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.