthalmic products 9. Manufacturing Consideration, Scale-Up and Validation in Sterile Ophthalmic Formulation 10. Safety Assessment and Toxicological Considerations of Nanocarriers in Ophthalmic Drug Delivery: Risk management, Animal Model and Preclinical Evaluation 11. Advanced packaging, container and closure system for complex ophthalmic products 12. Role of 3D Printing in Ophthalmic Products 13. Stability Studies of Ophthalmic Product 14. Regulatory Landscape of Ophthalmic Products
Neelesh Kumar Mehra is an Assistant Professor of Pharmaceutics in the Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Hyderabad, India. He has authored more than 140 peer-reviewed publications in high-repute international journals, and has contributed to over 50 book chapters. He holds 4 granted patents and has 5 patent applications filed on manufacturing processes and compositions to improve therapeutic efficacy for drug delivery. He has supervised 5 PhD students and 36 MS students, and is currently guiding 10 PhD and 7 MS students on their dissertations and research projects. His research focuses on the design, development, and evaluation of ophthalmic nanoemulsions, liposomes, lipid-polymer nanoparticles, carbon nanoparticles, and chitosan/PLGA-lipid nanoparticles for drug and biomolecule delivery in biomedical applications.