Description
The aim of the proposed book is to provide exhaustive information about the fundamental concepts, theory and applications of the simple and complex ophthalmic dosage forms with emphasis on the regulatory aspects of the same for formulators and academic / industrial researchers. The proposed book comprehensively covers the current research trends and industrial inputs beginning from the pharmaceutical product development strategy, composition, labelling, challenges, NDA vs ANDA filing to the advanced drug delivery approaches using novel micro and nanocarriers, fixed–dose combinations, role of preservatives in product development and so on. This book also covers various eye related disease like glaucoma, age-related macular degeneration, uveal melanoma, cataract, fungal keratitis, conjunctivitis, blindness etc. which need to be treatable. The sterile ophthalmic product development approaches inclusive of different drug delivery dosage form technologies have been revolutionary in current healthcare, pharmaceutical research and innovation. However, it has its own challenges in scale up and commercial aspects, which could be a reason for limited scope and availability of ophthalmic products in market. Development of complex sterile ophthalmic product is crucial and needs proper systematic approaches starting from pre-formulation till validation, scale up and commercialization including toxicological data. This book presents these approaches in vivid chapters contributed by renowned formulators, researchers and academician working in the fields of ophthalmic product development across the world. The primary audience for the proposed book would be academic and industrial researchers, PhD/postdoctoral research fellows, formulation scientists and bio-medical professionals. The comprehensive focus on fundamental concepts, advanced drug formulation and regulatory guidelines will benefit students as well as professionals in the field of ophthalmic medicine. This book, Complex Ophthalmic Dosage Forms: Advances in Biomedical Applications and Future Perspectives, offers a detailed overview of the latest innovations in ophthalmic drug delivery. Beginning with the fundamentals of ocular drug delivery systems and the anatomy of the eye, this book provides an exploration of drug delivery to both the anterior and posterior segments. A dedicated chapter on the fixed-dose combination approach examines its application in ocular diseases, highlighting both its therapeutic potential and associated challenges. Furthermore, the book delves into key aspects of ophthalmic product development, including reverse engineering, the role of preservatives, and the application of Quality by Design (QbD) principles. It includes discussions on the safety of nanoformulations, as well as an in-depth analysis of emerging nano-assisted platforms in ocular drug delivery, highlighting both opportunities and safety concerns. Recognizing the importance of packaging a dedicated chapter explores the critical role of sterility in ocular products, detailing sterility validation processes to ensure product safety and efficacy. This is followed by a thorough discussion on packaging, including the selection of appropriate containers and closure systems. Given that an optimized packaging system is essential for maintaining the stability, sterility, and overall quality of ophthalmic products, this section highlights key considerations in designing effective packaging solutions. Additionally, the book delves into regulatory considerations, challenges in clinical translation, and potential future developments that may redefine ophthalmic therapeutics.
ISBN 9789819663088
