Abstract
Technologies for long-term delivery of aerosol medications in asthma and chronic obstructive pulmonary disease have improved over the past 2 decades with advancements in our understanding of the physical chemistry of aerosol formulations, device engineering, aerosol physics, and pulmonary biology. However, substantial challenges remain when a patient is required to use multiple inhaler types, multiple medications, and/or combinations of medications. Combining multiple drugs into a single inhaler while retaining appropriate dosing of the individual agents in the combination may enhance patient adherence to therapy and reduce device errors that occur when patients are using multiple inhalers. Pressurized metered-dose inhaler (pMDI) devices are widely used by patients for acute symptom relief as well as maintenance treatment, so the pMDI may be a suitable option with which to explore medication combinations. However, optimizing drug formulation remains a key challenge for pMDI delivery systems. This article introduces a new pMDI formulation approach: co-suspension delivery technology, which uses drug crystals with porous, low-density phospholipid particles engineered to deliver combinations of drugs to the airways with accurate and consistent dosing via pMDIs, independent of medication types and combinations. We describe the key characteristics of pMDIs, and discuss the rationale for the co-suspension delivery technology platform based on the limitations associated with traditional formulations. Finally, we discuss the clinical implications of co-suspension delivery technology for developing combination drug therapies administered by pMDIs.
Highlights
We describe the key characteristics of pressurized metered-dose inhalers (pMDIs), and discuss the rationale for the co-suspension delivery technology platform based on the limitations associated with traditional formulations
Analysis of a co-suspension delivery technology-based triple combination therapy pMDI demonstrated that, after actuation, the drug crystals showed negligible inter-crystal interactions, remained attached to the porous particles when actuated in a dry environment (Fig. 3B), even after the inhalers were stored for 3 months at 40C and 75% relative humidity [25], and maintained drug delivery attributes across monocomponent and combination formulations
PMDIs are currently the most widely used aerosol delivery devices, challenges associated with pMDIs have meant that major drug classes and their combinations are not available for this inhaler type
Summary
Asthma and chronic obstructive pulmonary disease (COPD) are heterogeneous diseases with multiple components, including chronic inflammation, airway obstruction, and airway hyperresponsiveness [1]. Asthma and COPD are distinct diseases with defined treatment paradigms and objectives, but are currently treated with many of the same classes of inhaled medications due to their overlapping disease features [2,7]. Both are chronic diseases that require continued maintenance therapies, often with escalating interventions [9,10]. Despite the suitability and applicability of pMDIs in asthma and COPD therapy, important medicines and their combinations remain unavailable in this delivery device given the challenges of formulating them with modern hydrofluoroalkane (HFA) propellant systems. As the force of propellant evaporation provides the energy for drug aerosolization, a patient's inspiratory effort is required only for inhalation of the aerosol
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