FORMULATION AND CLINICAL TESTING OF GLYCERYL TRINITRATE OINTMENT FOR TREATMENT OF ANAL FISSURES

Abstract

Until know surgical intervention considered to be the cornerstone for treatment of anal fissure condition. Regarding all the circumstances that hinder the possibility of accomplishment of surgical operation and the possible post-urgical complications; all that motivates the necessity for a non-surgical procedure for treatment of anal fissure. This study was designed to establish a pharmaceutically active and chemically and physically stable formula of 0.4% (w/w) glyceryl trinitrate ointment. High Performance Liquid Chromatography (HPLC) was used to assay the active ingredient and to determine the rate of release of glyceryl trinitrate from the prepared ointment base. After establishing the formula, the prepared ointment was clinically tested on selected patients under supervision of specialized surgeons. After 3 months monitoring of a small scale pilot batch of 0.4% glyceryl trinitrate ointment and depending on Accelerated stability method, a physically and chemically stable formula was achieved with an unaltered pH and with a release rate value range between 83.4-85.1%. Up to 6 months of clinical follow up shows a variation in responses from complete healing to moderate relief of symptoms. Glyceryl trinitrate shows a high rate of healing for both acute and chronic anal fissures with tolerable side effect. A significant rate of pain relief and a high rate of complete healing lead to a conclusion of effectiveness of glyceryl trinitrate as a non-surgical treatment of both chronic and acute anal fissure.