Explore how evolving trends, formulation strategies, and excipient innovations are shaping the future of pulmonary drug delivery in respiratory care.
Inhalation therapy is experiencing strong global growth, driven by rising rates of respiratory disease, an ageing population, and increasing interest in targeted, non-invasive drug delivery beyond traditional respiratory indications.
We’re joined by Harry Peters, Senior Product Application Specialist at DFE Pharma, who brings over three decades of experience. In this interview, Harry shares his perspective on the key trends, technical considerations, and emerging opportunities shaping inhalation drug delivery - from pulmonary therapies to broader application areas.
A competitive advantage for your formulations
Through the combined strengths of DFE Pharma’s deep inhalation expertise and IMCD’s close customer collaboration, formulators gain a decisive edge in inhalation product development.
DFE Pharma brings advanced knowledge in inhalation-grade lactose and functional excipients, supporting the optimisation of powder flow, fine particle fraction, and API deposition. This is a critical parameter for successful DPI performance.
IMCD complements this by sourcing numerous APIs and working closely with customers to translate these capabilities into practical, application-focused solutions, supporting projects from early-stage development through to commercialisation.
Together, this partnership helps reduce variability, accelerate development timelines, and enhance product robustness in a competitive respiratory market.
Formulation excellence in inhalation applications
Developing high-performing DPI formulations requires precise control of the interaction between device, formulation, and API, an area where DFE Pharma’s technical leadership plays a central role.
Watch the video interview and take the next step
Watch the expert interview with Harry Peters from DFE Pharma and Anita Vasilevska from IMCD to learn more about trends, challenges, and opportunities in DPI formulation and how IMCD helps bring these solutions closer to you.
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With DFE Pharma’s excipient expertise and IMCD’s application-driven support, you gain access to tailored solutions across every stage of development. Get in touch with IMCD’s experts to discuss your next innovation and discover how we can help unlock the full potential of your inhalation products.
About our speaker
Harry Peters is a Senior Product Application Specialist at DFE Pharma and has over 30 years’ experience, gained at various companies including Solvay Pharmaceuticals, Sensient Technologies, and Friesland Campina. He holds a Bachelor of Science (BSc) in Food Technology from HAS University (Netherlands).
Read the full interview between Harry Peters (HP), DFE, and Anita Vasilevska (AV), IMCD
AV: What are the key trends in the asthma and COPD market, and how are they impacting inhalation therapies?
HP: Respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis are associated with significant global morbidity and mortality. These conditions are predominantly managed through pharmacological interventions, which can be administered via parenteral, oral, or pulmonary routes.
Pulmonary drug delivery is commonly achieved using nebulisers, pressurised metered-dose inhalers (pMDIs), and dry powder inhalers (DPIs). Among these, DPIs represent particularly complex drug delivery systems, requiring an in-depth understanding of the interplay between the device, the active pharmaceutical ingredient (API), and the powder formulation to ensure optimal performance and dose consistency.
AV: As the market continues to evolve, advances in active pharmaceutical ingredients are playing an increasingly important role in shaping how inhalation therapies are developed.
How are advances in APIs influencing formulation strategies in inhalation drug delivery?
HP: Pulmonary drug delivery is predominantly based on well-established therapeutic classes, with inhaled corticosteroids and β₂-agonists forming the cornerstone of treatment. These are administered either as single agents or as fixed-dose combination products within a single inhalation device.
In recent years, there has been significant growth in the availability of generic formulations for both monotherapies and dual combination therapies, increasing accessibility and market competition. At the same time, patented products—particularly triple combination therapies integrating inhaled corticosteroids (ICS), long-acting β₂-agonists (LABA), and long-acting muscarinic antagonists (LAMA), such as Trelegy and Foster - have captured a rapidly expanding share of the market.
This dynamic has driven increased interest in the generic pharmaceutical sector in developing equivalent triple-therapy formulations, despite the added complexity of multi-component formulations and device integration.
AV: Translating these advances into effective products requires not only the right APIs, but also the right formulation expertise and excipient solutions.
How can DFE Pharma support formulators in optimising inhalation product development?
HP: DFE Pharma supports formulators in optimising inhalation product development through its broad portfolio of inhalation-grade lactose excipients. This includes a comprehensive range of lactose monohydrates with tailored particle size distributions, as well as anhydrous lactose grades specifically designed for inhalation applications.
All grades comply with the latest USP monographs and are manufactured with a strong focus on batch-to-batch consistency, ensuring high product reliability. As a market leader, DFE Pharma is able to supply multiple batches to support robust formulation development, scale-up, and lifecycle management, while providing technical expertise to address formulation challenges.
In addition, DFE Pharma has invested in multiple production sites across different continents dedicated to the manufacture of inhalation-grade lactose, strengthening supply chain security and ensuring reliable global availability. These facilities produce both standard inhalation-grade lactose as well as customer-specific grades, co-developed in close collaboration with partners to optimise powder flow properties and enhance fine particle fraction and API deposition performance.
Complementing its excipient portfolio, DFE Pharma has expanded into contract research and consultancy services, delivered in collaboration with strategic partners such as Harro Höfliger and Sterling. This integrated approach enables customers to accelerate development timelines while ensuring optimised formulation and device performance.
AV: Alongside formulation innovation, regulatory requirements are becoming an increasingly important factor in guiding product development and design.
How do regulatory requirements impact inhalation drug delivery and DPI development?
HP: Several regulatory and policy developments are significantly influencing the prescription and use of respiratory medications. In Europe, the progressive phase-out of hydrofluoroalkane (HFA) propellants—driven by environmental regulations—is accelerating the reformulation of pressurised metered-dose inhalers (pMDIs) and supporting a shift towards dry powder inhalers (DPIs). This transition is already reflected in prescribing trends, with an increasing uptake of DPI-based therapies in recent years.
In parallel, ongoing discussions around the potential restriction of per- and polyfluoroalkyl substances (PFAS), including their use in device components and coatings, may further impact the long-term viability and design of pMDI systems, although the full implications are still evolving.
From a compendial perspective, the United States Pharmacopeia (USP) has recently updated its lactose monographs, introducing additional requirements for inhalation-grade lactose, thereby raising quality and characterisation standards for excipients used in DPI formulations.
Furthermore, emerging USP draft guidances now incorporate dissolution testing methodologies for inhaled products. These approaches aim to improve predictions of bioavailability and drug absorption, thereby supporting more robust in vitro–in vivo correlations (IVIVC). The development of advanced dissolution equipment and test methods by industry stakeholders is expected to enhance formulation screening and accelerate inhaled therapy development.
AV: Regulatory developments are not only shaping pulmonary drug delivery but also encouraging exploration of alternative, non-invasive routes of administration.
How can inhalation-grade excipients like lactose and trehalose support nasal drug delivery formulations?
HP: In addition to pulmonary applications, inhalation-grade lactose and stabilising sugars such as trehalose are increasingly being explored for use in nasal drug delivery platforms. Nasal formulations can be developed using carrier-based approaches similar to those employed in pulmonary delivery, with adaptations for particle size and deposition requirements.
For nasal delivery, APIs are typically engineered to a larger particle size distribution, with an average size of approximately 10–20 µm, to ensure effective deposition in the nasal cavity. This differs from pulmonary delivery systems, where the aerodynamic particle size generally needs to be below 5 µm to reach the lower respiratory tract.
Anhydrous lactose, due to its faster dissolution rate than monohydrate grades, can support more rapid API dissolution, potentially enhancing drug absorption and bioavailability in nasal applications.
In parallel, excipients such as trehalose and sucrose can be used in nasal formulations to stabilise sensitive molecules, including proteins and peptides, leveraging their well-established role in preserving structural integrity during processing and storage.
AV: As these new application areas gain momentum, the question becomes how inhalation technologies will continue to advance in the years ahead.
Looking ahead, what will define the next generation of inhalation therapies, and where should formulators focus today to stay ahead?
HP: An additional emerging trend is the increasing focus on systemic drug delivery via the pulmonary route. In particular, complex molecules such as proteins are being actively evaluated for inhalation-based delivery, leveraging the lungs' large surface area and high permeability to enable rapid systemic absorption.
AV: To what extent can protein-based therapeutics be delivered via existing inhalation platforms?
HP: The feasibility of delivering protein-based therapeutics via inhalation is highly dependent on the molecular complexity and the selected formulation strategy. Peptides, due to their relatively smaller size and higher stability, can in many cases be formulated using conventional carrier-based dry powder inhaler (DPI) systems.
In contrast, larger and more complex biologics present significant formulation challenges, as they cannot be readily micronised using standard techniques. Instead, particle engineering approaches such as spray drying are required to produce inhalable particles with suitable aerodynamic properties.
Spray drying of biologics necessitates the incorporation of stabilising excipients to preserve structural integrity and biological activity. In this context, DFE Pharma offers functional excipients such as trehalose and sucrose, which are well-established stabilisers for protein-based formulations.
To further strengthen its capabilities in this field, DFE Pharma has initiated contract research and collaborative development activities in partnership with Harro Höfliger and Sterling. Additionally, collaborative work with academic partners, such as the University of Parma, has demonstrated the successful spray drying of peptides like semaglutide into stable, inhalable formulations. These developments have generated strong interest and highlight the growing potential of pulmonary delivery for complex therapeutics.
With DFE Pharma’s excipient expertise and IMCD’s application-driven support, you gain access to tailored solutions across every stage of development. Get in touch with our experts to discuss your next innovation and discover how we can help unlock the full potential of your inhalation products.
"DPIs require a precise balance between formulation, device, and excipient functionality. This is where targeted innovation makes the difference.’’ - Harry Peters, DFE Pharma
