Particle Matter determination in Biosimilar Parenteral Product by the Application of Dynamic Light Scattering (DLS) Followed by Statistical Evaluation

Abstract

Particulate matter in parenteral dosage forms can emerge from numerous causes, external, intrinsic, as well as inherent within the product, with a special emphasis on biopharmaceuticals. Aqueous impurities, pharmaceutical precipitates, dirt, glass, rubber, pollutants from the environment, fibres, and various other insoluble materials are all common sources of particulates. When assessing the possible harm to patients, particulate matter size is a crucial issue to consider. Particles as fine as 2 μm overall diameter were found related with microthrombi development. The DLS (Dynamic Light Scattering) technique has been used to measure and control the subvisible particulate particles in biopharmaceutical parenteral drug products since the technique can measure the submicron particle size in the parenteral formulation. The purpose of using DLS is to measure and control the subvisible particles in a biopharmaceutical formulation. A generic biopharmaceutical product viz. Calcitonin Salmon injection was used for particulate matter analysis by using Dynamic Light Scattering. DLS is a non-invasive method for detecting the size of suspended particles as well as molecules which is used for the control and optimization of processes, and the improvement of product quality and performance by analysing the time-dependence in regard to intensity of the dispersed light (auto correlation) to determine the diffusion speed (Brownian motion) of particles/molecules, and subsequently determine the hydrodynamic size. Keywords: Particulate matter; DLS; Biosimilars; Parenteral dosage forms