Article
Pharmacology & Pharmacy
Benedykt Kozuch, Johanna Weber, Julia Buske, Karsten Maeder, Patrick Garidel, Tim Diederichs
Summary: A comparative stability study was conducted to investigate the oxidative degradation tendencies of surfactants polysorbate 20 (PS20) and polysorbate 80 (PS80) at different concentrations stored for 48 weeks at varying temperatures. PS80 showed stronger degradation and earlier onset of oxidation compared to PS20, with significantly less oxidative processes observed at higher PS concentrations. Iron impurities, oxygen in the vial headspaces, and the pH values of the formulations were identified as main contributing factors to accelerate PS oxidation.
Article
Chemistry, Analytical
Ling Bai, Yanlan Zhang, Cai Zhang, Yuchen Lu, Zhiguo Li, Gang Huang, Bo Meng
Summary: This study investigated the stability of polysorbate 80 in different formulation buffers used in biopharmaceuticals, aiming to understand the influence of excipients on its degradation. The degradation of polysorbate 80 can affect the quality of drug products and lead to protein aggregation and particle formation. The study used different assays to monitor the degradation trend and found that excipients can impact the kinetics of degradation, with histidine buffer being more prone to degradation than acetate, phosphate, or citrate buffers.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2023)
Article
Pharmacology & Pharmacy
Tim Diederichs, Judith J. Mittag, James Humphrey, Sohnke Voss, Stefan Carle, Julia Buske, Patrick Garidel
Summary: Monoclonal antibodies are widely used in the pharmaceutical industry, but they can be destabilized by various factors, such as hydrophobic interfaces. Polysorbates are commonly used to stabilize these antibodies, but their chemical instability can lead to the formation of particles. In this study, the protective function of different fractions of polysorbate 20 (PS20) was evaluated, and it was found that certain fractions showed superior protection against mechanical-induced stress compared to others. However, further research is needed to understand the specific effects of polysorbates on monoclonal antibodies.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2023)
Article
Chemistry, Medicinal
Nidhi Doshi, Karen Rutherford, Asil Najjar
Summary: The degradation of Polysorbate 20 (PS20) in drug product formulations can lead to the generation of free fatty acids (FFAs) which can form visible and/or sub-visible particles. However, the FFAs particles dissolve immediately upon dilution in intravenous solutions, reducing the risk of these particles being administered to a patient intravenously.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2021)
Article
Chemistry, Multidisciplinary
Nidhi Doshi, Kyle Ritchie, Tamanna Shobha, Jamie Giddings, Kathrin Gregoritza, Rosalynn Taing, Stephen Rumbelow, Jeff Chu, Anthony Tomlinson, Aadithya Kannan, Miguel Saggu, Si Kai Cai, Victor Nicoulin, Wenqiang Liu, Steve Russell, Lin Luis, Sandeep Yadav
Summary: The study evaluated a modified high purity polysorbate 20 (RO HP PS20) with lower levels of certain esters as a surfactant in biopharmaceutical drug products. Results showed that RO HP PS20 delayed the onset of FFA particle formation upon hydrolytic degradation compared to HP PS20.
PHARMACEUTICAL RESEARCH
(2021)
Article
Medicine, Research & Experimental
Hannah Knoch, Maximilian H. Ulbrich, Judith J. Mittag, Julia Buske, Patrick Garidel, Heiko Heerklotz
Summary: Polysorbates are versatile surfactants used for stabilizing biologicals and solubilizing active ingredients. This study characterizes the complex association behavior of two types of Polysorbates, showing that different Polysorbate species gradually enter initial micelles with increasing concentrations. The variation of micelle properties differs between Polysorbate grades and can progress up to at least 10 mM concentration.
MOLECULAR PHARMACEUTICS
(2021)
Article
Pharmacology & Pharmacy
Nils Gluecklich, Stefan Carle, Tim Diederichs, Julia Buske, Karsten Maeder, Patrick Garidel
Summary: Polysorbates are widely used surfactants in biologics, but they can be degraded via enzymatic hydrolysis. This study investigates the impact of specifically hydrolyzed polysorbate 20 on the stabilization of two monoclonal antibodies during accelerated shaking stress conditions and finds that the enzymatic degradation pattern of polysorbate can influence the colloidal stability of biopharmaceutical formulations.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Chemistry, Analytical
Abd al-karim F. Ali, Neil D. Danielson
Summary: A simple and green micellar liquid chromatography method using Tween 20 and Tween 40 as mobile phase modifiers was developed for the separation of hydroxycinnamic acid derivatives. The method showed faster separation and less peak tailing using Tween 20 compared to Tween 40.
Article
Chemistry, Analytical
Christoph A. Paschen, Denis Klemm, Tobias Graf, Robert Kopf, Cosimo Pinto, Claudia Mueller, Christian H. Bell, Janina Pfaff
Summary: Polysorbates and Poloxamer 188 are commonly used surfactants in biopharmaceutical formulations, but recent studies have raised concerns about potential risks associated with their use. A mixed-mode liquid chromatography method was developed to simultaneously determine the content of Polysorbate 20 and Poloxamer 188 in biopharmaceutical formulations, offering a promising approach to address these concerns.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
(2021)
Article
Medicine, Research & Experimental
Ankit D. Kanthe, Miriam R. Carnovale, Joshua S. Katz, Susan Jordan, Mary E. Krause, Songyan Zheng, Andrew Ilott, William Ying, Wei Bu, Mrinal K. Bera, Binhua Lin, Charles Maldarelli, Raymond S. Tu
Summary: This study aimed to investigate the competitive adsorption mechanism between proteins and surfactants, finding that FM1000 saturates the interface faster than PS80 and is more effective in preventing protein adsorption.
MOLECULAR PHARMACEUTICS
(2022)
Article
Engineering, Mechanical
Seyed Abbas Asgari, Reyhaneh Gholami, Mohammad Reza Tavakoli Nejad, Alireza Allafchian, Saleh Akbarzadeh
Summary: This study investigates the effect of adding Reduced Graphene Oxide (RGO) nano-particles to engine base oil (Poly-Alpha-Olefin-PAO) on the thermo-physical properties of a nano-fluid. The addition of surfactants and nano-particles in different concentrations was studied to find the best combination in terms of viscosity, thermal conductivity, and friction coefficient. The results showed that the final nano-fluid exhibited similar viscosity to the base oil, increased thermal conductivity with higher concentration, and significantly reduced friction coefficient compared to base oil and common anti-friction material used in industry.
PROCEEDINGS OF THE INSTITUTION OF MECHANICAL ENGINEERS PART J-JOURNAL OF ENGINEERING TRIBOLOGY
(2023)
Article
Pharmacology & Pharmacy
Patrick Garidel, Michaela Blech, Julia Buske, Alfred Blume
Summary: The study focused on determining the self-association properties of compendial grade polysorbate 20 HP (PS 20 HP) and polysorbate 80 HP (PS 80 HP) regarding micelle size, critical micelle concentration range (cmr), and surface tension. Results showed that PS 80 HP formed larger micelles compared to PS 20 HP, with critical micelle concentration range values (cmr) at 25 degrees Celsius being considerably lower for PS 80 HP. The temperature dependency of the micelle size was more pronounced for PS 80 HP.
JOURNAL OF PHARMACEUTICAL INNOVATION
(2021)
Article
Pharmacology & Pharmacy
Marwa M. R. R. Ayoub, Michael I. Lethem, Alison B. Lansley
Summary: The study found that certain ingredients can increase mucin secretion, potentially affecting mucociliary clearance rate and the clinical efficacy of drugs delivered.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)