Nanotechnology in Drug Discovery- Development and Delivery

1
Nanotechnology in Drug Discovery- Development and
Delivery

• Dr. Basavaraj K. Nanjwade
• KLE University College of Pharmacy
• Belgaum-590010
• E-mail bknanjwade_at_yahoo.co.in
• Cell No 00919742431000

2
Nanotechnology

• Nanotechnology breakthrough research in
  Pharmaceutical Biopharmaceutical Industry.
• Nanotechnology, a field of science and technology
  that aims to control matter at the atomic and
  molecular level.

3
Drug Discovery and Development

• Validate specific targets
• Discover the right molecule (potential drug) to
  interact with the target chosen
• Test the new compound in the lab and clinic for
  safety and efficacy and
• Gain approval and get the new drug into the hand
  of doctors and patients.

4
Drug Discovery and Development

• Success requires immense resources
• The best scientist minds, highly
  sophisticated technology and complex project
  management.
• It is also takes persistence and sometimes luck.
  
• Ultimately the process of drug discovery
  brings hope and relief to millions of patients

5
Drug Development and Delivery

• The multi-disciplinary field of nanotechnology is
  making small device, closer and closer to
  reality.
• Manipulate and organize matter on the nano-scale.

6
Drug Development and Delivery

• Drug filled nano-capsules, release their
  biological compounds on contact with cancers
  only.
• Nanotechnology will be applied at all stages of
  drug development, from formulations for optimal
  delivery to diagnostic applications in clinical
  trials.

7
Discovery
8
Development
9
Pre-Discovery
10
Pre-Discovery

• Before any potential new medicine can be
  discovered, scientist work to understand the
  disease to be treated as well as possible.
• Try to understand how the genes are altered, how
  that affects the proteins.

11
Target Identification

• Once have enough understanding of the underlying
  cause of a disease, pharmaceutical researchers
  select a target for a potential new medicine.
• A target is generally a single molecule, such as
  gene or protein, which is involved in a
  particular disease.
• Early stage in drug discovery it is critical to
  researchers pick a target that is drugable.

12
Target Validation

• After choosing a potential target, scientist must
  show that it actually is involved in the disease
  and can be acted upon by a drug.
• Target validation is crucial to help scientists
  avoid research paths that look promising, but
  ultimately lead to dead ends.
• Researchers demonstrate that a particular target
  is relevant to the disease being studied through
  complicated experiments in both living and in
  animal models of disease

13
Drug Discovery and Development Activities
14
Drug Discovery and Development
15
Lead Compound

• Nature
• De Novo
• High-throughput screening
• Biotechnology

16
Early Safety Tests

• Absorbed into the bloodstream
• Distributed to the proper site of action in the
  body
• Metabolized efficiently and effectively
• Successfully excreted from the body and
• Demonstrated to be not toxic

17
Lead Optimization

• Lead compounds that survive the initial screening
  are then optimized or altered to make them more
  effective and safer.
• Hundreds of different variations or analogues
  of the initial leads are made and tested.
• Early stage, researchers begin to think about how
  the drug will be made, considering formulation,
  delivery mechanism and large-scale manufacturing

18
Preclinical Testing

• Scientist carry out in vitro and in vivo test
• In vitro test are experiments conducted in the
  lab, usually carried out in the test tube and
  beakers (vitro is glass in Latin)
• In vivo studies are those in living cell cultures
  and animal models (vivo is life in Latin)

19
Development of IND (Investigational New drug)

• IND application contains information in three
  broad areas
• 1.Animal Pharmacology and Toxicology Studies
• 2.Manufacturing Information of drug including
  manufacturer, composition, stability and controls
• 3.Clinical Protocols and Investigator Information

20
Phase 1 Clinical Trial

• Phase I studies are carried out in healthy
  volunteers, which are small in number usually
  20 to 100.
• The purpose of phase I studies is to mainly
  determine safety profile.

21
Phase 2 Clinical Trial

• Phase 2 includes the early controlled clinical
  studies conducted to obtain some preliminary data
  on the effectiveness of the drug.
• Phase 2 studies are typically well-controlled,
  closely monitored, and conducted in a relatively
  small number of patients, usually involving
  several hundred people

22
Phase 3 Clinical Trial

• The additional information about effectiveness
  and safety that is needed to evaluate the overall
  benefit-risk relationship of the drug.
• Phase 3 studies usually include several hundred
  to several thousand people.

23
Manufacturing

• Going from small-scale to large-scale
  manufacturing is a major undertaking.
• In many cases, companies must build a new
  manufacturing facility or reconstruct an old one
  because the manufacturing process is different
  from drug to drug.
• Each facility must meet strict FDA guidelines for
  Good Manufacturing Practices (GMP)

24
Ongoing Studies Phase 4 Trial

• Phase IV, also known as Post Marketing
  Surveillance is also carried out once the drug is
  approved and marketed.
• The aim of Phase IV is to find out safety profile
  in large patient pool across the world and to
  establish the safety profile of the drug.

25
NDA Review Process
26
ANDA/AADA Review Process
27
OTC Drug Monograph Process
28
Successful Therapy Combines Drug Discovery and
Delivery
29
Nanotech Components
30
Nanotechnology Regulatory
31
Nanotechnology Collaboration
32
Research Priorities
33
Suggested Topics and Modules
34
Nanoparticles in the context of Biopharmaceuticals
35
Current Nanoparticle Products
36
Current Nanoparticle Products
37
Nanoparticles As Emulsion
38
Nanoparticles Reduce Size
39
Nanoparticles Grow Them
40
Nanoparticles Emulsion/Diffusion
41
Structure
42
Release
43
Drug Delivery Carriers
44
Methods of Drug Delivery
45
(No Transcript)
46

• THANKING YOU
• E-mail bknanjwade_at_yahoo.co.in
• Cell No 0091 9742431000