Dissolution of Polysorbate 20 Degradation Related Free Fatty Acid Particles in Intravenous Bag Solutions

Degradation of Polysorbate 20 (PS20), a commonly used surfactant in drug product (DP) formulations, is phenomenon increasing concern to the biopharmaceutical industry. One most prevalent modes PS20 degradation enzymatic hydrolysis resulting from co-purified hydrolases that make their way into biologic DP formulations at trace levels. Enzymatic results generation free fatty acids (FFAs) have limited solubility aqueous and can form visible and/or sub-visible particles which undesirable for parenteral stability administration. Many therapeutic monoclonal antibodies are administered intravenously after first diluting an infusion solution (e.g., 0.9% normal saline, 0.45% half saline or 5% dextrose). The purpose this work understand if FFA dissolve intravenous solutions prior Our assessment indicates contain high levels lauric, myristic palmitic immediately upon dilution (at exceeding two fold) regardless bag type. Therefore, risk low particles, comprised FFAs DPs, being patient.