Particle size distribution testing describes the variation in particle size within a drug product. Particles in a pharmaceutical product may vary depending on their shape. Particle diameters are used for spherical particles, while length and width values can be used for oval or irregularly shaped particles.
Since particle size distribution can affect the porosity and surface area of the pharmaceutical product, it may lead to changes in important parameters such as manufacturability, efficacy, quality, bioavailability, shelf life and drug performance in product formulation trials.
Non-specific particle sizes can prevent production and reduce efficiency, so determining the values of particles by particle size distribution testing is very important for pharmaceutical products.
Three D values are used to calculate the particle size distribution curve;
- D50: Indicates the average particle size. 50% of the particle sizes are below this value, and 50% are above it.
- D10: 10% of the particles in the distribution are smaller than this value.
- D90: 90% of the particles in the distribution are smaller than this value.
Since D values are closer to each other, the particle sizes are more uniform, the distribution curve will be at the desired level.
In order to develop more efficient products with the Spraytec laser diffraction system in our WMINOLAB Innovation Laboratories, we analyze the size distributions of spray particles and spray droplets accurately and precisely.
Droplet/particle size distributions are measured in a reproducible manner with the Inhaler and Nebulizer Accessory and Nasal Spray Accessory as part of bioequivalence studies or production quality control.
We are able to work in a wide range of sizes with Spraytec, quickly analyze droplet size changes over time by measuring up to 10,000 measurements per second, and thus provide the criteria of robustness, repeatability and reliability in the data we obtain.