Chemistry, Manufacturing, and Control of Ophthalmic Formulations

A road map to develop ophthalmic formulations for topical ocular applications is provided in this chapter. This includes design of appropriate studies, development of formulations matching target product profile, selection of suitable packaging, stability assessment, and critical aspects of manufacturing. Uniqueness and challenges associated with ophthalmic formulation development are also described. The chapter further outlines the regulatory requirements necessary to file IND and NDA.