Particle effects - 5 possible mechanisms that may cause harm
SUMMARY:
The effects of inadvertent particles found in intravenous solutions are influenced by particle size, number, shape and surface characteristics. Larger particles are more likely to cause vascular blockages whilst protein aggregates from therapies such as monoclonal antibodies have immunogenicity concerns.
How can infused particles of any size impact ICU patients’ health?
No matter what size particles are, they have the potential to hurt the human body once they are in the circulatory system.
The effect of infused particles depends on several factors, such as
- particle size
- shape
- number
- characteristics
- electrical charge.1,2
Infused particles may lead to
- blockages of blood vessels3-5
- systemic hypercoagulability effects due to the activation of the coagulation system6
- an impairment of the microcirculation7-9
- immune-modulation effects and inflammatory reactions.10-13
Furthermore, proteinaceous particles from therapeutic proteins, such as monoclonal antibody therapies may lead to immunogenicity and hypersensitivity reactions.14-16
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References
1.Perez M., Maiguy-Foinard A., Barthélémy C., Décaudin B., Odou P. (2016). Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients. Pharm. Technol. Hosp. Pharm.; 1(2): 91-103
2.Langille, S.E. (2013). Particulate Matter in Injectable Drug Products. PDA J Pharm Sci and Tech; 67: 186-200
3.Ilium L. et al. (1982) et al. Blood clearance and organ deposition of intravenously administered colloidal particles. The effects of particle size, nature and shape. Int J Pharm.; 12(2): 135-46
4.Bradley J.S., Wassel R.T., Lee L., Nambiar S. (2009). Intravenous ceftriaxone and calcium in the neonate: assessing the risk for cardiopulmonary adverse events. Pediatrics; 123(4): e609-13
5.Puntis J.W.L. et al. (1992). Hazards of parenteral treatment: do particles count? Archives of Disease in Childhood; 67: 1475-1477
6.Boehne M. et al. (2013). In-line filtration minimizes organ dysfunction: New aspects from a prospective, randomized, controlled trial. BMC Pediatrics, 13 (21): 1-8
7.Kirkpatrick CJ. et al (2013). Non-Equivalence of Antibiotic Generic Drugs and Risk for Intensive Care Patients. Pharmaceut Reg Affairs; 2(1): 1-7
8.Schaefer SC. et al (2008). 0.2 µm in-line filters prevent capillary obstruction by particulate contaminants of generic antibiotic preparations in postischemic muscle. Chemother J; 17: 172-8
9.Lehr HA., Brunner J., Rangoonwala R., and Kirkpatrick C.J. (2002). Particulate Matter Contamination of Intravenous Antibiotics Aggravates Loss of Functional Capillary Density in Postischemic Striated Muscle. Am J Respir Crit Care Med; 165: 514-520
10.Jack T. et al. (2012). In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med, 38, 1008-1016
11.Jack T. et al. (2010). Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unit. Intensive Care Med; 36:707-711
12.Schmitt E. et al. (2019). In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Critical Care; 23 (373): 1-11
13.Chisholm C.F., Behnke W., Pokhilchuk Y., Frazer-Abel A.A., Randolph T.W. (2020). Subvisible Particles in IVIg Formulations Activate Complement in Human Serum. J Pharm Sci.; 109(1): 558-565
14.Berger M. (2013). Adverse effects of IgG therapy. Journal of Allergy and Clinical Immunology: In Practice; 1(6): 558-566.
15.Kessler M., Goldsmith D., Schellekens H. (2006). Immunogenicity of biopharmaceuticals. Nephrol Dial Transplant; 21 [Suppl 5]: v9–v12
16.Rosenberg A.S. (2006). Effects of protein aggregates: An immunologic perspective. The AAPS Journal; 8: E501–E507
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