Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program

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 ophthalmic 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.

Furthermore, it is also noted that suitable bioequivalence methods are lacking for many generic ophthalmic formulations, including suspensions and emulsions. Therefore an investigation of the relationship between various physicochemical properties and their effect on ocular bioavailability will help the FDA in establishing guidelines for the determination of bioequivalence of ophthalmic suspensions and emulsions.

The scope of the program will cover two types of inquiries:

a) In vitro study – Formulations with different physicochemical properties are manufactured using a selected steroid and characterized in vitro. Drug release and stability tests are conducted to understand how differences in physicochemical properties may affect ocular bioavailability.

b) In vivo study – Formulations selected based on the results of the in vitro study are tested in an animal model. A pharmacokinetic study should be conducted by assessing the ocular distribution of the steroid in various eye tissues and organs at various time points.

In order to support these initiatives, the Food and Drug Administration is set to administer funds in the amount of $400,000.

The institutions and organizations who will be deemed eligible to submit an application under this program are the following:

a) Private and Public Non-profit entities

b) State and Local Governments

c) Indian Tribal Governments and Organizations

d) Faith-based Organizations

e) Community-based Organizations

f) Institutions of Higher Education

g) Private and Public Colleges and Universities

h) Independent School Districts

The United States Department of Health and Human Services, the mother agency funding the Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability Program, is country’s premiere agency for protecting the health of all Americans and providing essential human services, especially to those who medically challenged and vulnerable.