MDIs in Transition

MDIs in Transition: Evolving Science and Regulation

Thursday • May 8, 2025 • 2:00–4:00 PM
Moderator: Stephen Stein, Ph.D., Kindeva Drug Delivery, Woodbury, USA

Safety Overview of Zephex® 152a as a Low GWP Medical Propellant
Isaac Mohar
Gradient
A Priori Formulation Design of Solution Metered Dose Inhalers with Next Generation Propellants
David Lewis
Oz-UK Limited
FDA's Current Perspectives on the Propellant Transition: Work Towards Global Harmonization
Elizabeth Bielski
U.S. Food & Drug Administration
Navigating the Regulatory Landscape: Advances in Respiratory Modeling and Simulation
Jan De Backer
FLUIDDA

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The Transition to Low GWP Propellants in pMDIs: Increasing Your Probability of Success Using a Collaborative Approach
Ross Errington and Ameet Sule
Bespak and H&T Presspart
Navigating the Global Regulatory Landscape Enabling the Sustainability Transition in the pMDI Space
Mark Boelens, Andrew Van Deusen, Nilesh Wagh and Michiel Ullmann
Honeywell and Lupin
Technical Challenges in Sustaining Medical Propellant Supply During The Low GWP Transition
Paul Watkinson and Darren Bromley-Davenport
Orbia Fluor & Energy Materials
Development of Albuterol Sulfate pMDI using a Low Global Warming Potential Propellant 1,3,3,3-Tetrafluoropropene (HFO-1234ze) to Match Ventolin® HFA Inhaler: I. Formulation, Container Closure System and Actuator Selection Considerations
Lei Mao and Ross Errington
Bespak
Development of Albuterol Sulfate pMDI Using a Low Global Warming Potential Propellant 1,3,3,3-Tetrafluoropropene (HFO-1234ze) to Match Ventolin® HFA Inhaler: II. Human Factors Engineering Considerations
Lei Mao and Ross Errington
Bespak
Mapping the Product Design Space: Understanding and Controlling Manufacturing Variability in Pressurized Metered Dose Inhalers
Karl Bass
Bespak
Investigation of In Vitro Techniques for Evaluating Ipratropium Bromide Formulations
Ameet Sule
H&T Presspart
Performance Comparison of Beclomethasone, Formoterol, and Glycopyrronium Solution Formulations in HFO-1234ze(E) to Reference Listed Drugs
Gregory Smith
Honeywell
Understanding Drug Deposition in USP and OPCM Throats for HFA-152a Solution pMDIs
Aaron Taylor
Kindeva
An Evaluation of Extractable Levels from Various Polybutylene Terephthalate Suppliers in the Presence of Ethanol in Formulations Containing HFA-152a and HFO-1234ze
Oliver Ingham
Kindeva
Enhancing the Efficiency of pMDIs Through an Innovative Mesh Grid Design
Mona Mohammadkhani
Lakehead University
Effects of Airway Wall Dynamics During Inhalation on Drug Delivery via Pressurized Metered Dose Inhalers Using Patient-Specific Airway Models
Mahsa Jahed
Lakehead University
Assessment of Suspension Characteristics of Budesonide Micronized by Traditional Jet Milling and by Sonocrystallization Suspended in High and Low Global Warming Propellants
An Assessment of the Potential Manufacturing Scale Flammability of Low Global Warming Potential Formulations
Plume Temperature: HFA-134a & HFA-227ea Compared to Low GWP Propellants HFA-152a & HFO-1234ze
David Lewis
Oz-UK Limited
Correlation of Leakage and Aerosol Performance Measurement for Five Valved Holding Chambers with Pediatric Facemasks
Andrea Winzen
PARI Pharma
Refining Regional Deposition Predictions in Metered Dose Inhalers: A Comparison of Static and Dynamic ICRP Models
Jag Shur
RIGImmune
Leveraging Chemo-Immunotherapy to Remodel the Tumor Microenvironment and Enhance Treatment Efficacy in Osteosarcoma Lung Metastases
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