AGC Pharma Chemicals offering soon micronization services
Micronization is an important technology in the pharmaceutical world and is widely used, in oral formulations. The process of micronization consists of the reduction of the particle size of an active pharmaceutical ingredient (API) down to the micrometre, or in some cases nanometre, level by applying a dynamic high-pressure homogenization. The result is an increase of the relative surface area and the improvement of the drug’s solubility. This is also known as oral bioavailability and is integral to the drug performance; what good is a high-potency API if the gastrointestinal tract can’t absorb it in time?
In addition to this important benefit, there are many advantages to the process, including its high yield, speed, efficiency, low cost, and scalability, from pre-formulation development up to commercial-scale production. From a regulatory point of view, micronization is a proven, viable technology for improving bioavailability and producing better content uniformity in low dose drugs.
The demand on micronization has rapidly increased since it was first introduced in the 1960s. One factor is the growing number of poorly soluble drug candidates. According to the American Pharmaceutical Review, only 5% to 10% of drug candidates were classified as poorly water-soluble in the 1970s. Nowadays, this number has increased from 70% to 80%. This rise has contributed to the growing need for more controlled and robust particle size reduction over the past 50 years.
More than 30% of today’s APIs require micronization. In the forthcoming years, it is expected this figure to grow due to the rise of high-potency APIs (HPAPIs), which will require the usage of particle size reduction technologies.
The need of this service across the pharmaceutical market is making it an increasingly attractive technology for CDMOs to offer. AGC Pharma Chemicals, the small molecules CDMO of Japan’s AGC Group, following the acquisition of the manufacturing site in Malgrat de Mar, Spain, felt the immediate necessity to perform micronization in-house rather than outsourcing to broaden its service level for customers.
AGC Pharma Chemicals opted for a dual system mill from Hosokawa Alpine to enable wider applications. Thanks to the multi-process system including opposed bed jet milling and mechanical impact milling, the company is able to achieve both fine (e.g. 2µm) and coarse (e.g. 50µm) particle size diameters.
The unit includes a classifier wheel, which rejects the particles that are still too large and transports them back to the fluidised bed. An isolator is used for product loading while product discharge is done using continuous liner, with automated weigh adjustment and labelling system. The selected micronization unit handles capacities of 20-30 kg/h (max 50 kg/h). In addition, the unit can operate HPAPI compounds with OEB4 (OEL band1-10µg/m3).
AGC Pharma Chemicals Europe will start offering integrated or standalone micronization service to customers in December 2021 on top of its API manufacturing capabilities under cGMP conditions
To find out more about the company and its other API manufacturing capabilities, please contact us.