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Sorting Through Soft Mists: Generics, Biologics and Beyond

Murnane D, Eng B, Martin A, Rogueda PG.

Respiratory Drug Delivery 2024. Volume 1, 2024: 102-110.

Abstract:

Inhaled soft mist aerosols have undergone development in multiple generations of devices, with significant advancements occurring since the 1990s. The Respimat® device, which has been the most commercially successful approach, entered the market in 2003 after a decade of device formulation and clinical development by Boehringer Ingelheim. Currently, there are eight marketed Respimat drug products (four in USA and four in Europe), including a re-usable option, all of which utilize aqueous formulations. With a broad array of new active pharmaceutical ingredients for local and systemic action deviating from the traditional water-soluble, small molecular weight compounds previously commercialized, there is a growing interest to expand soft mist aerosolization technologies for inhaled drug delivery. As key patents expire, there is a surge in efforts to reformulate existing products into generic soft mist inhalers, reinforced by newly established regulatory frameworks. A deeper knowledge base is also being leveraged to innovate alternative soft mist technologies, extending their application to deliver biologics, nanoparticles, and poorly-water soluble compounds. Additionally, there may be opportunities to improve nasal drug delivery with soft mist technology.