Abstract

FORMULATION AND DEVELOPMENT OF SALBUTAMOL PRESSURIZED METERED DOSE INHALER

Swati S. Rawat* and Chetan R. Vaidya

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Abstract

Pulmonary delivery has gained increased interests over the past few decades. For respiratory conditions, targeted drug delivery directly to the site of action can achieve a high local concentration for efficacy with reduced systemic exposure and adverse effects. For systemic conditions, the unique physiology of the lung evolutionarily designed for rapid gaseous exchange presents an entry route for systemic drug delivery. Although the development of inhaled formulations has come a long way over the last few decades, many aspects of it remain to be elucidated. The purpose of the present research work was to develop a robust and physiochemically stable Pressurized Metered Dose Inhaler formulation for pulmonary delivery of a bronchodilator, the-Salbutamol. Salbutamol in the plasma following oral administration is predictable from its very high clearance, which would be expected to result in a high first pass metabolism. Therefore, targeting Salbutamol as pMDI form, as spray formulation for the management of Asthma & Chronic Obstructive Pulmonary Disease. Salbutamol was formulated by pressure filling technique as Metered Dose Inhaler formulation. Salbutamol Pressurized Metered Dose Inhaler. 100 mcg was evaluated for different parameters like identification of Pressurized Metered Dose Inhaler type, physical, chemical and packaging characterizations. Hence the studied suspension for pulmonary delivery was found to be physically stable at 30°C/65%RH, 40°C/75%RH for 3 months in final container.

Keywords: Salbutamol, Bronchodilator, Pressurized Metered Dose Inhaler, Chronic Obstructive Pulmonary Disease.