Publication details
Komparativní analýza gastroretentivních vlastností a disolučních profilů originálních a generických tablet s prodlouženým uvolňováním metforminu
| Title in English | Comparative analysis of gastroretentive properties and dissolution profiles of original and generic metformin extended-release tablets |
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| Authors | |
| Year of publication | 2024 |
| Type | Article in Periodical |
| Magazine / Source | Diabetologie, metabolismus, endokrinologie, výživa |
| MU Faculty or unit | |
| Citation | |
| Web | https://www.tigis.cz/images/stories/DMEV/2024/03/DMEV_3_24_info%20Zeman.pdf |
| Keywords | metformin; gastroretention; extended-release; gel layer; dissolution profile; generic substitution |
| Description | Modern drug formulations with extended-release of metformin hydrochloride for the treatment of type 2 diabetes should ensure prolonged gastric retention. Metformin belongs to the class of drugs with a narrow absorption window (duodenum and jejunum), and potential gastroretention of the drug formulation allows for the creation of a gastric reservoir, which gradually releases the drug into the target absorption area. In recent years, several generic extended-release formulations have appeared in our market as well. The aim of this study is therefore to compare the gastroretention capabilities between the original medicinal product and two selected generic products, and also evaluate the influence of different pH levels of the surrounding environment on the dissolution profiles of the samples, to determine any potential impact on the release behavior of metformin. The measured results indicate that despite the bioequivalence studies, these generic products may not have the same in vivo properties, as not all of them use similar technology in tablet formulation, and some of them may therefore lack the necessary gastroretentive properties. Additionally, one generic showed a significant difference in the dissolution profile at higher pH, which could potentially have an impact when taken concurrently with antacids or in the presence of pathological conditions that increase stomach pH. The absence of gastroretention and high pH in the stomach can then negatively affect the therapy. It is therefore necessary to take these facts into account and take extra caution when making a generic substitution. |