Technology Advantages of Micronization
STREAMLINED REGULATORY PATHWAY
As the most established BA enhancing technology over the last several decades, micronization is well-known to regulators worldwide. 100’s of NDA approvals have been granted using micronization as the primary technology for BA enhancement. At Microsize, our facilities have been FDA inspected on numerous occasions with a stellar compliance record and cGMP systems. We also host numerous client audits each year ranging from small biotechs to the world’s largest global pharma companies.
Micronization is an infinitely scalable technology for BA enhancement which speeds process scale up. What makes Microsize different is that we are not just users of micronization equipment; we are pioneers in the design and manufacture of the micronization equipment that we use. Microsize has the equipment and capabilities to offer seamless scale up with mills ideal for R&D, clinical, and commercial volumes. Staying with one provider streamlines the product development cycle.
Micronization is generally a high yielding approach to BA enhancement. Our unique micronization technology affords clients much higher yields, and in drug development, when clients can be “API-starved”, our high yielding technology is critical to client success. These yields carry through clinical and commercial volumes. Small scale batch sizes as little as 1 gram can be run for feasibility and large scale batch sizes with 99% plus recoveries are routinely achieved.
SUPERB PRECISION / REPRODUCIBILITY
Micronization provides a homogenous grinding environment, inherent to the micronization process, resulting in a narrow, fine and Guassian particle size distribution curve. Most API distributions can be micronized to under 10 microns, with average particle sizes in the low single digit micron range. These shape distributions (along with limited variables that have process influence), allow for excellent reproducibility. Typical commercial products run routinely at Microsize have ~1 micron variance around the median D50 value over 1000’s of batches, providing reliable product performance and unmatched consistency.