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 Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

619
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...
619
Hepatic Drug Clearance: Role of Transporters01:14

Hepatic Drug Clearance: Role of Transporters

90
In the liver and bile canaliculi, influx and efflux transporters modification can influence intrinsic clearance. Transporters play a significant role in moving drugs within liver cells. Elaborate models, such as the Biopharmaceutical Classification System (BCS), are essential to relate transporters to drug disposition. This system categorizes drugs into four classes based on solubility and permeability, providing insights into elimination routes and the effects of transporters following oral...
90
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

162
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...
162
Mechanisms of Drug Absorption: Paracellular, Transcellular, and Vesicular Transport01:23

Mechanisms of Drug Absorption: Paracellular, Transcellular, and Vesicular Transport

614
Drugs need to permeate cell membranes to reach their target sites after administration. Orally administered drugs must transcend intestinal epithelial membrane barriers to infiltrate the systemic circulation. Drugs with a molecular weight of less than 500 Daltons diffuse through gaps between neighboring cells, called paracellular pathways.
However, most drugs use the transcellular route, traversing directly through the cell membranes via two mechanisms: passive and active transport. Passive...
614
Cellular Membranes and Drug Transport01:24

Cellular Membranes and Drug Transport

705
Drugs must traverse multiple biological barriers, such as multi-layered skin, single-layered intestinal epithelium, and the plasma membrane, to reach their target sites within the body. The plasma membrane, a highly structured composite of phospholipids, carbohydrates, and proteins, is the cell's protective boundary, facilitating selective substance exchange.
Phospholipids arrange themselves into a bilayer, with hydrophilic heads oriented outward and hydrophobic tails facing inward.
705
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

241
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...
241

You might also read

Related Articles

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

Sort by
Same author

Lymphoma incidence, survival and prevalence 2004-2014: sub-type analyses from the UK's Haematological Malignancy Research Network.

British journal of cancer·2015
Same author

Determinants of survival in patients with chronic myeloid leukaemia treated in the new era of oral therapy: findings from a UK population-based patient cohort.

BMJ open·2014
Same author

Comparison of canine and human gastrointestinal physiology.

Pharmaceutical research·2013
Same author

Salt screening and characterization for poorly soluble, weak basic compounds: case study albendazole.

Die Pharmazie·2013
Same author

Biowaiver monographs for immediate release solid oral dosage forms: lamivudine.

Journal of pharmaceutical sciences·2011
Same author

Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride.

Journal of pharmaceutical sciences·2010

Related Experiment Video

Updated: Jul 31, 2025

Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers
18:57

Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers

Published on: October 17, 2013

46.5K

Drug Permeability - Best Practices for Biopharmaceutics Classification System (BCS)-Based Biowaivers: A workshop

M Mehta1, J E Polli2, P Seo1

  • 1US Food & Drug Administration, Silver Spring, MD, USA.

Journal of Pharmaceutical Sciences
|May 4, 2023
PubMed
Summary

This workshop explored drug permeability best practices for Biopharmaceutics Classification System (BCS) based biowaivers. It aimed to enhance global drug development by standardizing permeability data evaluation and facilitating biowaiver implementation.

Keywords:
BCSBiopharmaceutics classification systemBiowaiverCaco2 cell lineICH M9Permeability

More Related Videos

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
11:07

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Published on: November 24, 2021

2.9K
Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
06:08

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

Published on: March 11, 2017

10.7K

Related Experiment Videos

Last Updated: Jul 31, 2025

Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers
18:57

Models and Methods to Evaluate Transport of Drug Delivery Systems Across Cellular Barriers

Published on: October 17, 2013

46.5K
Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging
11:07

Visualizing and Quantifying Pharmaceutical Compounds within Skin using Coherent Raman Scattering Imaging

Published on: November 24, 2021

2.9K
Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump
06:08

Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

Published on: March 11, 2017

10.7K

Area of Science:

  • Pharmacology and Drug Development
  • Regulatory Science
  • Biopharmaceutics

Background:

  • The Biopharmaceutics Classification System (BCS) based biowaivers streamline drug product development.
  • ICH M9 guideline finalized BCS based biowaivers, necessitating updated best practices for permeability assessment.
  • Industry, academia, and regulatory bodies convened to discuss experiences with permeability data.

Purpose of the Study:

  • To share industrial, academic, and regulatory experiences in generating and evaluating drug permeability data.
  • To facilitate the global implementation of BCS based biowaivers and efficient drug product development.
  • To address challenges and explore opportunities in permeability testing for regulatory submissions.

Main Methods:

  • Virtual workshop format with lectures, panel discussions, and breakout sessions.
  • Review of case studies from Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) stages.
  • Focused discussions on in vitro, in silico, and literature-based permeability assessment methods.

Main Results:

  • Identified typical deficiencies in permeability assessment for BCS biowaivers.
  • Discussed evidence types for demonstrating high permeability and method suitability.
  • Explored excipient impact, global acceptance of methods, and expanded biowaiver use (e.g., non-Caco-2 assays, totality-of-evidence).

Conclusions:

  • Standardizing permeability data evaluation is crucial for BCS biowaiver implementation.
  • Further research and discussion are needed on alternative permeability models and excipient effects.
  • Global harmonization of permeability testing methods will enhance drug development efficiency and regulatory consistency.