Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

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...

Factors Influencing Drug Absorption: Pharmaceutical Parameters

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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...

In Vitro Drug Dissolution: Compendial Testing Models I

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...

In Vitro Drug Dissolution: Alternative Methods

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...

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

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...

In Vitro Drug Dissolution: Compendial Testing Models II

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...

You might also read

Related Articles

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

Sort by

Same author

Probing the adsorption of weak acids on graphite using amplitude modulation-frequency modulation atomic force microscopy.

Langmuir : the ACS journal of surfaces and colloids·2015

Same author

Preparation, characterization, and biochemical activities of N-(2-Carboxyethyl)chitosan from squid pens.

Journal of agricultural and food chemistry·2015

Same author

Deficiency of the B cell-activating factor receptor results in limited CD169+ macrophage function during viral infection.

Journal of virology·2015

Same author

Probing the interaction between air bubble and sphalerite mineral surface using atomic force microscope.

Langmuir : the ACS journal of surfaces and colloids·2015

Same author

[Meta-analysis of pylorus-preserving pancreaticoduodenectomy in the treatment of periampullary adenocarcinoma].

Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery·2015

Same author

Image superresolution reconstruction via granular computing clustering.

Computational intelligence and neuroscience·2015

Search research articles

Related Experiment Video

Updated: Jun 5, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Published on: July 4, 2014

A Quality by Design approach to investigate tablet dissolution shift upon accelerated stability by multivariate

Jun Huang¹, Chimanlall Goolcharran, Krishnendu Ghosh

¹Pfizer Inc., Peapack, NJ 07977, USA. jun.huang1@pfizer.com

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|December 21, 2010

Summary

This study used experimental design and multivariate analysis to understand and control tablet dissolution shifts during stability testing. These Quality by Design methods ensure consistent drug product performance.

More Related Videos

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

Related Experiment Videos

Last Updated: Jun 5, 2026

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Coherent anti-Stokes Raman Scattering (CARS) Microscopy Visualizes Pharmaceutical Tablets During Dissolution

Published on: July 4, 2014

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

An In Vitro Dissolution Determination of Multi-Index Components in Tibetan Medicine Rhodiola Granules

Published on: November 4, 2022

Area of Science:

Pharmaceutical Sciences
Drug Product Development
Chemical Engineering

Background:

Tablet dissolution is a critical quality attribute (CQA) that can shift over time, impacting drug product performance.
Understanding and controlling dissolution shifts during stability is crucial for ensuring consistent drug efficacy and safety.
Accelerated stability testing is essential for predicting long-term product behavior.

Purpose of the Study:

To investigate the root cause of tablet dissolution slow-down during stability.
To develop control strategies for maintaining desired dissolution profiles.
To demonstrate the application of experimental design and multivariate techniques in drug product development.

Main Methods:

Design of Experiments (DOE) to evaluate factor effects on dissolution.
Multivariate analysis, including multi-way principal component analysis (MPCA), for dissolution profile analysis.
Quality by Design (QbD) principles and ICH-Q8 tools for process understanding and control.

Main Results:

Identified key factors influencing dissolution shifts during stability.
Established design spaces to ensure desired dissolution profiles and minimize stability-induced shifts.
Demonstrated the effectiveness of MPCA in revealing batch relationships and factor impacts.

Conclusions:

Experimental design and multivariate techniques provide a robust framework for understanding and controlling tablet dissolution.
Quality by Design (QbD) principles are effective in achieving a deeper understanding of tablet dissolution upon stability.
These methodologies facilitate the development of stable drug products with consistent performance.