Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program

by:

The Food and Drug Administration, otherwise referred to as FDA, is a federal government agency operating within the United States Department of Health and Human Services that is primarily responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs.

The grants and programs of the FDA are all geared towards the achievement of its primary agency mission which is to "protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products."

In this capacity, the Food and Drug Administration has recently established the Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program in an attempt to study the effects of various physicochemical properties of ophthalmic suspensions and emulsions on ocular bioavailability.

To this effect, the program will cover the key physicochemical properties which may impact clearance, distribution, and drug release; specifically globule/particle size distribution, surface change, osmolality, pH, viscosity, and dispersibility.

It is known that there are several kinds of opthalmic drugs which are available in the market today. The goal of this study is to determine which manufacturing differences may result in physicochemical differences which in turn may affect clearance, distribution, and release of the drug.   (continued...)

Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program
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