Formulation of Dorzolamide HCl (2 %) (w/v) Ophthalmic Drop/تصييغ تركيبة دورزولامايد هايدروكلورايد w/v) ) (%2) قطرة عين

Abstract

Dorzolamide hydrochloride is a carbonic anhydrase inhibitor used for treatment of glaucoma and ocular hypertension . The present study aimed to prepare a pharmaceutical sterile isotonic ophthalmic solution contains dorzolamide HCL (2%) as an active ingredients with additives in order to obtain an acceptable and effective formula which meets with requirements of pharmacopeia. Different formulas were prepared using hydroxyl ethyl cellulose as a thickening agent to obtain a clear viscous solution, the viscous solution was sterilized in autoclave at (121 °C) for (20 min). Benzalkonim chloride was added as preservative , sodium citrate as stabilizer and mannitol to adjust tonicity. The pH was adjusted with sodium hydroxide or hydrochloric acid to remain the pH within United States pharmacopeia range (4.0 – 6.0). The stability study was carried out according to International Conference Harmonization (ICH) conditions .Optimized formula was kept in stability chambers at specified temperatures and humidity especially (25⁰C/ 60%RH, 30⁰C/65%RH and 40⁰C/75%RH) for six months in order to reach shelf life. The results of stability was indicated that ,the proposed formula was stable and no physico-chemical changes were observed.