Biosafety of mesoporous silica nanoparticles: a combined experimental and literature study

Abstract

Mesoporous silica (MS) particles have been explored for various healthcare applications, but universal data about their safety and/or toxicity are yet to be well-established for clinical purposes. Information about general toxicity of hollow MS (HMS) particles and about immunotoxicity of MS particles are significantly lacked. Therefore, acute toxicity and immunotoxicity of HMS particles were experimentally evaluated. A systematic and objective literature study was parallelly performed to analyze the published in vivo toxicity of MS particles. Lethal acute toxicity of MS particles is likely to arise from their physical action after intravenous and intraperitoneal administrations, and only rarely observed after subcutaneous administration. No clear relationship was identified between physicochemical properties of MS particles and lethality as well as maximum tolerated dose with some exceptions. At sub-lethal doses, MS particles tend to accumulate mainly in lung, liver, and spleen. The HMS particles showed lower inflammation-inducing ability than polyinosinic-polycytidylic acid and almost the same allergy-inducing ability as Alum. Finally, the universal lowest observed adverse effect levels were determined as 0.45, 0.81, and 4.1 mg/kg (human equivalent dose) for intravenous, intraperitoneal, and subcutaneous administration of MS particles, respectively. These results could be helpful for determining an appropriate MS particle dose in clinical study.

Nanomaterials as Ultrasound Theragnostic Tools for Heart Disease Treatment/Diagnosis

“…NM biosafety, which is a prerequisite for NM human administration, depends on several interdependent factors such as NM administration route, physico-chemical properties or compositions [126]. Therefore, it is difficult to draw general conclusions about NM biosafety.…”

“…The latter needs to be assessed on a case-by-case basis. For certain types of NMs such as silica NPs [126], liposomes [127], polymer NPs [128], or iron oxide NPs [129], conditions that could guarantee their biosafety have been suggested in terms of specific values of NM concentration, administration route, formulation, size, charge, and/or composition.…”

Ordered Mesoporous Silica Delivering siRNA as Cancer Nanotherapeutics: A Comprehensive Review

“…and s.c. administration. 133 MacCuaig and group have performed the toxicity assessment of MSN upon i.v. injection in mice.…”

Delivery of Therapeutic Biopolymers Employing Silica-Based Nanosystems

“…Nevertheless, SiO 2 is generally considered a safe material by the FDA and is widely employed in food industry and even as a structural basis for certain living organisms [ 21 ]. Indeed, there are many examples in which biosafety and biocompatibility of silicas have been demonstrated [ 22 , 23 , 24 ], suggesting that silica may be used either alone or as a component for the development of new nanotherapeutics, being even employed by certain diatom algae as structural materials [ 21 ]. In this review, the most relevant advances based on porous silica particles able to deliver biomacromolecules with therapeutic potential are covered, as well as other targeting strategies [ 25 , 26 , 27 ] and those employed as diffusion barriers in the development of controlled release nanosystems [ 28 , 29 ] ( Figure 1 ).…”