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An Update to Dialysis-Based Drug Release Testing-Data Analysis and Validation Using the Pharma Test Dispersion
Marc-Phillip Mast1,2, Harshvardhan Modh3, Julian Knoll2
1Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany.
Pharmaceutics
|December 28, 2021
Summary
This study presents advanced strategies for validating dialysis-based drug release assays for complex non-oral dosage forms. The findings highlight improved methods for analyzing drug permeation and validating assay robustness.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Analytical Chemistry
Background:
- Complex non-oral dosage forms require robust in vitro performance testing methods.
- Harmonized procedures for evaluating drug release from novel formulations like nanoparticles and liposomes are lacking.
- Dialysis-based techniques offer potential for assessing drug release from advanced drug carriers.
Purpose of the Study:
- To provide advanced strategies and practical advice for developing and validating dialysis-based drug release assays.
- To investigate key parameters influencing drug release, including hydrodynamics, membrane selectivity, and excipient effects.
- To introduce a novel computer model for calculating error-corrected release profiles and identifying critical quality parameters.
Main Methods:
- Investigation of hydrodynamics in a dialysis device at varying stirring rates.
- Assessment of membrane selectivity for particles and molecules.
- Evaluation of excipient impact on drug permeation.
- Development and application of a computer model for release profile analysis.
- Testing with hydrophilic diclofenac creams (Voltaren Emulgel, Olfen gel) to demonstrate assay robustness.
Main Results:
- A twofold increase in membrane permeation rate was observed at the highest stirring rate (0.99 × 10^-3 to 2.17 × 10^-3 cm²/h).
- The developed computer model aids in identifying critical quality parameters and calculating corrected release profiles.
- The assay demonstrated robustness when tested with semisolid dosage forms like diclofenac creams.
Conclusions:
- Validated dialysis-based techniques are crucial for the reliable in vitro assessment of complex non-oral drug delivery systems.
- The study provides a framework for assay development, validation, and data interpretation, enhancing reproducibility.
- The novel computer model and demonstrated robustness offer significant advancements for drug release testing methodologies.
Keywords:
creamsdialysisdissolutiondrug releaseliposomesnanomedicinerelease testingsemisolidstopical formulationsvalidationMore Related Videos
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