Dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS) is a common disorder of the tear film caused by decreased tear production or increased evaporation and manifests with a wide variety of signs and symptoms. The present review from interpretation of the literature gives detailed information on the prevalence, definition, causes, diagnostic tests, and medical management of dry eye disease. A number of systems contribute to the physiological integrity of the ocular surface and disruption of system may or may not produce symptoms. Therefore accurate diagnosis of dry eyes with no or minimal disruption of physiological function is necessary. The paper also discusses different colloidal drug delivery systems and current challenges in the development of topical ophthalmic drug delivery systems for treatment of KCS. Due to the wide prevalence and number of factors involved, newer, more sensitive diagnostic techniques and novel therapeutic agents have been developed to provide ocular delivery systems with high therapeutic efficacy. The aim of this review is to provide awareness among the patients, health care professionals, and researchers about diagnosis and treatment of KCS and recent developments and future challenges in management of dry eye disease.
Introduction: The purpose of present study was to design and evaluate bepotastine besilate ophthalmic solution 1.5% to develop a stable formulation using buffering agent, tonicity modifier and preservative. Method: In this study the concentration of preservative and tonicity modifier concentration are adjusted in such a way so that the final formulation will have least concentration of preservative still it will be protected from microorganisms and isotonic so that after instillation when formulation will come in contact with tissues there should not be any swelling, contraction or discomfort. Result: The preservative content was selected in the range of 0.002-0.012% and tonicity modifier in the range of 0.45-0.9%. Bepotastine besilate ophthalmic solution 1.5% filled in LDPE container having fill volume 5 mL is clear, colourless solution having pH range 6.8-7.0, drop size of 38.6 µl and % water loss after 3 months as 1.9748%. The percent purity of bepotastine besilate and preservative was determined using RP-HPLC method was found to be 100.50 and 51.648% with % RSD as 0.84 and 0.65% respectively. The samples of the formulation also subjected to stability as per ICH guidelines and 6 months data was generated. Draize test protocol was also followed to study invivo eye irritancy of the formulation to produce a safe and effective formulation. Conclusion: Laboratory prepared formulation of bepotastine besilate ophthalmic solution 1.5% has showed good stability at both 25°C and 40°C as the drug and preservative content was within the accepted range.
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