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Related Concept Videos

Model Approaches for Pharmacokinetic Data: Compartment Models01:14

Model Approaches for Pharmacokinetic Data: Compartment Models

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Compartmental analysis is a widely adopted approach to characterizing drug pharmacokinetics. It uses compartment models that conceptualize the body as a collection of reversibly communicating compartments, each representing a group of tissues exhibiting similar drug distribution characteristics. The movement rate of the drug between these compartments is typically described by first-order kinetics.
Two primary types of compartment models are recognized: mammillary and catenary. The more...
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Compartment Models: Two-Compartment Model01:20

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The two-compartment model divides the body into central and peripheral compartments to account for varying blood perfusion rates among organs and tissues, affecting drug distribution. The central compartment includes blood and highly perfused tissues with rapid drug distribution, while the peripheral compartment contains tissues with slower drug distribution. After a single IV bolus dose, the drug concentration is high in plasma and low in tissues. The drug distribution between compartments...
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Three-Compartment Open Model01:06

Three-Compartment Open Model

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The three-compartment open model is a pharmacokinetic model used to describe the distribution and elimination of drugs following extravascular administration. It comprises a central compartment representing the plasma and two peripheral compartments. The highly perfused peripheral compartment represents organs and tissues with a rich blood supply, such as the liver, kidneys, and lungs. The scarcely perfused peripheral compartment represents tissues with lower blood supply, such as adipose...
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Compartment Models: Single-Compartment Model01:14

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The single-compartment model serves as a simplified representation of the human body. This model assumes that the body functions as a single, well-mixed open compartment. When a drug is administered intravenously, it enters the body and quickly distributes uniformly. The drug then undergoes biotransformation and elimination, ultimately leaving the body. The volume of this compartment is referred to as the apparent volume of distribution into which the drug can uniformly distribute. In this...
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Two-Compartment Open Model: Overview01:05

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Multicompartmental models are crucial tools in pharmacokinetics, providing a framework to understand how drugs move within the body. The two-compartment model is a crucial subtype, segmenting the body into central and peripheral compartments. The central compartment represents areas with high blood flow, such as plasma and highly perfused organs like the kidneys and liver, while the peripheral compartment signifies tissues with lower blood flow, like adipose tissue and muscle tissue.
The...
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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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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...
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High-Throughput Dissolution/Permeation Screening -A 96-Well Two-Compartment Microplate Approach.

Ann-Christin Jacobsen1, Anna Krupa2, Martin Brandl3

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A new high-throughput method screens drug dissolution and permeation simultaneously for advanced oral formulations like amorphous solid dispersions (ASDs). Permeation testing proved a better predictor of in vivo bioavailability than dissolution alone.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Formulation Development

Background:

  • Early screening of oral drug formulations, particularly amorphous solid dispersions (ASDs), is crucial for efficient development.
  • Traditional methods like dissolution testing have limitations in predicting the in vivo performance of complex formulations.
  • Developing high-throughput screening methods is essential to accelerate the formulation development process.

Purpose of the Study:

  • To develop and validate a high-throughput screening approach for simultaneously assessing drug dissolution and permeation.
  • To evaluate the predictiveness of this new method by comparing its results with in vivo bioavailability data.
  • To optimize screening conditions for enhanced accuracy in formulation assessment.

Main Methods:

  • A novel two-compartment 96-well plate system was utilized to screen drug dissolution and permeation concurrently.
  • Amorphous and crystalline tadalafil formulations, with and without Soluplus®, were prepared via freeze-drying from hydro-alcoholic solutions.
  • The workflow involved dispersion, incubation across a dialysis membrane, and quantification using UHPLC-UV, with variations in dispersion/acceptor media and incubation times.

Main Results:

  • The high-throughput method successfully screened dissolution and permeation for tadalafil formulations.
  • The use of surfactants in the acceptor medium significantly increased tadalafil permeation.
  • Biomimetic media enhanced dissolution, and in some cases, permeation, while permeation testing generally showed better correlation with in vivo bioavailability compared to dissolution alone.

Conclusions:

  • The developed high-throughput dissolution and permeation screening method is a promising tool for early-stage formulation development.
  • Simultaneous assessment of dissolution and permeation offers a more predictive evaluation of oral drug formulation performance.
  • This approach can accelerate the identification of optimal formulations, especially for advanced systems like ASDs.