Ustekinumab pharmacokinetics after subcutaneous administration in swine model.
Swine
biologics
pharmacokinetics
skin
ustekinumab
Journal
Journal of veterinary science
ISSN: 1976-555X
Titre abrégé: J Vet Sci
Pays: Korea (South)
ID NLM: 100964185
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
02
02
2021
revised:
22
04
2021
accepted:
23
05
2021
pubmed:
24
8
2021
medline:
16
11
2021
entrez:
23
8
2021
Statut:
ppublish
Résumé
Due to multiple similarities in the structure and physiology of human and pig skin, the pig model is extremely useful for biological drug testing after subcutaneous administration. Knowledge of the differences between subcutaneous injection sites could have a significant impact on the absorption phase and pharmacokinetic profiles of biological drugs. This study aimed to analyze the impact of administration site on pharmacokinetics and selected biochemical and hematological parameters after a single subcutaneous administration of ustekinumab in pigs. Drug concentrations in blood plasma were analyzed by enzyme-linked immunosorbent assay. Pharmacokinetic analyses were performed based on raw data using Phoenix WinNonlin 8.1 software and ThothPro v 4.1. The study included 12 healthy, female, large white piglets. Each group received a single dose of ustekinumab given as a 1 mg/kg subcutaneous injection into the internal part of the inguinal fold or the external part of the inguinal fold. The differences in absorption rate between the internal and external parts of the inguinal fold were not significant. However, the time of maximal concentration, clearance, area under the curve calculated between zero and mean residence time and mean residence time between groups were substantially different ( Healthy breeding pigs are a relevant model to study the pharmacokinetic profile of subcutaneously administered ustekinumab.
Sections du résumé
BACKGROUND
BACKGROUND
Due to multiple similarities in the structure and physiology of human and pig skin, the pig model is extremely useful for biological drug testing after subcutaneous administration. Knowledge of the differences between subcutaneous injection sites could have a significant impact on the absorption phase and pharmacokinetic profiles of biological drugs.
OBJECTIVES
OBJECTIVE
This study aimed to analyze the impact of administration site on pharmacokinetics and selected biochemical and hematological parameters after a single subcutaneous administration of ustekinumab in pigs. Drug concentrations in blood plasma were analyzed by enzyme-linked immunosorbent assay. Pharmacokinetic analyses were performed based on raw data using Phoenix WinNonlin 8.1 software and ThothPro v 4.1.
METHODS
METHODS
The study included 12 healthy, female, large white piglets. Each group received a single dose of ustekinumab given as a 1 mg/kg subcutaneous injection into the internal part of the inguinal fold or the external part of the inguinal fold.
RESULTS
RESULTS
The differences in absorption rate between the internal and external parts of the inguinal fold were not significant. However, the time of maximal concentration, clearance, area under the curve calculated between zero and mean residence time and mean residence time between groups were substantially different (
CONCLUSIONS
CONCLUSIONS
Healthy breeding pigs are a relevant model to study the pharmacokinetic profile of subcutaneously administered ustekinumab.
Identifiants
pubmed: 34423596
pii: 22.e47
doi: 10.4142/jvs.2021.22.e47
pmc: PMC8460463
doi:
Substances chimiques
Dermatologic Agents
0
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e47Subventions
Organisme : Narodowe Centrum Badań i Rozwoju
ID : POIR.01.01.01-00-0407/17-00
Pays : Poland
Informations de copyright
© 2021 The Korean Society of Veterinary Science.
Déclaration de conflit d'intérêts
The authors declare no conflicts of interest.
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