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

Abstract

Salbutamol sulphate nebules is considered as the most rapid effective route of
administration for treatment of acute attacks of asthma .
This study was carried out to formulate a stable formula of salbutamol nebules
containing 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 was
equal to 3.5 years for formula F .In addition the bioequivalency of this formula
incomparison to ventolin® nebules was measured and it was equal to (± 5.2) %.
Also it was found that there was no significant difference between the formula
and ventolin® nebules regarding their pharmacokinetic parameters which include
elimination rate constant, elimination t 0.5 and amount of the unchanged drug excreted
in urine, 30 min. after administration (p<0.05) . This study may suggest that the
prepared formula could be used successfully in the preparation of salbutamol sulphate
nebules.