Pharmesuticals PPT 2
Pharmesuticals PPT 2
ls
Designing & Producing Effective
Medicines
GOAL
2024-08-15_v1.0
Breakout Development Team
wondered...
• How a pharmaceutical drug reaches its site
Why might drugs be
administered in different ways,
of action in your body? like by mouth or by injection?
• How to build the most efficient drug delivery
system you can?!
Because depending on the
way its administered can
maybe detirine howfast its
delivered into your system
and where it travels to or
works.
3
PART 1
Engineering
Applications to
Pharmaceuticals
4
What are
Pharmaceutical Drugs?
• Pharmaceuticals are an important aspect of
medicine: some people need them to survive.
• Pharmaceuticals are chemical substances used
for the prevention or treatment of a disease,
and they help restore or correct functions in
the body.
PHARMACEUTICAL
MANUFACTURING EQUATION:
Active
Pharmaceutica Excipient
Drug
l Ingredient s
(API)
BIOLOGICALLY INACTIVE
ACTIVE FILLERS
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How are engineers involved with
pharmaceuticals?
BIOMEDICAL ENGINEERING CHEMICAL ENGINEERING
Design and manage the production of life-saving Determine the complex chemical process by
medical equipment, including pacemakers, artificial which to synthesize active drug ingredients &
limbs, and wearable pharmaceutical drug delivery design a drug’s unique method of action to reach
devices a specific target
This pharmaceutical drug delivery device delivers The receptor shown is Drug A’s target. Drug-target
drug directly to the intestine via a surgically installed interactions are specific & can be understood by
tube system. the lock-key analogy: the target is a lock on the door
that only a certain drug (the key) can bind to and
open. 6
How are engineers involved with
pharmaceuticals?
MECHANICAL ENGINEERING MECHANICAL ENGINEERING
Design and develop complex machines and Analyze production of pharmaceutical drugs in order
equipment used for drug product manufacturing to make more efficient manufacturing processes– the
goal
is reduce defective batches
Production lines, like this one shown, consist of Drug manufacturers turn to advanced automation
several pieces of equipment. technologies, as shown, in order to reduce time,
cost, and risk of production.
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Engineering Connection
to the Common Good
• Humanity has always sought to transcend
barriers, overcome challenges, and create
opportunities that improve people’s lives.
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Engineer Testament about ANSWER ME!
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PART 2
Methods of
Pharmaceutical Drug
Delivery
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Pharmaceutical Drug
Delivery Systems
Pharmaceutical drug delivery systems WHY ARE PHARMACEUTICAL DRUG
DELIVERY SYSTEMS IMPORTANT?
are engineered technologies for the
targeted delivery and/or the They help ensure that the active
controlled release of the active drug is available at the site of action
pharmaceutical ingredient (API) in the (“the right place”) in the body
human body. according to the need of the patient
for an intended duration (“the right
time”)
Toxic side effects for patients are
reduced since drug is selectively
delivered only to unhealthy cells.
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Different Types of Pharmaceutical Drug
Delivery
ORAL ADMINISTRATION INHALATION
taken by mouth through the digestive tract - taken directly into the bloodstream via the lungs
in liquid or pill form
2 1
3. The needle is held by an
adhesive patch stuck to the
skin
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Watch and Answer ANSWER ME!
2. Improved patient
compliance
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PART 3
Fundamentals of
Diffusion
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Drug Transport via Diffusion across Cell
Membranes
BLOOD
VESSEL
DRIVING FORCE
The concentration gradient is the
Driving Force for diffusion
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Simple Diffusion vs
Facilitated Diffusion
Membranes are composed of lipids… Factors that Increase Rate of Diffusion:
● Decreases in…
○ Membrane thickness
V ○ Drug molecule size
s
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Diffusion through Engineered Barriers
Large
molecules
cannot go
through the
membrane!
Selective diffusion
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Diffusion: Chemical Engineering
Connection
Chemical engineers must understand the
fundamentals of diffusion when designing a
variety of processes…
WATER TREATMENT GAS SCRUBBING BIOLOGICAL PROCESSES
Reverse osmosis is the process where dirty Gas scrubbing devices are used for air Diffusion allows for oxygen absorption
water diffuses through a semipermeable pollution control: they remove by the lungs. Oxygen then diffuses to
membrane to filter out contaminants, like particulates from flue gas to release oxygen-poor parts of the body, like
salt water ions. clean gas. muscles.
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PART 4
Your Pharmaceutical
Drug Delivery
Challenge
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How is drug release
controlled in the body?
ENTERIC COATINGS
Enteric coatings are commonly adopted in
oral pharmaceutical drug delivery systems
to…
1. Form a shell to protect a particular
drug
2. Prevent it from leaking out before
reaching the targeted site
POLYMERS
are materials of long, repeating chains of
molecules that dissolve over time…
Engineers often formulate enteric
coatings from polymers so drug release
is delayed over time.
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Choosing Polymers for
Enteric-Coated Drug
Capsules
In this lab, you will be using Polyvinyl Polymer Coatings for Dry Filled
Alcohol (PVA) as your polymer. Capsule
HARD GELATIN
What do all of these polymers have in ● Most common
common that make them suitable capsule
materials for pharmaceutical drug ● Cheapest option
delivery?
● Water-soluble
● Safe to consume
● Non-allergenic HYDROXYPROPYL
● Economical METHYLCELLULOSE
(HMPC)
Compared to gelatin, HPMC is more suitable for:
● Highly reactive molecules
● Moisture-sensitive products
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A Closer Look into
Polyvinyl Alcohol (PVA)
The subscript “n” denotes the
degree of polymerization, that
is, the number of repeating
PVA SHEET units linked together.
Chemical
Formula
(C2H4O)n
What is the value of n for this
structure?
Chemical
Structure
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Dual Delayed Release PEAK 1
Systems
DDR drug delivery systems have a a
PEAK 1
PEAK 2
(about 1 hour after pill
is swallowed)
plasma concentration-time profile
PEAK 2
characterized by 2 distinct peaks, leading
Releases in more distal
to an extended duration of therapeutic regions of small intestine
action. at pH 6.75 (about 5
hours after pill is
swallowed
EXAMPLE: DEXLANSOPRAZOLE
● For treatment of acid reflux
● The DDR technology uses 2 types of
enteric-coated granules with different
pH-dependent dissolution profiles
The pill is able to pass
the stomach (pH <5)
PEAK 1 without dissolving before
RELEASE it reaches its site of
action (the intestine).
PEAK 2
RELEASE
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The Essential Question
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Think
Pretend you are a chemical engineer.
How would you use the Engineering
Design Process to create a dual
delayed release drug delivery
system?
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The Components for Pharmaceutical Drug
Delivery
3 x Paper
Clips 1 x Napkin
BEFORE YOU BEGIN:
PLEASE NOTE!!!
Do NOT consume any of
the materials used for
this lab!
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Engineering Process
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Engineering Process
Step One: Identify the Problem
ANSWER ME! What problem are you trying to solve? Why is solving this problem important?
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Watch the video, and record
Engineering Process your observations from the
video regarding how fast each
Step Two: Research tablet dissolves. Take note of
how the material affects the
rate of diffusion.
Overall observations:
The tablets with the more
water soluable paper like
yellow and red dissolve way
faster than the blue which is
less soluable paper
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Engineering Process
Step 3: Design your
Solution
Engineers use criteria and constraints in order to
evaluate which of their solution ideas is the most
effective. A constraint is a condition or limitation that
your design must have. Consider the constraints below
as you design your solution.
Tape or other
material to secure
YOUR CONSTRAINTS tablets together
● Two differently colored tablets will be used in your
drug delivery system (red, blue, or yellow). They
are to be separately wrapped in layering materials
to meet the timepoints of color release. Tablet Tablet
1 2
● Secure the two individually wrapped tablets
together. Be creative! You can use tape,
rubberbands, paperclips, or your own idea.
● When submerged in water, the pill should release
each color at different times.
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Engineering Process:
Design your Solution
Consider how the water solubility of your coating BE CREATIVE
materials will affect the delay of release of each tablet. You may use staples, tape, glue,
Note: you may choose to only use 1 coating per tablet. or other materials to secure the
layers around the tablet.
COATING 1
COATING 2
Inner Coating
Outer Coating
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Engineering Process: Test
TIME: 50 SECONDS
TIME: 15 SECONDS TIME: 5 MINUTES
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Design of Drug Delivery System: Prototype #1
Engineering Process: Test
Insert Drawing of Prototype #1
your tablets and how you (Record your
packaged/wrapped them. results below).
Time of Did your solution meet What can you change to achieve the desired 5
Tablet 1 Color Tablet the goal? and 30 second release?
Release (Too Early, On Time, Too Late) (Too Early, On Time, Too Late)
Insert photo when Tablet 1 Insert photo when Tablet 2 Insert photo when both tablets
began release. began release. were completely released..
Time: _____________ Time: _____________ Time: _____________
Did your results match the targeted color Write your observations here
of solution at each time point? Write any
observations to the right.
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Design of Drug Delivery System: Prototype #1
Engineering Process: Test
Prototype
Insert Drawing of your #2
tablets and how you (Record them.
packaged/wrapped your results below).
Time of Did your solution meet What can you change to achieve the desired 5
Tablet Color Tablet the goal? and 30 second release?
Release (Too Early, On Time, Too Late) (Too Early, On Time, Too Late)
Insert photo when Tablet 1 Insert photo when Tablet 2 Insert photo when both tablets
began release. began release. were completely released..
Time: _____________ Time: _____________ Time: _____________
Did your results match the targeted color Write your observations here
of solution at each time point? Write any
observations to the right.
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Design of Drug Delivery System: FINAL DESIGN
Engineering Process: Test
Insert Drawing ofFinal Design
your tablets (Record your
and how you packaged/wrapped results below).
them.
Time of Did your solution meet What can you change to achieve the desired 5
Tablet Color Tablet the goal? and 30 second release?
Release (Too Early, On Time, Too Late) (Too Early, On Time, Too Late)
Insert photo when Tablet 1 Insert photo when Tablet 2 Insert photo when both tablets
began release. began release. were completely released..
Time: _____________ Time: _____________ Time: _____________
Did your results match the targeted color Write your observations here
of solution at each time point? Write any
observations to the right.
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Engineering Process ANSWER ME!
Step Six: Analyze Your Did you notice that the colored
tablets release gas when they
Results
The colored tablets are made from sodium dissolved in water?
bicarbonate, which undergo the following reaction
when in contact with water: Type your answers here
CARBO
N
DIOXIDE
BUBBLE
S
The gas
release you
saw in the lab
is carbon
dioxide!
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Engineering Process
Step Six: Analyze Your Results
Fill out this chart to see the cost of the materials for your
design!
Cost per Product
Cost Quantity (Column C: Multiply Column A by Column
Pharmaceutical Drug Delivery Material (Column A) (Column B) B)
1 tablet $1.00 2 $2
1 water soluble (8"x8") $0.10
1 toilet paper sheet $0.10
1 paper towel (2"x2") $0.10
1 tissue wrapping paper (2"x2") $0.10
1 Kleenex facial tissue (2"x2") $0.10
1 staple $0.10
Tape (1") $0.10
Glue $0.20
Drug Delivery Method
Total Cost
(Sum Column C)
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Reflection
ANSWER ME!
Complete the
mandatory 5-
minute Exit
Ticket by
clicking HERE!
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Continue to Explore
● Materials Science
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Extension Activity
This section will provide an overview of the optional
extension activity. This activity is an opportunity for
students to dive deeper and ideate. The materials
associated with the extension labs may not provide
as many detailed instructions as the main lab
activity.
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Optional Extension Activity
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Biological Drug
Manufacturing Manufacturing Basics
Biomanufacturing involves
engineering a cell to produce
a specific protein.
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A Closer Look at Fermentation
Watch this video!
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Operation Modes of
Bioreactors
Batch: no inflow, no outflow
All nutrients are provided at the beginning of
the cultivation
Products removed at the end
Advantages Operational simplicity, easy to Longer process (because Longer process with faster
manage cells don’t run out of production time than fed
nutrients as fast as batch
Less chance of contamination as batch)
nutrients are only added at Can control the growth rate
beginning (opening the bioreactor Less down time (determined by the rate you
for inputs poses risk of refresh the medium)
contamination) Can be used to switch
genes on or off by Removal of cell debris and
Separation of batch material for changing the feed waste products throughout
traceability process
Disadvanta Short duration, long downtime to More complex and prone Most complex and prone to
ges clean bioreactor in between runs to contamination than error
batch (due to feed
Initial conditions are important addition) Nutrient feed use is inefficient
(slight deviation in media may and wasted as it is
ruin batch) No removal of cell debris continuously fed
or waste products
No removal of cell debris or waste The products cannot be neatly
products separated into batches for 57
Activity Overview
Steps:
Your Challenge: Pretending that yeast is your cell
culture, determine an optimal nutrient formulation 1. Learn about biological
for your own bioreactor design! drug processing,
specifically focusing on the
fermentation step
2. Design various nutrient
formulations to feed your
“cells”
3. Build your “bioreactors” by
mixing yeast, warm water,
and nutrient formulation in
a sealed plastic bag
4. Test your formulations
5. Learn from your results
and design a bioreactor
operation!
Lab Materials
● 5 Small Ziploc
Bags
● 1 tbsp cornstarch
● Warm water
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Fermentation Breakdown
General Fermentation Biological Drug Processing Lab Activity
↓ ↓ ↓
1. Label a
resealable snack- 3. Add ~¼ cup of
size plastic bag warm water, and
with the seal bag
formulation # immediately
(removing as
2. To each bag,
much air as
add the
possible)
appropriate
amount of yeast 4. Mix gently for
and sugar ~10 seconds and
according to the lay bag flat and
Formulation Table start a stopwatch
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Activity Setup
5. Monitor bags:
Measure bag
thickness and take
observational notes
on the provided table
at 2.5 minute
increments**
**Release bag if it
becomes too inflated
to avoid popping it! If
time allows, you can
let bags sit longer to
see further inflation
occur… just don’t let it
pop!!
MEASURING TIP: Place a flat object (like a clipboard or another
ruler) on top of the bag to make it level when taking measurements
of bag thickness at each timepoint.
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Activity Observations
Fill in the empty values for each timepoint
1 1 0
2 1 0
3 1 0
3 0 1
Observational Notes
at Time Point:
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Calculating Reaction
Rates
● It’s time to calculate a reaction rate for each formulation. Follow the series of calculations in the
table below.
● NOTE: We are assuming 0.1 cm back thickness is equal to 2 L of gas produced.
● Fill in the empty values in the table below
Final Values
COLUMN A COLUMN B COLUMN C COLUMN D
1 1 0 10
2 1 0 10
3 1 0 10
3 0 1 10
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Fermentation Chemical
Reaction Equation
Think: Why is yeast
not in the chemical
reaction equation?
Yeast is a catalyst
A catalyst is a
substance that
increases the rate of
a chemical reaction,
without itself
undergoing any
permanent chemical
change
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Mole Ratios in
Chemical Reactions Mole Ratios
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Designing Your
Bioreactor
Parameter Description Design Value or
Condition
Feed Type What nutrient formulation was the most optimal feed
(sugar or cornstarch)?
pH of Influent Feed Look up the pH of your feed type (example: Glucose sugar
is pH 7)
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Thank you!