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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Various dissolution theories provide insight into the factors that influence the dissolution rate. Danckwerts' Model suggests that turbulence, rather than a stagnant layer, characterizes the dissolution medium at the solid-liquid interface. In this model, the agitated solvent contains macroscopic packets that move to the interface via eddy currents, facilitating the absorption and delivery of the drug to the bulk solution. The regular replenishment of solvent packets maintains the...
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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
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Anomalous Water-Sorption Kinetics in ASDs.

Dominik Borrmann1, Andreas Danzer1, Gabriele Sadowski1

  • 1Laboratory of Thermodynamics, Department of Chemical and Biochemical Engineering, TU Dortmund University, Emil-Figge-Str. 70, 44227 Dortmund, Germany.

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Anomalous water sorption in amorphous solid dispersions (ASDs) is due to slow polymer swelling. A diffusion-relaxation model accurately predicted this behavior, revealing more pronounced effects in ASDs than in pure polymers.

Keywords:
ASDsdiffusionrelaxationswelling controlledwater-sorption kinetics

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Area of Science:

  • Materials Science
  • Physical Chemistry
  • Pharmaceutical Sciences

Background:

  • Anomalous water-sorption kinetics in amorphous solid dispersions (ASDs) are primarily attributed to the slow swelling of the polymer matrix.
  • Understanding these kinetics is crucial for predicting drug release from ASDs.

Purpose of the Study:

  • To predict the anomalous water-sorption kinetics in poly(vinyl-pyrrolidone)-co-vinyl-acetate (PVPVA) and indomethacin (IND) ASDs using a diffusion-relaxation model.
  • To elucidate the underlying mechanisms causing anomalous water sorption in these ASDs.

Main Methods:

  • Utilized a diffusion-relaxation model incorporating the Williams-Landel-Ferry (WLF) and Arrhenius equations.
  • Model predictions were based on the viscosities of pure PVPVA, pure IND, and water-sorption kinetics of pure PVPVA.
  • Compared model predictions with experimental data for qualitative and quantitative agreement.

Main Results:

  • The diffusion-relaxation model successfully predicted various types of anomalous water-sorption behavior in ASDs.
  • ASDs exhibited more pronounced anomalous two-stage water-sorption than pure PVPVA.
  • Higher viscosity of glassy ASD-water mixtures compared to PVPVA-water mixtures was identified as the cause for slower swelling.

Conclusions:

  • The developed modeling approach accurately captures anomalous water-sorption kinetics in ASDs.
  • The study highlights the significant impact of polymer swelling dynamics on water sorption in ASDs.
  • This modeling strategy can be applied to predict diffusion- or swelling-controlled drug release from ASDs.