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30 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Manufacturing M icronization is an important tool for developing new drugs, its primary advantage being that it is scalable from the early stages of development through to com- mercial volumes. The micronization process is both well-understood and cost-effective. With the increased number of potent drugs in development, having the capabilities to handle and process them is becoming imperative. De- velopment partners with the specialized expertise and infrastructure required to handle potent APIs play a key role in the supply chain of next generation medicines. Particle-size reduction leads to an increase in the surface area of drug molecules, enabling a faster dissolution rate while potentially improv- ing the bioavailability of poorly soluble compounds. By controlling the particle size, better content uniformity is achievable, as well as reduced segregation/sedimentation of formulation blends. For high potency APIs (HPAPIs), micronization is a cost-effective method of helping to ensure content uniformity. For HPAPIs, where batch volumes are often smaller and of higher value, ensuring dose uni- formity and reducing process waste is crucial. Beyond HPAPIs, microni- zation is useful for the development of inhaled powders, oral suspensions, and ocular formulations, as these approaches require a specific particle size to ensure formulation performance and patient acceptance. Micronization for oral drug delivery The Developability Classification System (DCS), which is an exten- sion of the Biopharmaceutics Classification System (BCS) shown in Containing and Enhancing Potent Particles with Micronization Andy Maitland A multilayered processing approach ensures safe handling and content uniformity of highly potent APIs. Andy Maitland is operations and supply chain director, Catalent. KWANCHAIFT - STOCK.ADOBE.COM