Formulation of Sodium Bicarbonate (8.4% w/v) as Intravenous Infusion تصييغ بيكاربونات الصوديوم (8.4% w/v) كمحلول وريدي

Abstract

Sodium Bicarbonate formula is infusion intravenous a sterile, aqueous, pyrogen free, hypertonic solution used to treat severe blood acidosis when the (pH) is less than (7.1). The aim of present study was to formulate intravenous solution containing sodium bicarbonate (84 mg / ml) in water for injection as an active ingredient with other excipient . Different formulas were prepared without using, preservative, buffering agents disodium edetate anhydrous was added a stabilizer for getting formula matching with constitution pharmacopeia specifications . For easy solubility of sodium bicarbonate in water allowed to obtain the final formula by few and simple steps. The (pH) was adjusted by sodium hydroxide to obtain hypertonic solution with pharmacopeial range (7.0 - 8.5). The tonicity of sodium bicarbonate formula was measured by Osmometer and found with normal value. The stability study was carried out according to International Conference Harmonization (ICH) Guidelines at (25 ºC / 60 % RH , 30 ºC / 65 % RH and 40 ºC / 75 % RH) in order to estimated the shelf-life ,which was be maintained to less than two years . The result showed stability study has indicated the prepared formula was stable and non physico-chemical changes were observed .