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Particle analysis plays a key role in the pharmaceutical industry, whether it is the production results or production process. Particle size can affect the solubility of excipients or active pharmaceutical ingredients (API), and may also affect pharmaceutical formulations. Various existing particle analysis technologies can fully meet the particle size measurement requirements required by today's pharmaceutical market.
However, in some cases, simply controlling the particle size does not completely control the final product. It is especially important for monitoring and controlling particle shape. In recent years, in the research and quality control of the pharmaceutical industry, understanding the shape of particles has promoted the development of image analysis.
Most particle size analysis methods assume that the particles are spherical when analyzing the particles, and the output report is also the result of "equivalent spherical diameter". This assumption is unacceptable in most cases. For example, in the flow production process of a sample, it is not accurate to monitor the particle size alone. Some particles may be spherical, some may be rectangular, and spherical particles are more fluid than rectangular particles-requiring less energy. To ensure even flow of rectangular particles, more energy is required. The shape of the particles affects the fluidity, and the ability of the particles to properly mix with other sample components will affect the final product results.
The image analysis system can measure particle size, shape, and concentration, and allows users to set measurement parameters for specific particles. When selecting auxiliary materials, the measurement of particle shape is very important in the production process. Like lubricants, excipients with low surface roughness or high form factor can promote powder flow and tablet formation. During the production process, fillers with rough surfaces will affect the adhesion and dissolution of the drug, and affect the location of API release in the digestive tract. The advent of dynamic image analyzers has achieved unprecedented automated information transfer. In this case, Particle Insight distinguishes the types of auxiliary materials according to the surface roughness, and in the production process, surface roughness is also an important feature of particles.
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