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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Physical Chemistry

Background:

  • Sildenafil citrate's therapeutic uses have evolved from angina to erectile dysfunction and pulmonary arterial hypertension.
  • As a Biopharmaceutics Classification System Class II drug, sildenafil citrate exhibits low bioavailability due to first-pass metabolism.
  • Optimizing sildenafil citrate's biopharmaceutical profile is crucial for developing advanced drug formulations.

Purpose of the Study:

  • To create and characterize a 1:1 inclusion complex of sildenafil citrate with 2-hydroxypropyl-beta-cyclodextrin.
  • To evaluate the pharmaceutical compatibility of this inclusion complex with six different excipients.
  • To investigate potential chemical interactions between sildenafil citrate and selected excipients.

Main Methods:

  • Complex stoichiometry was determined using molecular modeling, Job's method, and the Benesi-Hildebrand method.
  • Characterization of the inclusion complex and binary mixtures was performed using Attenuated Total Reflectance Fourier-Transform Infrared (ATR-FTIR) spectroscopy.
  • Thermal analysis, including Thermogravimetric (TG/DTG) and Differential Scanning Calorimetry (DSC), was employed to assess thermal stability and interactions.

Main Results:

  • ATR-FTIR confirmed the absence of chemical interactions between the sildenafil citrate inclusion complex and all six excipients at ambient temperature.
  • Thermal analysis (TG/DTG and DSC) revealed chemical interactions between the inclusion complex and three of the excipients under non-isothermal heating conditions.
  • The 1:1 molar ratio inclusion complex formation was successfully validated.

Conclusions:

  • A novel sildenafil citrate and 2-hydroxypropyl-beta-cyclodextrin inclusion complex was successfully prepared and characterized.
  • The inclusion complex demonstrates significant pharmaceutical compatibility with the tested excipients, crucial for preformulation studies.
  • These findings support the development of advanced sildenafil citrate delivery systems with improved biopharmaceutical properties.