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

Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

Factors Affecting Dissolution: Particle Size and Effective Surface Area

903
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...
903
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

158
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...
158
Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

598
The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
598
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

238
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...
238
Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

828
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...
828
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

348
Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
348

You might also read

Related Articles

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

Sort by
Same author

Evaluation of USP 3 Apparatus to Develop Biopredictive Fasted and Fed Dissolution Methods for Extended-Release Desvenlafaxine Succinate Tablets.

ACS omega·2026
Same author

Dicentrine Purified from the Leaves of <i>Ocotea puberula</i> Controls the Intracellular Spread of <i>L. (L.) amazonensis</i> and <i>L. (V.) braziliensis</i> Amastigotes and Has Therapeutic Activity as a Topical Treatment in Experimental Cutaneous Leishmaniasis.

Microorganisms·2025
Same author

Microemulsions: An Encapsulation Strategy to Increase the Thermal Stability of D-limonene.

Pharmaceutics·2023
Same author

Agarose fibers with glycerol and graphene oxide and functional properties for potential application in biomaterials.

International journal of biological macromolecules·2023
Same author

Development of Extended-Release Formulations Containing Cyclobenzaprine Based on Physiologically Based Biopharmaceutics Modeling and Bioequivalence Safe Space.

Journal of pharmaceutical sciences·2023
Same author

Development of a Discriminative Dissolution Method, Using In-Silico Tool for Hydrochlorothiazide and Valsartan Tablets.

Pharmaceutics·2023

Related Experiment Video

Updated: Jul 29, 2025

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

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

Published on: July 27, 2022

1.1K

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets.

Gustavo Vaiano Carapeto1, Marcelo Dutra Duque2, Michele Georges Issa1

  • 1Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes 580, São Paulo 05508-080, SP, Brazil.

Pharmaceutics
|May 27, 2023
PubMed
Summary

A new biopredictive dissolution method for desvenlafaxine extended-release (ER) tablets was developed using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM). This method reduces generic drug development risks by predicting bioequivalence virtually.

Keywords:
DoEPBBMTaguchibiopredictive dissolution methoddesvenlafaxine

More Related Videos

Formation of Dispersible Taohong Siwu Tablets
05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

1.7K
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
11:27

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

Published on: August 9, 2022

2.1K

Related Experiment Videos

Last Updated: Jul 29, 2025

Self-Nanoemulsification of Healthy Oils to Enhance the Solubility of Lipophilic Drugs
08:18

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

Published on: July 27, 2022

1.1K
Formation of Dispersible Taohong Siwu Tablets
05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

1.7K
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
11:27

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

Published on: August 9, 2022

2.1K

Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Biopharmaceutics

Background:

  • Developing generic drug products requires robust methods to ensure bioequivalence.
  • Desvenlafaxine extended-release (ER) tablets present formulation challenges for generic development.
  • Reducing the risk of product failure in bioequivalence studies is crucial.

Purpose of the Study:

  • To develop a biopredictive dissolution method for desvenlafaxine ER tablets.
  • To utilize design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) for method development.
  • To minimize the risk of failure in pivotal bioequivalence studies for generic desvenlafaxine ER tablets.

Main Methods:

  • A physiologically based biopharmaceutics model (PBBM) was developed using GastroPlus®.
  • A Taguchi L9 design was employed to evaluate drug product and dissolution condition impacts.
  • The influence of tablet surface area/volume ratio (SA/V) on desvenlafaxine release was assessed.

Main Results:

  • Specific dissolution conditions (900 mL 0.9% NaCl, 50 rpm paddle, sinker) were identified as biopredictive.
  • Virtual bioequivalence was demonstrated for reference and generic desvenlafaxine ER tablets.
  • External validation using Generic #3 confirmed the method's reliability.

Conclusions:

  • A rational approach for developing a biopredictive dissolution method for desvenlafaxine ER tablets was established.
  • The developed method aids in the efficient development of generic drug products.
  • This strategy provides valuable insights for drug product and dissolution method optimization.