Article
Pharmacology & Pharmacy
Daniela Fiedler, Carolina Alva, Joana T. Pinto, Martin Spoerk, Ramona Jeitler, Eva Roblegg
Summary: This study investigated a flexible method for the production of biologics using inkjet printing and vacuum drying to stabilize the products. The addition of a surfactant was found to improve the printability and stability of the formulations. The investigated formulations showed no significant protein aggregation after drying and achieved the targeted dose after reconstitution.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Chemistry, Multidisciplinary
Patrick Bonnick, John Muldoon
Summary: Over the past 15 years, significant advancements in the Li+ conductivity of inorganic solid electrolytes have rekindled interest in solid state batteries, specifically with the aim of realizing the lithium metal anode. However, the problem of lithium dendrite penetration through solid electrolytes still persists. Recent research suggests that the low self-diffusion rate of Li-0, along with lithium plating/stripping hot spots, is the primary cause of lithium penetration. Various approaches have been attempted to mitigate this issue. Additionally, solid-state cathodes face challenges related to crack formation due to the expansion and contraction of the active material. Soft electrolytes, such as composite electrolytes, may offer some relief. This article explores the challenges faced by solid state cells, the attempted solutions, and the most promising paths towards success.
ENERGY & ENVIRONMENTAL SCIENCE
(2022)
Review
Chemistry, Medicinal
Klaus Wuchner, Linda Yi, Cyrille Chery, Felix Nikels, Friederike Junge, George Crotts, Gianluca Rinaldi, Jason A. Starkey, Karoline Bechtold-Peters, Melissa Shuman, Michael Leiss, Michael Jahn, Patrick Garidel, Rien de Ruiter, Sarah M. Richer, Shawn Cao, Sebastian Peuker, Sylvain Huille, Tingting Wang, Virginie Le Brun
Summary: This article summarizes the industry practices of using Polysorbate (PS) 20 and 80, the main surfactants for stabilizing biopharmaceutical products, based on a confidential survey and discussions by 16 globally acting major biotechnology companies. Part 1 focuses on the current practice and use of PS, including its stability, routine quality control testing, and regulatory aspects. Part 2 focuses on understanding, monitoring, predicting, and mitigating PS degradation pathways to propose an effective control strategy, which is supported by the survey results and extensive cross-company discussions.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Chemistry, Multidisciplinary
Melissa A. Pegues, Karol Szczepanek, Faruk Sheikh, Seth G. Thacker, Baikuntha Aryal, Mohamed K. Ghorab, Steven Wolfgang, Raymond P. Donnelly, Daniela Verthelyi, V. Ashutosh Rao
Summary: The fatty acid composition of polysorbate 80 may promote sub-visible particulate formation under stress conditions, but does not directly impact protein aggregation or biological activity.
PHARMACEUTICAL RESEARCH
(2021)
Article
Medicine, Research & Experimental
Kevin B. Vargo, Patrick Stahl, Brian Hwang, Erica Hwang, Daniel Giordano, Peyton Randolph, Christina Celentano, Robert Hepler, Ketan Amin
Summary: The research aimed to investigate whether the interfacial properties of proteins could predict the surfactant formulation requirements for end-to-end stability of drug products, and to determine the minimum surfactant concentration required to prevent particle formation in different diluents through shaking studies.
MOLECULAR PHARMACEUTICS
(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)
Review
Chemistry, Multidisciplinary
Jiaojiao Yang, Dingwei Li, Mengjiao Zhang, Gaolong Lin, Sunkuan Hu, Helin Xu
Summary: The treatment of inflammatory bowel diseases (IBDs) has shifted from small molecule therapies to biologics. Biologics targeting integrins, cytokines, and cell adhesion molecules are the first-line treatments for moderate-to-severe IBDs. Other biologics such as growth factors, antioxidative enzymes, anti-inflammatory peptides, nucleic acids, stem cells, and probiotics have also been explored. However, delivering these biologics poses challenges due to their liable nature. This review summarizes the usage of biologics for IBDs, their challenges in delivery, and potential strategies to overcome these challenges.
JOURNAL OF CONTROLLED RELEASE
(2023)
Article
Environmental Sciences
Lais Frigini Postay, Dandara Silva Cabral, Otavio Arruda Heringer, Luiza Valli Vieira, Lauro Roger de Moraes, Gabrieli Freitas, Levy Carvalho Gomes
Summary: The study found that the use of surfactants T20 and T80 in the anesthesia of Oreochromis niloticus can improve anesthetic effectiveness without significantly increasing toxicity.
ENVIRONMENTAL SCIENCE AND POLLUTION RESEARCH
(2021)
Article
Chemistry, Multidisciplinary
Nasim Shadmani, Sepehr Gohari, Azin Kadkhodamanesh, Parivash Ghaderinia, Maryam Hassani, Motahare Sharifyrad
Summary: In this study, PCL-T micelles loaded with Curcumin were successfully synthesized and characterized. The results showed that the Cur-loaded PCL-T micelles were more effective than free Cur at the same concentration, and they were able to overcome the delivery obstacles of Cur drug.
Review
Pharmacology & Pharmacy
Solene Masloh, Maxime Culot, Fabien Gosselet, Anne Chevrel, Leonardo Scapozza, Magali Zeisser Labouebe
Summary: Recombinant biological molecules, due to progress in biotechnology and understanding of subcellular processes, have become cutting-edge in biomedical research. They are increasingly used as drugs for various diseases. However, their limited bioavailability when orally delivered has led to the development of accurate models to determine their capacity to cross the intestinal mucosa. Additionally, strategies to enhance their intestinal permeability and stability have been explored.
Article
Infectious Diseases
Maiken Cavling Arendrup, Sevtap Arikan-Akdagli, Mariana Castanheira, Jesus Guinea, Jeffrey B. Locke, Joseph Meletiadis, Oscar Zaragoza
Summary: The study evaluated the application of a modified EUCAST method in Candida isolates, and the results showed that the method significantly reduced inter-laboratory variation, identified wild-type populations, and separated mutants successfully, except for isolates with weak mutations.
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
(2023)
Review
Chemistry, Medicinal
Klaus Wuchner, Linda Yi, Cyrille Chery, Felix Nikels, Friederike Junge, George Crotts, Gianluca Rinaldi, Jason A. Starkey, Karoline Bechtold-Peters, Melissa Shuman, Michael Leiss, Michael Jahn, Patrick Garidel, Rien de Ruiter, Sarah M. Richer, Shawn Cao, Sebastian Peuker, Sylvain Huille, Tingting Wang, Virginie Le Brun
Summary: This study report presents the industry practices, stability, and regulatory aspects of polysorbates in biopharmaceutical products, comparing the findings with available scientific literature. The upcoming second part of the report will focus on exploring the degradation pathways of polysorbates and developing effective control strategies.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Chemistry, Medicinal
Caterina Riccardi, Dane P. Carlson, Kenneth S. Graham, Mohammed Shameem, Douglas E. Kamen
Summary: The activity of host-cell lipases in monoclonal antibody drug products can lead to degradation of polysorbate 20, a stabilizer in the formulations. This study investigates the impact of decreasing levels of polysorbate 20 on the in-use stability of an intravenous admixture prepared from such a drug product. Experimental approaches were used to determine the minimum level of polysorbate 20 required in the drug product and evaluate the in-use stability of the admixture as polysorbate 20 degrades. The results suggest that although the degradation of polysorbate 20 does not affect the quality attributes of the drug product, the in-use stability of the admixture can be impacted.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Editorial Material
Pharmacology & Pharmacy
Alavattam Sreedhara, Jakob Buecheler, Sebastian Brosig, Danny Chou, Twinkle Christian, Tapan Das, Isabella de Jong, Jonas Fast, Bharat Jagannathan, Annette Medina Morales, Ehab M. Moussa, M. Reza Nejadnik, Indira Prajapati, Allison Radwick, Yusra Rahman, Shubhadra Singh
Summary: This article describes the common approach for surfactant selection and control strategy for protein-based therapeutics, including key studies, common issues, mitigations, and rationale. It focuses on surfactant stabilization, selection strategy, risk identification, mitigation, and control strategy. The article also emphasizes the impact of surfactant material attributes on drug performance.
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
Pharmacology & Pharmacy
Jing Yu, Sachin Dubey, Yogeshvar N. Kalia
EXPERT OPINION ON DRUG DELIVERY
(2018)
Article
Chemistry, Multidisciplinary
S. Dubey, Y. N. Kalia
JOURNAL OF CONTROLLED RELEASE
(2010)
Article
Chemistry, Multidisciplinary
S. Dubey, Y. N. Kalia
JOURNAL OF CONTROLLED RELEASE
(2011)
Article
Chemistry, Multidisciplinary
S. Dubey, Y. N. Kalia
JOURNAL OF CONTROLLED RELEASE
(2014)
Article
Biochemistry & Molecular Biology
Anirban Banerjee, Sachin Dubey, Praveen Kaul, Brajesh Barse, Markus Piotrowski, U. C. Banerjee
MOLECULAR BIOTECHNOLOGY
(2009)
Article
Medicine, Research & Experimental
S. Dubey, R. Perozzo, L. Scapozza, Y. N. Kalia
MOLECULAR PHARMACEUTICS
(2011)
Meeting Abstract
Biochemical Research Methods
S. Dubey, R. Perozzo, L. Scapozza, Y. Kalia
Article
Chemistry, Medicinal
Raj Kumar, Nirjhar Saha, Priyank Purohit, Sanjeev K. Garg, Kapileswar Seth, Vachan S. Meena, Sachin Dubey, Khyati Dave, Rohit Goyal, Shyam S. Sharma, Uttam C. Banerjee, Asit K. Chakraborti
EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY
(2019)
Article
Nanoscience & Nanotechnology
Gautam Singhvi, Siddhanth Hejmady, Vamshi Krishna Rapalli, Sunil Kumar Dubey, Sachin Dubey
DELIVERY OF DRUGS, VOL. 2: Expectations and Realities of Multifunctional Drug Delivery Systems
(2020)
Article
Pharmacology & Pharmacy
S. Dubey, R. Perozzo, L. Scapozza, Y. N. Kalia
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2020)
Proceedings Paper
Computer Science, Theory & Methods
Sachin Dubey, Reena Rani, Saroj Kumari, Neelam Sharma
2013 IEEE INTERNATIONAL CONFERENCE ON EMERGING TRENDS IN COMPUTING, COMMUNICATION AND NANOTECHNOLOGY (ICE-CCN'13)
(2013)
Review
Microbiology
S. Manpreet, S. Sawraj, D. Sachin, S. Pankaj, U. C. Banerjee
MALAYSIAN JOURNAL OF MICROBIOLOGY
(2005)
