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Related Concept Videos

Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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...
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Factors Influencing Drug Absorption: Physicochemical Parameters01:22

Factors Influencing Drug Absorption: Physicochemical Parameters

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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
Enhanced drug absorption can be achieved by reducing particle sizes and increasing surface areas, thereby facilitating...
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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

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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...
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Methods for Studying Drug Absorption: In vitro01:16

Methods for Studying Drug Absorption: In vitro

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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...
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Drug Absorption: Overview01:17

Drug Absorption: Overview

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The process of drug absorption signifies the transition of a drug from its site of administration into the plasma. This process is influenced by various factors, including the route of administration, the anatomy of the absorption site, the mechanism of absorption, gut motility, and the drug's physicochemical properties.
When drugs are injected intravenously, they directly enter the systemic circulation. Alternatively, orally administered drugs navigate through the gastrointestinal (GI)...
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Updated: Dec 22, 2025

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment
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An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

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A physiologically-based drug absorption modeling for orally disintegrating tablets.

Atsushi Kambayashi1, Tsuyoshi Kiyota1

  • 1Pharmaceutical Research and Technology Labs, Astellas Pharma Inc., 180 Ozumi, Yaizu, Shizuoka 425-0072, Japan.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|May 7, 2020
PubMed
Summary

This study simulated atorvastatin pharmacokinetic profiles from orally disintegrating tablets (ODTs) without water. The in silico model accurately predicted ODT performance, highlighting the need for formulation-specific gastric emptying parameters.

Keywords:
AtorvastatinIn silico modeling and simulationIn vitro biorelevant dissolutionOral drug absorptionOrally disintegrating tabletsOrodispersible tabletsPharmacokinetics

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Area of Science:

  • Pharmacokinetics
  • Pharmaceutical Technology
  • Computational Modeling

Background:

  • Orally disintegrating tablets (ODTs) offer administration advantages, but their oral pharmacokinetic (PK) profiles, especially without water, require thorough investigation.
  • Atorvastatin's PK profile is crucial for its therapeutic efficacy, necessitating accurate prediction models for novel dosage forms like ODTs.

Purpose of the Study:

  • To simulate the oral pharmacokinetic (PK) profiles of atorvastatin from ODTs administered without water in fasted humans.
  • To evaluate the in vitro dissolution of different ODT formulations and integrate these data into an in silico model for PK prediction.

Main Methods:

  • In vitro dissolution testing of three ODT formulations in fasted-state simulated gastric and intestinal fluids (FaSSGF and FaSSIF-V2).
  • Development of an in silico PK simulation model incorporating gastric emptying kinetics and dissolution data.
  • Application of first-order kinetics for pellet-based drug release from ODTs, with rate constants ranging from 0.69 to 8.3 h⁻¹.

Main Results:

  • Dissolution rates in FaSSIF-V2 were significantly influenced by prior exposure to FaSSGF, indicating a complex interplay between gastric and intestinal environments.
  • The in silico PK simulation model successfully described the plasma concentration profiles of atorvastatin from ODTs.
  • The model indicated that distinct gastric emptying parameters are necessary for each ODT formulation to accurately predict human PK.

Conclusions:

  • The developed prediction model is effective for simulating atorvastatin PK from ODTs administered without water.
  • Accurate PK prediction necessitates accounting for formulation-specific gastric emptying characteristics.
  • Further refinement of the model with individual gastric emptying parameters will enhance predictive accuracy for ODTs.