J Vet Sci.  2021 Sep;22(5):e47. 10.4142/jvs.2021.22.e47.

Ustekinumab pharmacokinetics after subcutaneous administration in swine model

Affiliations
  • 1Polpharma Biologics SA, 80-172 Gdańsk, Poland
  • 2Sub-Department of Pharmacology, Toxicology and Environmental Protection, Faculty of Veterinary Medicine, University of Life Sciences, 20-033 Lublin, Poland
  • 3Department of Immunology, Pathophysiology and Veterinary Preventive Medicine, Wroclaw University of Environmental and Life Sciences, 50-375 Wrocław, Poland
  • 4Department of Physiology and Biochemistry, University School of Physical Education in Wroclaw, 51-612 Wrocław, Poland

Abstract

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
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
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
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 (p > 0.05). The relative bioavailability after administration of ustekinumab into the external part of the inguinal fold was 40.36% lower than after administration of ustekinumab into the internal part of the inguinal fold.
Conclusions
Healthy breeding pigs are a relevant model to study the pharmacokinetic profile of subcutaneously administered ustekinumab.

Keyword

Swine; biologics; ustekinumab; skin; pharmacokinetics
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