Transcript Reverse Engineering Problems Pharmacists Solved

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
[email protected]
SKYPE: needdavid
Darts
Drums
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 epidural
With Skin patch
With Oral tablet form
With Ointments
With Suppository
Group Assignments
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 _______________________________________
Sign Up in groups of 4-5
by Monday 7th Nov
Title, slide 1
1. How did Pharmacists Solve the “Morphine
Delivery” Problem?
Frederik
Sofie
Cristoffer
Mathilde
With Patient controlled analgesic (PCA)
metered system using i.v. injection
Overall System, slide 2
Overall System
Target
Supply
Morphine
PCA Intravenous injection
Pain Center in the Brain
Sites for Toxicity?
• 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……
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
Design methodology Scheme we will work through
Define the function
Device to pump fluids
4
LAWS
5
Material Selection
Component Design
Tentative choice of material
Tentative component design
7
Assemble Materials Data
iterate
6
Approximate stress analysis
iterate
Analysis of Materials Performance
8
Detailed Specifications and Design
9
Choice of Production Methods
10
iterate
Prototype Testing
Performance in Service
10
Further Development
iterate
11
3
12
Let’s take a break
Coffee and Danish
Drug Delivery F23-1
Theme 3 -a Course Enhancement Project
Part 2
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
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) to dissolve morphine in liquid solution
b)
c)
d)
.
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 :
Function
a) to dissolve morphine in
liquid solution
b)
c)
d)
Law, Theory, Model
Concentration of Morphine
Component Design slide 6
Component Design
What are the basic
components of the Morphine
Delivery System?
What does the design look
like?
What are the environmental
stresses on the delivery and
its individual components in
service?
1.
2.
3.
4.
5.
6.
7.
8.
Saddle, seat
Crossbar
Gearshift
Handlebars
Brake cable
Brake lever
Front brake
Rim
9.
10.
11.
12.
13.
14.
15.
16.
17.
Tire
Crank
Pedal
Front derailleur
Chain
Rear derailleur
Spokes
Rear brake
Pump
Materials Choice, slide 7
What materials are the components of the Morphine
delivery system made from (assemble materials data CSP)?
Materials Choice
Component
Composition
Structure
Property
Saddle, seat:
Rails
Pan
Pad
Cover
Steel
HDPE plastic
Poly urethane
cellulose
FCC
Semi-crystalline polymer
foam
Woven fiber
200 GPa
4 GPa
0.01 GPa
35 GPa
2. Crossbar
3. Gearshift
4. Handlebars
5. Brake cable
6. Brake lever
7. Front brake
8. Rim
9. Tire
10. Crank
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
Specification Sheet, slide 9
Specification Sheet (FDA)
For Traditional Engineering:
http://www.shure.com/americas/products/microphones/sm/sm58-vocalmicrophone
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
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
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!
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!
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!