Crystal Control TechnologyTM (CCT)
GenSyn’s Crystal Control TechnologyTM (CCT) is a unique continuous crystallization process for producing small molecule crystals with a mean particle size ranging from 50 nanometers to 20 microns. CCT produces narrow particle size distributions and can incorporate coating of the particles or formation of liposomes. Any dosage form (powders, suspensions, emulsions) can be produced in a scalable, highly reproducible rapid throughput process.
CCT combines crystal chemistry, fluid dynamics and organic chemistry to achieve precise particle control and customization at each process phase:
- Nano-Nucleation Phase. GenSyn controls the size and frequency of nuclei formed by controlling the ratio of solvent/anti-solvent, the pressure of the solvent and anti-solvent, the volume and location of the cavitation zone and the hydrostatic pressure within the chamber. The location and degree of cavitation is vastly different for API’s which nucleate slowly than for API’s which nucleate rapidly. This control is particularly important for particles of the nano scale.
- Controlled Crystal Growth and Shape Phase. By controlling the quantity of API in the chamber GenSyn can control the maximum size to which any particle can grow. For nano materials, the ratio of anti-solvent to solvent can be quite large. Incorporating particles within the anti-solvent (recirculation) allows GenSyn to grow larger particles and affect changes in the shape of the particles formed.
- Particle Stabilization Phase. Surfactants and/or polymers can be included in one or more of the process streams. This allows stabilization of high surface energy particles by tying up the most energetic sites on the surface. GenSyn has been very successful in stabilizing nano particles with this technique.
Crystal Control TechnologyTM (CCT) Applications
Crystal Control TechnologyTM is particularly effective at addressing bioavailability issues associated with solubility and/or low permeability (biopharmaceutical classifications II and IV). In addition to controlling the size and shape of the particle, GenSyn can also use CCT to encapsulate the particle with a coating to enhance its permeability. The technology can support multiple dosage forms, including inhalants, injectables, pills and tablets. The results delivered by CCT are highly reproducible, and since CCT is a continuous process, it scales easily.