Understanding particle formation: solubility of free fatty acids as polysorbate 20 degradation byproducts in therapeutic monoclonal antibody formulations N Doshi, B Demeule, S Yadav Molecular pharmaceutics 12 (11), 3792-3804, 2015 | 94 | 2015 |
Improving prediction of free fatty acid particle formation in biopharmaceutical drug products: incorporating ester distribution during polysorbate 20 degradation N Doshi, J Martin, A Tomlinson Molecular pharmaceutics 17 (11), 4354-4363, 2020 | 32 | 2020 |
A comprehensive assessment of all-oleate polysorbate 80: free fatty acid particle formation, interfacial protection and oxidative degradation N Doshi, J Giddings, L Luis, A Wu, K Ritchie, W Liu, W Chan, R Taing, ... Pharmaceutical research 38, 531-548, 2021 | 29 | 2021 |
Evaluation of super refined™ polysorbate 20 with respect to polysorbate degradation, particle formation and protein stability N Doshi, R Fish, K Padilla, S Yadav Journal of pharmaceutical sciences 109 (10), 2986-2995, 2020 | 25 | 2020 |
Evaluating a modified high purity polysorbate 20 designed to reduce the risk of free fatty acid particle formation N Doshi, K Ritchie, T Shobha, J Giddings, K Gregoritza, R Taing, ... Pharmaceutical Research 38, 1563-1583, 2021 | 13 | 2021 |
Dissolution of polysorbate 20 degradation related free fatty acid particles in intravenous bag solutions N Doshi, K Rutherford, A Najjar Journal of Pharmaceutical Sciences 110 (2), 687-692, 2021 | 10 | 2021 |
A mechanistic understanding of monoclonal antibody interfacial protection by hydrolytically degraded polysorbate 20 and 80 under IV bag conditions A Kannan, J Giddings, S Mehta, T Lin, A Tomlinson, K Ritchie, I Shieh, ... Pharmaceutical Research 39 (3), 563-575, 2022 | 7 | 2022 |
Impact of silicone oil on free fatty acid particle formation due to Polysorbate 20 degradation R Fish, J Lin, N Doshi Pharmaceutical Research 37, 1-15, 2020 | 7 | 2020 |
Formulation mitigations for particle formation induced by enzymatic hydrolysis of polysorbate 20 in protein-based drug products: insights from a full-factorial longitudinal study IH Yuk, T Koulis, N Doshi, K Gregoritza, C Hediger, V Lebouc-Haefliger, ... AAPS Open 8 (1), 18, 2022 | 5 | 2022 |
Polysorbate Mixtures Having Modified Fatty Acid Ester Distribution S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava US Patent App. 18/495,374, 2024 | | 2024 |
Polysorbate mixtures having modified fatty acid ester distribution S Yadav, N Doshi, T Shobha, A Tomlinson, A Srivastava US Patent 11,833,206, 2023 | | 2023 |