Correction to: Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs

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CORRECTION

Correction to: Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs Andrea Allmendinger 1 & Stefan Fischer 1

# Springer Science+Business Media, LLC, part of Springer Nature 2020

Correction to: Pham Res (2020) 37: 184 https://doi.org/10.1007/s11095-020-02906-9 Table 2 of the article ‘Tissue Resistance during Large-Volume Injections in Subcutaneous Tissue of Minipigs’ encountered formatting errors in the (original) pdf version with misplacement of text and columns. The pdf version of the article was updated to correct for formatting issues. The online version was correct.

The online version of the original article can be found at https://doi.org/10. 1007/s11095-020-02906-9 * Andrea Allmendinger [email protected]

1

Pharmaceutical Development & Supplies Biologics Europe, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, 4070 Basel, Switzerland

N=10 (12 randomized minipigs, 3 study days)

80 mbar (10 mL at 0.02 N=3 (9 randomized mL/s); 240 mbar (1 pigs, 3 study days) mL at 0.1 mL/s); max 800 mbar

120 mbar (10-11 mL); max 300 mbar EFG applied: 200 – 500 mbar; max 1000 mbar Tissue resistance reaches constant value of ~120 mbar when injection volume goes as high as 11 mL, independent on viscosity and injection rate. Plateau for all injection profiles. Artificial pressure leads to per se higher tissue resistance independent the absolute value for the range tested, but not translated 1:1. Well defined injection rates for all conditions tested.

1 and 14 mPa·s

Pharm Res

Findings:

Present study

Injection pump; 10 and pressure sensor in 1 – 10 mL 30 mL syringe; 25G fluid path of infu½” Sureflo winged sion set butterfly set

0.003 – 0.02 mL/ in vivo; abdomen of Yorkshire s swine for 10 mL injections; up to 0.2 mL/s for 1 mL injections The subcutaneous pressures increased with increasing flow rate but not with increasing dose volume. Pressure graphs reached a plateau. Increasing variation with increasing flow rate. 11 mL, 4.5 mL 1 – 20 0.025 – 0.2 mL/s in vivo; inguinal Injection pump; 5 and force sensor Dextran solumPa·s SC tissue 20 mL syringe; 26G tions; saline minipig 3/8” needle solution

PBS; povidone solution

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Findings:

Doughty et al. [19]

50 mbar – 400 mbar; min 10 mbarmax 1.2 bar in vivo; inguinal SC tissue minipig

N=10 (10 randomized minipigs, 3 study days)

Median ~500 mbar; min N=8 175 mbar, max 900 mbar

N=3 (25 randomized subjects, 4 study days)



human abdomen; 11 diabetes patients (male)

~200 – 1200 mbar

No. (N) of subjects

~10 – 60 mbar; max 250 mbar

ex vivo, porcine adipose tissue (20x20x10 mm)

~1 mPa·s 0.01 mL/s – 0.1 mL/s

Tissue resistance

human abdomen; 12 diabetes and 13 healthy subjects

Injection site

Injection volume Viscosity Injection rate

5 mL syringe, 21/27G tensile test machine 1 mL needle (l=20/25 mm)

Instrumental set-up

Linear increase in tissue resistance with increasing injection rate. Injection forces exhibit a plateau upon injection. Deltran® pressure 0.18 – 0.48 mL ~1 mPa·s Dynamic; 0.0002 Patte