Performance Indicating Acoustic Emission Measurements on a Dry Powder Inhaler

Webinar on an MVDA application involving acoustic measurements in device operational performance assessment.

Guest presenters: Dr. Lars Karlsson* & Dr. Mats Josefson**, Pharmaceutical Technology & Development, AstraZeneca R&D, Gothenburg

Acoustic Emission (AE) has previously been used in adherence monitoring applications to medical inhalation devices. We have extended the exploration of AE into the use in inhalation device and formulation development by monitoring the acoustic data of units being analysed on an automatic platform. The aim is that this application will:

  • Improve metadata capacity for inhalation unit analysis
  • Capture potential deviations in inhaler performance
  • Assist in designing in robustness in the mechanical performance of the inhaler

In this webinar our approach is outlined, where the information rich acoustic signal is assessed and interpreted using chemometrics. Using Python scripts, raw sound data is Fourier transformed to frequency spectra, and inserted into data tables ready for multivariate data analysis. Some applications are shown, focusing on how and to what degree the acoustic characteristics, for the load, trig and powder release operations, change with e.g., different formulation carriers.

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*) Dr. Lars Karlsson, Senior Scientist in the Inhalation Unit within Pharmaceutical Technology & Development, AstraZeneca R&D, Gothenburg, focuses on development and analysis of inhalation devices, as well as on the use of automation in the development of inhaled medicines. With a Ph.D. in Analytical Chemistry, he was appointed Associated Professor in Analytical Chemistry, University of Lund in 1999. Lars has held several positions within AstraZeneca including both science and management based roles. With a track record of research on sample handling, separation and the use of chemometrics in the analysis of solid formulations, his research focus shifted in 2012 to the development of Inhalation Products.

**) Dr. Mats Josefson, Principal Scientist within Pharmaceutical Technology & Development, AstraZeneca R&D, Gothenburg, focuses on design of experiments, multivariate data analysis, and other means of mathematical modelling for support of pharmaceutical development projects. This also includes analytical instrumentation, software, and regulations for Process Analytical Chemistry and Quality by Design and the use chemometrics for GMP purposes. His research interests include the development of spectroscopic methods together with chemometrics, signal processing in analytical chemistry, statistical designs, and hyperspectral image analysis, all applied to analytical and pharmaceutical applications in order to better understand the properties of raw materials and intermediate or finished pharmaceutical products