Transcript Nanotechnology in Drug Discovery-Development and

Nanotechnology in Drug DiscoveryDevelopment and Delivery
Dr. Basavaraj K. Nanjwade
KLE University College of Pharmacy
Belgaum-590010
E-mail: [email protected]
Cell No: 00919742431000
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.
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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.
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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
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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 nanoscale.
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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.
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Discovery
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Development
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Pre-Discovery
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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.
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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”.
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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
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Drug Discovery and Development Activities
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Drug Discovery and Development
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Lead Compound
• Nature
• De Novo
• High-throughput screening
• Biotechnology
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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
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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
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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)
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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
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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.
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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
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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.
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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)
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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.
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NDA Review Process
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ANDA/AADA Review Process
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OTC Drug Monograph Process
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Successful Therapy Combines
Drug Discovery and Delivery
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Nanotech Components
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Nanotechnology Regulatory
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Nanotechnology Collaboration
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Research Priorities
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Suggested Topics and Modules
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Nanoparticles in the context of
Biopharmaceuticals
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Current Nanoparticle Products
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Current Nanoparticle Products
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Nanoparticles: As Emulsion
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Nanoparticles: Reduce Size
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Nanoparticles: Grow Them
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Nanoparticles: Emulsion/Diffusion
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Structure
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Release
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Drug Delivery Carriers
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Methods of Drug Delivery
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Liposome's
Niosomes
Carbon Nanotube
Bilosomes
Ethosomes
Drug Delivery
System
Polymeric
Nanoparticles
Aquasome
Dendrimers
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THANKING YOU
E-mail: [email protected]
Cell No: 0091 9742431000
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