Formulation of Ketorolac Tromethamine (0.5% w/v) Ophthalmic Drop تصييغ تركيبة كيتورولاك تروميثامين (0.5% w/v) قطرة للعين

Abstract

Ophthalmic preparation are specialized dosage forms designed to be instilled on the external surface of the eye (topical). Ketorolac tromethamine ophthalmic drop is a non-steroidal anti-inflammatory and analgesic indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. The aim of the study was to formulate and evaluate a sterile isotonic aqueous solution contains (0.5%) ketorolac tromethamine as an active ingredient and other materials. Different formulations were prepared using benzalkonium chloride as preservative, sodium metabisulfite as antioxidant, sodium edetate as chelating agent and sodium chloride was added to adjust the tonicity. The stability study was carried out according to international conference harmonization(ICH)guidelines after exposure the formula to different conditions involved temperatures and humidity at ( 25 °C/60 % RH , 30°C/ 65 %RH & 40°C /75 %RH ) in order to reach a suitable and effective formula which meets with the requirements of pharmacopeial specifications. The results of stability study indicated that the proposed formula was stable and no physico-chemical reaction was observed.