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.
Highlights
Anal fissure is a superficial tear in the mucosa of the distal anal canal of a triangular shaped area of ulceration and inflammation characterized by pain on defecation, rectal bleeding and spasm of the anal sphincter (Sweetman, 2009; Stevens and Lowe, 2000).Most fissures are located dorsally
In anther study it was found that 0.6% glyceryl trinitrate ointment concentration has no additional benefit over 0.2% concentration (Nelson, 2004). because of the above mentioned information, a 0.4% (w/w) glyceryl trinitrate ointment concentration was selected to this study
The assay of glyceryl trinitrate ointment was performed applying High Performance Liquid Chromatography (HPLC) method based on British Pharmacopeia, 2004 with some modifications
Summary
Anal fissure is a superficial tear in the mucosa of the distal anal canal of a triangular shaped area of ulceration and inflammation characterized by pain on defecation, rectal bleeding and spasm of the anal sphincter (Sweetman, 2009; Stevens and Lowe, 2000). The discovery of pharmacological agents that cause smooth muscle relaxation such as Glyceryl trinitrate, Botulinum (Sweetman, 2009) and Diltiazem (Jonas et al, 2002) which effectively heal most fissures has led to approximately two-thirds of patients avoiding surgery (Dhawan and Chopra, 2007). These medicinal substances act as inhibitory neuro-transmitter involved in relaxation of the sphincter presents a possible alternative treatment (McCallion and Gardiner, 2001; Evans et al, 2003). In anther study it was found that 0.6% glyceryl trinitrate ointment concentration has no additional benefit over 0.2% concentration (Nelson, 2004). because of the above mentioned information, a 0.4% (w/w) glyceryl trinitrate ointment concentration was selected to this study
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