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The majority of pharmaceutical powders require a size <500 μm for ease of manufacture and biopharmaceutical performance. Powder behaviour of particles in this size-range spans cohesive to aeratable powders. Powder performance is dependent on the powder bulk density and micromeritic properties of individual particles, but also crucially the structuring of particles within the powder bed. Micromeritic assessment is also routinely performed using image analysis or particle sizing techniques such as laser diffraction analysis. However, there is a clear need for techniques that provide non-destructive granular information of pharmaceutical powder structures.

Formulation equivalence between different batches of products or between comparator innovator and generic products has emerged as a hot topic of consideration in regulatory science. Microstructural equivalence (Q3) for powder products is complex, and particularly in the case of Dry Powder Inhalation (DPI) formulations. It is in the characterization of the bulk powder that microstructural assessment is a particular challenge. Current methods for measuring critical material attributes such as the particle size and shape suffer from low resolution, image in 2D or make shape assumptions.

In this webinar, we will present some new approaches using X ray Microscopy (XRM) from nano- to micro-scale that can be utilized for characterizing inhalation powder blends non-destructively to obtain fully 3D information on particle size and shape, its distributions, and powder bed packing. Novel methodologies developed to identify individual chemical phases within blends, their crystal orientations and interactions in 3D will also be presented. The results show the promise for XRM as a valuable powder characterisation technique that develops our fundamental understanding of powder microstructure, and microstructural descriptors for the United States Food and Drug Administration Q3 microstructural assessments.

Presenter:

Dr Hrishikesh Bale - Marketing Solutions Manager, Engineering Materials
Carl Zeiss -  Research Microscopy Solutions
 

Key Takeaways

In this webinar you will learn:

• About the importance of pharmaceutical powder microstructure and the current landscape of the methods for microstructural characterization
• How X-ray Microscopy (XRM) can provide information on key microstructrual metrics, as well as the interaction between formulation components.
• How the unique microstructural insight provided by XRM can help understand powder performance
• About a range of applications of XRM to pharmaceutical powders, including powder beds and complex inhalation formulations.

Who is this webinar aimed at?

This interactive webinar is designed for all users, from both academic and industrial sectors, who are interested in powder characterisation. The webinar is suitable for both a technical and non-technical audience and will provide insight into applications of XRM as a microstructural characterisation technique.

About ZEISS
ZEISS is an internationally leading technology enterprise operating in the optics and optoelectronics industries. ZEISS develops and distributes lithography optics, measuring technology, microscopes, medical technology, eyeglass lenses, camera and cine lenses, binoculars and planetarium technology. With its solutions, the company constantly advances the world of optics and helps shape technological progress. The company is divided up into the six business groups Industrial Metrology, Microscopy, Medical Technology, Vision Care, Consumer Optics and Semiconductor Manufacturing Technology. Founded in 1846 in Jena, the company is headquartered in Oberkochen, Germany
 

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