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

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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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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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Factors Influencing Drug Absorption: Drug Dissolution01:27

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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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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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When drugs are administered extravascularly, a comprehensive evaluation through noncompartmental analysis becomes imperative. This analytical approach considers various parameters that play a crucial role in understanding the pharmacokinetics of these drugs.
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Mathematical models of dissolution testing: Challenges and opportunities toward real-time release testing.

Kensaku Matsunami1, Alexander Ryckaert1, Valérie Vanhoorne2

  • 1Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, Ghent, 9000, Oost-Vlaanderen, Belgium.

International Journal of Pharmaceutics
|December 2, 2024
PubMed
Summary

Mechanistic models offer a promising approach for real-time release testing (RTRt) in pharmaceutical manufacturing. These models require less data and are more interpretable than data-driven methods, potentially reducing RTRt development costs.

Keywords:
Continuous manufacturingFirst principle modelMathematical modelingProcess analytical technologyTablet dissolution

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology (PAT)

Background:

  • Real-time release testing (RTRt) is crucial for efficient pharmaceutical manufacturing, especially with continuous manufacturing.
  • Current RTRt often relies on data-driven models, which can be computationally fast but lack interpretability.
  • Mechanistic models offer broader applicability and interpretability for dissolution testing.

Purpose of the Study:

  • To explore the potential benefits and challenges of applying mechanistic models for RTRt of solid dosage forms.
  • To provide a comprehensive literature review on mechanistic dissolution models and RTRt.

Main Methods:

  • Comprehensive literature review of mechanistic dissolution models and RTRt.
  • Analysis of benefits and challenges of mechanistic models compared to data-driven models.
  • Discussion on computational time requirements for mechanistic model implementation.

Main Results:

  • Mechanistic models require less experimental data, reducing time and cost for RTRt development.
  • Interpretability and broader applicability are key advantages of mechanistic models.
  • Computational efficiency is a critical factor for implementing mechanistic models in RTRt.

Conclusions:

  • Mechanistic models present opportunities for robust and reliable RTRt in pharmaceutical manufacturing.
  • Addressing computational time through simplified models or surrogate modeling is essential for practical RTRt implementation.
  • Further research into mechanistic models can enhance product quality assurance without destructive testing.