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Related Concept Videos

Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model01:09

Theories of Dissolution: The Danckwerts' Model and Interfacial Barrier Model

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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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Theories of Dissolution: Diffusion Layer Model01:15

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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Predictive dissolution modeling across USP apparatuses I, II, and III.

Alexander M Kubinski1, Ricardo D Sosa1, Gayathri Shivkumar2

  • 1Product Development, Science & Technology, Operations, AbbVie Inc., North Chicago, IL 60208, United States.

Journal of Pharmaceutical Sciences
|March 19, 2025
PubMed
Summary
This summary is machine-generated.

This study characterizes dissolution apparatus III, developing a predictive dissolution model (PDM) that scales drug release kinetics across USP apparatuses I, II, and III, enhancing formulation development.

Keywords:
1-D ModelApparatus IApparatus IIApparatus IIICFDDissolutionHydrodynamicsKineticsMass Transport

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Computational Pharmaceutics

Background:

  • Dissolution testing is crucial for in vitro drug release characterization of oral dosage forms.
  • USP apparatuses I and II are common, with existing predictive dissolution modeling (PDM) tools.
  • USP apparatus III, offering higher agitation and multivessel capabilities, lacks characterized physics for PDM.

Purpose of the Study:

  • To characterize the transport physics and thermodynamics of dissolution apparatus III.
  • To establish and validate a 1-D predictive dissolution model (PDM) for apparatus III.
  • To enable scaling of release kinetics across USP apparatuses I, II, and III.

Main Methods:

  • Characterization of transport physics and thermodynamics for dissolution apparatus III.
  • Development and validation of a 1-D PDM.
  • Calibration using dissolution experiments at varied agitation levels; validation with erosion-based formulations.

Main Results:

  • A validated 1-D PDM was established, successfully scaling release kinetics with agitation.
  • The model predicts drug release across apparatuses I, II, and III using calibration data from any combination.
  • Apparatus III vessel residence time analysis was demonstrated.

Conclusions:

  • The developed PDM effectively bridges the knowledge gap for dissolution apparatus III.
  • This model enhances predictive capabilities for solid oral dosage form development across multiple USP apparatuses.
  • The approach allows for robust prediction of drug release kinetics within defined design spaces.