Catalent Micronization Technology Solutions from Development to Commercial

As a leading provider for the most specialized requirements in pharmaceutical micronization, Catalent can enhance and advance your API from development to commercialization. Our versatile portfolio of micronization, jet milling, and cryogenic milling technology, high potent handling capabilities and associated analytical services, can help overcome even the most complex bioavailability, stability and manufacturability challenges.

In both the early stages of research and development and the later commercial phases, achieving reliable and accurate particle size analysis is crucial for the success of pharmaceutical products. As a trusted CDMO, Catalent has an experienced team and equipment dedicated to particle size analysis, offering a cost-effective and efficient solution for pharmaceutical companies seeking to enhance their analytical capabilities. This article delves into fundamentals of understanding particle size characterization and the analytical capabilities used to assess micronized particles.

Micronization can improve the solubility, dissolution rate, and bioavailability of the active pharmaceutical ingredient (API) in the final drug product. The smaller particle size also leads to improved flow properties and handling, which can make the API easier to manufacture and process. Watch this on-demand webinar to understand how micronization can address the challenges and solutions to scale, yield and cost of goods for API particle engineering from formulation development through to commercial supply

For HPAPIs, micronization is a well-established, cost-effective and scalable process to address bioavailability and drug delivery challenges facing certain highly potent oral drugs. Catalent has extensive experience and ability to provide enhanced containment suitable for highly potent compounds with occupational exposure limit (OEL) values as low as 0.05 µg/m³. Read this article to learn more about safe and successful HPAPI product development and manufacturing using micronization.

Drugs containing HPAPIs are becoming increasingly prevalent in the development pipeline due to their significant benefits in treating various medical conditions including cancer and rare diseases. This eBook explores the challenges and strategies involved in developing and manufacturing HPAPIs as well as highlights the benefits of partnering with an experienced CDMO that can effectively address the challenges of manufacturing potent drugs and support the successful delivery of safe and effective treatments to patients.