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DDL 2019 highlighted sustainability issues in the inhaled drug delivery industry

In his talk on “Implications for Patient Care and Disease Management,” Omar Usmani of Imperial College London and Royal Brompton Hospital called the recommendation that stable patients should be switched from MDIs to DPIs “crazy,” noting that several studies have shown that patients using MDIs have better outcomes than patients using the same drug in a DPI and that such a mandate would “depersonalize” medicine. In addition, he pointed out that globally 90% of reliever inhalers are MDIs, and when it comes to the use of DPIs in the emergency department, he said, “It’s absolute nonsense to think about this.” If this were to actually take place, he suggested, “It’s going to set care of patients back 50 years.”

Usmani took note of the Chiesi announcement regarding HFA 152a, which has a much lower global warming potential (GWP) than HFA 134a and which has the potential to make the carbon footprint of MDIs similar to that of DPIs, and in their talks, John Pritchard and Gregor Anderson discussed the potential of HFA 152a in more detail, with Anderson declaring that, “152a is a game changer, and I take my hat off to Chiesi for actually doing this.”

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In his presentation, titled, “The environmental impact of MDI propellants – what now?” Pritchard noted that regulation has already been fairly successful in reducing greenhouse gas emissions already and that other factors such as cost are also in play; as other uses for F gases decline, he pointed out, the cost of current MDI propellants will rise and their use will decline over time. While little data on HFA 152a have been published, he said, the properties look good for solution formulations, though the low density may make suspension formulations problematic. The larger question, he acknowledged, is the flammability of 152a, though he noted that many consumer products use flammable propellants. In addition, he suggested that technology such as i2c’s tablet in can filling technology could help with safety in filling.

Anderson called on the industry to work harder to address sustainability issues with inhalers, particularly by increasing recylability, shelf life, and refillability, and by moving toward lower GWP propellants such as HFA 152a. In addition, he noted that education and training in inhaler use could help reduce waste; connected inhalers might help, he added, but cost is a barrier and the electronics would need to be recyclable or reusable. As for 152a, “It’s a no-brainer,” he said; but he encouraged the industry not to put it in the same old devices, proposing that reformulation for HFA 152a would be an opportunity to improve actuators and suggesting the avoidance of color on inhalers to increase efficiency in manufacturing.

Ensuring the future of OINDP research

In the session titled, “FUTURE DIRECTIONS: Prediction and Personalization,” Otmar Schmid offered an opportunity for reducing another sort of waste, observing that preclinical development of aerosols would be more efficient if researchers actually tested aerosols instead of pipetting drugs onto submerged cell cultures or into animal respiratory systems. He encouraged delegates to make use of available technology, including air-liquid interface cultures, Inhalation Sciences‘s PreciseInhale, ALICE-CLOUD technology, and the flexiVent system for more predictive pre-clinical studies.

Several other speakers discussed collaborative efforts to enhance the chances for continuing success in the industry by improving the efficiency of aerosol drug development. Darragh Murnane summarized the work of the INFORM 2020 consortium to develop better approaches for modeling of products and processes in dry powder inhaler development and manufacturing. These more realistic modeling approaches, he said, may allow for better decision making about formulation and manufacturing before significant amounts of API become available.

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published on December 19, 2019

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