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An Orthogonal Approach for Complex Drug Characterization
Detailed particle characterization, including shape and size analysis and chemical identification, enables thorough understanding of drug formulations. This level of knowledge creates confidence and control in optimized development and manufacture processes.In this webinar, we will focus on the orthogonal application of particle characterization tools for the development of both innovator and generic dry powder inhalers (DPIs).
DPIs are an increasingly popular means of delivering a therapeutic dose to the respiratory system for local action. DPI formulations typically consist of finely micronized drug particles, which are either co-agglomerated to form soft pellets, or, more traditionally, blended with coarse excipient particles to improve the overall flow properties of the powder and to aid metering of the low dosagestypically required for local drug action.The complexity of these particle interactions within a DPI formulation governs aerosol dispersion and regional deposition and disposition of the aerosolized dose within the airways.
A principal challenge fordevelopers of both innovator and generic DPIs is understanding the relationship between in vitro dosing parameters and the fate of the inhaled dose in vivo. Investigations into the state of aggregation for both the formulated blend contained within a unit dose blister, capsule or reservoir DPI device and the resulting arrangement of the dispersed dose are therefore of increasing interest.
In this webinar, we examine the orthogonal use of Morphologically-Directed Raman Spectroscopy (MDRS)and UniDose-enabled dissolution testing to characterize the microstructure of DPI formulations and improve inhaled drug delivery profiles.
Key Learning Objectives
- Gain greater understanding of the impact of particle characteristics on inhaled drug delivery
- Explore the use ofMDRS to complement dissolution testing for DPI microstructural characterization
- Understand how formulation microstructure can affect dry powder inhaler efficacy
- Learn how analytical technologies can be used orthogonally to aid DPI developmen
Presented By
Dr. Deborah Huck-Jones, Product Manager: Analytical Imaging- Malvern Panalytical
Debbie became Product Manager for Malvern Panalytical's Analytical Imaging range at the beginning of 2014. She joined Malvern Panalytical as product technical specialist for the imaging products in 2005, and later became PTS Supervisor for imaging and laser diffraction. In these roles, Debbie worked closely with customers and existing users all around the world, providing applications development and support for the Morphologi and other imaging instruments. She also worked with our imaging development team, supplying applications feedback for the Morphologi G3 and Morphologi G3-ID. Previously, Debbie worked for ABB, in the instrumentation business unit. She has a MChem with European study from the University of Exeter and a PhD in Chemistry which was jointly awarded by the University of Exeter and Universite Louis Pasteur in Strasbourg - this focused on the synthesis and characterization of metal-based liquid crystals.
Dr. Jag Shur, Managing Director, Nanopharm Ltd.
Dr Jag Shur is Managing Director of Nanopharm Ltd., and Research Fellow at the University of Bath - School of Pharmacy and Pharmacology. His main area of research is investigation ofthe bioequivalence of orally inhaled and nasal drug products (OINDPs). The key theme of his research has been the development and application of novel tools to understand and quantify the microstructure of OINDPs. He began his career with Profile Drug Delivery (now Philips Respironics) where he was developing liquid dose drug delivery systems for cystic fibrosis patients, and went on to work for GlaxoSmithKline. Jag holdsa BSc (Hons) in Chemistry and completed his PhD, entitled "Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis", at Portsmouth School of Pharmacy. Following this, he was a post-doctoral fellow at the London School of Pharmacy, investigating the fabrication of microparticles for vaccine delivery using supercritical fluid technology.