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![DriversforMarket Adoption
Nano
DDS
Development in
Drug Delivery Devices
Lowering cost
for large-scale
production
Increase in take-up rate
by Health Institutions and
Consumers [Demand]
Improvement in
performance
and accuracy
of Nano DDS
Source:
IntelliCap electronic oral drug
delivery technology wins prestigious
European ‘High-Tech Innovation
Award’
http://news.engineering.iastate.edu/2
015/02/09/materials-science-assistant-
professor-uses-affordable-tools-to-
create-nanoparticle-catalysts-and-
drug-delivery-systems/](https://image.slidesharecdn.com/nanotechnologyindrugdelivery-240528084208-9606e503/75/NANO-TECHNOLOGY-Particles-IN-DRUG-DELIVERY-system-37-2048.jpg)
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NANO TECHNOLOGY & Particles IN DRUG DELIVERY system
- 1. Nanotechnology in Drug DeliverySystem MT5009 ANALYZING HI-TECHNOLOGY OPPORTUNITIES FOONG SHI WEN A0133491 LAM CHEE YEN, KELVIN A0132425 SEOW WHEI-ZHNG A0132427
- 2. • Introduction toNanotechnology in Drug Delivery • Definition of Nanotechnology, Nanomedicine, Nano DDS • Nano DDS –Vehicle, Cargo, Route, Targeting • Nano vs Traditional Drug Delivery • Current Status of Market & Advances • Changing Economics of Nano Drug Delivery • Market growth that shows optimism • Drug delivery system that is currently in market • Drug that are going to be released in near future (clinical trial) • Economical Feasibility of Nanotechnology DDS • Improvement and advances over the next 5 to 10 years • Current Challenges / Issues • Drivers for Market Adoption • Entrepreneur Opportunities • Conclusion Agenda
- 3. • Introduction toNanotechnology in Drug Delivery • Definition of Nanotechnology, Nanomedicine, Nano DDS • Nano DDS –Vehicle, Cargo, Route, Targeting • Nano vs Traditional Drug Delivery • Current Status of Market & Advances • Changing Economics of Nano Drug Delivery • Market growth that shows optimism • Drug delivery system that is currently in market • Drug that are going to be released in near future (clinical trial) • Economical Feasibility of Nanotechnology DDS • Improvement and advances over the next 5 to 10 years • Current Challenges / Issues • Drivers for Market Adoption • Entrepreneur Opportunities • Conclusion Agenda
- 4. Nanotechnology Science, engineering, andtechnology conducted at the nanoscale (1-100nm), where unique phenomena enable novel applications
- 5. Nanomedicine http://www.britishsocietynanomedicine.org/what-is-nanomedicine.html • T he medicalapplication of Nanotechnology • Diagnosis, prevention and treatment of diseases • Usage of nanoparticles to improve the behavior of drugs Different structures of nanoparticles & their approx. sizes They are in similar size range as biological nanostructures Q: How do the Nanoparticles carry drugs?
- 6. Ans.: Nanoparticles act asa vehicle on which the drugs are encapsulated within or chemically bonded • Usage of engineered nanoparticles to deliver drugs in a more targeted, efficient way, with less unpleasant side effects to patients Liposome: Most commonly used nanoparticle Nano Drug Delivery System Let’s look at Liposome as an example
- 7. Nano Drug DeliverySystem – Vehicle & Cargo Liposome as a Nano drug vehicle Biocompatible as it has similar membrane as human cells Specifically targets certain molecules to bind to Nano drugs within are protected during travel http://sitn.hms.harvard.edu/flash/2011/materials-for-drug-delivery/ Nano drugs of different solubility properties are carried within the Liposome
- 8. Injections Etheridge M.L., CampbellS.A., Erdman A.G., Haynes C.L., Wolf S.M., McCullough J., The big picture of nanomedicine: the state of investigational and approved nanomedicine products, Nanomedicine: NBM 2013;9:1-14 Most commonly used route, as the drug can be administered directly to site and thus effect is more rapid Nano Drug Delivery System - Route Q: How are Nanoparticles carrying drug administered into body?
- 9. Nano Drug DeliverySystem- Targeting Q: How do the Nanoparticles deliver drugs to targeted tissues? • Purely Size & Geometry dependent mode • Normal blood vessels: • Cell wallshave tight junctions with spaces smaller than the Nanoparticle • Nanoparticle carrying drug is not able to enter , preventing toxicity to normal tissues • Cancerous blood vessels: • Cell wallsare dilated with large gaps (200-1200nm) & compromised lymphatic drainage • Highly permeable for nanoparticles up to dia.400nm to enter and preferentially accumulate at tumor sites Passive Targeting
- 10. Nano Drug DeliverySystem- Targeting • Not dependent on size or geometry • Affinity ligands (e.g. antibodies, DNA/RNA) are attached to Nanoparticle surface • T hisallow the Nanoparticle carrying drug to recognize and bind to target cellshaving specific receptors on theirsurfaces, e.g. tumor cells • After the nanoparticle isbound to the target cells, the drugs carried within isreleased inside the target cells Active Targeting http://www.medscape.com/viewarticle/770397_3
- 11. http://nano.cancer.gov/learn/ http://www.nature.com/labinvest/journal/v82/n5/full/3780460a.html Nano vs. TraditionalDrugDelivery Criteria Traditional Nano Specificity Drugs will pass through unaffected sites before reaching affected site Delivered in more targeted manner to the affected site Dosage Release Higher initial dosage required No control ability Able to control dosage by trigger, requirement, and even time-release Efficacy Drug concentration in affected site is low Drug concentration in affected site is more optimized Side Effects Inevitable exposure of unaffected sites to drugs Lesser exposure of unaffected sites to drugs
- 12. http://nano.cancer.gov/learn/ http://www.nature.com/labinvest/journal/v82/n5/full/3780460a.html Nano vs. TraditionalDrugDelivery Nano Drug Delivery Controlled Release Targeting Effective
- 13. • Introduction toNanotechnology in Drug Delivery • Definition of Nanotechnology, Nanomedicine, Nano DDS • Nano DDS –Vehicle, Cargo, Route, Targeting • Nano vs Traditional Drug Delivery • Current Status of Market & Advances • Changing Economics of Nano Drug Delivery • Market growth that shows optimism • Drug delivery system that is currently in market • Drug that are going to be released in near future (clinical trial) • Economical Feasibility of Nanotechnology DDS • Improvement and advances over the next 5 to 10 years • Current Challenges / Issues • Drivers for Market Adoption • Entrepreneur Opportunities • Conclusion Agenda
- 14. Nanotechnology in Drug DeliveryMarket GBI Research,2010 Opportunities for New Drug Delivery Companies Nanotoxicity of Nanomaterials Market Growth Need of Understanding Biological behaviour Need of Understanding Distribution Pattern of Nanomaterial Licensing Opportunities Opportunities Unmet Needs
- 15. Increasing Global Investmentsin Nanotechnology Expectation of lucrative market
- 16. U.S. sets aside thehighest amt of funding for Nanotechnology Increasing Global Investmentsin Nanotechnology
- 17. U.S. Investmentsin Nanotechnology 16.5%+ 25.7% 42.2%of NNI Budget is allocated for Commercialization & technology transfer! National Nanotechnology Initiative (NNI) – U.SGovt R&D initiative involving 20 department, independent academic and industry agencies U.SFederal Budget 2016 setsaside $1.5 billion for NNI.Cumulatively, $22 billion since NNIinception in 2001 THE NATIONAL NANOTECHNOLOGY INITIATIVE, Mar 2015
- 18. U.S. Focus on Nano-basedBiomedical Research DHHS/NIH (nanotechnology- based biomedical research at the intersection of life and physical sciences) is allocated $448.6 mil or 30%of total NNI budget in 2016 signifiesemphasis on accelerating improvement in biomedical, e.g. nanomedicine
- 19. Main Areas of NanoDrug Application Cancer, Infection Control, Cardiovascular disease The big picture on nanomedicine: the state of investigational and approved nanomedicine products
- 20. Contribution of Nano-Enabled Productson Cancer The big picture on nanomedicine: the state of investigational and approved nanomedicine products • At present, cancer is one of the largest therapeutic areas in which nano-enabled productshave made major contributions • Cancer is a prime focus for nanopharmaceutical R&D
- 21. Evolution of ControlledDDS Facing the Truth about Nanotechnology in Drug Delivery. ACS Nano. 2013 September 24.
- 22. Components of DDS NanoDrug Delivery System Structure-Based • Microneedle arrays through skin painlessly • Microneedle patch for vaccine delivery Electrically-Based Vehicle-Based • Electrically controlled drug delivery nanocomposite composed of graphene oxide (GO) deposited inside a conducting polymer • Nanosponges are a promising vehicle in treating cancer • Releasing medication at the tumor site at a steady, controlled rate Targeting Strategies • Plant virus nanoparticles that can target prostate cancer cells July 2013 Newsletter, NATIONAL INSTITUTE OF BIOMEDICAL IMAGING AND BIOENGINEERING
- 23. Structure-Based- Microneedle Silicon microneedleshave been fabricated to serve as neural probes by dicing a silicon substrate to create a grid pattern of deep groovesand then acid etching the resulting pillars to create sharpened probe tips http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419303/ Price of Silicon microneedles is expected to decrease
- 24. Electrically-Based - Nanocomposite T hehigh level of temporal control and dosage flexibility provided by the electrically controlled graphene oxide nanocomposite drug delivery platform makes it suitable for on-demand drug delivery http://pubs.acs.org/doi/abs/10.1021/nn406223e Price of nanocomposite is expected to decrease
- 25. Vehicle Based &TargetingStrategies Journal of Nanomaterials, Volume 2013,Article ID 629681,12 pages http://dx.doi.org/10.1155/2013/629681 Year Drug (Cargo) Nanoparticle (Vehicle) For Route Features of Vehicle Improvement over non-nano version 1995 Doxorubicin PEGylated Liposomes (80-90nm) AIDS- related Kaposi’s sarcoma, Breast cancer IV Passive targeting, accumulate at tumor sites due to small size Much lesser cardiotoxicit y 2006 Peg-l- asparaginas e Polymer– protein conjugate Leukemia IM, IV Active targeting and catalysing asparagine to aspartic acid & ammonia, depriving Leukemic cells of asparagine Longer drug retention (Half life 357h vs 20h) Less allergic reaction (11% vs 25%) 2005 Paclitaxel Albumin nanoparticles (100-200nm) Various cancers IV >Non polar vehicle, ideal for hydrophobic Paclitaxel >Active targeting to protein that is expressed by cancer cells Faster response rates (33% vs 19%) Delay Tumor progression (23 wks vs 16.9 wks) Examples of Nano DDS currently in the market
- 26. Vehicle Based &TargetingStrategies Drug (Cargo) Nanoparticl e (Vehicle) For Current Clinical Trial Route Features of Vehicle MicroRNA - 122 Liposome with high- affinity collagen Pancreatic, bile duct, gastric, colonic and stomach cancers Phase II/III Fast Track Designation Approved in Philippines IV Active Targeting to cancer collagen 1st of its kind (Gene therapy of cancer) selling in market Doxorubicin Heat-activated Liposomes Liver cancer, Breast cancer Phase III Fast Track Designatio n IV Heat-activated (≥39.5∘C) release of drugs within seconds Doxorubicin , Cyclophosp hamide Non- PEGylated Liposomes Metastastic Breast cancer Phase III in US Approved in EU and Canada IV Passive targeting Quick release of cargo (90% released in 24h) Examples of upcoming Nano DDS Journal of Nanomaterials, Volume 2013,Article ID 629681,12 pages http://dx.doi.org/10.1155/2013/629681
- 27. • Introduction toNanotechnology in Drug Delivery • Definition of Nanotechnology, Nanomedicine, Nano DDS • Nano DDS –Vehicle, Cargo, Route, Targeting • Nano vs Traditional Drug Delivery • Current Status of Market & Advances • Changing Economics of Nano Drug Delivery • Market growth that shows optimism • Drug delivery system that is currently in market • Drug that are going to be released in near future (clinical trial) • Economical Feasibility of Nanotechnology DDS • Improvement and advances over the next 5 to 10 years • Current Challenges /Issues • Drivers for Market Adoption • Entrepreneur Opportunities • Conclusion Agenda
- 28. Nano DDS-Economic Feasibility Economic Feasibility ImprovedProcesses - Route of Delivery - Targeting Strategies Government Policies and Regulations by FDA - Reduction of Transaction costs Geometric Scaling - Increase in Scale - Reduction in Scale Creating New Materials - New Nanoparticles - New Drugs Source: 1) Jeffrey L. Funk and Pei-Sin Ng, When do New Technologies Become Economically Feasible? The Case of Three-Dimensional Television, Technology and Society, forthcoming 2) Jeffrey L. Funk, What Drives Exponential Improvements, California Management Review, August 2013
- 29. Creating New Materialthat exploit phenomenon Source: https://news.mit.edu/2014/glowing-magnetic-nanoparticles-1009 https://www.youtube.com/watch?v=KdHksgstcXY New Nanoparticles - can be tracked within body or inside a cell - can seek out and bind with particularmolecules glow with color- coded light manipulated with magnets have a coating of a bioreactive substance Improvements: • May add additional materials to the particles’ coating • Either for diagnosis or treatment
- 30. • A "smartcapsule"can be manipulated when and where the medicine was released inside a simulated gastrointestinal tract. • When the capsule reachesthe organ, a magnet worn on the patient's hip would trigger electrical components in the device to release the medicine. Creating New Material that exploit phenomenon Source: http://www.jconline.com/story/news/college/2015/07/26/purdue-smart-capsule/30699373/ Improvements: • Release (medicine) into a specific location more accurately and timely • Manipulated by Magnet
- 31. • Philips’ IntelligentPill (iPill) can be programmed to deliver medicine in a controlled fashion according to a pre-defined drug release profile which is to be created per patient and condition. It ismostly focused on treating conditions in different areas of the intestine based on the acidity of its surroundings (pH Value). Creating New Material that exploit phenomenon Source: http://thefutureofthings.com/3794-philips-smart-pill-to-deliver-drugs/ Improvements: • FDA approved camera pills for diagnostic application • Programmable • Based on patient’s condition in drug release profile (customised)
- 32. New Process for movingnanoparticles Source: http://www.engadget.com/2015/06/19/swimming-nanobots-target-cancer/ https://www.youtube.com/watch?v=eRxyN9yxOP0 Nanobots for targeting cancer cells • Researchers at the Israel Institute of Technology (Technion) have now found an artful way to propel such 'bots. • They created a "nanoswimmer" the width of a silk fiber, made of several links of polymer and magnetic nanowires. The team can control exactly where the nanobots finish up -- at a particular organ, say -- by modulating the field. Improvements: • Control exactly where the nanobots • Reduce need for surgery, speedy recovery, lower risk
- 33. New Process for movingnanoparticles • The proposed Local Electromagnetic Steering System (LESS) uses a small electromagnet that isattached to a robotic manipulator to steer the nanoparticlesinside the blood vessels. • The main advantage of LESSisthat it significantly reduces the cost (a few thousand dollars) and also the size of the system; as compared to multi-million dollar MRI -based drug delivery in chemotherapy as one of the important procedures in the cancer therapy. Source: http://contest.techbriefs.com/2015/entries/medical/6254 Improvements: • Reduction in size (LESS) • Reduction in costs (a few thousands dollars)
- 34. New Process for producingnanoparticles Materials science assistant professor uses affordable tools to create nanoparticle catalysts and drug-delivery systems ▶ Histeam set out to develop a low-cost approach to nanoparticles synthesis - low-cost “scissor” to chop blocks of metals into small particles while also forming and organizing other layers on the metal surface to create an onion-like nanoassembly. ▶ The advantage is that when the drug is attached to the squishy particle it can respond to acidity changes in the body. The drug would only be released in regions with high pH, a common feature of tumors and inflammation; thereby, attacking the disease or foreign object only where needed. Source: http://news.engineering.iastate.edu/2015/02/09/materials-science-assistant-professor- uses-affordable-tools-to-create-nanoparticle-catalysts-and-drug-delivery-systems/ Improvements: • Affordable tools
- 35. Improvements and Advancesof DDS • Manipulated withmagnets • Programmable (drug release • profile) • Reductioninsizeof manipulators • (MRIvsLESS) • Reductioninsizeinproduction tools Summary • New nanoparticleswith new coating • Smart capsule, iPill, NanoBots New Materials New Processes Geometric Scaling • FDA approval in camera pills Government Policies and Regulations
- 36. Challenges and Issues •According to the Pharmaceutical Research Manufacturers of America (PhRMA) in 2009, the average total cost to push a new drug through development in the United States is more than $800 million. • The process takes an average of 12 to 15 years, leaving only five to eight years of U.S. patent protection. PhRMA further notes that just one in 5,000new compounds survives the process to become a new drug in the marketplace.
- 37. DriversforMarket Adoption Nano DDS Development in DrugDelivery Devices Lowering cost for large-scale production Increase in take-up rate by Health Institutions and Consumers [Demand] Improvement in performance and accuracy of Nano DDS Source: IntelliCap electronic oral drug delivery technology wins prestigious European ‘High-Tech Innovation Award’ http://news.engineering.iastate.edu/2 015/02/09/materials-science-assistant- professor-uses-affordable-tools-to- create-nanoparticle-catalysts-and- drug-delivery-systems/
- 38. Types of EntrepreneurialOpportunities Top left: “Smart” insulin patch which can actively controls blood sugar levels Top Right: Red Dot Design Award for KiCoPen , Smart Insulin Pen Bottom: SmartDose system from West Pharmaceutical Services.
- 39. Types of EntrepreneurialOpportunities • Disease Diagnosis and Imaging • Preventing and Treating Diseases • Smart Drug Delivery System and Device • Skin Patches and Micro needles (3M and Novinject)
- 40. FutureT rends The use ofelectronics opens up new possibilities in the era of Smart Drug Delivery System • Active Feedback System (Health Care Workers and Patients) • Programmable Drug Release Profile • Improve Ease of Use (self-administer)
- 41. Nano Drug Deliverystill has lots of room for improvement Facing the Truth about Nanotechnology in Drug Delivery. ACS Nano. 2013 September 24;7(9): 7442–7447. doi:10.1021/nn404501g. • By using Nanoparticles to delivery drug, >95% administered drug still ends up at non-target site (non-tumor) • BUT, it is still 5x more efficient delivery than non-nano drug delivery method • This 5x more efficient delivery can be exploited for maximizing drug efficacy A: Traditional drug solution B: Nanoparticle formulation 5x more
- 42. Conclusion • The useof nanotechnology for diagnosis and treatment of cancer and other diseases is largely still in the research and development phase • We will need to find new materials (e.g. new nanoparticles) that are appropriate for more specific applications • We will also need to find new processes (e.g. new nonmanufacturing process) that produce nanoparticles cheaply and in large quantities • Increasing alliance between pharmaceutical companies and DDS Research Institutions (Invention Innovation Commercialisation)
- 43.