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

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.

SUBMITTER: Mamagkaki A

PROVIDER: S-EPMC8078810 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundOver 50% of adults currently use dietary supplements (DS) but manufacturers do not have to prove the safety or efficacy of a DS before it is marketed. Therefore, consumers may be exposed to inaccurate DS information, may lack confidence in choosing appropriate DS and may seek advice for usage. The objective of this study was to examine trends in usage, attitudes, and sources of information regarding DS according to geographic location, demographic group, and lifestyle choices.MethodsEligible individuals completed a 10-item researcher-developed survey tool to determine DS use, sources of DS information, and DS-related knowledge and attitudes over the previous year. Healthy participants (637 individuals aged 21-75 years) from two population-based cohorts that had been recruited for lipoprotein assessment studies at Tufts University in Boston, Massachusetts and University of California at Davis. Outcome measures included participants' use, beliefs regarding essentiality of DS, confidence in choosing appropriate DS, and sources of information on DS. Univariate and multivariate logistic regression were utilized to examine differences in survey responses between groups.ResultsOf the total population 72.7% reported taking dietary supplements in the previous year. Those living on the West Coast (80.3%) had greater use than those living on the East Coast (60.7%). Those on the East Coast were more likely to believe DS were essential to health (48.7%) and to feel confident in choosing DS that were appropriate for them (51.0%). Overall, physicians were the most frequent source of DS information for more than 50% of participants on both coasts.ConclusionBecause DS usage is widespread, health care providers and nutrition educators must encourage patients to discuss their DS use and be equipped to provide information conducive to safe, efficacious consumption. Tailoring interventions for healthcare providers, media sources, industry, and the public may allow for dissemination of up-to-date information regarding DS.

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

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