Biorelevant in-vitro performance testing of orally administered dosage forms

2012 ◽  
Vol 64 (7) ◽  
pp. 919-930 ◽  
Author(s):  
Christos Reppas ◽  
Maria Vertzoni
2014 ◽  
Vol 31 (7) ◽  
pp. 1867-1876 ◽  
Author(s):  
Christos Reppas ◽  
Horst-Dieter Friedel ◽  
Amy R. Barker ◽  
Lucinda F. Buhse ◽  
Todd L. Cecil ◽  
...  

2016 ◽  
Vol 13 (5) ◽  
pp. 1688-1698 ◽  
Author(s):  
Abdulmalik Alqurshi ◽  
Zahrae Kumar ◽  
Rebecca McDonald ◽  
John Strang ◽  
Asma Buanz ◽  
...  

Pharmaceutics ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 2007
Author(s):  
Marc-Phillip Mast ◽  
Harshvardhan Modh ◽  
Julian Knoll ◽  
Elena Fecioru ◽  
Matthias G. Wacker

Currently, a wide variety of complex non-oral dosage forms are entering the global healthcare market. Although many assays have been described in recent research, harmonized procedures and standards for testing their in vitro performance remain widely unexplored. Among others, dialysis-based techniques such as the Pharma Test Dispersion Releaser are developed for testing the release of drugs from nanoparticles, liposomes, or extracellular vesicle preparations. Here, we provide advanced strategies and practical advice for the development and validation of dialysis-based techniques, including documentation, analysis, and interpretation of the raw data. For this purpose, key parameters of the release assay, including the hydrodynamics in the device at different stirring rates, the selectivity for particles and molecules, as well as the effect of excipients on drug permeation were investigated. At the highest stirring rate, a more than twofold increase in the membrane permeation rate (from 0.99 × 10−3 to 2.17 × 10−3 cm2/h) was observed. Additionally, we designed a novel computer model to identify important quality parameters of the dialysis experiment and to calculate error-corrected release profiles. Two hydrophilic creams of diclofenac, Voltaren® Emulgel, and Olfen® gel, were tested and provide first-hand evidence of the robustness of the assay in the presence of semisolid dosage forms.


2007 ◽  
Vol 25 (5) ◽  
pp. 1186-1192 ◽  
Author(s):  
Anne H. de Boer ◽  
Jeroen Wissink ◽  
Paul Hagedoorn ◽  
Iwan Heskamp ◽  
Wilbur de Kruijf ◽  
...  

ASAIO Journal ◽  
2012 ◽  
Vol 58 (4) ◽  
pp. 420-425 ◽  
Author(s):  
Ralf Borchardt ◽  
Peter Schlanstein ◽  
Ilona Mager ◽  
Jutta Arens ◽  
Thomas Schmitz-Rode ◽  
...  

2019 ◽  
Vol 26 (3) ◽  
pp. 28-37
Author(s):  
Elena Fecioru ◽  
Martin Klein ◽  
Johannes Krämer ◽  
Matthias G. Wacker

2018 ◽  
Vol 42 (8) ◽  
pp. 1334-1341 ◽  
Author(s):  
Suvajyoti Guha ◽  
Nivetita Ravi ◽  
Joshua S. Silverstein ◽  
Jeffrey Cooper ◽  
Matthew R. Myers

2018 ◽  
Vol 25 (3) ◽  
pp. 6-18 ◽  
Author(s):  
Andreea Floroiu ◽  
Martin Klein ◽  
Johannes Krämer ◽  
Claus-Michael Lehr

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