modelSapropterin
Extends from Pharmacolibrary.Drugs.ATC.A.A16AX07.
Information
| name: | Sapropterin | |
| ATC code: | A16AX07 | route: | oral |
| compartments: | 1 | |
| dosage: | 10 | mg |
| volume of distribution: | 8.8 | L |
| clearance: | 15.3 | L/h |
| other parameters in model implementation | ||
Sapropterin dihydrochloride is a synthetic form of tetrahydrobiopterin (BH4), a natural cofactor for the enzyme phenylalanine hydroxylase. It is used as an adjunct treatment for phenylketonuria (PKU) in both pediatric and adult patients who have been shown to be responsive to this therapy. Sapropterin is an FDA- and EMA-approved medication.
Pharmacokinetics
Pharmacokinetic parameters following a single oral dose (10 mg/kg) in healthy adult volunteers.
References
Muntau, AC, et al., & Rogoff, D (2017). Efficacy, safety and population pharmacokinetics of sapropterin in PKU patients <4 years: results from the SPARK open-label, multicentre, randomized phase IIIb trial. Orphanet journal of rare diseases 12(1) 47–None. DOI:10.1186/s13023-017-0600-x PUBMED:https://pubmed.ncbi.nlm.nih.gov/28274234
Feillet, F, et al., & Foehr, E (2008). Pharmacokinetics of sapropterin in patients with phenylketonuria. Clinical pharmacokinetics 47(12) 817–825. DOI:10.2165/0003088-200847120-00006 PUBMED:https://pubmed.ncbi.nlm.nih.gov/19026037
Sanford, M, & Keating, GM (2009). Sapropterin: a review of its use in the treatment of primary hyperphenylalaninaemia. Drugs 69(4) 461–476. DOI:10.2165/00003495-200969040-00006 PUBMED:https://pubmed.ncbi.nlm.nih.gov/19323589
Parameters
| Type | Name | Default | Description |
|---|---|---|---|
| Modelica.Units.SI.Mass | weight (from PK_1C) | 75 | patient weight (kg) |
| Modelica.Units.SI.SpecificVolume | VdPerKg (from PK_1C) | 0.9 | Volume of distribution (L/kg) |
| Modelica.Units.SI.MassFraction | F (from PK_1C) | 0.8 | bioavailiability (0-1) |
| Pharmacolibrary.Types.Clearance | Cl (from PK_1C) | 20 | clearance |
| Modelica.Units.SI.Time | adminTime (from PK_1C) | 60 | first administration time (s) |
| Modelica.Units.SI.Time | adminDuration (from PK_1C) | 600 | administration duration (s) |
| Modelica.Units.SI.Time | adminPeriod (from PK_1C) | 8*60*60 | period of administration (default 8 hours)(s) |
| Pharmacolibrary.Types.Mass | adminMass (from PK_1C) | 1000 | administration mass (mg) |
| Integer | adminCount (from PK_1C) | 8 | number of dose administered (1) |
| Pharmacolibrary.Types.Volume | Vd (from PK_1C) | VdPerKg*weight | Volume of distribution (m3) |
| Pharmacolibrary.Types.MassConcentration | Cmin (from PK_1C) | 0.004 | minimal therapeutic range |
| Pharmacolibrary.Types.MassConcentration | Cmax (from PK_1C) | 0.008 | minimal therapeutic range |
| Pharmacolibrary.Types.MassConcentration | Ctox_peak (from PK_1C) | 0.012 | toxicity peak level |
| Pharmacolibrary.Types.MassConcentration | Ctox_trough (from PK_1C) | 0.006 | toxicity trough level |
| Pharmacolibrary.Types.TransferRate | ka (from PK_1C_enteral) | 0.016666666666666666 | first order absorption rate |
| Modelica.Units.SI.Time | Tlag (from PK_1C_enteral) | 600 | delay between oral administration and absorption (default 10min) |
Connectors
| Type | Name | Default | Description |
|---|---|---|---|
| Types.ConcentrationOutput | C_central (from PK_1C) | ||
| Interfaces.ConcentrationPort_b | centralCPort (from PK_1C) |
Components
| Type | Name | Default | Description |
|---|---|---|---|
| Pharmacokinetic.NoPerfusedTissueCompartment | central (from PK_1C) | ||
| Pharmacokinetic.ClearanceDrivenElimination | elim (from PK_1C) | ||
| Sources.PeriodicDose | periodicDose (from PK_1C) | ||
| Modelica.Units.SI.Time | t1_2 (from PK_1C) | elimination half-life |
Revisions
- 06/2025 Tomas Kulhanek, generated model from data extracted from PUBMED, DrugBank and LLM(GPT4.1)