Micronization Technology

Capsugel provides integrated product development to our clients which includes our premier particle engineering capability through micronization, with capabilities from early stage design through scale-up and commercial quantities.

Micronization and nano-milling are used routinely in many applications in solid oral and other dosage forms:

  • Enhance BA through dissolution optimization for oral drugs
  • Improve the palatability properties of a compound
  • Generate particles fine enough to be properly delivered to the lungs (for inhalation product development)
  • Help ensure absorption of a drug across the skin (in the development of transdermal products)

Capsugel Quakertown is a full service provider of particle size reduction and particle size control / classification technologies. With over 20 years of manufacturing experience, we routinely develop robust processes at any scale of development through commercialization:

  • FDA-registered with excellent inspection record
  • 7 cGMP suites with independent air handling, HEPA filtration, and temperature / humidity controls
  • Dedicated non-GMP suite from feasibility and development
  • Phase-appropriate equipment for all stages of drug product development
  • Proprietary mill designs and processing

High containment capability is in place in support of particle size reduction of highly potent and cytotoxic compounds. A range of mechanical and jet milling capabilities are available within an isolator designed to meet containment levels down to 1µg/m3 at scales from 2-100kg batch sizes.

Nano-milling capability is also in place through a Netzsch DeltaVita® media mill. This equipment provides additional size reduction to nano-scale, and produces development and production quantities. The DeltaVita uses proprietary wet grinding technology to produce batch sizes ranging from 15mL to 300mL, with appropriate processing parameters and a suitably formulated solution to stabilize the sub-micron particles.