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

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: 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...

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 Affecting Dissolution: Particle Size and Effective Surface Area

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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...

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,...

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...

You might also read

Related Articles

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

Sort by

Same author

Deconstructing Annealing Phenomena in Modified Release Lipid Multiparticulates.

Molecular pharmaceutics·2025

Same author

Integrating Clinical Variability into PBPK Models for Virtual Bioequivalence of Single and Multiple Doses of Tofacitinib Modified-Release Dosage Form.

Clinical pharmacology and therapeutics·2024

Same author

Atovaquone-proguanil for treating uncomplicated Plasmodium falciparum malaria.

Emergencias : revista de la Sociedad Espanola de Medicina de Emergencias·2023

Same author

Scalable training of graph convolutional neural networks for fast and accurate predictions of HOMO-LUMO gap in molecules.

Journal of cheminformatics·2022

Same author

Using ensembles and distillation to optimize the deployment of deep learning models for the classification of electronic cancer pathology reports.

JAMIA open·2022

Same author

Development and validation of a Level A in-vitro in-vivo correlation for tofacitinib modified-release tablets using extrudable core system osmotic delivery technology.

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences·2019

Same journal

Enhanced Stability and Transdermal Delivery of Semaglutide Using an L-Arginine Based Dissolving Microneedle System.

AAPS PharmSciTech·2026

Same journal

The Preparation and Physicochemical Characterization of a Triple Synergistic Nanoplatform Designed for Targeted Subcutaneous Delivery of Sitagliptin with Potential for β-Cell Preservation.

AAPS PharmSciTech·2026

Same journal

Repurposing Non-oncologic Drugs via Targeted Nanocarriers for Cancer Therapy: Mechanisms, Synergistic Combinations, and Clinical Translation.

AAPS PharmSciTech·2026

Same journal

Targeting Permeability Barriers By Strategic Selection of Thiol Containing Coformer for Novel Cocrystals of Metformin.

AAPS PharmSciTech·2026

Same journal

Plume Geometry Matters: Investigating the Contribution of Mass-Based Plume Geometry to Aerosol Delivery Efficiency in pMDIs.

AAPS PharmSciTech·2026

Same journal

Eigenrate-Based Thermodynamic Decomposition of Competing Release Mechanisms in Polymeric Nano- and Microspheres: The MMIR-S Framework with Arrhenius Dual-Population Burst Kinetics and Log-Normal Polydispersity Averaging.

AAPS PharmSciTech·2026

See all related articles

Search research articles

Related Experiment Video

Updated: Oct 11, 2025

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Developing a Biorelevant Dissolution Method for an Extrudable Core System (ECS) Osmotic Tablet.

Raymond Chen¹, Andrew Blanchard², Joseph Kushner³

¹Analytical Research and Development, Worldwide Research, Development and Medical, Pfizer Inc., Groton, Connecticut, 06340, USA. raymond.chen@pfizer.com.

AAPS Pharmscitech

|December 1, 2021

Summary

This summary is machine-generated.

A new biorelevant dissolution method was developed for tofacitinib modified-release tablets, enabling successful In Vitro In Vivo Correlation (IVIVC) and quality control.

Keywords:

Biorelevant Dissolution Extrudable core system Modified release Osmotic tablet Tofacitinib citrate

More Related Videos

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Related Experiment Videos

Last Updated: Oct 11, 2025

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs

Published on: July 27, 2022

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients

Published on: August 9, 2022

Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Biopharmaceutics

Background:

Developing biorelevant dissolution methods is crucial for predicting in vivo drug performance.
The tofacitinib 11 mg modified-release tablet utilizes a single-layer extrudable core system (ECS).
Establishing In Vitro In Vivo Correlation (IVIVC) is essential for regulatory approval and clinical study support.

Purpose of the Study:

To develop and validate a biorelevant dissolution method for the tofacitinib 11 mg modified-release tablet.
To support the clinical study by establishing a Level A IVIVC.
To ensure the method is suitable for quality control.

Main Methods:

Apparatus 2 (paddles) was chosen over Apparatus 1 (baskets) to minimize variability.
A 50 mM potassium phosphate buffer at pH 6.8 was selected to mimic small intestinal conditions.
Designed experiments (DoE) and Japanese basket sinkers were employed to optimize conditions and reduce variability.

Main Results:

The optimized dissolution method demonstrated reduced variability and eliminated artificial shifts in dissolution profiles.
The method was validated according to ICH and FDA guidelines, confirming its discriminatory power.
A Level A IVIVC was successfully established, confirming the method's biorelevance.

Conclusions:

The developed dissolution method is biorelevant and suitable for quality control of tofacitinib modified-release tablets.
This method supports the clinical study and regulatory requirements for the tofacitinib ECS tablet.
The established IVIVC provides a reliable link between in vitro performance and in vivo outcomes.