Formulation, Stability and Bioequivalency Study of Prepared Salbutamol Sulphate Nebules.

Abstract

Salbutamol sulphate nebules is considered as the most rapid effective route ofadministration for treatment of acute attacks of asthma .This study was carried out to formulate a stable formula of salbutamol nebulescontaining 0.1% (2.5mg / 2.5ml) of the active ingredient in a buffered solution .Stability study in different buffers at pH 3 showed that the longest shelf life wasequal to 3.5 years for formula F .In addition the bioequivalency of this formulaincomparison to ventolin® nebules was measured and it was equal to (± 5.2) %.Also it was found that there was no significant difference between the formulaand ventolin® nebules regarding their pharmacokinetic parameters which includeelimination rate constant, elimination t 0.5 and amount of the unchanged drug excretedin urine, 30 min. after administration (p<0.05) . This study may suggest that theprepared formula could be used successfully in the preparation of salbutamol sulphatenebules.