Environmental Engineering Reference
In-Depth Information
delivery in pharma industry is expected to grow from a current value of
2.3 billion
$
to
136 billion by the year 2021 which is accounted for 15 % of global nanotech-
nology market lead by Asian country with compound annual growth rate (CAGR)
of 32.5 % [
1
]. Injectables are mainly to contribute to this growth in areas of
liposomes, microspheres and nanoparticles in diabetes and oncology followed by
a steady succession of imaging and diagnostic products. In summary, nanotechnol-
ogy is a growing field in pharmaceuticals employed via injectable, oral and dermal
route and offers great potential. To make optimum use of nanoparticles is equally
important to understand the correlations between their properties and the related
biological responses in vitro and in vivo.
Potential higher risk is mainly for particles below 100 nm which is defined as the
“nanoparticle” by the FDA defined as National Nanotechnology Initiative (NNI).
Depending upon the nature of nanoparticle, e.g. metal, magnetic it show unique
mechanism of breakdown in body which might lead to unpredictable and excep-
tional toxic effect, that is difficult to predict as they are involved in many catalytic
and oxidative reactions in vivo. Reliable systematic quantitative predictions of
pharmacokinetics and pharmacodynamics of nanoparticles are essential to develop
or to design nanoparticles for therapeutic and diagnostic applications. This infor-
mation will help to understand the behavior of non-specificity of nanoparticle
toward tissues and different cell types which later can serve as the basis in
determination of related toxicity and future investigative directions.
Many leading organization worldwide, e.g. Organization for Economic
Co-operation and Development (OECD), European Commission (Registration,
Evaluation, Authorisation and Restriction of Chemicals legislation—REACH,
NANO Safety Cluster), European Food Safety Authority (EFSA), Scientific Com-
mittee on Consumer Products (SCCP), and Environmental Protection Agency
(EPA) are trying to determine and regulate the suitable endpoints in toxicity
assessment testing in addition to the legislated tests and experimental procedures.
The main purpose of this chapter is to discuss toxicity aspects of nanoparticles and
understand the basic factors that might affect the toxicity of nanoparticle. This
chapter reviews techniques, assays and other prediction tools, which can be used in
assessment of toxicity behavior of nanoparticles.
$
6.1.2 Currently Used Nano-based Drug Delivery Systems
and the Stress They Generate In Vivo
Recently, the U.S. Food and Drug Administration had issued three final guidances
and one draft guidance aimed at providing greater regulatory clarity on the use of
nanotechnology in FDA-regulated products to help ongoing research activities and
developments by industries [
2
]. FDA has approved more than 25 nanoparticles
based on various drug delivery systems. This clearly indicates potential efficacy of
nanoparticles in the treatment of infectious or non-infectious diseases. In pharma,
