Evaluation of Respirable Fraction by Next Generation Impactor for Beclomethasone and Formoterol Fumarate Dihydrate Metered Dose Inhaler

Introduction:

Asthma and Chronic Obstructive Pulmonary Disease are treated with a combination pharmaceutical aerosol (Pressurized Metered Dose Inhaler) dose form, such as Formoterol fumarate dihydrate and Beclomethasone dipropionate pressurized inhalation solution, contains 6 μg and 100 μg, respectively.

Aim:

The in vitro aerodynamic characteristic-respirable fraction using cascade impactors simulate drug particle deposition on patient's lungs. The current work aimed to evaluate respirable fraction as aerodynamic characteristics of the delivered dose using Next Generation Impactor and a sensitive high pressure liquid chromatography approach.

Materials and Methods:

The samples are subjected to Next Generation Impactor and analyzed on a ODS Hypersil (250 mm×4.6 mm), 5 μm with 40ºC column oven, volume of injection 100 μL and 1.2 mL per min flow rate using a mobile phase that is a 35:65% v/v combination of ammonium phosphate buffer and acetonitrile in high pressure liquid chromatography. The designed approach was validated for its anticipated function and determined respirable fraction of delivered dose.

Results:

Respirable fraction (fine particle dose) in μg for Formoterol fumarate dihydrate and Beclomethasone dipropionate were observed 2.6 and 44.1, respectively. Fine particle fraction in percentage for Formoterol fumarate dihydrate and Beclomethasone dipropionate were observed 51.5 and 52.8, respectively. Mass Median aerodynamic diameter in μm for Formoterol fumarate dihydrate and Beclomethasone dipropionate were observed 1.8 and 1.7, respectively.

Conclusion:

The technique produced a trustworthy result and can be used to quantify aerodynamic characteristics-respirable fraction of delivered dose of Formoterol fumarate dihydrate and Beclomethasone dipropionate in inhaler form, are ≤ 5 μm in size and equivalent to lung deposition.