From solid dosage form development to drug product manufacturability, the flowability of powder is largely dependent on the size and shape distribution of particles. Laser diffraction (LD) has long been the golden standard for measuring the particle size distribution of pharmaceutical powders such as API, excipients, and drug product blends; however, it lacks accuracy (a) when particles deviate from an equant shape (e.g. needles or rods), (b) when particles are less than 10 μm, and c) when there is a mixture of small and larger particles, which are often the case in pharma solid powder testing. Therefore, a dynamic image analysis (DIA) system was placed in-line with a standard laser diffraction (LD) system, which visualizes the particles while collecting the diffraction data. The live imaging system performs real-time model-fitting to the imaged particles to generate shape attributes such as equivalent area circular diameter, rectangular particle length, width, and aspect ratio. The DIA system can produce a total of 31 attributes, offering insights into particle engineering and particle flowability to compliment the standard LD particle size data.

Simultaneous dynamic image analysis and laser diffraction particle size measurements of pharmaceutical materials

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