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Drug Delivery F23-1 Theme 3 -a Course Enhancement Project

Drug Delivery F23-1 Theme 3 -a Course Enhancement Project. How did Pharmacists Solve the “Morphine Delivery” Problem?. David Needham Professor, Dept Mechanical Engineering and Material Science Duke University, Durham NC 27708, USA d.needham@duke.edu. Darts. SKYPE: needdavid. Drums.

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Drug Delivery F23-1 Theme 3 -a Course Enhancement Project

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  1. Drug Delivery F23-1Theme 3 -a Course Enhancement Project How did Pharmacists Solve the “Morphine Delivery” Problem? David Needham Professor, Dept Mechanical Engineering and Material Science Duke University, Durham NC 27708, USA d.needham@duke.edu Darts SKYPE: needdavid Drums

  2. An introduction to a new way to look at and learn pharmacy content • posing a problem and solving it with a well established engineering design scheme, called engineering design methodology. • Your Content framework, • framework in which you will place all the pharmaceutical, chemical, physiological, pathological, clinical etc content, as a design scheme for a product that performs in the clinic. • Reverse Engineer any problem that has already been Solved • Why would we want to solve a problem that has already been solved? • It was not solved by you, and we know we can find the answer! • You will learn how to pose and answer questions that you can use to pose and solve any problem Huh?

  3. Outcomes • Educators want to develop “problem solvers” and “critical thinkers”. • Fundamental skills that will allow you to work in any environment and succeed • Reverse engineering makes you solve a problem(s) and think critically about the information and its relationships to the design. • In Pharmacy we can pose the general question, • How did Pharmacists Solve the “X” Problem? • We will ask, • How did Pharmacists Solve the “Morphine Delivery” Problem? • Develop a series of powerpoint slides that contain images and text that you will present and hand in at the end of the course. • So let’s look at those slides now and how to construct them

  4. How did Pharmacists Solve the “Morphine Delivery” Problem? With Patient controlled analgesic (PCA) metered system using i.v. injection • With Metered epidural • With Skin patch • With Oral tablet form • With Ointments • With Suppository

  5. Group Assignments Sign Up in groups of 4-5 by Monday 7th Nov

  6. Title, slide 1 1. How did Pharmacists Solve the “Morphine Delivery” Problem? With Patient controlled analgesic (PCA) metered system using i.v. injection Frederik Sofie Cristoffer Mathilde

  7. Overall System, slide 2 Overall System Target Supply • Morphine is supplied to the blood stream from a device called patient controlled analgesia, (PCA) via an intravenous injection. • Its target is the pain center in the brain. Toxicity can include…… Morphine PCA Intravenous injection Pain Center in the Brain Sites for Toxicity?

  8. Design Methodology Scheme • A design methodology scheme that will allow us to ask additional specific questions in order to reverse engineer the overall system, its supply and its target • Actually, why don’t you see if you can come up with a design scheme yourselves. • What questions would you want to ask in order to learn as much as you can (reverse engineer) a simple cup. Write down all the questions you might want answered, I’ll start you off, • “What is it made of?” (check your answers on the next slide)

  9. Check your answers here • What is it for? • How should it work? • What is it made of? • What are the characteristics of the material? • How is it made? • Has anybody made something similar? • Does it really work? You just reverse engineered a plastic cup! The idea is to now apply this same series of questions to your morphine delivery system and formulation

  10. Component Design Material Selection Tentative choice of material Tentative component design Assemble Materials Data Approximate stress analysis iterate iterate Analysis of Materials Performance Detailed Specifications and Design Choice of Production Methods iterate iterate Prototype Testing Further Development Design methodology Scheme we will work through Define the function Device to pump fluids 4 LAWS 5 7 6 8 9 10 11 Performance in Service Performance in Service 3 12

  11. Let’s take a break Coffee and Danish

  12. Drug Delivery F23-1Theme 3 -a Course Enhancement Project Part 2

  13. Performance-in-Service, slide 3 How does the Morphine delivery System perform in service? --quantify Performance-in-Service • Describe the clinical data that quantifies its performance • web, books, journals, your class notes, your professor(s)) • Be quantitative e.g., • mls solution per minute, • mass drug per mass of patient, • etc

  14. Define the Function, slide 4 What is the function of the PCA Morphine delivery System? Define the Function The Function of the PCA Morphine Delivery System is to: a) b) c) d) to dissolve morphine in liquid solution

  15. Laws, Theories, Models, slide 5 . What are the Laws, Theories, and Models of the PCA Morphine Delivery System that correspond to each Function ? Laws, Theories, Models The Laws, Theories, and Models of the PCA Morphine Delivery System that correspond to each Function are :

  16. Component Design slide 6 What are the basic components of the Morphine Delivery System? Component Design What does the design look like? • Saddle, seat • Crossbar • Gearshift • Handlebars • Brake cable • Brake lever • Front brake • Rim What are the environmental stresses on the delivery and its individual components in service? Tire Crank Pedal Front derailleur Chain Rear derailleur Spokes Rear brake Pump

  17. Materials Choice, slide 7 What materials are the components of the Morphine delivery system made from (assemble materials data CSP)? Materials Choice

  18. Analysis of Material’s Performance, slide 8 Can the materials bear the loads, moments concentration stresses etc., without deflecting too much, collapsing, or failing in some other way? Analysis of Material’s Performance • Start by looking at the mechanism proposed in slide 6, and the properties of a material component in slide 7, and try to connect the two in terms of how the device has to function (slide 4), given the laws (slide 5) that govern its function • Concentrate on the • tubing of the i.v., and epidural, • or the protective layer and adhesive of the skin patch, • or the binders of the tablet • or the oil of an ointment • or the fatty material of the suppository

  19. Specification Sheet, slide 9 Specification Sheet (FDA) For Traditional Engineering: http://www.shure.com/americas/products/microphones/sm/sm58-vocal-microphone For Pharmaceuticals: European Medicines Agency (Europe): www.ema.europa.eu/ Food and Drug Administration (USA): www.fda.gov Drugs.com: www.Drugs.com Search for your formulation and see how some of what you have already found out is an integral part of the FDA approval, For example see http://www.drugs.com/pro/morphine-injection.html

  20. Production, slide 10 How is the morphine delivery system be made from these materials? What is the size of the production run? How will the components be finished and joined to other components; What does it cost?” Production How are the various components of your morphine delivery system in fact made? Plastic tubes and needles of the i.v. and epidural systems, or the porous membrane or outer covering of the transdermal patch the sintering of tablets, the emulsification of oils the molding of a suppository

  21. Prototypes, slide 11 At what point in the evolution and development of this particular morphine delivery device did a delivery system appear that could (your function statement here) …and thereby confer an advantage on pharmaceutical drug delivery? Prototypes Search for your device at: US patent and trademark office http://www.uspto.gov or European patent office http://www.epo.org/ For example you might search and find: • United States Patent 6,054,584, Process for Extracting and Purifying Morphine From Opium, April 25, 2000 • Or Cocaine-Laced Toothache Remedy Ad Targeted Children in 1885!

  22. Further Development , slide 12 Did any of this stimulate a new idea, concept, device or process or a way to improve or fix any failures of the current system? Further Development This is your chance to get inventive! I bet you all have ideas now!

  23. Target --the pain center in the brain • We can also apply this reverse engineering scheme to understand more about the physiology, cell biology and molecular biology of pain control by going through the same scheme, but this time for the brain and pain! Reverse Engineer Nature’s designs!

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