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Related Concept Videos

Methods for Studying Drug Absorption: In vitro01:16

Methods for Studying Drug Absorption: In vitro

261
In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
261
Methods for Studying Drug Absorption: In situ01:09

Methods for Studying Drug Absorption: In situ

269
In situ experiments, such as the Doluisio method and Single-Pass Perfusion technique, provide critical insights into drug uptake by simulating in vivo conditions for drug absorption.
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
269
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

231
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...
231
Theories of Dissolution: Diffusion Layer Model01:15

Theories of Dissolution: Diffusion Layer Model

814
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...
814
Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

579
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...
579

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Related Experiment Video

Updated: Jul 22, 2025

In Vitro and In Vivo Approaches to Determine Intestinal Epithelial Cell Permeability
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Development of a buccal in vitro permeation method - exploring aQbD implementation.

Ariana Sena1, Alain Costa1, Francisca Bastos2

  • 1Bluepharma - Indústria Farmacêutica S.A., São Martinho do Bispo, 3045-016 Coimbra, Portugal.

International Journal of Pharmaceutics
|July 23, 2023
PubMed
Summary

Developing accurate in vitro buccal permeation methods is crucial for drug delivery. A systematic Quality by Design approach identifies and manages variables, improving method reliability for pharmaceutical development.

Keywords:
Analytical quality by designBuccal mucosaCritical method parametersIn vitro permeabilityPermeation method

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Biomaterials Science

Background:

  • The buccal mucosa offers a promising route for local and systemic drug delivery due to its vascularization and permeability.
  • Accurate in vitro permeation assessment is a significant challenge for oromucosal preparations during pre-clinical drug development.
  • Diffusion cell-based methodologies are emerging as alternatives to traditional cell-based models for in vitro permeation studies.

Purpose of the Study:

  • To systematically develop and optimize an in vitro buccal permeation method using a risk-based Quality by Design (QbD) approach.
  • To identify and manage critical variables affecting the buccal permeation process and method performance.
  • To provide a step-by-step model and experimental validation for accurate buccal permeation assessment.

Main Methods:

  • Application of a systematic risk-based analytical Quality by Design (QbD) approach.
  • Identification and analysis of variables related to study conditions, setup, and formulation.
  • Development of a step-by-step model guided by experimental data to demonstrate the impact of critical variables.

Main Results:

  • All sources of variability affecting the buccal permeation process were identified, explained, and managed.
  • The QbD approach successfully demonstrated the impact of critical variables on the in vitro method's performance.
  • Experimental data validated the effectiveness of the systematic approach in optimizing the permeation method.

Conclusions:

  • A risk-based QbD approach is essential for developing robust and accurate in vitro buccal permeation methods.
  • Managing critical variables through QbD ensures reliable pre-clinical drug delivery assessments.
  • This systematic methodology streamlines development, reducing costs and improving the accuracy of oromucosal drug delivery evaluations.