Methods of reduction toxicity in the nanoformulations and loopholes in the regulation of nanomaterials

1. Different Methods for Reduction of Nanotoxicity in Nanoformulation
Presented by
Pankaj Kumar
PhD Scholar
DPSRU New Delhi

2. Nanoformulation:
The aims for nanoparticle entrapment of drugs are either enhanced delivery to, or uptake by, target cells
and/or a reduction in the toxicity of the free drug to non-target organs.
Nanoparticles may be needed for loading a sufficient amount of
drug onto the particles.
Nanoparticles as having dimensions below 0.1 μm or 100 nm
Goals of nanoformulation -
More specific drug
targeting and delivery
Reduction in
toxicity
Greater safety and
biocompatibility
Faster development of
new safe medicines
R. H. Müller, M. Radtke, and S. A. Wissing, “Nanostructured lipid matrices for improved microencapsulation of drugs,”
Int. J. Pharm., vol. 242, no. 1–2, pp. 121–128, 2002, doi: 10.1016/S0378-5173(02)00180-1.

3. Methods to reduce the nanotoxicity of nanoparticles
 Functionalization
Chemical functionalization is based on the covalent bond of functional
groups onto carbon form of CNTs. It can be performed at the end caps
of nanotubes or at their sidewalls which have many defects.
 Toxicity can be also reduced by using organic NP
 SNEDDS
 SLN
 NLC
 ETHOSOMES
 LIPOSOME
 MICELLES
 NIOSOEMS
 TRANSFEROSOMES

4.  Reduce the size and length of nanoparticles
Ex. length less than 5 μm CNT, gold NP (3-10nm)
 Change shape of NP
Ex. AU NP Triangular shape
 Surface Modification e
Ex. Chitosan , folic acid and PEG
 Ion Release And Solubility
 modified NP with suitable biomimetic polymers
 Modify surface charge of NP
M. A. Iqbal, S. Md, J. K. Sahni, S. Baboota, S. Dang, and J. Ali, “Nanostructured lipid carriers system: Recent advances in
drug delivery,” J. Drug Target., vol. 20, no. 10, pp. 813–830, 2012, doi: 10.3109/1061186X.2012.716845

5. Regulation of nanoparticles
USFDA and the European Union (EU) have strong regulatory bodies and guideline legislation to control the
potential risks of NPs.
Loopholes
 Stand Alone proposal: There are not common principles for the nanomaterials regulation that's why
Nano drugs regulation are always cornerstone
 Nanotechnologies require prudential regulators able to facilitate responsible development and to gain trust of
organization
 There is insufficient knowledge about the paths of technological developments and the characteristics and
behavior of nanomaterials, including data on exposure and hazards
 Requires broad ANALYTICAL FRAMEWORK: for the analysis of emerging regulation
B. R. Dorbeck-Jung and N. Chowdhury, “Is the European Medical Products Authorisation Regulation Equipped to Cope with the
Challenges of Nanomedicines?,” Law Policy, vol. 33, no. 2, pp. 276–303, 2011, doi: 10.1111/j.1467-9930.2011.00339.x.
.