Iraqi Pharmaceutical Formula for Sildenafil Citrate Oral Suspension it is used to Treat Pulmonary Arterial Hypertension in Pediatric Patients, with its Stability Study

Abstract

Abstract: This research has been carried out to formulation and evaluation of pharmaceutical product national drug contains (2.5mg/ml)(w/v)sildenafil citrate as oral suspension is used to treat Pulmonary arterial Hypertension in pediatric patients. Several formulations were prepared using different suspensions bases, preservatives and suspending agent. Selection of best formula relied solely on physicochemical testing of sample exposed to different thermal stresses. Stability study was conducted on the product at different temperatures and humidity(30ºC±2 ºC / RH 65%±5%,and 40ºC±2 ºC / RH 75%±5%) to determine the expiration date and the best storage conditions. From the study we obtained suspension of good homogeneity free sugar and free alcohol. This product is prepared for the first time in the middle east . The expiry date calculated to be not less than (2) years.