PrefaceSection A. Introduction and background
1. Introduction and History of Ophthalmic Product Development
Sesha Neervannan
2. Ocular Surface Anatomy and Physiology: Impact on Product Development
Patrick M. Hughes and Jie Shen
3. Anatomy and Physiology of the Anterior Chamber - Impact on Product Development
SP. Srinivas, Giovanna Guidoboni, Anirudh Burli, Bhavya Harjai, Uday B. Kompella
Section B. Fundamental approach to Ophthalmic Product Development
4. Back of the eye anatomy & physiology - Impact on product development
C G Wilson
5. Physicochemical and Biological Fundamentals for Drug Delivery to the EyeImran Ahmed
6. Topical Ophthalmic Dosage Form Development - Key Components and Critical Quality Attributes
Anuradha Gore and Chetan Pujara
7. Intra-ocular Injectable Dosage Form Development
Key Components and Critical Quality Attributes
Kenneth Reed
8. Microbiological Considerations for Ophthalmic Products - Sterility, Endotoxin Limits and Preservatives
Ayako Hasegawa, Melissa Gulmezian-Sefer, Ying Cheng, and Ramakrishnan Srikumar
9. Packaging Development - Multi-dose container closure for preservative free products, extractable/leachables from packaging, new technologies
Michael Regn
Section C. Pharmaceutical Product Development
10. Liquid ophthalmic drug products - physicochemical properties, formulations and manufacturing considerations.
Hovhannes J Gukasyan and Richard Graham
11. Emulsions for topical eye delivery: state of the art and future perspectives
Frederic Lallemand, Jean-Sebastien Garrigue
12. Emulsions for topical eye delivery: state of the art and future perspectivesFrederic Lallemand and Jean-Sebastien Garrigue
13. Microparticle Products For The Eye - preformulation, formulation, and manufacturing considerations
Vanessa Andrés-Guerrero, Irene T. Molina-Martínez,
Irene Bravo-Osuna and Rocío Herrero-Vanrell
14. NANOPARTICLE PRODUCTS FOR THE EYE: preformulation, formulation and manufacturing considerations
Sánchez-López E.; Eliana B. Souto; Espina M.; Cano, A.; Ettcheto, M; Camins15. Advanced Hydrogel Formulations for the Eye
Hu Yang
16. Ophthalmic Product Development for Biologics
Gitanjali Sharma, Chen Zhou, Saurabh Wadhwa, Ashwin C. Parenky, Kenneth S. Graham, Amardeep S. Bhalla, Dingjiang Liu, Hunter H. Chen, Mohammed Shameem
Section D. Specialty Products and Generic Development
17. Implantable Devices to Treat Ophthalmic Conditions -Drug Delivery Systems
Susan Lee, Laszlo Romoda, Michael Robinson
18. Development of Artificial Tears Products for Ocular Conditions
Peter Simmons
19. Approval of Topical Ophthalmic Generic Products in the US - Simple to Complex Dosage Forms and Establishing Equivalency
Stephanie H. Choi, Yan Wang, and Darby Kozak
20. The development and commercialization of sustained-release ocular drug delivery technologies
Michael J.O'Rourke and Clive G Wilson
21. Manufacturing considerations and challenges for AAV Ocular Gene Therapy
Gerard A. Rodrigues, Evgenyi Shalaev, Thomas K. Karami, James Cunningham, Hongwen M. Rivers, Shaoxin Feng, Dinen Shah and Nigel K. H. Slater
22. Transcorneal Kinetics of Topical Drugs and Nanoparticles
Sangly P. Srinivas, Wanachat Chaiyasan, Anirudh Burli, Giovanna Guidoboni, Riccardo Sacco Abhishek Anand, Amreen H. Siraj, Hemant Kumar Daima, Uday B. Kompella
Section E. Conclusions
About the Author:
Seshadri Neervannan, Ph.D., Chief Operating Officer, Tarsus Pharmaceuticals Inc. is a distinguished thought leader and an expert in global drug development. His expertise spans a broad range of novel therapeutic agents beginning from their discovery through commercialization. He is focused on innovation, processes, and strategies, and he has a demonstrated record of securing multiple global product approvals in eye care and other therapeutic areas. Spanning over two decades in R&D, leading various product development functions, he has developed many drug products including topical ophthalmic preparations, intraocular sustained release injectables, dermal products, drug-device combination products, oral dosage forms and parenteral injectables for small molecules and biologics. He received his Ph.D. in Pharmaceutical Chemistry from the University of Kansas.
Uday B. Kompella, Ph.D., Professor of Pharmaceutical Sciences, Ophthalmology, and Bioengineering and Co-director of the Colorado Center for Nanomedicine and Nanosafety the University of Colorado, is an expert in ocular drug delivery and development. He is a Co-founder of Ocugen, Inc., a public company focused on developing novel biologics for treating eye diseases. Dr. Kompella is a Fellow of the American Association of Pharmaceutical Scientists and the Association for Research in Vision and Ophthalmology. Dr. Kompella is a recipient of the Distinguished Scientist Award and Distinguished Teacher Award at the University of Nebraska Medical Center; Dean's Mentoring Award and Innovations in Science Award at University of Colorado Anschutz Medical Campus; and Undergraduate Alumni Teaching Excellence Award at Auburn University. He is also a recipient of the ARVO Foundation for Eye Research/Pfizer Ophthalmics/Carl Camras Translational Research Award in Ophthalmology. Dr. Kompella has extensive experience as an editor of scientific journals, including Expert Opinion on Drug Delivery (Editor-in-Chief, 10 years), Pharmaceutical Research (Editor, 16 years), Journal of Ocular Pharmacology and Therapeutics (Associate Editor, 10 years), and Clinical Research and Regulatory Affairs (Editor, 4 years). Dr. Kompella obtained his Ph.D. in Pharmaceutical Sciences from the University of Southern California.
