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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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 2 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 3 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 19/08/2011 Srinivas College of Pharmacy, Mangalore 4 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 5 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 6 Discovery 19/08/2011 Srinivas College of Pharmacy, Mangalore 7 Development 19/08/2011 Srinivas College of Pharmacy, Mangalore 8 Pre-Discovery 19/08/2011 Srinivas College of Pharmacy, Mangalore 9 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 10 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”. 19/08/2011 Srinivas College of Pharmacy, Mangalore 11 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 19/08/2011 Srinivas College of Pharmacy, Mangalore 12 Drug Discovery and Development Activities 19/08/2011 Srinivas College of Pharmacy, Mangalore 13 Drug Discovery and Development 19/08/2011 Srinivas College of Pharmacy, Mangalore 14 Lead Compound • Nature • De Novo • High-throughput screening • Biotechnology 19/08/2011 Srinivas College of Pharmacy, Mangalore 15 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 19/08/2011 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 19/08/2011 Srinivas College of Pharmacy, Mangalore 17 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) 19/08/2011 Srinivas College of Pharmacy, Mangalore 18 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 19/08/2011 Srinivas College of Pharmacy, Mangalore 19 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 20 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 19/08/2011 Srinivas College of Pharmacy, Mangalore 21 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 22 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) 19/08/2011 Srinivas College of Pharmacy, Mangalore 23 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. 19/08/2011 Srinivas College of Pharmacy, Mangalore 24 NDA Review Process 19/08/2011 Srinivas College of Pharmacy, Mangalore 25 ANDA/AADA Review Process 19/08/2011 Srinivas College of Pharmacy, Mangalore 26 OTC Drug Monograph Process 19/08/2011 Srinivas College of Pharmacy, Mangalore 27 Successful Therapy Combines Drug Discovery and Delivery 19/08/2011 Srinivas College of Pharmacy, Mangalore 28 Nanotech Components 19/08/2011 Srinivas College of Pharmacy, Mangalore 29 Nanotechnology Regulatory 19/08/2011 Srinivas College of Pharmacy, Mangalore 30 Nanotechnology Collaboration 19/08/2011 Srinivas College of Pharmacy, Mangalore 31 Research Priorities 19/08/2011 Srinivas College of Pharmacy, Mangalore 32 Suggested Topics and Modules 19/08/2011 Srinivas College of Pharmacy, Mangalore 33 Nanoparticles in the context of Biopharmaceuticals 19/08/2011 Srinivas College of Pharmacy, Mangalore 34 Current Nanoparticle Products 19/08/2011 Srinivas College of Pharmacy, Mangalore 35 Current Nanoparticle Products 19/08/2011 Srinivas College of Pharmacy, Mangalore 36 Nanoparticles: As Emulsion 19/08/2011 Srinivas College of Pharmacy, Mangalore 37 Nanoparticles: Reduce Size 19/08/2011 Srinivas College of Pharmacy, Mangalore 38 Nanoparticles: Grow Them 19/08/2011 Srinivas College of Pharmacy, Mangalore 39 Nanoparticles: Emulsion/Diffusion 19/08/2011 Srinivas College of Pharmacy, Mangalore 40 Structure 19/08/2011 Srinivas College of Pharmacy, Mangalore 41 Release 19/08/2011 Srinivas College of Pharmacy, Mangalore 42 Drug Delivery Carriers 19/08/2011 Srinivas College of Pharmacy, Mangalore 43 Methods of Drug Delivery 19/08/2011 Srinivas College of Pharmacy, Mangalore 44 Liposome's Niosomes Carbon Nanotube Bilosomes Ethosomes Drug Delivery System Polymeric Nanoparticles Aquasome Dendrimers 19/08/2011 Transfersomes Srinivas College of Pharmacy, Mangalore 45 THANKING YOU E-mail: [email protected] Cell No: 0091 9742431000 19/08/2011 Srinivas College of Pharmacy, Mangalore 46