Formulation of Dexamethasone (0.1% w/v) with Tobramycin (0.3%w/v) Eye Drop تصييغ تركيبة دكساميثازون (% 0.1 وزن / حجم ) مع توبرامايسين (% 0.3 وزن / حجم ) قطرة للعين

Abstract

Tobramycin with Dexamethasone eye suspension is a sterile isotonic multiple dose of antibiotic and steroid combination for topical ophthalmic use. It contains steroid for reducing inflammation and antibiotic for treating or preventing infections. The aim of the study is to prepared a pharmaceutical ophthalmic solution Contains dexamethasone (0.1%) (w/v) and (0.3%) (w/v) tobramycin as an active ingredients with excipients in order to obtain an acceptable and effective formula which match with requirements of pharmacopeia. The study was carried out and prepared aseptically using Hydroxy ethyl cellulose as thickening agent to improve the viscosity, sterilized by autoclaving at (121°C) for(30) minutes. Benzalkonium chloride, polysorbate (80) (tween 80) were used as surfactant or wetting agent to avoid any damage to eye tissues , Disodium edetate as chelating agent was used to increase transient residence time, sodium sluphate as antioxidant and sodium chloride was added to adjust tonicity. All the excipients were sterilized by filtration using Millipore (o.22µ) filter to avoid thermal degradation. The formulation was carried out based on physico-chemical properties such as pH, appearance, tonicity and homogenicity.The stability study was carried out according to International Conference Harmonization (ICH) Guidelines involved temperatures and humidity at (25°C/60% RH, 30°C/65% RH and 40°C/75% RH) to determine the shelf-life of prepared formula which is expected to be two years.