Milling/Micronization of APIs
Generally, poor bioavailability is the result of poor solubility. The finer the particle size of APIs, the higher the dissolution rate, which leads to faster absorption by the human body. Nowadays, the demand for pharmaceutical materials containing micronized APIs is steadily increasing, and one of the ways to improve the solubility of drugs is to reduce their particle size and thus increase their total surface area. Currently, milling/micronization is a well-established technique that is commonly used to reduce the particle size of APIs.
Advantages of the milling/micronization of APIs
- Uniformity of particle size
- Better solubility
- Improved bioavailability
- Improved appearance/brightness
- Increased surface area
- Time release engineering
Figure 1. API solid form classification based on structure and composition. (Anna, K.; et al. 2018)
Our Services
To make it easier and better for researchers, BOC Sciences provides milling/micronization of APIs service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
- Facilities equipped with advanced air mills can provide you with the highest quality of milling/micronization
- Standard milling/micronization operations are performed under cGMP conditions
- Co-micronization: We blend the excipients with APIs prior to micronization which results in a micronized drug product with decreased agglomeration between API particles (API agglomeration), enhanced hydrophilicity character and solubility, improved dissolution rates, and better flow properties
- After micronization is completed, our experts perform subsequent characterization of the micronized drug to understand its bulk properties and further design downstream processes as well as contract manufacturing methods
Milling/Micronization of APIs Workflow
Aiming to deliver an optimal design and optimization of the milling/micronization process, BOC Sciences has established a skilled and cross-functional team consisting of Powder Technology, Analytical Chemistry and Production departments. We can provide full characterization and analysis of the milled product.
1) Milling feasibility research
2) Selection of the appropriate milling technology based on PSD specifications
3) Screening and determination of milling process parameters/conditions
4) Milling process analysis, improvement and optimization
5) Operating window screening studies and design of experiments (DoE)
6) Milling process validation
7) Non-GMP and cGMP milling production and production troubleshooting
8) Powder characterization/analysis method development, transfer and validation
9) Powder impact sensitivity studies and other safety testing
Figure 2. Approaches for cocrystal prediction and screening. (Anna, K.; et al. 2018)
Our available micronization instruments
BOC Sciences has a dedicated process engineering team responsible for all particle size reduction activities. We are able to provide different types of micronization support from laboratory scale to commercial scale under cGMP conditions.
- Wet mill
- Hammer mill
- Ball mill
- Pin mill
a. Pilot/commercial pinmill machine - Jet mill
a. Different lab scale machines
b. Pilot scale jetmill
c. Different brands of commercial scale machines - Conical mill
a. Pilot machine
b. Commercial scale machine
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of milling/micronization of APIs at competitive prices for global customers. Personalized and customized services of milling/micronization of APIs can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Anna, K.; et al. Pharmaceutical Cocrystals: New Solid Phase Modification Approaches for the Formulation of APIs. Pharmaceutics. 2018. 10(1): 18
