This document summarizes the key points from a presentation on the safety and toxicity related to nanopharmaceuticals. It discusses nanotoxicology and some of the reasons nanoparticles can be toxic, such as their large surface area to volume ratio. It covers toxicological factors, routes of exposure including inhalation, skin contact and ingestion. Diseases associated with nanoparticles are mentioned. The document provides an overview of ensuring safety in nanopharmaceuticals through measures like material safety data sheets, personal protective equipment, safety engineering controls and proper disposal procedures. It concludes more research is still needed to understand nanoparticle toxicity and ensure safer materials can be developed.
Safety and toxicity of nanoparticles in pharmaceuticals
1. SAFETY AND TOXICITY RELATED TO
NANOPHARMACEUTICALS.
PRESENTED BY- MO. ASAD FAROOQUI
DATE- 11/03/2018
2. CONTENT
i. NANOTOXICOLOGY. 1
ii. REASONS OF TOXICITY IN NANOPARTICLES. 2
iii. KEYTOXICOLOGICAL FACTORS. 3
iv. OVERVIEW OF NANOTOXICOLOGY. 4
v. ROUTES OF EXPOSURES. 5
vi. DISEASES ASSOCIATED TO NANOPARTICLE, 6
vii. SAFETY IN NANOPHARMACEUTICLES. 7-10
viii. NANOSAFTEY.
ix. CONCLUSION.
x. REFERENCE.
PG. NO.
3. NANOTOXICOLOGY
Nanotoxicology is the study of the toxicity of
nanomaterials.
Because of quantum size effects and large
surface area to volume ratio, nanomaterials
have unique properties compared with their
larger counterparts.
1
4. REASONS FOR TOXICITY OF
NANOPARTICLES
As it is well known fact that, when the particle size of a material
decreases, its surface area to volume ratio increases, leading to
SPECIAL characteristic properties as well different adverse
effects on ENVIRONMENT.
Due to the quantum size of these nanoparticles these possess
toxicity.
Like all nanomaterials, iron-based nanoparticles ,like these can
vary in their toxicity, depending on their chemical composition,
coating, size, and shape.
2
5. KEY TOXICOLOGICAL FACTORS
Composition and
Structure
Solubility
Reactivity
Surface Chemistry
Aggregation Potential
Surface Area
Shape
Density
Particle Size
5
Chemical Related Physical Related
3
7. Routes Of Exposure.
Exposure through respiratory system-
Inhalation of nanoparticles leads to deposition of nanoparticles in respiratory tract
and lungs.
Caused lung-related disease. E.g. asthma, bronchitis, lung cancer, pneumonia etc.
Exposure through skin-
o Skin exposure to cosmetics, sunscreens and dusts resulted in accumulation of
nanoparticles.
o Baroli et al. reported that metallic nanoparticles smaller than 10nm could
penetrate the hair follicle and stratum corneum and sometimes reach the viable
epidermis.
Exposure through Ingestion-
Cytotoxicity means that nanoparticles prevent cell division, hinder cell
proliferation, damage DNA and biological system and lead to cell death by
biological process called apoptosis
.
5
9. NANOSAFETY-
“Nanosafety” is a broad term and a lack of specific
objectives can lead to ineffective use of resources.
Thus to maintain diversity and cover the main
spectrum of “Nano-Safety”, the following topics are
covered:
* What are the exposure routes?
* MSDS (Material Safety Data Sheet)
* PPE (Personal Protective Equipment)
* Safety Engineering Equipment.
* Disposal of nanoparticles/materials.
* Information sharing to keep a safe
environment for nano-research..
7
10. MATERIAL SAFETY DATA SHEET- MSDS
A person who work with engineered
nanoparticles should be reading the
MSDS
A person should be familiar with known
chemical hazards
IF THERE IS NO MSDS ON THE
PACKAGE DO NOT OPEN, RETURN
TO MANUFACTUER!!!!
8
11. PPE PERSONAL PROTECTION FOR
NANOMATERIAL EXPOSURE-
* The last line of defense
for acting safely. PPE is a
barrier to protect the body
And prevent leakage of
particles.
9
12. SAFETY ENGINEERING CONTROLS -
Glove Box
Glove Bag
Clean Room
HVAC
Develop a
Preventative
Maintenance plan
(PM)
This plan will help:
Maintain maximum
protection
Meet or exceed the
life of the Warranty
Reduce human
error.
Must have a Waste
Disposal Operations
procedures (WDOP)
for workers10
13. CONCLUSION
More research is required in this field as ultra fine particles could
pose a human health hazard . Research is now showing that when
harmless bulk materials are made into ultrafine particles, they tend
to become toxic. Generally, the smaller the particles (<10µm), the
more reactive and toxic are their effects.
If nano research helps us to understand the root causes of toxicity
in these materials, then safer materials can be engineered which
can save to the human lives as well as dollars can be made.
Industry consortiums, environmental real data on toxicity into the
iterative groups and individual corporations need to take strong
action to determine the safety of materials and products before they
reach into the market.
There is a need to identify specific regulatory regimes to protect
personnel involved in the production and use of NPs for cosmetic,
medical and agricultural purposes.
14. REFERENCES-
1-DE JONG WH, BORM PJ. DRUG DELIVERYAND NANOPARTICLES: APPLICATIONS AND HAZARDS.
INTERNATIONAL JOURNAL OF NANOMEDICINE. 2008;3(2):133.
2HTTPS://WWW.GOOGLE.CO.IN/SEARCH?Q=SAFETY+AND+TOXICITY+RELATED+TO+NANOPHARMACEUTIC
3-KWON J-T, HWANG S-K, JIN H, KIM D-S, MINAI-TEHRANI A, YOON H-J ET AL. BODY DISTRIBUTION OF
INHALED FLUORESCENT MAGNETIC NANOPARTICLES IN THE MICE. JOURNAL OF OCCUPATIONAL HEALTH.
2008;50(1):1–6.
4-OBERDORSTER G, SHARP Z, ATUDOREI V, ELDER A, GELEIN R, LUNTS A ET AL. EXTRAPULMONARY
TRANSLOCATION OF ULTRAFINE CARBON PARTICLES FOLLOWING WHOLE-BODY INHALATION EXPOSURE
OF RATS. JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH PART A. 2002;65(20):1531–43.
5-COLEMAN KP, TOSCANO WA, WIESE TE. QSAR MODELS OF THE IN VITRO ESTROGEN ACTIVITY OF
BISPHENOL AANALOGS. QSAR AND COMBINATORIAL SCIENCE. 2003;22(1):78–88.
6-SERVICE RF. NANOTECHNOLOGY—CAN HIGH-SPEED TESTS SORT OUT WHICH NANOMATERIALS ARE SAFE?: AMERICAN
ASSOCIATION OF ADVANCEMENT SCIENCE 1200, NEW YORK AVENUE, NW, WASHINGTON, DC 20005, USA; 2008.
PARK MV, LANKVELD DP, VAN LOVEREN H, DE JONG WH. THE STATUS OF IN VITRO TOXICITY STUDIES IN THE RISK
ASSESSMENT OF NANOMATERIALS. NANOMEDICINE. 2009;4(6):669–85
FOR REST OF REFERENCES PLEASE REFER BOOK CHAPTER:
7-DEY S., MAZUMDER B., PATHAK Y., 2015. MODELS FOR RISK ASSESSMENTS OF NANOPARTICLES. IN: SUTARUYA,
V.B., PATHAK Y., (EDS.), BIOINTERACTIONS OF NANOMATERIALS. TAYLOR & FRANCIS GROUP, LLC, PP. 384-413.