Single-Step Process

The compound is dissolved in the solvent of choice and pumped under high pressure through the RightSize Nozzle. Here, rapid mixing of the supercritical fluid and the solution takes place. This results in a dramatic decrease of the solubility of the active pharmaceutical ingredient/drug substance in the solvent and the formation of very fine particles.

The size and polymorph of the produced particles is controlled by simply varying process parameters, such as the solvent used, temperature and pressure. 

Facilitating Validation

The closed system technology greatly facilitates validation. Particle size, size distribution and polymorph are easily controlled by varying the working conditions. A wide range of crystallization conditions can thereby be tested. This enables Quality by Design production of particles with specific characteristics.

Low Environmental Impact

Using carbon dioxide (CO2) as supercritical fluid is very common within pharmaceutical applications. It is generally regarded as safe (GRAS), chemically inert, non-flammable, and non-toxic. Furthermore, it is inexpensive and abundant in pure form worldwide.

Most CO2 used for industrial purposes is manufactured by purification of waste streams, e.g. from fermentation processes. This means no additional CO2 is added to the atmosphere. The use of CO2 can instead contribute to an improved environment as alternative processes, such as crystallization, use substantially greater amounts of organic solvents. A production facility for RightSize Particle technology can be constructed with a CO2 recycling unit.