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Sie suchen in allen Bereichen nach dem Autor Löber D.
In der Rubrik Zeitschriften haben wir 2 Beiträge für Sie gefunden
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MerkenExtractables profile of inner-coated containers for pharmaceutical use
Rubrik: Originale
(Treffer aus pharmind, Nr. 04, Seite 382 (2023))
Zuccato D | Rudigier-Voigt E | Löber D
Extractables profile of inner-coated containers for pharmaceutical use / Zuccato et al. • Inner-coated containers · Zuccato D1, Rudigier-Voigt E2, Löber D1 · 1SCHOTT Pharma AG & Co. KGaA, Mainz (Germany) und SCHOTT AG, Mainz (Germany)
Borosilicate glass Cyclic Olefin Polymers Coated vial Alkaline solution Extractables Advanced characterization Oxygen transmission rate The interaction between drug solution and primary packaging containers should be reduced to a minimum extent [ 4 ] during the entire drug product’s shelf life. Leaching of glass elements can trigger adverse effects such as protein aggregation or drug inactivation that may compromise the treatment efficacy and, therefore, become a significant source of risk especially for highly sensitive biologics [ 5 ]. For this reason, the chemical resistance of the primary packaging represents one of its most relevant properties. Thanks to its high chemical ...
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MerkenOptimizing the Inner Surface of Primary Packaging
Rubrik: Technik
(Treffer aus pharmind, Nr. 09, Seite 1192 (2020))
Rupertus V | Hladik B | Löber D
Optimizing the Inner Surface of Primary Packaging / Siliconization versus PICVD. What is the difference? · Rupertus V, Hladik B, Löber D · SCHOTT Pharmaceutical Systems, Mainz
The trend to focus more and more on biomolecule-based parenterals for drug development opens automatically a far more complex field of interaction processes with the primary packaging container during drug shelf life. Adhesion processes on nanoscale at the inner container surface causing denaturation of the respective molecules as well as dissolved glass elements in the buffer solution lead to a variety of complex interaction processes, also depending on the individual glass compositions available in the market. Type I borosilicate glass, which has been used for decades for nearly all application fields of parenteral pharmaceuticals, has become the gold standard for ...
