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.
