Particle size and particle size distribution measurements help us understand, optimize and control products and processes throughout the pharmaceutical development and manufacture workflow. In fact, this analysis touches every step of the process, from raw material selection, through formulation development, to manufacturing and quality control. Consequently, it can be tempting to default to one particle sizing method across the entire workflow, rather than adapting to specific requirements.
So, why is optimizing particle size analysis so crucial? In this webinar, we'll take a closer look at the reasons, and consider how this information can help with the selection of appropriate methods. We'll review the guidance provided in ICH Q6A, which recommends that formulation developers investigate the impact of particle size changes on a drug product's stability, processability, uniformity and bioavailability. We'll also consider the application of technologies including laser diffraction and automated image analysis in materials selection and explore the impact of formulation processes on product performance.
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Key learning objectives:
- Understanding why particle size analysis is important for pharmaceutical safety and efficacy
- Appreciation of the regulatory guidance which relates to particle size analysis
- Overview of the impact of particle size changes on pharmaceutical processes and products
- Guidance on how to find the appropriate particle sizing method for your application
Who should attend?
- Those engaged in developing methods for particle size analysis
- Those working in pharmaceutical formulation development
- Those who set specifications for pharmaceutical raw materials or intermediates
- Those interested in understanding the role of different particle size analysis techniques in pharmaceutical development and manufacture