Drug Delivery F23-1Theme 3 -a Course Enhancement Project
How did Pharmacists Solve the “Morphine Delivery” Problem?
David NeedhamProfessor,
Dept Mechanical Engineering and Material ScienceDuke University,
Durham NC 27708, USA
Darts
DrumsSKYPE: needdavid
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?
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
How did Pharmacists Solve the “Morphine Delivery” Problem?
With Patient controlled analgesic (PCA) metered system using i.v. injection
With Metered epiduralWith Skin patchWith Oral tablet formWith OintmentsWith Suppository
Group Assignments
Sign Up in groups of 4-5 by Monday 7th Nov
GROUP 1 Topic Names
A) PCA 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
B) Epidural 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
C) Skin Patch 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
D) Ointment 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
E) Tablet 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
F) Suppository 1_______________________________________ 2 _______________________________________ 3 _______________________________________ 4 _______________________________________ 5 _______________________________________
1. How did Pharmacists Solve the “Morphine Delivery” Problem?
With Patient controlled analgesic (PCA) metered system using i.v. injection
Title, slide 1
Frederik CristofferSofie Mathilde
Overall System
• 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……
Supply Target
PCA Intravenous injection Pain Center in the Brain
Morphine
Overall System, slide 2
Sites for Toxicity?
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)
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
Performance in Service
10
Design methodology Scheme we will work through
Define the function Device to pump fluids
Material Selection Component Design
Tentative component design
Approximate stress analysis
Tentative choice of material
Assemble Materials Data
Analysis of Materials Performanceiterate
Detailed Specifications and Design
Choice of Production Methods
Prototype Testing
Performance in Service
Further Development
iterate
iterateiterate
LAWS
3
12
11
10
9
8
7 6
54
Let’s take a break
Coffee and Danish
Drug Delivery F23-1Theme 3 -a Course Enhancement Project
Part 2
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
Performance-in-Service, slide 3 How does the Morphine delivery System perform in service? --quantify
Define the Function
The Function of the PCA Morphine Delivery System is to:a)b)c)d)
Define the Function, slide 4 What is the function of the PCA Morphine delivery System?
to dissolve morphine in liquid solution
Laws, Theories, ModelsThe Laws, Theories, and Models of the PCA Morphine Delivery System that
correspond to each Function are :
Laws, Theories, Models, slide 5 What are the Laws, Theories, and Models of the PCA Morphine Delivery System that correspond to each Function ?
Function Law, Theory, Model
a) to dissolve morphine in liquid solution
Concentration of Morphine
b)
c)
d)
.
Component Design
Component Design slide 6 What are the basic components of the Morphine
Delivery System?
What are the environmental stresses on the delivery and its individual components in service?
What does the design look like?
1. Saddle, seat2. Crossbar3. Gearshift4. Handlebars5. Brake cable6. Brake lever7. Front brake8. Rim
9. Tire10. Crank11. Pedal12. Front derailleur13. Chain14. Rear derailleur15. Spokes16. Rear brake17. Pump
Materials ChoiceComponent Composition Structure Property Saddle, seat:
Rails PanPadCover
SteelHDPE plasticPoly urethane cellulose
FCCSemi-crystalline polymerfoamWoven fiber
200 GPa4 GPa0.01 GPa35 GPa
2. Crossbar
3. Gearshift
4. Handlebars
5. Brake cable
6. Brake lever
7. Front brake
8. Rim
9. Tire
10. Crank
Materials Choice, slide 7 What materials are the components of the Morphine delivery system made from (assemble materials data CSP)?
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
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?
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
Specification Sheet, slide 9
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, orthe porous membrane or outer covering of the transdermal patchthe sintering of tablets,the emulsification of oilsthe molding of a suppository
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?”
PrototypesSearch for your device at:US patent and trademark office http://www.uspto.gov orEuropean 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!
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?
This is your chance to get inventive! I bet you all have ideas now!
Further Development
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?
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!
