Nasal Drug Product Development Webinar Series

Nasal drug products present significant opportunities to deliver drugs topically or systemically via innovative formulations or device designs. These products vary in device type and formulation (solution / suspension) however can be an ideal platform for the delivery of both small and large molecules. Teresa Iley, Intertek’s Director of Pharmaceutical Development & Manufacturing, presented an introduction to nasal drug products including the benefits of this platform, regulatory considerations and approaches to over the challenges of development for this product type. 

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Teresa Iley is currently Intertek’s Director of Pharmaceutical Development & Manufacturing. Following graduation from Anglia Ruskin University in 1993, Teresa’s career has spanned over twenty years leading teams in inhalation development and production. She joined Intertek in 2017.

In-vitro testing approaches are invaluable to the support the development of this product class allowing a deep understanding of critical quality attributes (CQAs). In this webinar, Mark Parry, Technical Director, presented an in-depth review of the in-vitro testing required for nasal drug products including USP / EP testing requirements, typical analytical approaches, set-up, testing considerations and typical stability programmes with a particular focus on spray characterisation & particle sizing (DSD, spray pattern, plume geometry, morphologically directed Raman spectroscopy).

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Mark joined Intertek Melbourn (formally Melbourn Scientific) after graduating from Cambridge University with a Master’s Degree in Chemistry (Natural Sciences). Mark now has over 16 years’ experience working within the pharmaceutical analysis and formulation development industry, with a particular focus on OINDPs. Mostly working in the pre-approval stages, Mark’s background includes extensive experience with product and formulation development, as well as method development and validation, stability studies, pharmaceutical development activities, and clinical trial manufacturing for a wide range of clients.

The inhaled product class includes a diverse group of products including Pressurized Metered Dose Inhalers (pMDI) which can exist in solution or suspension form with a range of different propellants, Dry Powder Inhalers (DPI) which can include multi-unit dose blister devices, capsule-based devices or reservoir products. Strategic formulation and manufacturing approaches for nasal sprays must be adapted to the drug/device in question to ensure successful development. In this webinar, David Ward, Intertek’s Formulation/Manufacturing Lead, presented an introduction to the formulation and manufacturing approaches for nasal drug products including; solubility experiments, excipient selection, device selection / screening, formulation processes and batch scale up.

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David is Intertek’s Formulation/Manufacturing Lead for Intertek Melbourn. He has worked in the pharmaceutical sector for nearly 20 years, specialising in formulation, analysis and production approaches for orally inhaled and nasal drug products.