A Novel Metered Dose Inhalation Formulations with Formoterol 6 Mcg and Beclomethasone 200 Mcg by Using Breath Actuated Inhaler

Metered spray inhalers represent a broadly utilized dosage form for delivering anti-asthmatic drugs to the pulmonary system. The drug-device combination formulation, which includes beclomethasone dipropionate (BDP) and formoterol fumarate (FF), are widely employed for the treatment of bronchial asthma and chronic obstructive pulmonary diseases (COPD). The current formulation available in the market contains both active ingredients, FF and BDP, dissolved in a mixture of hydrofluoroalkane (HFA) 134a and ethanol are commonly used together as a co-solvent. However, individuals with religious or cultural concerns may opt to avoid using inhalers containing alcohol. In such cases, they may prefer non-alcoholic alternatives that are also accessible in the market. This study presents an innovative formulation strategy for metered-dose inhalers based on HFA that are non-alcoholic in combination therapy of FF and BDP inhalers. The novelty of the recently developed formulation lies in the substitution of ethanol with PEG 1000 as a co-solvent. Additionally, PEG 1000 serves the dual function of acting as a dispersing agent, thereby stabilizing the developed formulation. Moreover, it facilitates the delivery of synergistic effects by lubricating the valve components, ensuring smooth and flawless spray performance. The assay results for FF were 99.7 and 98.4%, while for beclomethasone, they were 101.0 and 99.7%, respectively, for pMDI and breath actuated inhaler (BAI). The percentage of emitted dose was 43.7 and 44.2% for pMDI, and 42.9 and 49.8% for BAI. Overall, both the developed conventional pMDI formulations and BAI exhibited efficient performance characteristics with equivalent performance.