Manufacture APIs within a 1–10 micron average particle size

Particle size reduction is increasingly utilized to address a range of formulation issues facing oral solid and inhaled dosage forms. Stability, flowability, dissolution rate and bioavailability are critical performance parameters impacted by particle size distribution. Micronization through jet milling is a core strength of Lonza with unparalleled expertise, track record and capacity in place to meet these challenges.

 

Meet specific particle size distribution targets

Micronization is an established technology and manufacturing technique for producing APIs within a 1–10 micron average particle size. We utilize proprietary jet milling technology to effectively meet specific particle size distribution targets across the full range of compound properties. Phase-appropriate jet mills are in place for non-GMP development studies and cGMP production of clinical and commercial intermediates. Specialized processing is in place for handling highly potent compounds and APIs with elastic or semi-solid properties.

Our particle size reduction services have a range of applications for oral, inhaled and transdermal drug delivery:

  • Improve API dissolution rate to provide sufficient bioavailability
  • Improve palatability properties of drug compounds
  • Generate API particles within a tight particle size distribution for proper delivery to the lungs
  • Help ensure absorption of a drug for transdermal delivery

How do micronization & jet milling technologies work?

Using high velocity compressed gas, jet milling accelerates particles to supersonic speeds to achieve sub-10 micron particle distributions. A compressed gas source is used for accelerating API particles in a tornado-like flow path within the grinding chamber of the jet mill. As particles travel in the circular path, particle-on-particle attrition is effected and particle size reduction occurs. Large particles continually migrate to the outside of the mill via centrifugal force while micronized particles migrate to the center mill outlet via drag force. 

The resultant superfine particles have Gaussian distribution curves with excellent reproducibility. The process is conducted at ambient conditions due to the instantaneous pressure drop of the grinding gas within the milling chamber, cooling and colliding particles which makes jet milling an ideal technology for sensitive pharmaceutical ingredients.  Pressure, feed rate and proprietary mill design attributes are utilized to influence particle size distribution.

Highly Potent Compounds - High containment capabilities support particle size reduction of high potent and cytotoxic compounds. A range of mechanical and jet milling capabilities are used within isolators or glove boxes designed to meet containment levels to 1mcg / cubic meter

Cryogenic Micronization - For APIs with elastic or semi-solid properties, Lonza utilizes this technology to meet target particle size distributions. Liquid nitrogen gas allows for chilled jet milling at extremely low temperatures (to -30C), which results in more friable powder and facilitates improved particle size reduction than is possible at ambient conditions. 

Your next contract development and manufacturing organization (CDMO)

Working with you, as a CDMO, from our micronization centers of excellence in Monteggio, Switzerland and Quakertown, PA, we want to enable you to meet challenging deadlines and address your patients’ needs. 

Our years of experience has taught us that innovation does not happen in isolation. It is underpinned by strong synergies across all our R&D focus areas. Our R&D group is active in viral vectors, cell line construction, cell culture media, cell and gene therapies, capsule design and manufacturing, other oral dosage forms, chemical active pharmaceutical ingredients (APIs) and parenteral formulation and delivery. We’re looking forward to hearing from you

This on-demand webinar provides an overview of micronization and common scale-up challenges and presents a robust process development strategy that ensures all attributes are maintained for even the most difficult APIs.

View our webinar on-demand

How To Deal With A Difficult-To-Micronize Drug Substance

Technologies & Products


centers of excellence

Monteggio, Switzerland

Production, Research & Development, Sales & Support

Via Cantonale 4
Monteggio 6998
Switzerland

Quakertown, PA, USA

Production

20 Pacific Dr.
Quakertown, PA 18951
United States of America

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