20.500.12556/RUL-167794 Additive effects of the new viscosity-reducing and stabilizing excipients for monoclonal antibody formulation The subcutaneous administration of biopharmaceuticals is advantageous over intravenous administration, particularly with regard to improved patient compliance. However, in highly concentrated protein formulations lower viscosity of the formulation and stability of the protein is difficult to achieve. One approach involves using the viscosity-reducing excipients to diminish the interactions between protein molecules. In this context, the main objective of the study was to develop an optimal formulation for a model monoclonal antibody (mAb) and to evaluate new test compounds as viscosity-reducing agents. The test compounds were investigated both individually at increasing concentrations up to 200 mM and in combinations for their viscosity-reducing effect. Our results showed that all individual test compounds reduced the viscosity of the mAb formulation by more than 30 %, with reduction achieved by the six test compounds exceeding that achieved by proline (Pro). A reduction in the viscosity of the formulation below the 20 mPas threshold was achieved either by combining two test compounds or by increasing the concentration of a single compound above 25 mM. An accelerated stability study showed similar stabilization effects regardless of whether the test compounds were used alone or in combination. The percentage of aggregates was below 5 % in most formulations. These viscosity-reducing and stabilization effects corresponded to the dynamic light scattering results, which indicated that the test compounds reduced the attractive forces between the mAb molecules. biopharmaceuticals subcutaneous administration highly concentrated mAb formulations viscosity-reducing agents stability biofarmacevtski izdelki subkutano dajanje visoko koncentrirane formulacije mAb sredstva za zmanjšanje viskoznosti stabilnost true false true Angleški jezik Slovenski jezik Članek v reviji 2025-03-12 10:37:08 2025-03-12 10:37:13 2025-03-13 16:00:44 0000-00-00 00:00:00 2025 0 0 13 str. art. 125451 Vol. 674 Apr. 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 542:615.4 0378-5173 10.1016/j.ijpharm.2025.125451 228674563 1-s2.0-S037851732500287X-main.pdf 1-s2.0-S037851732500287X-main.pdf 1 A12F07627E97484759E633BCD575ADC9 808e48ada2a1e4315ffc14cdc81958099b0ef06af45c04872defaa324af68bda defc2c6c-ff24-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=200565 https://www.sciencedirect.com/science/article/pii/S037851732500287X 1 9b556862-ff24-11ef-b232-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=200563 Fakulteta za farmacijo 0 0 0