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BACKGROUND Ocular implants are small, polymer-based discs or cylinders that improve the delivery of therapeutic drugs into the eye (1). Some common types of implants include epischleral implants, which are placed at the equator of the eye, and intravitreal implants, which are surgically placed in the vitreous humor of the eye (2). Figure 1 provides a visual representation of ocular anatomy and the placement of various implants. Ocular implants are used to treat a variety of ailments such as diabetic retinopathy and macular degeneration (1). Apparatus 4 dissolution was chosen as the technique for testing this product because the laminar flow through the sample cell correlates well with the likely in vivo conditions, and the open-loop configuration is effective for providing sink conditions for compounds with low solubility.

Low-Level Drug Release-Rate Testing of Ocular Implants Using USP Apparatus 4 Dissolution and HPLC End Analysis