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Saliva versus Plasma Therapeutic Drug Monitoring of Gentamicin in Jordanian Preterm Infants. Development of a Physiologically-Based Pharmacokinetic (PBPK) Model and Validation of Class II Drugs of Salivary Excretion Classification System.
- Source :
-
Drug research [Drug Res (Stuttg)] 2020 Oct; Vol. 70 (10), pp. 455-462. Date of Electronic Publication: 2020 Sep 02. - Publication Year :
- 2020
-
Abstract
- Gentamicin has proven to be a very successful treatment for bacterial infection, but it also can cause adverse effects, especially ototoxicity, which is irreversible. Therapeutic drug monitoring (TDM) in saliva is a more convenient non-invasive alternative compared to plasma. A physiologically-based pharmacokinetic (PBPK) model of gentamicin was built and validated using previously-published plasma and saliva data. The validated model was then used to predict experimentally-observed plasma and saliva gentamicin TDM data in Jordanian pediatric preterm infant patients measured using sensitive LCMS/MS method. A correlation was established between plasma and saliva exposures. The developed PBPK model predicted previously reported gentamicin levels in plasma, saliva and those observed in the current study. A good correlation was found between plasma and saliva exposures. The PBPK model predicted that gentamicin in saliva is 5-7 times that in plasma, which is in agreement with observed results. Saliva can be used as an alternative for TDM of gentamicin in preterm infant patients. Exposure to gentamicin in plasma and saliva can reliably be predicted using the developed PBPK model in patients.<br />Competing Interests: The authors declare no conflict of interest.<br /> (Thieme. All rights reserved.)
- Subjects :
- Bacterial Infections blood
Chromatography, High Pressure Liquid instrumentation
Chromatography, High Pressure Liquid methods
Dose-Response Relationship, Drug
Drug Dosage Calculations
Drug Monitoring instrumentation
Female
Gentamicins administration & dosage
Gentamicins adverse effects
Gentamicins isolation & purification
Humans
Infant, Low Birth Weight
Infant, Newborn
Infant, Premature
Jordan
Limit of Detection
Male
Ototoxicity blood
Ototoxicity etiology
Plasma chemistry
Saliva chemistry
Salivary Elimination physiology
Tandem Mass Spectrometry instrumentation
Tandem Mass Spectrometry methods
Bacterial Infections drug therapy
Drug Monitoring methods
Gentamicins pharmacokinetics
Models, Biological
Ototoxicity prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 2194-9387
- Volume :
- 70
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Drug research
- Publication Type :
- Academic Journal
- Accession number :
- 32877949
- Full Text :
- https://doi.org/10.1055/a-1233-3582