Subvisible/submicron particles are considered the new frontier in the pharmaceutical and cosmeceutical fields as delivery system for active principles. Particle size distribution, composition, internal structure of the single particle population in a complex formulation are fundamental physical characteristics required for the technological optimization of the final product. In fact, these properties can affect a lot of parameters, including bulk properties, product performance, processability, stability and appearance of the end product, dissolution, absorption rates, and content uniformity.

Market overview – Example of the drug delivery system market – The Drug Delivery System (DDS) is used to deliver specific drugs at the right time and place in the body. It can be used in a variety of ways, such as transporting a drug directly to the site of action, releasing a drug in a time-controlled manner, or mixing several drugs to achieve a synergistic effect. Drug delivery is an evolution of normal administration. DDS requires that a drug, once taken, is released over time in a controlled manner, using fixed implants or nanosystems. In doing so, the drug necessary to cover a certain period of treatment is administered all at once and the matrix that protects the active ingredient preserves its effectiveness and guarantees its gradual and controlled release. By now DDS technology can compete with traditional methods of oral or injection, with great benefit for patients, reducing pain, frequency, and dosing schedules.

Quality control and R&D – The controlled release of an active ingredient can be monitored using dissolution tests. A liquid simulates the pH, temperature and other parameters of the target biological liquid. By analyzing how the particles with the active ingredient behave over time, we are able to predict their behavior. However, it is not easy to be able to distinguish excipients from active ingredients, nor to understand if they separate or evolve over time.

Classizer™ ONE added value – Classizer™ ONE allows you to monitor in real time and continuously 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/SPES² methods 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.

Classizer™ ONE empowers the developments and quality controls of simple and mixes of subvisible/submicron devices for controlled drug release, where particle monodispersion, stability, and constant drug loading are required. EOS technology provides the chance to fully characterize biocompatible systems such as liposomes and polymeric particles in terms of

Size
Polydispersity
Concentration (particle number)
Particle composition
Particle structure (i.e. solid or core-shell)

CLASSIZER™ ONE has the unique capability to detect and classify delivery systems directly in the target bioliquids of interest allowing their characterization without purification or filtration procedures.

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