| 13 Juillet 2012
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| The Quadro Ytron® HV-Emulsifier Group Seri |
Waterloo, Canada, July 11, 2012 - Size Reduction or Milling of APIs (Active Pharmaceutical Ingredients) is a key step in the drug development process. When milling an API, the developer requires a tight particle size distribution that ensures 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, costs associated with containment and at times, detrimental impact on physical properties such as the creation of amorphous material 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 homogenizers, high pressure valve homogenizers and media mills which are restricted by low capacities, high energy consumption, and frequent maintenance requirements.
To overcome these restrictions, Quadro has developed the Quadro Ytron® HV-Emulsifier. The Quadro Ytron® HV is an inline emulsifier and wet mill in one, and offers more than fifty-five times (55x) 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 Quadro Ytron® HV produced 60% smaller particles than other conventional wet mills. Several of the compounds tested were found to mill down to a mean volume (mV) of 10 - 15µm, compared to 28 - 35µm with traditional wet mills.
Other pharmaceutical applications for the Quadro Ytron® HV-Emulsifier include the development of submicron emulsions (high shear homogenizing with a droplet size = 0.2-1µm), drug suspensions (high shear wet milling with a particle size = 1-10µm) and topical formulations & semi-solids (droplet/particle size = 0.4-3µm).
The HV-Series features three (3) different models ranging from 7.5 to 60 HP with capacities ranging from 1 l/min up to 285 l/min. All models utilize energy optimized 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 that eliminates potential trap areas around the rotor shaft for improved CIP/SIP results and can be customized for easy integration.
New wet mill dramatically improves api milling capabilities