Subvisible/submicron particles are considered the new frontier in the pharmaceutical and cosmeceutical fields as delivery systems for active ingredients.
A comprehensive understanding of particle size distribution, composition, and internal structure within complex formulations is essential for the technological optimization of the final product. These properties influence numerous parameters, including bulk behaviour, product performance, processability, stability, appearance, dissolution and absorption rates and content uniformity of the final product.

Market overview – Examples from the Drug Delivery System (DDS) Market
Drug Delivery Systems (DDS) are designed to deliver specific drugs at the right time and place in the body. They function in a variety of ways, such as transporting a drug directly to the site of action, enabling time-controlled drug release, or combining several drugs to achieve a synergistic effect. Drug delivery represents an advancement over conventional administration methods. DDS enables the controlled release of a drug over time, using fixed implants or nanosystems. This allows a single administration to cover an extended treatment period, with a protective matrix ensuring drug stability and a gradual, controlled release. DDS technology now competes with traditional oral or injection administration methods, with significant benefit for patients, reducing pain, dosing frequency and treatment burden.

Quality Control and R&D – The controlled release of an active ingredient can be monitored using dissolution testing. A liquid reproduces the pH, temperature and all the other parameters of the target biological environment. By analysing how the particles with the active ingredient behave over time in these controlled conditions, it becomes possible to predict their in vivo performance. However, distinguishing excipients from active ingredients remains challenging, as does determining whether they separate or evolve over time.

The added value of the Classizer™ ONE – the Classizer™ ONE allows you to monitor continuously in real time the presence and evolution of the particles released by the drug directly into its environment. The possibility of regulating the flow and extracting information even from a few ml of liquid allow the SPES family of technologies to be adapted to the user’s needs. If excipients and active ingredients have distinct optical properties, they can be quantified independently of each other with a sampling rate down to 1 second.

Classizer™ ONE facilitates both the development and quality control of mixtures of subvisible/submicron DDS for controlled drug release, where particle monodispersion, stability, and consistent drug loading are required. Its unique capability to detect and classify delivery systems directly within the target biological fluids enables their  characterization without prior purification or filtration procedures.

Find out more