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Publikováno v:
Journal of Pharmaceutical Sciences. 110:1718-1726
The solid-state diversity of active pharmaceutical ingredients can provide theoretical guidance for the production and storage of drugs. In this study, three solid forms of glipizide were obtained through various methods, and the solid-state transfor
Autor:
Renuka Thirumangalathu, Vineet Kumar, Sandeep Somani, Danika Rodrigues, Laura M. Tanenbaum, Kai Zhang, Santosh V. Thakkar, Ketan Amin
Publikováno v:
Journal of Pharmaceutical Sciences. 110:1077-1082
Developing ultra-high concentration biotherapeutics drug products can be challenging due to increased viscosity, processing, and stability issues. Excipients used to alleviate these concerns are traditionally evaluated at lower protein concentrations
Autor:
Ragna Berthelsen, Korbinian Löbmann, Nele-Johanna Hempel, Matthias Manne Knopp, Flemming Morsch
Publikováno v:
Journal of Pharmaceutical Sciences. 110:155-163
Microwave-induced in situ amorphization is a promising approach to circumvent stability and manufacturing issues associated with amorphous solid dispersions (ASD). Using in situ amorphization, the crystalline state of the drug is converted into its a
Publikováno v:
Journal of Pharmaceutical Sciences. 109:1008-1019
For successful formulation of amorphous solid dispersions (ASDs) using hot-melt extrusion, it is imperative to understand the effect that heat and shear rate has on the physicochemical properties of the excipient. In this study, we investigated the i
Autor:
Jinjiang Li, Swathi Pinnamaneni, Ramesh K. Ramakrishnan, Junshu Zhao, Mario Hubert, Sergei Nazarenko, Li Tao, Shasad Sharif
Publikováno v:
Journal of Pharmaceutical Sciences. 109:1050-1058
The effect of vapor sorption on the free volume of drug-polymer spray-dried dispersions (SDDs) was investigated, along with the crystallization propensity of drug molecules in SDDs after exposure to humidity. Subsequently, the correlation of free vol
Publikováno v:
J Pharm Sci
Reconstitution of lyophilized disaccharide formulations results in the formation of nano-sized air bubbles that persist in suspension for weeks. If proteins are present, interactions with nanobubbles may cause loss of monomeric protein and formation
Publikováno v:
Journal of Pharmaceutical Sciences. 108:3272-3280
The present study investigated the impact of solid-state disorders generated during milling on the chemical reactivity of simvastatin. An amorphous and a partially crystalline simvastatin powders were generated via cryomilling simvastatin crystals fo
Autor:
Bradley D. Morrical, Martin W. Jetzer
Publikováno v:
Journal of Pharmaceutical Sciences. 108:2949-2963
The accumulation of electrostatic charge on drug particles and excipient powders arising from interparticulate collisions or contacts with other surfaces can lead to agglomeration and adhesion problems during the manufacturing process, filling, and d
Autor:
Lihua Huang, Steven J. Thomas, Tingting Wang, Natarajan Rajagopalan, Ning Wang, Matthew Clemens, Markham Aaron Paul
Publikováno v:
Journal of Pharmaceutical Sciences. 108:1264-1271
Poloxamer 188 (P188) is a triblock copolymer of the form polyethylene oxide-polypropylene oxide-polyethylene oxide (PEO-PPO-PEO). The center PPO block is hydrophobic, and the side PEO blocks are hydrophilic, resulting in surface-active properties. P1
Publikováno v:
Journal of Pharmaceutical Sciences. 107:2514-2518
Macrolide antibiotics are widely used at clinical sites. Clarithromycin (CAM), a 14-membered macrolide antibiotic, was reported to gelate under acidic conditions. Gelation allows oral administration of acid-sensitive CAM without enteric coating by hi