Metered Dose Inhalers

Metered Dose Inhalers (MDIs) have been available since the late 1950s and are the most frequently prescribed inhalation devices. Patients appreciate MDIs because they are easy to use and pocket-sized.

MDIs traditionally contained a chlorofluorocarbon (CFC) propellant. These CFC propellants deplete the ozone layer and are no longer used. The pharmaceutical industry supported the effort to switch these delivery devices over to non-CFC propellants and has spent more than 10 years working on new hydrofluoroalkane (HFA) propellants. Two suitable propellants have been identified: HFA134a and HFA227.

HFA134 and HFA227 are qualified for human use and have no depleting effect on the ozone layer. Additionally, they have a 65% reduced global warming potential (GWP) compared with CFCs. These properties make HFAs excellent replacements for CFCs from an environmental perspective. Nevertheless, the technical challenge to replace CFCs by HFA134/227 propellants was considerable due to the complex interactions between propellant, valve materials and active ingredient. Frequently this has led to reduced product stability and failures in development.

SkyePharma was involved in this process from the beginning and built a strong expertise in developing HFA-MDI formulations. SkyePharma also made several inventions to overcome the traditional HFA-MDI formulation problems, which resulted in a range of proprietary formulation technologies and several late-stage or fully developed products.

Our first development in HFA-MDI was Pulmicort® HFA-MDI. This was filed by AstraZeneca in 2005 in Europe. SkyePharma developed this new HFA-MDI formulation as a full turn key development for AstraZeneca employing its proprietary formulation technology. SkyePharma conducted the full chemistry, manufacturing and controls (CMC) development as well as managed the clinical and regulatory development programme for AstraZeneca. The product has been approved in a large number of countries, including Germany, Spain and Switzerland, and has already been launched in numerous markets.

SkyePharma PLC is a public limited company registered in England and Wales, registration number 0107582.
Registered office: 105 Piccadilly, London, W1J 7NJ, United Kingdom

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