Formulation of Salbutamol Sulphate (0.5%w/v) Nebulizer Solution تصييغ محلول سالبيوتامول سلفيت%) 0.5 وزن / حجم) للاستنشاق الفموي

Abstract

Inhaled medications are widely used in patients suffering at bronchial diseases. Salbutamol sulphate nebulizer solution is commonly considered as the most rapid effective route of for treatment of acute attacks of asthma. The aim of present study was to formulate nebulizer solution containing salbutamol sulphate (0.5%) (w/v) as an active ingredient and other excipients. Different formulas were prepared without using preservative, stabilizer, sodium EDTA as chelating agent, sodium metabisulphite as antioxidant , sodium chloride was added to adjust tonicity and sulphuric acid to adjust the pH between (0.3 – 0.5).The clarification of solution was obtained by filtration through membrane filter size (0.2µm) and filled under nitrogen gas in sterile suitable container. The tonicity was administration measured by Osmometer device.Sterilization was achieved by autoclaving at (121) °C for 30 minutes. The stability study was carried out according to International Conference Harmonization (ICH) at (25°C /60% RH, 30°C /65% RH and 40°C /75% RH) in order to estimate the shelf-life of formula. The result showed stability study has indicated that, the prepared formula was stable and non physico-chemical changes were observed, with expected shelf life of not less than two years.