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A Novel Apparatus for the Determination of Solubility in Pressurized Metered Dose Inhalers

ABSTRACT The accurate solubility of salbutamol sulfate, budesonide, and formoterol fumarate dihydrate in hydrofluoroalkane propellant 134a at 25°C for 24 h, are reported. The authors describe a novel reusable in-line pressurized solubility apparatus containing an integral filter holder and a continuous decrimpable valve for the determination of drug/excipients solubility in pressurized metered dose inhalers. The solubility was determined by high-performance liquid chromatography. Solubility of salbutamol sulfate was determined as being below the detection limits while budesonide and formoterol fumarate dihydrate solubility were 23.136 ± 2.951 μg.g−1 and 0.776 ± 1.023 μg.g−1, respectively (n = 3). This novel solubility apparatus offers an improved ease of use and potential higher analytical throughput.