Proper characterization of particles in your drug product is important throughout the development and production process.
Particle analysis provides you with the data you need to ensure the stability, safety, and efficacy of your product.
With FlowCam, you have an efficient and reliable method for particle characterization, helping you to bring drugs to market quickly and ensure quality and consistency throughout the drug development process.
With industry-leading image quality combined with automated statistical pattern recognition software, FlowCam dynamic imaging particle analysis allows you to simultaneously count and classify particles in your sample - and provides you with the critical data you need to ensure product safety.
Using FlowCam overcomes the limitation of particle counters, while giving additional particle information typically only found by using microscopy.
Some examples of how FlowCam can be utilized for pharmaceutical applications include:
While designed for the analysis of particulates in fluids, FlowCam is also very useful for analysis of particulates that are dry in their native state. Simply suspend the dry particles in any liquid that is inert to the particles under study. There are many benefits to using this approach compared to traditional dry particle analysis method because the effects of static electricity on the particles is eliminated. Plus any gravitational effects found in dry analyzers are eliminated.
Many pharmaceutical products and ingredients, such as active pharmaceutical ingredients (APIs), fillers, and excipients are commonly supplied and handled as dry powders. Particle size and shape of the particulates is critical to product performance in many different aspects of the manufacturing process. Particle shape is critical to flowability in the manufacturing process, as well as adherence when tabletized. It can also affect taste.
In the example shown below, two samples of Sorbitol, supplied as a dry powder, were analyzed in the FlowCam system to determine particle size and shape. It was suspected that the two sources being used were supplying different quality product, and imaging particle analysis was the method chosen to characterize the samples. Since Sorbitol is water-soluble, mineral oil was used to suspend the particles for analysis in the FlowCam. The results clearly showed differences in the two samples.
Microencapsulation is a process where a small amount of a substance (active ingredient) is packaged inside a second substance in order to shield the active ingredient from the surrounding environment. Microencapsulation processes are increasingly being used in the pharmaceutical industry, as they offer many benefits, including:
FlowCam is being used by several drug manufacturers in formulation research and production applications where microencapsulation is being used in the delivery methods. Using FlowCam, you can gain unique insights into the microencapsulation process because you can dynamically monitor capsule formation over time. This allows you to determine the effects of temperature, concentration, pH, and other variables on the process in near real-time.