Influence of Sodium hyaluronate molecular weight on critical quality attributes and filterability of solutions
Hyaluronan (HA) is a glycosaminoglycan composed of disaccharide repeats of N-acetylglucosamine and glucuronic acid (Bartosikova et al., 2008). It can be present in various molecular weight (MW) forms, each of them having different biological activities (Morozkina et al., 2020). Sodium salt of hyaluronate is a widely used agent in pharmaceutical preparations such as injectables, eye drops and nasal solutions. Due to its thermal liability (Kalina et al., 2015), sterile drug products containing HA cannot be terminally sterilized and filtration trough 0.2 μm sterilizing grade filter is sterilization method of choice. Nevertheless, these solutions are often highly viscous and can be challenging to filter. Furthermore, HA concentration, as well as its molecular weight are directly related to final product critical quality attributes (CQA).