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

PLoS One. 2021 Apr 27;16(4):e0250599. doi: 10.1371/journal.pone.0250599. eCollection 2021.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Capsules / chemistry
  • Capsules / therapeutic use
  • Chemistry, Pharmaceutical*
  • Chromatography, High Pressure Liquid
  • Dietary Supplements*
  • Excipients / chemistry
  • Excipients / therapeutic use
  • Genistein / chemistry
  • Genistein / therapeutic use*
  • Humans
  • Therapeutic Equivalency

Substances

  • Capsules
  • Excipients
  • Genistein

Grants and funding

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), and received salary from R.G.C.C., which funded this study. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.