Aqueous delivery
Darragh Murnane of the University of Hertfordshire pointed out in his talk titled, “Sorting through Soft Mists: Generics, Biologics and Beyond” during the “Aqueous Advances” session that SMIs have considerably lower global warming potential than MDIs since they do not use propellants, even more so for multi-use SMIs. Murnane noted that many SMIs came to market starting in the 1990s, saying “I think one of the key drivers for these devices to be developed in the 90’s was associated with the changeover forced by the Montreal protocol.” He also highlighted the potential for the use of SMIs for biologics.
In the technology exhibit, Boehringer Ingelheim, which first launched Respimat SMI products in the early 2000’s, promoted the availability of partnership opportunities “to put new APIs with Respimat into the market.” The company also paired with Kenox Pharmaceuticals, BI’s preferred CRO for Respimat development partnerships, to present a workshop titled “Build Your Own Soft Mist Inhaler.”
In an FDA poster titled, “Novel Method for Aerodynamic Particle Size Distribution Measurements from Respimat Inhalers,” the agency published research that it is undertaking in anticipation of generic versions of Respimat products. According to the poster abstract, “The intention is that these new in vitro study designs would apply to any drug product that uses a similar inhaler platform as the Respimat device.”
Advances in nebulization also received some attention with PARI presenting a workshop on “A New Approach to Optimize Delivery Performance and Treatment Time in Breath-Triggered Nebulizers” as well as a podium presentation, technology exhibit, and poster. Nebulizer makers Nebu-Flow and Pulmotree Medical presented research in the poster exhibit, and spacer manufacturer Inspiring presented a poster on the use of its universal spacer with a nebulizer.
Beyond asthma and COPD
During his presentation in the final session of RDD 2024, the FDA’s Luke remarked that he had not heard a single speaker talk about LAMAs and LABAs during the meeting. In fact, the conference was generally focused on indications other than asthma and COPD, including an entire session devoted to aerosol delivery of surfactants and a session on high dose delivery where presenters discussed of inhaled therapies for a variety of indications, including mycobacterial lung diseases, idiopathic pulmonary fibrosis, and pulmonary infections in cystic fibrosis patients.
