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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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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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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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An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules
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An empirical model for dissolution profile and its application to floating dosage forms.

Michael Weiss1, Worawut Kriangkrai2, Srisagul Sungthongjeen2

  • 1Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand; Department of Pharmacology, Martin Luther University Halle-Wittenberg, Halle, Germany.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|March 12, 2014
PubMed
Summary

A novel mathematical model using inverse Gaussian functions accurately describes drug dissolution profiles. This method quantifies theophylline release from floating tablets, aiding in understanding drug delivery processes.

Keywords:
Anti-tacking agentsDissolution modelFloating tabletsInverse Gaussian distributionSustained release

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Area of Science:

  • Pharmaceutical Sciences
  • Pharmacokinetics
  • Mathematical Modeling

Background:

  • In vitro dissolution testing is crucial for predicting drug performance.
  • Accurate modeling of drug release profiles is essential for formulation development.
  • Existing models may lack the flexibility to capture complex dissolution behaviors.

Purpose of the Study:

  • To introduce a flexible empirical model based on the sum of two inverse Gaussian functions for fitting in vitro dissolution data.
  • To apply this model to quantitatively describe theophylline release from effervescent floating tablets.
  • To utilize model parameters for characterizing dissolution behavior and release kinetics.

Main Methods:

  • Development and application of a sum of two inverse Gaussian functions model.
  • Nonlinear regression analysis utilizing mixed-effects modeling for parameter estimation.
  • Quantitative description of theophylline release from multi-layer coated floating tablets with varying anti-tacking agents (talc, glyceryl monostearate).

Main Results:

  • The proposed model successfully fitted the in vitro dissolution profiles of theophylline.
  • Estimated model parameters allowed for the determination of mean dissolution time.
  • Reconstruction of the time course of release rate and fractional release rate provided insights into dissolution processes.

Conclusions:

  • The sum of two inverse Gaussian functions offers a highly flexible and quantitative approach to modeling in vitro dissolution.
  • This modeling strategy can provide valuable diagnostic tools for classifying drug release mechanisms.
  • The approach enhances the understanding of drug release kinetics and formulation performance.