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Related Concept Videos

One-Compartment Open Model for IV Bolus Administration: General Considerations01:19

One-Compartment Open Model for IV Bolus Administration: General Considerations

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The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
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Two-Compartment Open Model: IV Bolus Administration01:18

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The two-compartment model for intravenous (IV) bolus administration illustrates drug distribution in the body, subdividing it into central and peripheral compartments. This model operates on the concept of two-compartment kinetics. The drug's plasma concentration shows a bi-exponential decline following IV bolus administration, signaling the presence of two disposition processes: distribution and elimination.
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Two-Compartment Open Model: IV Infusion01:15

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A two-compartment model is a vital tool in pharmacokinetics, providing an essential understanding of drug behavior, especially for those administered via zero-order intravenous infusion. This model outlines two compartments: the central compartment, where elimination occurs, and the peripheral compartment.
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Pharmacokinetic Models: Comparison and Selection Criterion01:26

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Physiological and compartmental models are valuable tools used in studying biological systems. These models rely on differential equations to maintain mass balance within the system, ensuring an accurate representation of the dynamic processes at play.
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Compartment Models: Single-Compartment Model01:14

Compartment Models: Single-Compartment Model

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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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The one-compartment open model is a simplified approach used in pharmacokinetics to understand the distribution and elimination of a drug administered through an intravenous bolus. This model assumes rapid drug dispersal throughout the body and elimination using a first-order process. Key pharmacokinetic parameters, such as the elimination rate constant (k), half-life (t1/2), and the apparent volume of distribution (Vd), can be estimated from this model. The elimination rate is calculated...
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SubQ-Sim: A Subcutaneous Physiologically Based Biopharmaceutics Model. Part 1: The Injection and System Parameters.

Xavier J H Pepin1, Iain Grant2, J Matthew Wood3

  • 1Regulatory Affairs, Simulations Plus, Lancaster, CA, USA.

Pharmaceutical Research
|August 27, 2023
PubMed
Summary
This summary is machine-generated.

A new model, SubQ-Sim, predicts injection forces and formulation behavior in subcutaneous tissue. It accounts for factors like viscosity and disease, crucial for understanding drug absorption.

Keywords:
PBBMback-flowbackpressuredepotinjectionmodeling and simulationphysiologysubcutaneous

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Area of Science:

  • Biopharmaceutics and Pharmacokinetics
  • Mathematical Modeling
  • Subcutaneous Drug Delivery

Background:

  • Accurate prediction of drug absorption after subcutaneous injection requires understanding initial device-formulation-tissue interactions.
  • Existing models often lack detailed mechanistic insights into the injection process and its impact on drug disposition.

Purpose of the Study:

  • To develop a mechanistic, physiologically based biopharmaceutics model (SubQ-Sim) for subcutaneous injection.
  • To predict device-formulation-tissue interactions during injection, including backpressure and formulation behavior.
  • To establish a foundation for predicting drug binding, degradation, distribution, and absorption.

Main Methods:

  • Developed SubQ-Sim, a mathematical model integrating subcutaneous tissue substructures and drug disposition dynamics.
  • Incorporated literature-derived parameters for healthy and diseased subjects.
  • Accounted for physiological 'life events' (temperature, exercise, stress) impacting pharmacokinetics.

Main Results:

  • The model accurately predicts injection backpressure based on injection rate, volume, and fluid viscosities.
  • It describes depot shape, formulation/protein concentrations, and predicts backflow/losses from premature needle withdrawal.
  • Explored the impact of type 2 diabetes and hyaluronidase on injection pressure.

Conclusions:

  • SubQ-Sim successfully predicts critical initial conditions for subcutaneous drug absorption: tissue pressure, depot characteristics, and formulation losses.
  • This model provides essential starting parameters for subsequent drug absorption predictions.
  • The next publication will detail the absorption model and clinical validation.