MDIs in Transition

SESSION 9: MDIs in Transition:
A Regulatory Roadmap to Market

Thursday • May 9, 2024 • 8:30–11:30 AM • Arizona Ballroom

Including

Explore with Experts Panel Discussion

Moderators: Ann Purrington and Nick Smalley, Kindeva Drug Delivery

FDA Perspectives on Scientific and Regulatory Considerations for MDIs Transitioning to a Low Global Warming Potential Propellant
Bryan Newman and Markham Luke
U.S. Food & Drug Administration
Generic Symbicort: Navigating the Technical and Regulatory Hurdles for Budesonide / Formoterol Fumarate Pressurized Metered Dose Inhaler
Stephen Stein
Kindeva Drug Delivery
A Regulatory Roadmap for the Transition to Low GWP pMDIs: A Proposal for Discussion
Richard Lostritto
Lostritto Consulting, LLC
EXPLORE WITH EXPERTS:
Ann Purrington and Nick Smalley, Kindeva Drug Delivery

Panel: Elizabeth Bielski, Richard Lostritto, Markham Luke, Bryan Newman, Stephen Stein

Discover More

Manufacturing pMDIs using Ultra-low Global Warming Potential Propellant HFO-1234ze(E)
Nick Atkinson and Gregory Smith
Bespak
Considering a Green pMDI? Q&A to Navigate an Evolving Regulatory Landscape
Andy Burns, Ann Purrington, Nick Smalley and Jon Walder
Kindeva Drug Delivery
Leachables Assessment from a New Generation of pMDIs using Low Global Warming Potential Propellants and the Impact of Ethanol Filling
Pauline Faucard and Benedicte Grosjean
Aptar Pharma
Development of Albuterol Sulfate Pressurized Metered Dose Inhalers using a Low Global Warming Potential Propellant 1,1-difluoroethane (HFA152a)
Lei Mao
Bespak
Development of Beclomethasone Dipropionate Pressurized Metered Dose Inhalers using a Low Global Warming Potential Propellant, 1,3,3,3-tetrafluoropropene (HFO1234ze)
Lei Mao
Bespak
Investigating the Impact of Device Design and Propellant Choice on the Aerosolization of Fluticasone Propionate Suspensions in HFA152a and HFO1234ze
Benjamin Thorne
Bespak
Designing a Sustainable Ipratropium HFA-152a pMDI: Actuator Geometry Considerations
Ameet Sule
H&T Presspart
Development of an MDI Coated Can with a Non-PFAS Polymeric Coating
Loy Britto
Healthy Airways
Two Isn’t Always Better Than One: A Single-Actuation Salbutamol Sulfate Metered Dose Inhaler Using Low-GWP Propellant HFO-1234ze(E)
Erik Boldt and Gregory Smith
Honeywell
An Assessment of the Effect of Vacuum Crimping on Dry Powder Filled pMDI Cans
Sally Stanford
Koura
Effects of Low Global Warming Potential Propellants HFA152a and HFO1234ze(E) on the Morphology of Suspension Based Pressurized Metered Dose Inhaler Sprays
Daniel Duke
Monash University
Manipulation of pMDI Spray Morphology via Orifice Length Variation with Propellants HFA134a, HFA227, HFA152a and HFO1234ze(E)
Daniel Duke and Lingzhe Rao
Monash University
Measurement of Vapor Pressure and Viscosity of Ethanol in HFA134a, HFA152a, and HFO1234ze(E) Mixtures used in pMDIs
Swetha Chowdary Vutlapalli and Daniel Duke
Monash University
Comparative Assessment of Plume Velocity in pMDI Solutions: A Study using Phase Doppler Anemometry and SprayView Analysis
Will Ganley and Nuria Manzano
Nanopharm
Case Studies on Reformulation of BDP MDIs using Low GWP Propellants HFO1234ze and HFA152a
Daniel Lewis
Oz-UK Limited
Aerosol Performance and Usability Evaluation of New Pediatric Facemasks for a Valved Holding Chamber
Andrea Winzen and Martin Schlun
PARI Pharma
Methodology for Measurement of Evaporation Fraction and Evaporation Rate: A Comparison of HFA-134a and HFA-152a pMDI Formulations
Lynn Jordan
Proveris Scientific Corporation
Inhalation and Exhalation Airflow Resistance of Valved Holding Chambers
Deborah Jones and Timothy Fallon
Proveris Scientific Corporation
Effect of Ethanol Content and Actuator Orifice Diameter on the Performance of Salbutamol Sulfate pMDI Suspensions in HFO1234ze(E)
Francesca Buttini
University of Parma
Comparison of In Vitro Aerosol Deposition by Salbutamol pMDI with Corrugated Tubing and Commercial Spacer
Patrick He
Woolcock Institute of Medical Research
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