Webinar: Development of Drug-Nebuliser Combination Products

Nebulizers offer precise delivery of high-value small molecule drugs and biologics directly to the lungs, ensuring rapid and efficient therapeutic effects. They can accommodate a wide range of formulations, including solutions, suspensions, and high viscosity drugs and encapsulated systems, making them versatile for various local and systemic treatments. Nebulizers provide consistent delivery up to very high doses, which is crucial for managing many chronic respiratory conditions. Additionally, their ease of use and the ability to integrate advanced features like breath actuation and connectivity enhance patient adherence and treatment outcomes.

During this webinar, experts from HCmed Innovations and Intertek combine their expertise to shed light on the formulation, device, and testing considerations when developing a nebulized product. First broadcast live on 18 September 2024.

Part 1: Formulation and device considerations.
•    Key requirements to select a suitable delivery platform. When are mesh nebulisers a suitable delivery system?
•    Advancement and new features in mesh nebulisers to improve delivery performance and usability.
•    Customization platform scope, from hardware to software – fulfilling requirements of different target populations and indications.
•    Data and studies that demonstrate the benefits of customizable mesh nebuliser platforms, such as Pulmogine and AdheResp.
•    Formulation considerations for control of key factors such as surface tension, viscosity, osmolality and physical constraints such as device reservoir volume, and operational temperatures which can affect the fluid dynamics within the nebuliser and ultimately droplet creation.

Part 2: Understanding nebuliser performance: Analytical and performance testing

•    Regulatory considerations, differences between EU and US, and how to structure studies dependent on your phase of development.
•    How do we define “good nebuliser performance”, what are the key parameters to look for.
•    Key analytical methods for determining performance, instrumentation needed, common analytical challenges and best practice based on hundreds of successful projects completed.

Henry Cuevas Brun

Business Development Manager and Aerosol Scientist, HCmed Innovations

Henry Cuevas Brun is Business Development Manager and Aerosol Scientist of HCmed Innovations. He has over 10 years of experience in the drug delivery field, holding a BS in Biomedical Engineering from National Tsing Hua University and a master’s in business administration. He is responsible for expanding and coordinating the establishment of new partnerships with global pharmaceutical and biotech companies, assessing and mapping strategic development of drug-nebuliser combination products from feasibility stages to commercialization. Moreover, Mr. Cuevas supports with the customization of HCmed’s delivery platforms, covering aspects related to the performance and usability of tailored devices for pharmaceutical partners.

​​Teresa Iley

Director of Pharmaceutical Development and Manufacture, Intertek Pharmaceutical Services

​​Teresa has over 25 years’ experience working within the pharmaceutical analysis and formulation development industry, with a particular focus on OINDPs. Mostly working in the pre-approval stages, Teresa’s background includes extensive experience with product and formulation development for novel and generic products, as well as method development and validation, stability studies, pharmaceutical development activities, and clinical trial manufacturing for a wide range of clients.​ 

Mael Heutte

Project Manager, Intertek

Mael is an industrial pharmacist and has over 10 years’ experience in the pharmaceutical industry, mainly in the CMC arena leading analytical / formulation development projects of new and generic products, with a particular emphasis on OINDPs. He started his career at Sanofi with a project management role in product industrialisation and technology transfer. As the next step in his professional journey, he joined Intertek to support a wide range of clients in their projects in the pre-approval phase.