Dose dumping of modified-release solid oral dosage forms
Authors:
Tomáš Bílik; Miroslava Pavelková; Kateřina Kubová; Jakub Vysloužil
Published in the journal:
Čes. slov. Farm., 2022; 71, 251-258
Category:
Přehledy a odborná sdělení
doi:
https://doi.org/https://doi.org/10.5817/CSF2022-5-251
Summary
The presented review article is a compilation of several foreign reviews and experimental papers, as well as several authority guidelines, which deal with the phenomenon of dose dumping of solid dosage forms with modified drug release. The aim of the publication is to present this often-neglected issue to a wider domestic audience. The work deals with two basic types of dose dumping, i.e., alcohol-induced dose dumping and food-induced dose dumping. It contains basic factors affecting this phenomenon as well as possible formulation solutions that can be used to eliminate it. Last but not least, the current requirements of the authorities are also mentioned, especially for testing newly introduced products with the presumed potential risk of dose dumping.
Keywords:
alcohol – dose dumping – modified release – modified release dosage forms
Zdroje
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