Please use this identifier to cite or link to this item: https://doi.org/10.3390/pharmaceutics13122007
Title: An update to dialysis-based drug release testing—data analysis and validation using the pharma test dispersion releaser
Authors: Mast, Marc-Phillip
Modh, Harshvardhan 
Knoll, Julian
Fecioru, Elena
Wacker, Matthias G. 
Keywords: Creams
Dialysis
Dissolution
Drug release
Liposomes
Nanomedicine
Release testing
Semisolids
Semisolids
Topical formulations
Validation
Issue Date: 25-Nov-2021
Publisher: MDPI
Citation: Mast, Marc-Phillip, Modh, Harshvardhan, Knoll, Julian, Fecioru, Elena, Wacker, Matthias G. (2021-11-25). An update to dialysis-based drug release testing—data analysis and validation using the pharma test dispersion releaser. Pharmaceutics 13 (12) : 2007. ScholarBank@NUS Repository. https://doi.org/10.3390/pharmaceutics13122007
Rights: Attribution 4.0 International
Abstract: 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. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.
Source Title: Pharmaceutics
URI: https://scholarbank.nus.edu.sg/handle/10635/233528
ISSN: 1999-4923
DOI: 10.3390/pharmaceutics13122007
Rights: Attribution 4.0 International
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