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Related Concept Videos

Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while adhering...
Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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...
In Vitro Drug Dissolution: Alternative Methods01:17

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...
In Vitro Drug Dissolution: Compendial Testing Models II01:09

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...
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
Drug Dissolution: Requirements and Profile Comparison01:14

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...

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Related Experiment Video

Updated: May 22, 2026

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
07:32

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles

Published on: August 28, 2015

Integrating drug permeability with dissolution profile to develop IVIVC.

Ryusuke Takano1, Makoto Kataoka, Shinji Yamashita

  • 1Pre-clinical Research Department, Chugai Pharmaceutical Co.,Ltd, 1-135 Komakado, Gotemba, Shizuoka, 412-8513, Japan.

Biopharmaceutics & Drug Disposition
|May 15, 2012
PubMed
Summary

Predicting oral drug absorption involves analyzing in vitro data for permeability, solubility, and dissolution. These methods help select drug candidates and understand absorption limitations for better oral drug product development.

Related Experiment Videos

Last Updated: May 22, 2026

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
07:32

Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles

Published on: August 28, 2015

Area of Science:

  • Pharmacokinetics and Drug Development
  • Biopharmaceutics
  • Computational Chemistry

Background:

  • Predicting in vivo oral absorption is crucial for drug discovery and development.
  • Understanding the factors limiting oral absorption, such as permeability and dissolution, is essential for candidate selection.

Purpose of the Study:

  • To review and introduce three distinct approaches for predicting in vivo oral absorption using in vitro data.
  • To highlight the application of maximum absorbable dose concept in evaluating absorption potential and identifying rate-limiting steps.

Main Methods:

  • Integration of drug permeability and dissolution data using an in vitro dissolution/permeation (D/P) system.
  • Application of an in silico model and simulation approach, incorporating an intrinsic dissolution parameter (z) and human physiological parameters.

Main Results:

  • The D/P system correlates permeated drug amounts with the fraction absorbed in humans (F(a)), aiding formulation and food effect evaluation.
  • The in silico approach reconstructs intestinal absorption, offering insights into drug particle dissolution and absorption processes.

Conclusions:

  • Both the D/P system and in silico modeling provide powerful tools for predicting oral drug absorption.
  • These predictive methods are valuable for optimizing oral drug product development through case study examples.