Wet Milling for Micronization in API Development
When discussing “Wet-Mill Micronization” in API (Active Pharmaceutical Ingredient) development, we’re talking about a process used to reduce the particle size of the API within a liquid environment.1 Here’s a breakdown:
Wet-Mill Micronization:
- Purpose:
- The goal is to decrease the particle size of the API, which can significantly impact its solubility, dissolution rate, and bioavailability. This is crucial for ensuring the drug works effectively.
- It also aids in creating a more uniform particle size distribution, leading to consistent dosing in the final drug product.4
- Process:
- Unlike dry milling, wet milling involves suspending the API in a liquid medium.
- Particle size reduction is achieved through forces like shearing, impact, and crushing, often using equipment with Wahals’ rotor-stator systems and/or Wahal ZR SPlash bead mills in series .
- This method is particularly useful for APIs that are sensitive to heat or static charge, which can be issues in dry milling.
- Pharma-compliant design – with Wahal
validation concept
The qualification documents DQ, IQ, OQ that are required for
validation or the certificates for the process-relevant machine
components such as calibration- and materials certificates are
available for all Wahal bead mills. On request, we can also carry
out the Factory Acceptance Test in our factory or the Site
Acceptance Test at your production site