OpportunityTitle: Effect of Physicochemical Properties of Ophthalmic Formulations on Ocular Bioavailability (U01)
AdditionalInformationOnEligibility: Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.  Foreign components, as defined in the HHS Grants Policy Statement, are allowed.
Description: The purpose of this project is to study the effect of various physicochemical properties of ophthalmic suspensions and emulsions on ocular bioavailability. Formulations having the same active and inactive ingredients in the same concentrations may still exhibit differences in physicochemical properties due to differences in the manufacturing process. Key physicochemical properties which impact clearance, distribution, and drug release will be investigated.The following physicochemical properties should be investigated in the project study:Globule/particle size distribution Surface chargeOsmolalitypHViscosityDispersibility Suitable bioequivalence methods are lacking for many generic ophthalmic formulations. Suspensions and emulsions are commonly employed as ophthalmic vehicles as they can easily be applied topically to the eye. The results from this project will help to understand the relationship between physicochemical properties and their impact on ocular bioavailability, and will also be used to help determine bioequivalence study recommendations for generic ophthalmic suspensions and emulsions.
GrantorContactEmailDescription: lisa.ko@fda.hhs.gov
GrantorContactText: Lisa Ko &lt;br/&gt;Grants Management Specialist &lt;br/&gt;