Understanding the importance of diversity of particle size methods
The particle size of Active Pharmaceutical Ingredients (API) has a significant effect on a drug product’s manufacturability and performance. With respect to manufacturability, particle size can affect compatibility, flowability and blend uniformity; with respect to product performance it can affect solubility, dissolution, and bioavailability.
WHILE most manufacturers employ methods to control particle size prior to product release, particularly if the API is not soluble, they do not always consider the impact of particle size on product manufacturability (Figure 1).1 We recommend the monitoring of particle size at all manufacturing stages, as doing so will contribute to the understanding of, and ability to control, the process and ensure quality and consistency in batches. Different methods will be needed for monitoring particle size at different points in the process.
The decision of when to monitor particle size – and using what method – depends on how relevant the particle size is to the product. There is great diversity in the PSD (particle-size distribution) methods that can be used on the same material during drug product development, depending on what property is being measured. Programme leaders and manufacturers are often confused by the array of PSD methods, as there is no general PSD method listed in pharmacopoeias. This article explains the different PSD methods that are based on laser diffraction and clarifies their potential applications in different project phases and for different purposes (Figure 2).
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