Mesoporous silica
particles (MSPs) can be used as food
additives,
clinically for therapeutic applications, or as oral delivery vehicles.
It has also been discussed to be used for a number of novel applications
including treatment for diabetes and obesity. However, a major question
for their possible usage has been if these particles persist structurally
and retain their effect when passing through the gastrointestinal
tract (GIT). A substantial breaking down of the particles could reduce
function and be clinically problematic for safety issues. Hence, we
investigated the biostability of MSPs of the SBA-15 kind prepared
at large scales (100 and 1000 L). The MSPs were orally administered
in a murine model and clinically in humans. A joint extraction and
calcination method was developed to recover the MSPs from fecal mass,
and the MSPs were characterized physically, structurally, morphologically,
and functionally before and after GIT passage. Analyses with N2 adsorption, X-ray diffraction, electron microscopy, and as
a proxy for general function, adsorption of the enzyme α-amylase,
were conducted. The adsorption capacity of α-amylase on extracted
MSPs was not reduced as compared to the pristine and control MSPs,
and adsorption of up to 17% (w/w) was measured. It was demonstrated
that the particles did not break down to any substantial degree and
retained their function after passing through the GITs of the murine
model and in humans. The fact the particles were not absorbed into
the body was ascribed to that they were micron-sized and ingested
as agglomerates and too big to pass the intestinal barrier. The results
strongly suggest that orally ingested MSPs can be used for a number
of clinical applications.