cGMP plant for particle engineering
Abstract: Delivery problems related to poor solubility are low bioavailability, low penetration of the drug into the skin, large injection volume for intravenous (i.v.) administration and undesired side effects after i.v. injection when using traditional formulations. All these issue can be overtaken by use nanocrystal drugs.
Description: Cerbios-Pharma SA has invested in a cGMP plant for particle engineering using super critical fluid technology. The plant is fully operative and is suitable to handle HPAIs (High Potency Active Ingredients).
Two different set up can be used: SAA (Supercritical Anti Solvent) and SAS (Supercritical Assisted Atomization).
SAA process is based on the solubilization of controlled quantities of supercritical carbon dioxide (SC-CO2) in liquid solutions formed by the solvent and the (solid) solute and on the subsequent atomization of the mixture through a nozzle thin wall. SAA process is covered by Cerbios’ patent.
SAS process works by putting into contact an organic solution with SC-CO2. During mixing, SC-CO2 is quickly dissolved in the organic solution, causing the precipitation of solutes by anti-solvent effect. Afterwards, SC-CO2 efficiently extracts the organic solvent, allowing obtaining of completely solvent-free products.
These two technologies give more options to achieve unique particle features including particle size distribution and specific surface area as well as superior formulation performance. Technology selection criteria are based on product affinity for carbon dioxide and the solvent to be used during processing.
By using these technologies is it also possible to obtain nanocrystals of drug substance dispersed in a polymeric matrix. The coating or encapsulation of nanoparticles has been found to be of particular interest for the controlled release of drugs, genes, and other bioactive agents.
Unlike traditional methods used for particle size reduction, supercritical fluid-processing techniques offer different advantages:
• Bottom-up technology, which means better control of nanoparticles morphology and shape
• Minimal Batch variation from the particle size point of view
• Mild technique API purity not adversely affected
• Narrow particle size distribution
This technology will expand Cerbios’ contract manufacturing services platform in the area of HPAIs, either in conjunction with the production of the HPAI itself or as a standalone option.
Nanosizing is one of the most important drug delivery platform approaches for the commercial development of poorly soluble drug molecules. The research efforts of many industrial and academic groups have resulted in various particle size reduction techniques.
Category: Business Process
Type: Small Molecules
Contact: Cerbios-Pharma BD Dept. ([email protected])