Inhalation 1-2-3 A brief update from Inhaltion Magazine.

pMDIs with lower GWP propellants and a need for compatible aerosol valves
imageAs the inhalation community develops pressurized metered dose inhalers (pMDIs) that utilize propellants with lower global warming potential (GWP), there is a need for aerosol valves compatible with those propellants. At the Respiratory Drug Delivery (RDD®) Europe 2023 Conference, RxPack presented a scientific paper titled "A roadmap for constructing a beclomethasone pMDI solution using HFA 152a." It described a study led by Professor Francesca Buttini of the University of Parma.

The study focused on development of a pMDI containing beclomethasone dipropinate (BDP) solution, 100 mg/shot, which utilized propellant HFA 152a and the RxPack KHFA valve. Study results showed:
  • With an ethanol content of 8%, it was possible to formulate BDP as a solution and avoid shaking of the canister before use
  • The KHFA 50 mcl valve showed high precision in drug delivery, ensuring complete filling of the metering chamber and avoiding the need for priming or repriming
  • The KHFA valve components remained unchanged
R&D activities are progressing with other active pharmaceutical ingredients (APIs) and propellant HFO1234ze.

RxPack S.r.l.
Italy: +39 0341 18960
in focus

imagePoint of view: A proposed roadmap for sustainable inhaler use in the UK that could support the NHS net zero ambition
In this opinion article, published in the October magazine, the authors discuss aspects of a potential sustainability roadmap for inhalation platforms that could lead to reaching the UK's National Health Service net zero goal. The authors believe that while new propellants are a major step forward, much more work must be done to meet this challenge. They suggest the industry needs an inhaler sustainability roadmap that would include the active pharmaceutical ingredients, device, packaging, transportation and other factors. It should consider eliminating, or at least reducing, waste throughout the "cradle to grave" lifecycle, utilize inhaler recycling/recovery, and have clear targets and key performance indicators. The authors also discuss other sustainability and circular concepts such as use of a Green Guide. That could set out "rules" for a business and its suppliers to follow when developing devices and address the "7R's," which are reduce, remove, refill, renew, reward, respect and recycle.

imageLimitations of metrics used in the regulation of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs)
In 2020 and 2021, Inhalation published three articles by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS): (1) The liability of fine particle dose (FPD); (2) Cascade impactor stage groupings: Poor decisions from degraded data; and (3) Efficient data analysis (EDA): Size, mass and common sense. The first and second articles discussed limitations of metrics commonly used in the regulation of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs). The third article proposed using independent assessment of the dimensions of APSD (size and mass) by Efficient Data Analysis. The articles were written to educate, dispel common misconceptions, raise awareness of risks and encourage scientists to scrutinize current practices. In this October magazine interview, one of the authors talks about reactions to the articles in the inhaler community since their publication.

Read part one – The liability of fine particle dose (FPD)
Read part two – Cascade impactor stage groupings: Poor decisions from degraded data
Read part three – Efficient data analysis (EDA): Size, mass and common sense

Click for information on the following industry event:
  • Drug Delivery to the Lungs 2023
Please visit Inhalation's website to see contact information for multiple industry organizations, many of which present conferences, workshops and other educational events:
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