ABSTRACT
Pressurized Metered-dose Inhalers (pMDIs) are complex drug-device combination products that are widely used to treat lung diseases, and may also be advantageously employed to deliver active pharmaceutical ingredients (APIs) to the systemic circulation through the lungs. pMDIs occupy ca. 70% of the respiratory inhaler device market share and are expected to continue their dominance in the foreseeable future. The transition from CFCs to hydrofluoroalkane (HFA) propellants has stimulated significant advances in this field, and the proposed phase out of HFAs as indicated in the Kigali amendment to the Montreal Protocol (starting in 2019) is expected to generate renewed interest in the design of alternative propellant systems and subsequently device components and formulations compatible with the more environmentally acceptable propellant alternatives to be used in the future medicinal aerosol formulations. Development of new technologies enabling: (i) the delivery of a broader class of APIs with pMDIs including biologics; (ii) the development of orally inhaled drug products containing nanomaterials; and (iii) the delivery of higher drug doses are some of the areas that are expected to help further the use of pMDIs and thus secure a larger share for orally inhaled products in the global drug delivery market.
