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Green Tea Catechins Decrease Solubility of Raloxifene In Vitro and Its Systemic Exposure in Mice.

Victoria O Oyanna1, Baron J Bechtold1, Katherine D Lynch1

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Area of Science:

  • Pharmacology and Drug Metabolism
  • Natural Products Chemistry

Background:

  • Green tea is a popular beverage with known interactions with drug metabolism.
  • A previous clinical study indicated green tea reduces systemic exposure to raloxifene by 34-43%.

Purpose of the Study:

  • To investigate if altered raloxifene solubility is the mechanism behind reduced systemic exposure after green tea consumption.
  • To assess the impact of green tea constituents on raloxifene solubility in simulated intestinal fluids.

Main Methods:

  • Assessed the effect of green tea extract, EGCG, and EGC on raloxifene solubility in fasted (FaSSIF) and fed (FeSSIF) state simulated intestinal fluids.
  • Evaluated changes in micelle size in FaSSIF and FeSSIF.
  • Conducted a mouse study to determine the effect of green tea extract and EGCG on raloxifene systemic exposure (Cmax and AUC).

Main Results:

  • (-)-Epigallocatechin gallate (EGCG) significantly decreased raloxifene solubility by 78% in FaSSIF, increasing micelle size.
  • (-)-Epigallocatechin (EGC) showed a minor decrease in solubility (13%) without affecting micelle size.
  • Raloxifene solubility was 3.4-fold higher in FeSSIF, and unaffected by green tea extract or EGCG.
  • In mice, green tea extract reduced raloxifene Cmax by 44%, while EGCG had no significant effect on Cmax or AUC.

Conclusions:

  • Flavan-3-gallate catechins, like EGCG, can reduce the solubility of poorly water-soluble drugs such as raloxifene.
  • This decreased solubility, particularly in the fasted state, may explain the reduced systemic exposure observed in clinical studies.
  • The findings highlight the importance of considering beverage-drug interactions in pharmaceutical research and clinical practice.