Genistein as a dietary supplement; formulation, analysis and pharmacokinetics study

The objective of this study is to improve and optimize the formulation of Genistein in capsules in order to result in a better pharmacokinetic profile comparing to existing commercial products. In order to do this, five different formulations of Genistein capsules were developed and examined by revi...

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Published inPloS one Vol. 16; no. 4; p. e0250599
Main Authors Mamagkaki, Alexandra, Bouris, Ioannis, Parsonidis, Panagiotis, Vlachou, Ioanna, Gougousi, Maria, Papasotiriou, Ioannis
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 27.04.2021
Public Library of Science (PLoS)
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ISSN1932-6203
1932-6203
DOI10.1371/journal.pone.0250599

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Summary:The objective of this study is to improve and optimize the formulation of Genistein in capsules in order to result in a better pharmacokinetic profile comparing to existing commercial products. In order to do this, five different formulations of Genistein capsules were developed and examined by reviewing their disintegration and dissolution properties. Furthermore, flowability of the powder along with potent incompatibilities between Genistein and its excipients were monitored through their thermal properties. The final formulation of Genistein was quantified using HPLC analysis and then its stability was evaluated thoroughly in real time and accelerated conditions. Finally, with the target to have a product with actual results, in vitro and in vivo studies were conducted. The final product proved to have better results in disintegration and dissolution. Moreover, R.G.C.C.’s capsules exhibited enhanced action in human cell lines as well as impressive pharmacokinetic results in animal models. The in vitro results showed an advantage of the R.G.C.C. product compared to the commercial one, whereas its maximum concertation in vivo was determined 34% higher than the commercial one.
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Competing Interests: The authors of this manuscript have read the journal’s policy and have the following competing interests: All the authors are employees of Research Genetic Cancer Centre S.A. (R.G.C.C. S.A.) and/or Research Genetic Cancer Centre International (R.G.C.C. International). There are no patents to declare with the developed product by R.G.C.C. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0250599