A Novel Apparatus for the Determination of Solubility in Pressurized Metered Dose Inhalers |
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| Authors: | Daniela Traini Paul M Young Robert Price Phillipe Rogueda |
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| Affiliation: | 1. Advanced Drug Delivery Group, Faculty of Pharmacy (A15), University of Sydney, Sydney, NSW 2006, Australia;2. Pharmaceutical Surface Science Research Group, Department of Pharmacy, University of Bath, Bath, BA2 7AY, UK;3. AstraZeneca R&4. D Charnwood, Pharmaceutical &5. Analytical R&6. D, Bakewell Road, Loughborough, Leics, LE11 5RH, UK |
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| Abstract: | ABSTRACTThe 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. |
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| Keywords: | pMDI Solubility HFA Salbutamol sulfate Budesonide Formoterol fumarate dihydrate |
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