Formulation of Ofloxacin) 0.3%w/v) Eye Drop تصييغ تركيبة افلوكساسين (0.3%w/v) قطرة للعين

Abstract

Ofloxacin ophthalmic drop is a sterile solution indicated for the treatment of conjunctivitis caused by certain strains of Gram positive and Gram negative bacteria . The present study aimed to prepare a pharmaceutical formula of Ofloxacin (0.3% w/v) ophthalmic solution for topical use . The study was carried out to prepare an acceptable formula through studying the effect of minimum concentration of benzalkonium chloride as preservative, sodium metabisulphite as antioxidant and sodium chloride was added to adjust tonicity . Different formulas were prepared of ofloxacin ophthalmic solution using different addative to observe the interaction of each ingredient and to stabilized the formula for the shelf –life period . The pH of prepared formula of ofloxacin ophthalmic solution was unbuffered , therefore , the pH was adjusted to 6.4 according to pharmacopeial range ( 6.0 – 8.0 ) , the final solution was isotonic .The sterilization was carried out by filteration system through millipore filter to obtain a sterile solution also good appearance which meets with the pharmacopeial requirements . The stability study was studied after exposure the prepared formula to different conditions involved temperatures and humidity especially) 25⁰C/60% RH, 30⁰C/65% RH, and 40⁰C/75% RH( according to International Conference Harmonization ( ICH) Guidelines. The result of stability study was indicated ,that the studied formula was stable and no physical and chemical changes were observed .