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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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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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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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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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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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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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A mechanistic framework for predicting tablet disintegration: Integrating the Representative Capillary Evolution

Jongmin Lee1, Jessica Hancock1, Daniel J Goodwin2

  • 1Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, Cambridge CB3 0AS, UK.

International Journal of Pharmaceutics
|October 15, 2025
PubMed
Summary

Predicting pharmaceutical tablet disintegration is now possible with a new framework. This approach combines advanced imaging and computational models to link material properties and processing to drug release performance.

Keywords:
DissolutionLiquid transportMechanistic modelPorosityPredictive modellingProcess Analytical Technology (PAT)Quality by Design (QbD)Representative CapillarySwellingTablet disintegrationTerahertz Pulsed Imaging (TPI)

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Area of Science:

  • Pharmaceutical Sciences
  • Computational Modeling
  • Materials Science

Background:

  • Tablet disintegration is crucial for drug release but difficult to predict.
  • Current methods lack mechanistic understanding of complex disintegration processes.

Purpose of the Study:

  • To develop a novel, mechanistically grounded framework for predicting immediate-release tablet disintegration.
  • To integrate experimental data with computational models for a comprehensive approach.

Main Methods:

  • Utilized Terahertz Pulsed Imaging (TPI) for real-time monitoring of liquid transport and matrix erosion.
  • Employed the Representative Capillary Evolution Model (RCEM) and Dynamic Void Fraction Evolution Model (DVFEM).
  • Integrated models using a Representative Capillary (RC) concept and proposed an iterative calibration strategy.

Main Results:

  • The framework successfully links Critical Material Attributes (CMAs) and Critical Processing Parameters (CPPs) to disintegration.
  • Demonstrated a method to account for simultaneous matrix erosion and liquid transport kinetics.
  • Showcased the potential for machine learning enhancement in model calibration.

Conclusions:

  • The developed framework provides a pathway to predict tablet disintegration behavior.
  • This approach aligns with Quality by Design (QbD) principles.
  • The framework has the potential to accelerate pharmaceutical formulation development and improve drug product performance.