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.