PMID- 35245984
OWN - NLM
STAT- MEDLINE
DCOM- 20220405
LR  - 20220715
IS  - 1092-874X (Electronic)
IS  - 1091-5818 (Linking)
VI  - 41
IP  - 2
DP  - 2022 Mar-Apr
TI  - Polysorbate 80-Induced Anaphylactoid Reaction and the Effects on Cardiovascular 
      Function: Dose Threshold and Species Comparison.
PG  - 99-107
LID - 10.1177/10915818211072780 [doi]
AB  - Polysorbate 80 (PS80) is commonly used in pre-clinical formulations. The dose 
      threshold for cardiovascular (CV) changes and hypersensitivity reaction in the 
      dog was assessed and compared to other species. PS80 was administered by 
      intravenous (IV) bolus (.5, 1 mg/kg), IV infusion (.3, .5, 1, 3 mg/kg), 
      subcutaneous (SC) injection (5, 10, 15 mg/kg) and oral gavage (10 mg/kg) to dogs 
      with CV monitoring. Monkeys and minipigs received PS80 by IV infusion at 3 mg/kg. 
      Plasma histamine concentration was measured following PS80 IV infusion and with 
      diphenhydramine pre-treatment in dogs only. In dogs, PS80 was not associated with 
      CV changes at doses up to 15 mg/kg SC and 10 mg/kg oral, but decreased blood 
      pressure and increased heart rate with IV bolus at >/= .5 mg/kg and IV infusion at 
      >/= 1.0 mg/kg and decreased body temperature with IV infusion at 3 mg/kg was 
      observed. Transient edema and erythema were noted with all administration routes, 
      in all three species including doses that were devoid of CV effects. In monkeys 
      and minipigs, PS80 did not induce CV, cutaneous or histamine concentration 
      changes. These results suggest that mild, transient skin changes occur following 
      PS80 administration at doses that are not associated with CV effects in the dogs. 
      In dogs, the cardiovascular effect threshold was <.5 mg/kg for IV bolus, .3 mg/kg 
      for IV infusion, 15 mg/kg for SC injection, and 10 mg/kg for oral administration. 
      Monkey and minipig were refractory to PS80-induced histamine release at 3 mg/kg 
      by IV infusion over 15 minutes.
FAU - Pouliot, Mylene
AU  - Pouliot M
AD  - Charles River Laboratories Montreal ULC, Laval, QC, Canada.
FAU - Bussiere, Jeanine
AU  - Bussiere J
AD  - 7129Amgen Inc, Thousand Oaks, CA, USA.
FAU - Coppi, Aldo
AU  - Coppi A
AD  - 7129Amgen Inc, Thousand Oaks, CA, USA.
FAU - Holbrook, Kristen
AU  - Holbrook K
AUID- ORCID: 0000-0001-6923-3580
AD  - 7129Amgen Inc, Thousand Oaks, CA, USA.
FAU - Shelton, Amy
AU  - Shelton A
AD  - 7412Genentech Inc, South San Francisco, CA, USA.
FAU - Sparapani, Samantha
AU  - Sparapani S
AD  - Charles River Laboratories Montreal ULC, Laval, QC, Canada.
FAU - Maher, Jonathan
AU  - Maher J
AD  - 7406Theravance Biopharma, Inc. South San Francisco, CA, USA.
FAU - Zabka, Tanja S
AU  - Zabka TS
AD  - 7412Genentech Inc, South San Francisco, CA, USA.
FAU - Boulay, Emmanuel
AU  - Boulay E
AD  - Charles River Laboratories Montreal ULC, Laval, QC, Canada.
AD  - Faculty of Veterinary Medicine, University of Montreal, St-Hyacinthe, QC, Canada.
FAU - Authier, Simon
AU  - Authier S
AUID- ORCID: 0000-0001-8134-4558
AD  - Charles River Laboratories Montreal ULC, Laval, QC, Canada.
AD  - Faculty of Veterinary Medicine, University of Montreal, St-Hyacinthe, QC, Canada.
LA  - eng
PT  - Journal Article
DEP - 20220304
PL  - United States
TA  - Int J Toxicol
JT  - International journal of toxicology
JID - 9708436
RN  - 0 (Polysorbates)
RN  - 820484N8I3 (Histamine)
SB  - IM
MH  - *Anaphylaxis/chemically induced
MH  - Animals
MH  - Dogs
MH  - Histamine
MH  - Injections, Intravenous
MH  - *Polysorbates/toxicity
MH  - Swine
MH  - Swine, Miniature
OTO - NOTNLM
OT  - beagle dog
OT  - blood pressure
OT  - body temperature
OT  - cynomolgus monkey
OT  - gottingen minipig
OT  - heart rate
OT  - histamine
OT  - polysorbate 80
OT  - tween 80
EDAT- 2022/03/06 06:00
MHDA- 2022/04/06 06:00
CRDT- 2022/03/05 05:24
PHST- 2022/03/06 06:00 [pubmed]
PHST- 2022/04/06 06:00 [medline]
PHST- 2022/03/05 05:24 [entrez]
AID - 10.1177/10915818211072780 [doi]
PST - ppublish
SO  - Int J Toxicol. 2022 Mar-Apr;41(2):99-107. doi: 10.1177/10915818211072780. Epub 
      2022 Mar 4.