Title : Development of stable liquid formulation of fibrinogen
Abstract:
Formulating plasma proteins as liquid dosage forms is challenging due to limited excipients and risks of physical and chemical instability, including aggregation and loss of efficacy. Strategies such as DoE, QbD, and rational design approaches, combined with stabilizers, buffers, surfactants, and tonicity modifiers, can improve stability. Liquid formulations offer significant advantages over lyophilized products, including ease of administration, elimination of reconstitution, cost efficiency, and suitability for emergency use. Given the rising global demand for plasma proteins, this study focused on developing a stable liquid formulation of fibrinogen, traditionally available only as a lyophilized product. Extensive formulation screening enabled 6-month stability at 2°C–8°C for fibrinogen concentrations of 7.5–10 mg/mL using sodium citrate and histidine. The developed liquid fibrinogen formulation demonstrated comparable results to two marketed lyophilized products, supporting its potential as a viable alternative for clinical use.
