title: 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 degrees 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 microg x g(-1) and 0.776 +/- 1.023 microg x g(-1), respectively (n = 3). This novel solubility apparatus offers an improved ease of use and potential higher analytical throughput.
authors.affiliation: Advanced Drug Delivery Group, Faculty of Pharmacy (A15), University of Sydney, Sydney, NSW 2006, Australia.
authors.forename: Daniela
authors.initials: D
authors.lastname: Traini
authors.forename: Paul M
authors.initials: PM
authors.lastname: Young
authors.forename: Robert
authors.initials: R
authors.lastname: Price
authors.forename: Phillipe
authors.initials: P
authors.lastname: Rogueda
mesh_terms: D000280:Administration, Inhalation; D000335:Aerosol Propellants; D000420:Albuterol / Q000008:administration & dosage; D019819:Budesonide / Q000008:administration & dosage; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation*; D005617:Chlorofluorocarbons, Methane; D004867:Equipment Design; D004983:Ethanolamines / Q000008:administration & dosage; D000068759:Formoterol Fumarate; D006801:Humans; D036501:Metered Dose Inhalers; D011312:Pressure; D012995:Solubility
chemical_list: D000335:Aerosol Propellants; D005617:Chlorofluorocarbons, Methane; D004983:Ethanolamines; D019819:Budesonide; D000420:Albuterol; D000068759:Formoterol Fumarate