| abstract |
The present invention relates to the preparation and therapeutic use of aqueous solutions of Progesterone or Testosterone, complexed with hydroxypropyl-β-cyclodextrin (HPβCD) suitable for oral administration. The solutions are characterized by a specific molar ratio between HPβCD and the hormones to ensure high plasma hormone levels, following oral administration, by optimizing their solubility, permeability, metabolic stability and ultimately their bioavailability. The formulation subject of this patent can achieve effective plasma concentrations following oral administration of lower doses of hormone in relation to oral formulations currently marketed (e.g. Prometrium, Andriol) for the benefit of greater safety and the compatibility of patients. |