In vitro dissolution/release methods for mucosal delivery systems
| Autor: | Željka Vanić, Jelena Filipović-Grčić, Anita Hafner, Mario Jug, Biserka Cetina-Čižmek, Jasmina Lovrić, Ivan Pepić, Maja Lusina Kregar |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
In vitro dissolution
Medicine (miscellaneous) 02 engineering and technology Drug action Pharmacology ocular drug delivery 030226 pharmacology & pharmacy Dosage form nasal drug delivery 03 medical and health sciences 0302 clinical medicine In vivo Pharmacology (medical) Dissolution testing General Pharmacology Toxicology and Pharmaceutics Chemistry lcsh:RM1-950 oromucosal drug delivery In vitro dissolution/release test rectal drug delivery vaginal drug delivery 021001 nanoscience & nanotechnology System characteristics lcsh:Therapeutics. Pharmacology Chemistry (miscellaneous) Drug delivery 0210 nano-technology Release methods Biomedical engineering |
| Zdroj: | ADMET and DMPK, Vol 5, Iss 3, Pp 173-182 (2017) ADMET and DMPK Volume 5 Issue 3 |
| ISSN: | 1848-7718 |
| DOI: | 10.5599/admet.5.3.425 |
| Popis: | In vitro dissolution/release tests are an indispensable tool in the drug product development, its quality control and the regulatory approval process. Mucosal drug delivery systems are designed to provide both local and systemic drug action following ocular, nasal, oromucosal, vaginal or rectal administration. They exhibit significant differences in formulation design, physicochemical characteristics and drug release properties. Therefore it is not possible to devise a single method which would be suitable for release testing of such versatile and complex dosage forms. Different apparatuses and techniques for in vitro release testing for mucosal delivery systems considering the specific conditions at the administration site are described. In general, compendial apparatuses and methods should be used as a first approach in method development when applicable. However, to assure adequate simulation of conditions in vivo, novel biorelevant in vitro dissolution/release methods should be developed. Equipment set up, the selection of dissolution media and volume, membrane type, agitation speed, temperature, and assay analysis technique need to be carefully defined based on mucosal drug delivery system characteristics. All those parameters depend on the delivery system and physiological conditions at the site of application and may vary in a wide range, which will be discussed in details. |
| Databáze: | OpenAIRE |
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