Particle Micronization: A Tool for Enabled Pharmaceutical Formulations

March 31, 2016 - 11:00am


Micronization is an enabling technology providing effective particle engineering for a range of pharmaceutical formulation applications. Micronization of crystalline API is a well-established approach for increasing the surface area, thereby improving the oral bioavailability of drugs whose absorption is dissolution-rate limited, i.e. developability classification system (DCS) IIa drugs. The technology is complementary to other delivery technologies for bioavailability enhancement, such as solid amorphous dispersions, that are applicable to drugs whose absorption is solubility-limited. Other micronization applications for oral delivery include jet milling of API or excipients for microparticle coating applications where particle size distribution is critical. Micronization can be tailored to the optimum particle size, distribution, and fine particle fraction required for specific applications and target product profile desired.
Here's what you'll learn as we present:
  • Various applications for particle micronization in pharmaceutical formulations and its use with a range of complementary technologies.
  • The application of micronization to enable specific drug formulations as described through representative case studies.
  • The range of milling process and equipment choice and capabilities, including choice of mill type and process parameters, containment/high potency requirements, and scale-up considerations.
Adi KaushalAdi Kaushal, Ph.D.
Senior Research Fellow
Capsugel Dosage Form Solutions
Dr. Kaushal is a Senior Research Fellow at Bend Research. He leads a group focused on development and manufacture of pharmaceutical formulations for early stage projects. Dr. Kaushal’s areas of expertise are immediate and controlled release oral formulations based on crystalline API or spray dried-dispersion intermediates. Dr. Kaushal has been with Bend Research since 2010. Prior to joining Bend Research, Dr. Kaushal was a Postdoctoral Associate in the College of Pharmacy at the University of Minnesota. He holds a Master of Science (Pharmaceutics) degree and a Ph.D. in Pharmaceutical Technology from National Institute of Pharmaceutical Education and Research, India.
TJ HigleyTJ Higley
Head of Quality
Powdersize Inc
TJ Higley was a former owner and functions as head of quality and business development at Powdersize. He overseas and directly participates in the development and onboarding all incoming milling/micronization/classification projects for the company to enable pharmaceutical formulations with bioavailability challenges and/or improve reproducibility within the finish dosage form(s). Higley’s areas of expertise are particle size reduction and control through a variety of milling technologies and ensuring suitable cGMP systems and control are integrated throughout product development and commercial manufacture. Higley has been with Powdersize since 2005. Prior to joining Powdersize, Higley held business development and engineering (product development) roles with Tosoh Bioscience and Eastman Kodak (medical imaging) respectively. He holds a Bachelor of Arts degree in Chemistry and a Master of Science degree in Biochemistry from University of Northern Colorado and a Masters of Business Administration from Portland State University (Oregon).