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Formulation, Stability and Bioequivalency Study of Prepared Salbutamol Sulphate Nebules

Alaa A. Abdul –Rasool علاء عبد الحسين عبد الرسول --- Bazigha K. Al –Temimy

Iraqi Journal of Pharmaceutical Sciences المجلة العراقية للعلوم الصيدلانية
ISSN: 16833597 Year: 2005 Volume: 14 Issue: 1 Pages: 65-74
Publisher: Baghdad University جامعة بغداد

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.