Development of a Controlled Release Ocular Insert for Brimonidine Tartrate

Glaucoma is the second leading cause of blindness in the United States. While several treatments currently exist, most require frequent dosing or invasive procedures. Brimonidine tartrate, an anti-glaucoma agent that is currently delivered as a twice daily topical eye drop medication, is one example of such treatments. Compliance with BT regimens has been shown to be as low as 50% in some cases, rendering this treatment ineffective. One attempt to address this issue is the formation of ocular inserts, such as the Ocusert ®, whose diffusion based control releases pilocarpine for a week long period. Controlled drug release technology provides an avenue for extending the release of such drugs for as long as one month from a singular insert. Currently, no controlled release formulations for BT exist, and there is a clinical need for such a device. Work presented on this poster will outline the development and characterization of a BT releasing ocular insert based off of a poly (lactic co-glycolic) acid (PLGA)/poly ethylene glycol (PEG) controlled release system. Our findings show that a 15% PEG formulation creates inserts with a linear release profile matching eye drop delivery estimates. Additionally, these films were shown, through the use of atomic force microscopy and scanning electron microscopy, to have smooth surfaces and consistent physical properties. Finally, at the time of presentation, data will be included that evaluates the cytotoxicity of these films.