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. Author manuscript; available in PMC: 2019 Nov 5.
Published in final edited form as: Nanomedicine. 2018 Oct 21;18:282–291. doi: 10.1016/j.nano.2018.10.001

Table 4.

Literature supporting safety of PLGA nanoparticles.

Citation Nanoparticle Formulation Dosing Regimen Follow-Up Observations/Results
41 Perfluorodecalin (PFD)-filled PLGA microcapsules (92% PLGA, 8% PEG-PLGA) Single dose i.v. (Rat) (1247 mg/kg) 0 to 4.5 h All animals survived dosing. Marked toxicity (increased enzyme activity, increased pro-inflammatory cytokines and complement factors). Transient hypotension in PFD-filled microcapsule group.
42 PLA/Cholate Single dose i.v. (Rat)
1. 440 mg/kg
2. 220 mg/kg
3. 75 mg/kg		 0 to 9 days 1. Reduced motor activity D1, dyspnea D1, 100% mortality D1.
2. Reduced motor activity D1, dyspnea D1, 40% mortality D4 D5.
3. No clinical signs detected. 0% mortality.
PEG-PLA Single dose i.v. (Rat)
1. 440 mg/kg
2. 220 mg/kg
3. 75 mg/kg		 0 to 9 days 1. No clinical signs detected. 0% mortality.
2. No clinical signs detected. 0% mortality.
3. No clinical signs detected. 0% mortality.
43 Docetaxel-encapsulated PEG-PLA Single dose i.v. (Rat)
1. 2000 mg/kg
2. 1500 mg/kg
3. 1000 mg/kg		 0 to 6 days 1. No changes in blood chemistry or body weight. 0% mortality.
2. No changes in blood chemistry or body weight. 0% mortality.
3. No changes in blood chemistry or body weight. 0% mortality.
Docetaxel-encapsulated PEG-PLA Single dose for 3 weeks i.v. (Cynomolgus monkey) 5 to 50 mg/m2 0 to 15 days Increased circulation half-life. No change in pharmacokinetic profile following repeat dosing. 0% mortality.
Docetaxel-encapsulated PEG-PLA Single dose every 3 weeks i.v. (Human) 3.5 to 75 mg/m2 - Increased circulation half-life. No change in pharmacokinetic profile following repeat dosing. 0% mortality.