In vivo oral toxicological evaluation of mesoporous silica particles.
BACKGROUND
Mesoporous silica particles are highly promising nanomaterials for biomedical applications. They can be used to improve bioavailability, solubility and drug stability and to protect drugs from the acidic conditions of the stomach, leading to increased drug effectiveness. Their biocompatibility in vivo has recieved little attention, in particular regarding oral administration.


OBJECTIVE
To study the oral tolerance of micron-sized nanoporous folic acid-templated material-1 (cylindrical, 2D hexagonal pore structure) and nanometer-sized anionic-surfactant-templated mesoporous silica material-6 (cylindrical, 3D cubic pore structure) mesoporous silica particles in Sprague Dawley rats.


METHODS
A dose stepwise procedure or range finding test was followed by a consequent confirmatory test. The confirmatory test included daily administrations of 2000 and 1200 mg/kg doses for nanoporous folic acid-templated material-1 and anionic-surfactant-templated mesoporous silica material-6, respectively.


RESULTS
The maximum tolerated dose for anionic-surfactant-templated mesoporous silica material-6 was not reached. Similar results were observed for nanometer-sized anionic-surfactant-templated mesoporous silica material-1 in most of the animals, although adverse effects were observed in some animals that are most probably due to the administration by oral gavage of the formulated particles.


CONCLUSIONS
The results are promising for the use of mesoporous silica materials as drug-delivery systems in oral administration.
Department of Engineering Sciences, Nanotechnology & Functional Materials Institution, Uppsala University, Uppsala, Sweden.
Natalia
N
Kupferschmidt
Xin
X
Xia
Roberto H
RH
Labrador
Rambabu
R
Atluri
Lluis
L
Ballell
Alfonso E
AE
Garcia-Bennett
D000284:Administration, Oral; D000818:Animals; D004337:Drug Carriers; D008855:Microscopy, Electron, Scanning; D051381:Rats; D017207:Rats, Sprague-Dawley; D012822:Silicon Dioxide / Q000008:administration & dosage*
D004337:Drug Carriers; D012822:Silicon Dioxide