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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Comparison of induction methods for supersaturation: Amorphous dissolution versus solvent shift.

Jakob Plum1, Christoffer G Bavnhøj1, Jannik N Eliasen1

  • 1Department of Pharmacy, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
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Summary
This summary is machine-generated.

This study compares solvent shift and amorphous dissolution methods for inducing drug supersaturation. Solvent shift can predict amorphous dissolution outcomes and precipitation inhibition effects of excipients.

Keywords:
AmorphousDissolutionPrecipitation inhibitorsSupersaturation

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Physical Chemistry

Background:

  • Solvent shift is a common method to induce supersaturation and study precipitation kinetics in early drug development.
  • Amorphous dissolution is an alternative method for investigating supersaturation.

Purpose of the Study:

  • To develop and compare a small-scale amorphous dissolution method with the solvent shift method for inducing supersaturation.
  • To investigate the effect of precipitation inhibitors (HPMC, PVP) on tadalafil supersaturation using both methods.
  • To assess the predictability of solvent shift for amorphous dissolution and precipitation inhibition.

Main Methods:

  • Developed a small-scale non-sink amorphous dissolution method.
  • Compared amorphous dissolution and solvent shift for albendazole, felodipine, and tadalafil.
  • Investigated the impact of hydroxypropyl methyl cellulose (HPMC) and polyvinylpyrrolidone (PVP) on tadalafil supersaturation.
  • Analyzed maximum dissolved drug concentration, precipitation rate, and solid form of the precipitate.

Main Results:

  • Solvent shift yielded maximum concentrations of 15.9, 208, and 108 µg/mL for albendazole, felodipine, and tadalafil, respectively.
  • HPMC and PVP increased tadalafil's maximum concentration via solvent shift to 180 µg/mL.
  • Amorphous dissolution achieved maximum concentrations comparable to solvent shift (76.1-102.5% for albendazole, felodipine, tadalafil).
  • Precipitate solid forms were generally consistent between methods, with an exception for tadalafil with HPMC.

Conclusions:

  • The maximum drug concentration achieved via amorphous dissolution can be estimated using the solvent shift method.
  • Precipitation inhibition effects observed with solvent shift can predict outcomes with amorphous dissolution.
  • Both methods are valuable for understanding supersaturation and precipitation in drug development.