Delivering Confidence in Respiratory Testing: Cormica’s View from RDD 2025
The 2025 Respiratory Drug Delivery (RDD) Conference, held in Estoril, Portugal, brought together experts, innovators and regulators to explore the current landscape and future direction of inhaled therapies.
Cormica’s Business Development Manager, Simon Bristow, attended as a delegate, gaining first-hand insights into the scientific advancements and regulatory developments that are shaping the industry.
Simon has detailed some of the key themes and takeaways from the event, and what they mean for respiratory manufacturers in this industry.
Authors:
Simon Bristow
Dr Simon Bristow is an analytical chemist with over 30 years’ experience in the pharmaceutical CRO industry, and delivers analytical solutions for Complex Generic drug development and manufacturing.
The Propellant Transition: A Major Industry Shift
One of the most prominent topics at this year’s RDD was the industry-wide transition to lower global warming potential (GWP) propellants in pressurised metered dose inhalers (pMDIs). Traditional hydrofluoroalkane (HFA) propellants, while effective for drug delivery, have a significant environmental footprint. Upcoming regulatory changes, tied to environmental frameworks like the Montreal Protocol, are mandating a shift to next-generation propellants with lower climate impact.
This transition affects both innovator and generic manufacturers. Companies are being required to demonstrate therapeutic equivalence between their existing formulations and those using new propellants. Regulatory bodies, including the FDA, are emphasising morphology studies as a critical part of the comparability package, especially for those seeking accelerated approvals.
Cormica is already seeing increased demand for morphology testing related to these projects, a clear sign that the transition is actively underway.
Testing Trends: Realistic APSD and Nasal Drug Delivery
Another testing development discussed at the conference was the move towards more realistic aerodynamic particle size distribution (APSD) testing methods. These involve the use of advanced in vitro models that more closely mimic human anatomy and breathing profiles, particularly through the use of realistic throat geometries. This helps better predict drug deposition throughout the respiratory tract.
Nasal sprays also featured prominently, with new methodologies emerging to measure droplet mass below specific size thresholds. These are becoming increasingly important in demonstrating consistency and safety of intranasal formulations.
Learn more about our approach to supporting nasal spray development and IVBE requirements in our Nasal Spray Device Equivalence Flyer.
Regulatory Focus: Complexity and Opportunity
It’s clear that the regulatory landscape for respiratory products is growing more complex, particularly for combination products and generic developers. As environmental policies tighten and therapeutic demands grow, companies will need robust testing strategies to support reformulation, comparability and long-term market access.
Cormica’s expertise in morphology, NGI testing, impactor analysis, and physical characterisation places us in a strong position to support manufacturers at every stage, from early-stage development to regulatory submission and post-approval changes.
How Cormica Can Support You
As the industry navigates the dual pressures of innovation and compliance, Cormica remains committed to enabling faster, safer product development for respiratory drug delivery. Our accredited facilities offer a full suite of testing services, including:
- Morphology and particle characterisation
- Aerodynamic particle size distribution (APSD) using NGI
- Microbiology and sterility support for inhaled products
- Support for novel propellants and reformulation studies
Whether you’re transitioning to next-generation propellants or developing complex generics, Cormica is equipped to help you meet evolving regulatory expectations with confidence.
Explore our full suite of analytical testing services to see how we can support your respiratory product development.
