New Wet Mill Dramatically Improves API Milling Capabilities

Quadro Engineering has developed the Quadro Ytron® HV-Emulsifier, an inline emulsifier and wet mill in one which dramatically improves API (Active Pharmaceutical Ingredients) milling capabilities.

The HV-Emulsifier offers more than fifty-five times the high shear energy of conventional rotor-stator systems with precise process scaling from lab formulation, to pilot and production processing. In independent tests across multiple compounds having a wide range of starting particle sizes, morphologies and mechanical properties, the HV-Emulsifier produced 60% smaller particles than other conventional wet mills. Several of the compounds tested milled down to a mean volume (mV) of 10 - 15µm, compared to 28 - 35µm with traditional wet mills.

“Size reduction of APIs is a key step in the drug development process. When milling an API, developers require a tight particle size distribution ensuring consistent drug substance and drug product quality. Traditionally, dry milling technologies, such as media mills and jet mills, have been employed, but have come under increased scrutiny due to yield losses, containment costs and, occasional detrimental impact on physical properties, such as amorphous material creation and surface defects. Wet milling offers a solution to some of these challenges. However, traditional rotor/stator technologies’ lower particle size limit is often a mean volume (mV) particle size of 30µm. As a result, wet milling has typically been performed by piston homogenisers, high pressure valve homogenisers and media mills, restricted by low capacities, high energy consumption and frequent maintenance requirements,” said Wilf Sangüesa, Quadro Liquids Product Manager. “To overcome these restrictions, Quadro has developed the Quadro Ytron® HV-Emulsifier.”

Other pharmaceutical applications for the HV-Emulsifier include: the development of submicron emulsions (high shear homogenising, droplet size = 0.2-1µm), drug suspensions (high shear wet milling, particle size = 1-10µm) and topical formulations & semi-solids (droplet/particle size = 0.4-3µm).

The HV-Series features three different models from 7.5 to 60 HP with capacities from 1l/min up to 285 l/min. All models utilise energy optimised tooling that operates at very high tip speeds up to 70m/s with the lowest power consumption in the industry. The HV is designed with a sanitary high-speed mechanical seal eliminating potential trap areas around the rotor shaft for improved CIP/SIP results and customisable for easy integration.