Formulation And Evaluation of Controlled Release Bromfenac Sodium Ocular Insert

Abstract

According to the World Health Organization, cataract operations are performed on one million people per year [1]. After cataract surgery, however, most patients still experience physiologically severe postoperative ocular inflammation. Uncontrolled intraocular inflammation causes discomfort, delayed recovery, poor visual results, and even more severe problems such as cystoid macular oedema and synechiae due to inflammatory cells and cytokines entering the aqueous humour. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat non-infectious ocular inflammation after ophthalmic surgery. As a result, NSAIDs appear to be potentially useful drugs for cataract surgery. [2] The U.S Food and Drug Administration has approved four ophthalmic NSAIDs to treat postoperative ocular inflammation followed by cataract surgery: bromfenac sodium, diclofenac sodium, Ketorolac tromethamine, and nepafenac.[3] The first approved NSAID for treating anterior chamber inflammation during cataract surgical treatment is bromfenac ophthalmic solution. Bromfenac is a more potent drug than other drugs for treating ocular inflammation. [4] The drug-loaded eye drop is easy to use. However, it has the inherent disadvantage that most medication is almost immediately diluted away in the tear film when the eye drops are introduced into the cul-de-sac and quickly exhausted from the precorneal cavity's constant tear flow. This process occurs more intensively in swollen eyes than in normal eyes and lachrymal-nasal drainage. [5,6] To avoid the previously stated side effects and increase the drug's effectiveness, a novel approach of an ocular insert that increases the drug's contact time in the eye should be chosen, thus improving patient compliance by increasing bioavailability and reducing frequent administration. [7] Ophthalmic inserts are skinny discs of polymeric substances that fit into the upper or lower conjunctiva sac. They have compensations over the conventional dosage forms and possess amplified ocular residence, discharge the drugs at a slow and consistent momentum, are capable of delivering precise dosing, lack preservatives, have augmented shelf life, and reduced systemic incorporation. [8] Our research intended to fabricate bromfenac sodium ocular inserts to amplify the contact time and offer a controlled release model that could advance patient compliance, cut dosing frequency, and attain superior curative usefulness.