Publication details
Příručka pro tvorbu a použití disoluční metody se zřetelem k perorálním léčivým přípravkům s okamžitým uvolňováním
| Title in English | Handbook for development and use dissolution method with respect to the oral medicinal products with immediate release |
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| Authors | |
| Year of publication | 2021 |
| Type | Monograph |
| MU Faculty or unit | |
| Citation | |
| Description | The booklet was created as a manual for the development and use of the dissolution method in the pharmaceutical industry in terms of research, clinical trials, production, and registration of drugs. It contains basic systems for the classification of drugs in terms of their solubility and absorption. Briefly describes the individual steps of the development of the dissolution methods, including an overview of dissolution media (standard and biorelevant), describes the dissolution conditions, and the construction and evaluation of dissolution curves. It also provides an overview of changes in industrial production (composition and technology) in the EU and the US, which can only be done on a dissolution basis. It also provides a basic overview of the most common drug dissolution testing problems and offers ways to solve them. Finally, it provides links to the necessary literature (scientific articles and guidelines), which deals with the issue in detail. |