Capsugel has developed an array of nanotechnology approaches for use in improving aqueous dissolution and solubility properties. These generate sub-micron-sized compounds or drug product intermediates based on core particle size engineering and solid dispersion technologies. Nanotechnology approaches augment the depth and range of technologies used to address bioavailability issues, and they are typically used based on highly specific compound or formulation parameters.
Nano-milling is a wet milling solution for the production of ultra-fine particles. Capsugel does nano-milling with a Netzsch DeltaVita® media mill, which provides additional size reduction to the nano-scale for development and production quantities. The DeltaVita is used for wet grinding of 15mL to approximately 300mL batches to generate sub-micron particles with the appropriate processing parameters in suitably formulated solutions that stabilize the fine particles that are formed.
SNCDs consist of drug crystals embedded in a polymer-rich matrix. The sub-micron, high-energy crystals are purposely formed from amorphous dispersions through crystallization of the drug in a spray-dried dispersion (SDD) under controlled temperature and relative humidity conditions.
SDNAs consist of solid amorphous dispersions adsorbed on the surfaces of high surface area insoluble materials, such as fumed silica and silicon dioxide. This approach greatly increases the surface area of the dispersion relative to normally dispersed particles, leading to rapid dissolution of the drug and, therefore, improved bioavailability relative to crystalline forms.