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Volume 22
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10.3390/ijms22179250
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Article

Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs

by
Charlotte Peloso
1,
Anne-Pascale Trichet
1,
Jacques Descotes
2,†,
Joël Richard
1,
Christophe Roberge
1 and
Adolfo Lopez-Noriega
1,*
1
MedinCell S.A., 3 rue des Frères Lumière, 34830 Jacou, France
2
ImmunoSafe Consultance, 120 Chemin des Bouleaux, 38480 Saint-Jean-d’Avelanne, France
*
Author to whom correspondence should be addressed.
†
This article is dedicated to the memory of our dear co-worker Prof. Dr. Jacques Descotes.
Int. J. Mol. Sci. 2021, 22(17), 9250; https://doi.org/10.3390/ijms22179250
Submission received: 22 July 2021 / Revised: 24 August 2021 / Accepted: 25 August 2021 / Published: 26 August 2021
(This article belongs to the Special Issue Challenges, Opportunities, and Innovation in Local Drug Delivery)
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Abstract

The present study aims to investigate the loco-regional tolerability and injection parameters (i.e., flow rate and administration volume) of an in situ forming depot (ISFD) in Göttingen minipigs, to secure both the therapeutic procedure and compliance in chronic medical prescriptions. The ISFD BEPO® technology (MedinCell S.A.) is investigated over 10 days, after a single subcutaneous injection of test item based on a DMSO solution of diblock and triblock polyethylene glycol-polylactic acid copolymers. Injection sites are systematically observed for macroscopic loco-regional skin reactions as well as ultrasound scanning, enabling longitudinal in vivo imaging of the depot. Observations are complemented by histopathological examinations at 72 h and 240 h post-injection. Overall, no treatment-emergent adverse effects are macroscopically or microscopically observed at the subcutaneous injection sites, for the tested injection flow rates of 1 and 8 mL/min and volumes of 0.2 and 1 mL. The histopathology examination confirms an expected foreign body reaction, with an intensity depending on the injected volume. The depot morphology is similar irrespective of the administration flow rates. These results indicate that the ISFD BEPO® technology can be considered safe when administered subcutaneously in Göttingen minipigs, a human-relevant animal model for subcutaneous administrations, in the tested ranges.
Keywords: loco-regional skin tolerability; in situ forming depots; subcutaneous injection; flow rate; minipig; sustained release drug delivery loco-regional skin tolerability; in situ forming depots; subcutaneous injection; flow rate; minipig; sustained release drug delivery

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MDPI and ACS Style

Peloso, C.; Trichet, A.-P.; Descotes, J.; Richard, J.; Roberge, C.; Lopez-Noriega, A. Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs. Int. J. Mol. Sci. 2021, 22, 9250. https://doi.org/10.3390/ijms22179250

AMA Style

Peloso C, Trichet A-P, Descotes J, Richard J, Roberge C, Lopez-Noriega A. Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs. International Journal of Molecular Sciences. 2021; 22(17):9250. https://doi.org/10.3390/ijms22179250

Chicago/Turabian Style

Peloso, Charlotte, Anne-Pascale Trichet, Jacques Descotes, Joël Richard, Christophe Roberge, and Adolfo Lopez-Noriega. 2021. "Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs" International Journal of Molecular Sciences 22, no. 17: 9250. https://doi.org/10.3390/ijms22179250

APA Style

Peloso, C., Trichet, A.-P., Descotes, J., Richard, J., Roberge, C., & Lopez-Noriega, A. (2021). Evaluation of Loco-Regional Skin Toxicity Induced by an In Situ Forming Depot after a Single Subcutaneous Injection at Different Volumes and Flow Rates in Göttingen Minipigs. International Journal of Molecular Sciences, 22(17), 9250. https://doi.org/10.3390/ijms22179250

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