Frank, Derek S Nie, Haichen Chandra, Anagha Coelho, Alexander Dalton, Chad Dvorak, Hannah Elkhabaz, Ahmed Fahy, Mairead Ormes, James Parker, Andrew
...
Published in
Journal of pharmaceutical sciences
Amorphous solid dispersions (ASDs) are an attractive option to improve the bioavailability of poorly water-soluble compounds. However, the material attributes of ASDs can present formulation and processability challenges, which are often mitigated by the addition of excipients albeit at the expense of tablet size. In this work, an ASD manufacturing...
Stocker, Michael W Tsolaki, Evangelia Harding, Matthew J Healy, Anne Marie Ferguson, Steven
Published in
Journal of pharmaceutical sciences
The addition of non-active components at the point of active pharmaceutical ingredient (API) isolation by means of co-processing is an attractive approach for improving the material properties of APIs. Simultaneously, there is increased interest in the pharmaceutical industry in continuous manufacturing processes. These often consist of liquid feed...
Janssen, Pauline H M Bastiaansen, Marly Buijvoets, Lisa B Frijlink, Henderik W
Published in
Journal of pharmaceutical sciences
The specifications of excipients are important to pharmaceutical manufacturers to ensure that the final product can be manufactured robustly over the entire lifecycle of a drug product. Particle size specifications are key for dry powder inhalation excipients and they should be agreed between users and suppliers. The current paper evaluates two dev...
Arellano, Helena Nardello-Rataj, Véronique Szunerits, Sabine Boukherroub, Rabah Fameau, Anne-Laure Fameau, Anne-Laure
The spread of new strains of antibiotic-resistant pathogenic microorganisms has led to the urgent need to discover and develop new antimicrobial systems. The antibacterial effects of fatty acids have been well-known and recognized since the first experiments of Robert Koch in 1881, and they are now used in diverse fields. Fatty acids can prevent th...
Myślińska, Monika Stocker, Michael W Ferguson, Steven Healy, Anne Marie
Published in
Journal of pharmaceutical sciences
Co-processing of APIs, the practice of creating multi-component APIs directly in chemical processing facilities used to make drug substance, is gaining increased attention with a view to streamlining manufacturing, improving supply chain robustness and accessing enhanced product attributes in terms of stability and bioavailability. Direct co-precip...
Erdemir, Deniz Gawel, John Yohannes, Bereket Yates, Phillip Tang, Dan Ha, Khan Breza, Brian DiMaso, Elyse Abebe, Admassu Zombek, Jessica
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Published in
Journal of pharmaceutical sciences
Continuous direct compression (CDC) of solid oral dosage forms requires materials exhibiting acceptable flow and compression properties. The desired active pharmaceutical ingredient (API) powder properties can be difficult to achieve through conventional particle engineering approaches, such as particle size and habit modification during crystalliz...
Jakaria, Sardar M Budil, David E Murtagh, James
Published in
Journal of pharmaceutical sciences
The degradation kinetics of the glycopeptide antibiotic dalbavancin in solution are systematically evaluated over the pH range 1-12 at 70°C. The decomposition rate of dalbavancin was measured as a function of pH, buffer composition, temperature, ionic strength, and drug concentration. A pH-rate profile was constructed using pseudo first-order kinet...
Mieczkowski, Carl A
Published in
Journal of pharmaceutical sciences
It has been nearly four decades since the first therapeutic monoclonal antibodies were approved and made available for widespread human use. Herein, US and EU approved antibody formulations are reviewed, and their nature and compositions are evaluated over time. From 1986 through Jan 2023, significant formulation trends have occurred and to represe...
Niederquell, Andreas Stoyanov, Edmont Kuentz, Martin
Published in
Journal of pharmaceutical sciences
Phosphate buffer is predominantly used instead of the more physiological bicarbonate buffer, as the latter requires a technical solution of adequate gas mixing. Recent pioneering work on how bicarbonate buffer affected drug supersaturation revealed interesting effects that call for more mechanistic understanding. Therefore, this study used hydroxyp...
Bajoria, Sakshi Antunez, Lorena R Kumru, Ozan S Klempner, Mark Wang, Yang Cavacini, Lisa A Joshi, Sangeeta B Volkin, David B
Published in
Journal of pharmaceutical sciences
Enterotoxigenic Escherichia coli (ETEC) is a common cause for diarrheal infections in children in low- and middle-income countries (LMICs). To date, no ETEC vaccine candidates have been approved. Passive immunization with low-cost, oral formulations of secretory IgA (sIgA) against ETEC is an alternative approach to protect high-risk populations in ...
