Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

375
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...
375
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

340
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...
340
In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

291
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...
291
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

406
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,...
406
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

428
In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
428

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Blood Pressure Assessment in Ophthalmology Clinics for Patients With Diabetes.

JAMA ophthalmology·2026
Same author

From simplicity to complexity: how excipients shape stability and disintegration of immediate-release tablets.

International journal of pharmaceutics·2026
Same author

Ventriculostomy-Related Infections by Country-Income Level: A Systematic Review and Bayesian Hierarchical Meta-analysis.

Journal of neurosurgical anesthesiology·2026
Same author

Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report.

Pharmaceutics·2026
Same author

TIM-1 and Tiny-TIM as Robust In Vitro Models for Oral Biopharmaceutics: Evidence from an International Ring Study.

Pharmaceutics·2026
Same author

When does 1:1 resuscitation really matter? An analysis of 4,858 patients from four traumatic hemorrhage studies.

The journal of trauma and acute care surgery·2026

Related Experiment Video

Updated: Feb 26, 2026

Aerobic Biodegradation Testing of Materials Using a Natural Marine Seawater Inoculum and Closed Loop Respirometer
08:43

Aerobic Biodegradation Testing of Materials Using a Natural Marine Seawater Inoculum and Closed Loop Respirometer

Published on: October 24, 2025

483

Validation of Dissolution Testing with Biorelevant Media: An OrBiTo Study.

James Mann1, Jennifer Dressman2, Karin Rosenblatt3

  • 1Pharmaceutical Technology & Development, AstraZeneca , Macclesfield, U.K.

Molecular Pharmaceutics
|July 25, 2017
PubMed
Summary

Biorelevant dissolution testing using simulated gastrointestinal fluids shows high interlaboratory reproducibility. This method reliably predicts drug release across different labs, even with varying media batches.

Keywords:
FaSSIFOrBiTobiorelevantdissolution testingin vivo predictive testingring studytransfer model

More Related Videos

Author Spotlight: Unraveling the Mysteries of Terrestrial Anaerobic Microorganisms in Uncharted Environments by In Situ Culturing
07:56

Author Spotlight: Unraveling the Mysteries of Terrestrial Anaerobic Microorganisms in Uncharted Environments by In Situ Culturing

Published on: January 12, 2024

1.6K
A Whole Cell Bioreporter Approach to Assess Transport and Bioavailability of Organic Contaminants in Water Unsaturated Systems
13:16

A Whole Cell Bioreporter Approach to Assess Transport and Bioavailability of Organic Contaminants in Water Unsaturated Systems

Published on: December 24, 2014

10.9K

Related Experiment Videos

Last Updated: Feb 26, 2026

Aerobic Biodegradation Testing of Materials Using a Natural Marine Seawater Inoculum and Closed Loop Respirometer
08:43

Aerobic Biodegradation Testing of Materials Using a Natural Marine Seawater Inoculum and Closed Loop Respirometer

Published on: October 24, 2025

483
Author Spotlight: Unraveling the Mysteries of Terrestrial Anaerobic Microorganisms in Uncharted Environments by In Situ Culturing
07:56

Author Spotlight: Unraveling the Mysteries of Terrestrial Anaerobic Microorganisms in Uncharted Environments by In Situ Culturing

Published on: January 12, 2024

1.6K
A Whole Cell Bioreporter Approach to Assess Transport and Bioavailability of Organic Contaminants in Water Unsaturated Systems
13:16

A Whole Cell Bioreporter Approach to Assess Transport and Bioavailability of Organic Contaminants in Water Unsaturated Systems

Published on: December 24, 2014

10.9K

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Biopharmaceutics

Background:

  • Biorelevant dissolution testing is crucial for predicting in vivo drug performance.
  • Limited data exists on the interlaboratory reproducibility of these advanced dissolution methods.
  • Standardizing and validating these techniques is essential for reliable pharmaceutical development.

Purpose of the Study:

  • To assess the interlaboratory reproducibility of biorelevant dissolution testing.
  • To evaluate the consistency of results across multiple academic and industrial laboratories.
  • To validate biorelevant dissolution media for pharmaceutical applications.

Main Methods:

  • Utilized the paddle apparatus (USP 2) for dissolution testing.
  • Employed simulated gastric fluid (FaSSGF) and simulated intestinal fluid (FaSSIF).
  • Conducted single-stage and two-stage (transfer) protocols using ibuprofen and zafirlukast tablets.

Main Results:

  • Biorelevant dissolution tests demonstrated high interlaboratory reproducibility.
  • Results were consistent across different batches of biorelevant media and between commercial and in-house preparations.
  • The two-stage test showed acceptable reproducibility, though with slightly higher variability than single-stage tests.

Conclusions:

  • Biorelevant dissolution testing is a highly reproducible method across laboratories.
  • The findings support the reliability of biorelevant dissolution testing for cross-laboratory comparisons.
  • This validated method enhances the prediction of drug behavior in the gastrointestinal tract.