On 31 December, the USA will introduce a total ban on the production and sale of pressurised metered dose inhalers (pMDI) using CFC propellants that contain the drug molecule Albuterol, most commonly used by asthma and emphysema sufferers. Production of ozone-depleting CFCs was banned by developed nations in 1996, in accordance with the 1987 Montreal Protocol. However, an ‘essential use’ exemption was granted to the pharmaceutical industry, notably for pMDI manufacture, permitting the development of replacement products using hydroflouroalkanes (HFA). As there are differences in the physicochemical properties between the two propellants, moving to HFA meant that both the drug formulation and the components of pressurised inhalers, particularly metering valves and gaskets, had to be completely redesigned.
Valois Pharma has undertaken research into HFA formulations, particularly regarding the way they interact with metering valve components. The company has established a dedicated Valois Pharma facility in Normandy, France to develop and manufacture elastomer gaskets. It also internally manages analytical tests, the control of extractibles and tests for compatibility with HFA formulations and has created Drug Master Files for FDA submission.
