nanotechnology in drug discovery- development and delivery

Nanotechnology in Drug Discovery- Development and Delivery

Dr. Basavaraj K. NanjwadeKLE University College of Pharmacy

Belgaum-590010E-mail: [email protected]

Cell No: 00919742431000

mailto:[email protected]

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.



• 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


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.


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.


Discovery

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Development


Pre-Discovery


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.


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”.


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


Drug Discovery and Development Activities


Lead Compound

• Nature

• De Novo

• High-throughput screening

• Biotechnology


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 toxic19/08/2011 Srinivas College of Pharmacy, Mangalore 16

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


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)


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


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.



• 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



• 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.


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)


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.


NDA Review Process


ANDA/AADA Review Process


OTC Drug Monograph Process


Successful Therapy Combines Drug Discovery and Delivery


Nanotech Components


Nanotechnology Regulatory


Nanotechnology Collaboration


Research Priorities


nanotechnology in drug discovery- development and delivery

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