APIs, API+Excipient blends
The EUROAPI Vertolaye site has a known expertise in micronization of API's using the jet milling technology for more than 40 years, and currently micronizes in routine production more than 30 different API’s.
This technology allows for the efficient milling at all scales of pharmaceutical powder. This can be desirable in several cases:
- If the API is poorly soluble, reducing particle size will increase dissolution rate and thus improve bioavailability
- In the case of low dosage strength, small particles are needed to efficiently blend the API with the excipient during formulation of the drug product
- If the drug particles are to be inhaled, they must meet very tight particle size specifications to impact in the lungs.
With 70% to 80% of new drug candidates having low aqueous solubility, enabling technologies are required to enhance bioavailability. Whereas micronization is a good solution for dissolution rate limited solubility, spray drying is best employed when absolute solubility is the issue and the physical form of the API must be altered.
Micronization is highly effective for:
- Milling all types of API's, even sticky powder, with very high yields
- Milling temperature sensitive products, as temperature is tightly controlled during the process
- Inhalables – small and precise particle sizes
- High volume products – large capacities and energy efficient
EUROAPI is equipped for all micronization needs
- Technologies: Homogenization, blade mill, hammer mill, cryo-pin milling (- 150 °C), High Pressure Homogenization, ultrasound sieving
- Micronization plates from 2 to 20 inches - from development to large scale production - from grams to tons
- Control of the process gas: Air, Nitrogen...
- Control of temperature and relative humidity
- Particle Size Distribution and crystallinity controlled to achieve the desired particle quality
- In-line PSD analysis with Insitec probe
- Dedicated solid-state development laboratory
- Small-scale process development, scale-up, scale-down, process transfer
- Optimizing large-scale production and trouble shooting
- Solid-state characterization expertise
- Scientific support for all solid-state related subjects (drying, milling, amorphous phase, polymorphism, particle size and morphology, stability, inhalables...)
- 100 % scale-up success: every process developed at lab scale has successfully been transferred to production