Aqueous oral solutions of steroid hormones and hydroxypropyl-beta-cyclodextrin with optimised bioavailability
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United States of America Patent
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May 12, 2020
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Oct 22, 2015
app pub date -
Nov 22, 2013
filing date -
Nov 28, 2012
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Abstract
The present invention concerns the preparation and the therapeutic use of aqueous solutions of Progesterone or Testosterone, complexed with hydroxypropyl-3-cyclodextrin (HPβCD) that are suitable for oral administration. The solutions are characterised by a specific molar ratio between HPβCD and the hormones such as to ensure high hormone plasma levels, following oral administration, thanks to the optimisation of their solubility, permeability, metabolic stability and ultimately, bio availability. The formulation object of the present patent makes it possible to achieve effective plasma concentrations following oral administration of lower doses of hormone with respect to oral formulations currently on the market (e.g. Prometrium, Andriol) to the advantage of greater safety and compliance of the patients.
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