TY  - JOUR
A1  - Mast, Marc-Phillip
A1  - Modh, Harshvardhan
A1  - Knoll, Julian
A1  - Fecioru, Elena
A1  - Wacker, Matthias
T1  - An update to dialysis-based drug release testing - data analysis and validation using the pharma test dispersion releaser
T2  - Pharmaceutics
N2  - 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.
KW  - nanomedicine
KW  - release testing
KW  - dialysis
KW  - semisolids
KW  - validation
KW  - liposomes
KW  - creams
KW  - topical formulations
KW  - dissolution
KW  - drug release
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/75469
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-754699
SN  - 1999-4923
VL  - 13
IS  - 12, art. 2007
PB  - MDPI
CY  - Basel
ER  -