modelR03AL11

Extends from Pharmacokinetic.Models.PK_2C.

Information

name:FormoterolGlycopyrroniumBromideAndBudesonide
ATC code:R03AL11
route:inhalation
compartments:2
dosage:320mg
volume of distribution:200L
clearance:60L/h
other parameters in model implementation

A fixed-dose combination inhalation medication used in the management of asthma and chronic obstructive pulmonary disease (COPD). It combines formoterol (a long-acting beta-2 agonist), glycopyrronium bromide (a long-acting muscarinic antagonist), and budesonide (an inhaled corticosteroid). Approved and used today for maintenance treatment to improve lung function and reduce exacerbations.

Pharmacokinetics

Estimated typical population pharmacokinetic parameters for adults with asthma or COPD treated via inhalation, based on published individual PK studies of each component, as no publication specifically reports the PK of the fixed triple combination.

References

  1. Dorinsky, P, et al., & Reisner, C (2018). Safety and pharmacokinetics of budesonide/glycopyrronium/formoterol fumarate dihydrate metered dose inhaler (BGF MDI) in healthy adult subjects of Japanese descent. Pulmonary pharmacology & therapeutics 51 18–25. DOI:10.1016/j.pupt.2018.05.001 PUBMED:https://pubmed.ncbi.nlm.nih.gov/29763659

  2. Chen, Q, et al., & Dorinsky, P (2019). Pharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study. Clinical therapeutics 41(5) 897–909.e1. DOI:10.1016/j.clinthera.2019.03.007 PUBMED:https://pubmed.ncbi.nlm.nih.gov/30982547

  3. Aurivillius, M, et al., & Gillen, M (2023). Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential. Pulmonary pharmacology & therapeutics 83 102245–None. DOI:10.1016/j.pupt.2023.102245 PUBMED:https://pubmed.ncbi.nlm.nih.gov/37607661

Parameters

TypeNameDefaultDescription
Modelica.Units.SI.Massweight (from PK_1C)75patient weight (kg)
Modelica.Units.SI.SpecificVolumeVdPerKg (from PK_1C)0.9Volume of distribution (L/kg)
Modelica.Units.SI.MassFractionF (from PK_1C)0.8bioavailiability (0-1)
Pharmacolibrary.Types.ClearanceCl (from PK_1C)20clearance
Modelica.Units.SI.TimeadminTime (from PK_1C)60first administration time (s)
Modelica.Units.SI.TimeadminDuration (from PK_1C)600administration duration (s)
Modelica.Units.SI.TimeadminPeriod (from PK_1C)8*60*60period of administration (default 8 hours)(s)
Pharmacolibrary.Types.MassadminMass (from PK_1C)1000administration mass (mg)
IntegeradminCount (from PK_1C)8number of dose administered (1)
Pharmacolibrary.Types.VolumeVd (from PK_1C)VdPerKg*weightVolume of distribution (m3)
Pharmacolibrary.Types.MassConcentrationCmin (from PK_1C)0.004minimal therapeutic range
Pharmacolibrary.Types.MassConcentrationCmax (from PK_1C)0.008minimal therapeutic range
Pharmacolibrary.Types.MassConcentrationCtox_peak (from PK_1C)0.012toxicity peak level
Pharmacolibrary.Types.MassConcentrationCtox_trough (from PK_1C)0.006toxicity trough level
Pharmacolibrary.Types.VolumeVdp (from PK_2C)VdpPerKg*weightVolume of distribution (m3)
Modelica.Units.SI.SpecificVolumeVdpPerKg (from PK_2C)0.9Volume of distribution peripheral(l/kg)
Pharmacolibrary.Types.Clearancek12 (from PK_2C)1intercompartmental C-P clearance
Pharmacolibrary.Types.Clearancek21 (from PK_2C)1intercompartmental P-C clearance

Connectors

TypeNameDefaultDescription
Types.ConcentrationOutputC_central (from PK_1C)
Interfaces.ConcentrationPort_bcentralCPort (from PK_1C)
Interfaces.ConcentrationPort_bperipheralCPort (from PK_2C)
Pharmacolibrary.Types.ConcentrationOutputC_peripheral1 (from PK_2C)

Components

TypeNameDefaultDescription
Pharmacokinetic.NoPerfusedTissueCompartmentcentral (from PK_1C)
Pharmacokinetic.ClearanceDrivenEliminationelim (from PK_1C)
Sources.PeriodicDoseperiodicDose (from PK_1C)
Modelica.Units.SI.Timet1_2 (from PK_1C)elimination half-life
Pharmacolibrary.Pharmacokinetic.TransferFirstOrderNonSymtransfer (from PK_2C)
Pharmacolibrary.Pharmacokinetic.NoPerfusedTissueCompartmentperipheral (from PK_2C)

Revisions

  • 06/2025 Tomas Kulhanek, generated model from data extracted from PUBMED, DrugBank and LLM(GPT4.1)