Current pharmaceutical engineering for the manufacture of binary and combined dry powder inhaler (DPI) dosage forms relies on destructive strategies such as micronisation to generate respirable drug particles. Such processes are inefficient and difficult to control to produce particles of defined quality and functionality for inhaled drug delivery, which can affect drug product performance throughout the shelf-life of the product. Furthermore, owing to current pharmaceutical manufacturing practises of combined inhalation products, these products are subject to greater variability in dose delivery of each active, which may be perpetuated as a function of product storage conditions and limit clinical efficacy of the drug product. Hence, there is a requirement of processes that may enable production of binary and combination DPI products that will allow actives to be delivered more efficiently and independently of dose variations. The aim, therefore, of this study was to develop the solution atomisation and crystallisation by sonication (SAX) process for engineering of single and combination drug particles with suitable physicochemical properties for delivery to the lungs. The SAX process consists of key stages, which include, solution atomisation to produce aerosol droplets, generation of highly supersaturated droplets by evaporation of carrier solvent from aerosol droplet, collection of droplets in a crystallisation vessel containing appropriate non-solvent and the application of ultrasonic waves to the crystallisation vessel. Atomisation of a 1.5% w/v solution of budesonide in dichloromethane resulted in particles with defined surface geometry, which were formulated in binary dry powder inhaler (DPI) formulations and assessed using the next generation impactor.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:501621 |
| Date | January 2008 |
| Creators | Pitchayajittipong, Chonladda |
| Contributors | Price, Robert |
| Publisher | University of Bath |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
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