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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Physical Chemistry

Background:

  • Highly supersaturated solutions of poorly water-soluble drugs can undergo liquid-liquid phase separation (LLPS).
  • LLPS is believed to enhance drug bioavailability, particularly during the dissolution of amorphous solid dispersions (ASDs).

Purpose of the Study:

  • To evaluate drug absorption behaviors using a novel high surface area, flow-through absorptive dissolution testing apparatus.
  • To investigate the influence of LLPS on the dissolution and absorption of ASDs.
  • To compare the performance of the absorptive dissolution apparatus with traditional closed-compartment dissolution testing.

Main Methods:

  • Development and utilization of a high surface area, flow-through absorptive dissolution testing apparatus.
  • Evaluation of drug absorption from solutions with varying supersaturation levels.
  • Simultaneous dissolution-absorption testing of ASDs with different drug loadings and polymer types.

Main Results:

  • The absorptive compartment significantly influenced ASD dissolution rates, particularly at high drug loadings.
  • Formation of drug-rich nanodroplets during dissolution enhanced drug transfer across the membrane.
  • Increased drug concentration above amorphous solubility correlated with enhanced mass transfer and more drug-rich particles.

Conclusions:

  • The novel absorptive dissolution apparatus provides more in vivo relevant conditions for formulation testing.
  • Including an absorptive compartment in dissolution testing is crucial for coupling dissolution with membrane transport.
  • This method allows for more meaningful comparisons of different formulations, especially those undergoing LLPS.