Abstract

PERFORMANCE EVALUATION OF ALCOHOLIC AND NON-ALCOHOLIC SALBUTAMOL AEROSOL FORMULATIONS

Vinod P. Musale* and Dr. Swati C. Jagdale

ABSTRACT

The purpose and interest of this research on the performance evaluation of alcoholic and Non-alcoholic Salbutamol pressurized inhaler. Metered dose inhalers are formulated in solution form or in suspension form. The present study was aimed at comparing two metered dose inhaler formulation containing Salbutamol Sulphate (100 μg) with alcohol and without alcohol. The current study intended to highlight the impact and necessities of alcohol for the manufacturing of Salbutamol Sulphate Inhaler. pMDI is the most common dosage form for inhalation by which the micronized drug is delivered from a pressurized container suspended in a liquefied gas (Propellant- HFA134a/HFA 227ea). Inhalation is the convenient way to deliver drugs to respiratory tract in treatment of respiratory disease like Asthma & Chronic Obstructive Pulmonary Diseases (COPD). The Respirable fraction of the dose is the particles deposited in the respiratory tract after inhalation. Solution formulations of metered dose inhalers of salbutamol sulphate performed better and gave lower mass median aerodynamic diameter (MMAD = 2.692) values as compared to their suspension formulation (MMAD = 3.583). Particle size distributions were compared determining mass balance and fine particle fraction <4.7μm aerodynamic diameter (FPF<4.7μm). Fine Particle Dose (FPD) determined by ACI for Salbutamol solution [F1] and suspension [F2] formulations i.e. 44.9% (47.31 μg/Spray) and 31.5% (34.94μg/Spray) respectively. The determined % Assay of salbutamol formulations shows that, [F2] 110.8% betters than the [F1] i.e. 105.5%. The study shows that the suspension formulation showing better results and the experimental evaluation shows that there is no any effective/major impact of ethanol on the Salbutamol inhaler formulation.

Keywords: Aerosol Formulations, Alcoholic Inhalers, Salbutamol, Suspension and Solution.