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Pharmaceutical drug developers continue to realize the strong therapeutic potential of highly potent active pharmaceutical ingredients (HPAPIs). This is particularly true for therapeutic areas such as oncology, where highly potent drugs are becoming more commonplace. Yet HPAPIs require specialized manufacturing and processing expertise, so with increased demand comes a critical need for safe manufacturing and containment technologies to ensure the safety of operators as well as maintaining product integrity. As such, engaging a manufacturing partner with expertise in processing HPAPIs is crucial for safe and successful product development and manufacturing. Beyond requiring safe handling procedures, poorly soluble HPAPIs require an effective formulation strategy. While numerous approaches exist, micronization is often considered because of its well understood process controls, cost effectiveness and simple scale-up. Micronization is a proven and widely used technology to address bioavailability and drug delivery challenges facing certain highly potent oral drugs. |
