Micronization

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.