ABSTRACT

Ophthalmic formulations are those that are intended for treating conditions of the eye; they may be intended to alleviate the signs or symptoms associated with a certain disease state, to provide relief from minor discomfort and irritation, or for treatment of the cause of a disease of the eye itself. This chapter provides a brief overview of ophthalmic formulation preservation, manufacturing and packaging, and regulatory pathways for bringing a formulation to market. It focuses on the anatomy and physiology of the eye and the challenges in drug delivery to this organ. The chapter aims to familiarize the reader with the biopharmaceutical aspects of drug delivery to the eye, the various strategies for targeting different tissues within the eye, and to provide a guide to a rational approach to formulation development for ophthalmic drug delivery. The eye globe is continually cleansed and hydrated by the secretions of the nasolacrimal system.