Intraocular Injectable Dosage Form Development: Key Components and Critical Quality Attributes

Abstract

This chapter focuses on products that are administered in an intraocular manner (occurs within the eye) and the numerous product characteristics which must be identified and successfully incorporated to ensure the medicinal products are effective and safe. These key product characteristics known as Critical Quality Attributes (CQAs) are physical, chemical, biological, or microbiological characteristics that define whether a product has been manufactured with sufficient quality.Commonly recognized CQAs (e.g., drug purity, sterility for injectable products) are mostly determined by the product’s dosage form. Advanced delivery systems, including intravitreal injections, injections of small implants, and the surgical placement of implants, demand special considerations in the definition of Critical Quality Attributes (CQAs). The products final compilation of CQAs is a combination of standard accepted CQAs, and the products unique CQAs determined experimentally during the development cycle.A development plan delineates the experimental studies needed to define a product’s CQAs and its quality design space. Relevant product attributes are used to select the final product formulation and packaging. Manufacturing process CQAs should be utilized in the definition of the manufacturing process as used in the production of pivotal clinical and primary stability batches. The knowledge and implementation of a drug product’s CQAs enables the elucidation of quality standards and results in the manufacture and distribution of quality drug product.