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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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, maintaining...
Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

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.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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...
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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

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

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 concentration...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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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Updated: Jul 6, 2026

Continuous Flow Chemistry: Reaction of Diphenyldiazomethane with p-Nitrobenzoic Acid
07:06

Continuous Flow Chemistry: Reaction of Diphenyldiazomethane with p-Nitrobenzoic Acid

Published on: November 15, 2017

Controlled flow-through dissolution methodology: a high-performance system.

Larry E Stevens1, Paul J Missel, Alan L Weiner

  • 1Alcon Research, Ltd., Fort Worth, TX, USA. larry.stevens@alconlabs.com

Pharmaceutical Development and Technology
|April 2, 2008
PubMed
Summary

A novel automated flow-through system enhances the precision and relevance of drug release rate measurements, particularly for challenging sparingly soluble compounds. This method offers significant advantages over traditional compendial techniques for formulation development.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery and Formulation
  • Physical Chemistry

Background:

  • Compendial methods for measuring drug release rates, especially for sparingly soluble compounds, often yield imprecise and biologically irrelevant results.
  • Existing stirred and flow-through systems lack the sensitivity and direct relevance needed for advanced formulation development and pharmacokinetic prediction.

Purpose of the Study:

  • To develop and validate an automated multisample flow-through system for precise drug release rate measurement.
  • To demonstrate the advantages of this new system over conventional compendial methods in terms of precision, relevance, and sensitivity.

Main Methods:

  • Employed a flow-through approach emphasizing convective diffusion and controlled physical-chemical parameters.
  • Developed an automated multisample system for high-throughput analysis.
  • Utilized finite element modeling to simulate the convective diffusion/dissolution process.

Main Results:

  • The automated flow-through system demonstrated superior precision compared to compendial stirred and flow-through methods.
  • Achieved enhanced physicochemical and in vivo relevance, alongside improved analytical and formulation sensitivity.
  • Finite element modeling predictions closely matched experimental measurements, with agreement within a few percent.

Conclusions:

  • The automated multisample flow-through system offers a significant advancement for drug release testing, particularly for challenging formulations.
  • This approach provides more precise, relevant, and sensitive data crucial for effective drug development and optimization.
  • The integration of computational modeling further validates the system's accuracy and predictive power.