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Abstract

Development of room temperature stable formulation of formoterol fumarate/beclomethasone HFA pMDI

Author(s): D Purohit, A Trehan, V Arora
Research & Development Centre (R&D I), Ranbaxy Laboratories Limited, Plot No. 20, Sector 18, Udyog Vihar Industrial Area, Gurgaon-122 015, India

Correspondence Address:
D Purohit Research & Development Centre (R&D I), Ranbaxy Laboratories Limited, Plot No. 20, Sector 18, Udyog Vihar Industrial Area, Gurgaon-122 015 India [email protected]

The primary aim of present investigation was to develop and formulate room temperature stable formulation of formoterol fumarate and beclomethasone dipropionate with extra fine part size of hydrofluoroalkane pressurized metered dose inhalers. Particle size distribution of hydrofluoroalkane pressurized metered dose inhalers was evaluated using Twin Stage Glass Impinger and Anderson Cascade Impactor. A tetrafluoroethane and/or heptafluoropropane were evaluated for preparation of hydrofluoroalkane pressurized metered dose inhalers. The fine particle fractions delivered from hydrofluoroalkane propellant suspension pressurized metered dose inhalers can be predicted on the basis of formulation parameters and is dependent of metering chamber of valve and orifice size of actuators. The results presented in investigation showed the importance of formulation excipients with formulation of pressurized metered dose inhalers viz, canister, valve and actuators used in formulations.



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