The document discusses transdermal patches, which deliver medication through the skin and into the bloodstream, providing controlled release. It notes the advantages of transdermal delivery over oral or intravenous methods. The document outlines different transdermal patch types, including single-layer and multi-layer drug-in-adhesive patches, reservoir patches, and matrix patches. It also discusses various applications of transdermal patches and considerations for their design and use.

1. By
Shrikant Athavale
Prathith Consultants
Pune India
117-06-2013

2. 217-06-2013
Background
A Transdermal Patch is a medicated adhesive patch
that is placed on the skin to deliver a specific dose of
medication through the skin and into the bloodstream.
Often, this promotes healing to an injured area of the
body. An advantage of a transdermal drug delivery route
over other types of medication delivery such as oral,
topical, intravenous, intramuscular, etc. is that the patch
provides a controlled release of the medication into the
patient, usually through either a porous membrane
covering a reservoir of medication or through body heat
melting thin layers of medication embedded in the
adhesive.

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Transdermal
patches
Transdermal Patch
Much more than a Surgical Tape
are simple to use
deliver drugs
straight
into the
bloodstream
through the
skin.

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Medicines
in
pill form
have a long,
tortuous journey
to get to
destination
must go
through the
digestive
system
they are
absorbed
into the
blood
they pass
through the
liver, before
circulating to
the rest of the
body
the liver must
eventually
eliminate them

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Transdermal
Medicines
pill
Comparison of Medicine Travel
Pill v/s Transdermal

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Transdermal Drug Delivery
Designing
The essential
Factors are Polymer
Selection
Drug
Stability
Release
Control
Minimize
Skin
Irritation
Improvement
of drug
absorption
Selection
of Drug

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Transdermal Drug Delivery
Designing
Polymer
Selection
The main polymers used
are
 silicone,
 polyisobutylene
and
 acrylic ( most dominating )

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Transdermal Drug Delivery
Designing
Release Control
solubilizes, and solubilizing
adjuvants

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Transdermal Drug Delivery
Designing
Improvement of
drug absorption
Transdermal absorption
Enhancers
Like
Isopropyl myristate
Oleyl alcohol

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Drug in Adhesive System
Backing
Adhesive with
Drug
Release
Liner
Simple DIA designs are popular, as they can be made by adding
the drug and other components to the adhesive, mixing them, and
then laminating them to a backing layer.

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Matrix System
Backing
Adhesive
Release
Liner
Drug
reservoir
Liquid reservoir designs have the drawback of needing great
precision in manufacturing to avoid the drugs leaking,

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Liquid Reservoir System
Backing
Rate Limiting membrane
Drug reservoir
Adhesive
Release
Liner
while the extra membranes create a more complex manufacturing
process. The matrix is often created by mixing a high concentration
of drug into an adhesive, as high as 30 per cent, compared to
around 5 per cent in DIA designs.

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Advantages of Transdermal Drug Delivery
 do not put too much load on digestive
system and liver
 avoid the pain on injection
 eliminate the adverse effects associated
with excessive absorption of drugs taken
orally
 thereby alleviate anxiety
 offer more comfort to patients
 produce excellent prolonged effects
 administration can be visually confirmed

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Transdermal Drug Delivery patches
May cause side effects
like
o light headedness
o dizziness
o redness or irritation of the skin ( covered by
the patch )
o flushing
some other side effects cab be serious
 slow or fast heart beat
 worsening chest pain
 fainting
 rash
 itching
 difficulty in breathing or swallowing

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symptoms of
overdose
may include
Transdermal Drug Delivery patches
The patient can suffer a overdose
• Headache
• confusion
• Fever
• dizziness
• slow or pounding heartbeat
• nausea
• Vomiting
• fainting
• shortness of breath
• sweating
• Flushing
• cold and clammy skin
• loss of ability to move the body
• coma ( loss of consciousness for
a period of time )

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Applications of Transdermal
Patches
Treatment of Ischemic Heart Disease
TDD with isosorbide dinitrade contain in adhesive
treats ischemic heart diseases such as angina pectoris,
when applied on chest or upper abdomen
release the drug
contribute to therapeutic improvement of cardic function.
For Local Anesthesia
with tulobuterol
( Respiratory function has a circadian rhythem and is known to decrease from
around midnight to early morning , generally known as "morning dip"
paients suffering from bronchial asthma, accacks often occur in the early morning
, caused by morning dip,
is a major stress factor
this patch offers a long lasting brochodilating effect

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Special precautions
when using transdermal patches
• apply patch to clean, dry, unbroken skin
• apply patch firmly ( it may take 20-30 seconds to get it
stick firmly in place)
• wash your hands after applying
• use only one patch at a time
• if ou need to conduct MRI test , the patch may need to
be removed
• if you develop skin irritation ( due to adhesive ) , appy
the next patch on another area
• when you remove the skin patch, fold it so the
adhesive edges stick together
• gently wash the area with soap and water

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The main
Components
The main components to a transdermal patch are:
Liner - Protects the patch during storage. The liner is
removed prior to use.
Drug - Drug solution in direct contact with release liner
Adhesive - Serves to adhere the components of the patch
together along with adhering the patch to the
skin
Membrane - Controls the release of the drug from the
reservoir and multi-layer patches
Backing - Protects the patch from the outer environment

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There are five main types
of transdermal patches.
Single-layer Drug-in-Adhesive
Multi-layer Drug-in-Adhesive
Reservoir
Matrix
Vapour Patch

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Single-layer Drug-in-Adhesive
The adhesive layer of this system also contains the drug. In this
type of patch the adhesive layer not only serves to adhere the
various layers together, along with the entire system to the skin,
but is also responsible for the releasing of the drug. The
adhesive layer is surrounded by a temporary liner and a
backing.

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Multi-layer Drug-in-Adhesive
The multi-layer drug-in adhesive patch is similar to the single-
layer system in that both adhesive layers are also responsible for
the releasing of the drug.One of the layers is for immediate
release of the drug and other layer is for control release of drug
from the reservoir. The multi-layer system is different however
that it adds another layer of drug-in-adhesive, usually separated
by a membrane (but not in all cases). This patch also has a
temporary liner-layer and a permanent backing.

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Reservoir
Unlike the Single-layer and Multi-layer Drug-in-adhesive
systems the reservoir transdermal system has a separate drug
layer. The drug layer is a liquid compartment containing a drug
solution or suspension separated by the adhesive layer. This
patch is also backed by the backing layer. In this type of system
the rate of release is zero order.

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Matrix
The Matrix system has a drug layer of a semisolid matrix
containing a drug solution or suspension. The adhesive layer in
this patch surrounds the drug layer partially overlaying it. Also
known as a monolithic device.

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Vapour Patch
In this type of patch the adhesive layer not only serves to adhere
the various layers together but also to release vapour. The
vapour patches are new on the market and they release essential
oils for up to 6 hours. The vapour patches release essential oils
and are used in cases of decongestion mainly. Other vapour
patches on the market are controller vapour patches that
improve the quality of sleep. Vapour patches that reduce the
quantity of cigarettes that one smokes in a month are also
available on the market.

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Popular uses
The highest selling transdermal patch in USA is the
nicotine patch,
Hormonal patches
Estrogen patches
contraceptive patch
testosterone patches for both men and women
Nitroglycerin patches
Transdermal scopolamine
The anti-hypertensive drug Clonidine
Vitamin B12 may also be administered through a
transdermal patch.

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Scope of our Supply
1. The Complete Plant and Machinery for manufacturing
2. The Adhesive formulations
3. The Raw Material sources
4. The Manufacturing Process parameters
Not in our Scope
1. The FDA approval
2. Other Govt. approvals if any necessary

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The Details of the Plant
and Machinery ,
supplied by us

28. 2817-06-2013
The Manufacturing Process
 The preparation and homogeneity of the bulk
drug containing
or non bulk drug containing adhesive mass
 the coating process , including those
parameters to control layer thickness
 drying , curing and removal of residual
solvent
 lamination steps
 the storage and handling of intermediate rolls
 roll conversion to patches
 primary packing

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The Coating
machine
We offer a Fully automatic
Programmable Machine Designed as
per GMP Standards ,
Complete Stainless Steel Construction
Inside , provided with clean Room
facility

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The Coating
machine
Specifications
Pl refer
MS Word File attached

31. 3117-06-2013
The Coating
machine Capacity
Installed
Coating plant
Capacity / Shift of 8 Hrs : 3,600 sq. Mtrs
Capacity / PM ( one Shift of 8 Hrs/ Day ) : 90,000 sq. Mtrs
Die Cuts into patches ( gen size 50 mm X 75 mm )
Capacity / Shift of 8 Hrs : 3,20,000 Nos.
Capacity / PM ( one Shift of 8 Hrs/ Day ) : 80,00,000 Nos.

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The
Supporting
Machines
( Production )
1. Adhesive Blending
2. Slitting Machine
3. Slicing Machine
4. Die Cutting Machine
5. Shrink Warp

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The
Supporting
Machines
( Testing )
1. Complete set of Testing equipment's for
Transdermal Patch and Surgical tape
Manufacturing.
The same is not in our Scope of supply

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The Installed Plant Location
, where
Contract manufacturing
is Possible
This Plant is Located in North Karnataka
about 460 KM south of Mumbai . We will
share the details at a appropriate time

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Our Comments on your points
1. Comparative analysis between contract
manufacturing and own production setup with a
working on capital and operational costs
The approximate Contract Manufacturing , cost per
sq. mtr. will be Rs. 40 - 45 ( Exclusive of Raw
material Cost ) , The same will be around Rs. 15 per
sq. mtr if you manufacture in house.
Capital investment will be approximately , Rs.
Lakhs.
Working Capital will depend on the production
quantity in sq. mtr. / PM

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Our Comments on your points
2. Liasoning with prospective contract manufacturers,
if that route is preferred.
This is also possible. We have spoken to the
Manufacturer and he is ready for Contract
Manufacturing

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3. Putting together a production unit with machinery, if
an own unit is to be set up
This is also possible. We will offer you a suitable
plant and Machinery , for manufacturing.
4. Setting up a supply chain for raw materials (other
than active pharmaceutical drugs); agreements with
preferred suppliers
We will assist you in providing Raw Material
manufacturers contact details.

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5. Assistance in formulations of new products
We will take care of this , and assist you with
formulations.

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The Products of your Interest
Transdermal products:
1. Elastic Bandages and Patches for relief from Injury pain,
inflammation and swelling
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.
2. Nasal patches for relief from nasal congestion, cold etc.
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.

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The Products of your Interest
Transdermal products:
3. Elastic Bandages and Patches for relief from Joint Pain,
Arthritis, Rheumatism etc.
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.
4. Patches for relief from Headache, Fever, Anxiety, Sleep
Deprivation etc.
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.

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The Products of your Interest
Transdermal products:
5. Patches for Motion Sickness
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.
6. Hydrogel Cosmetic Masks and Psoriasis Patches for lesions
due to dry and scale skin
We will help you in Adhesive formulations for the same.
The suitable Drug additive for the same to be supplied by you.

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Types of Transdermal
patches available today
 transdermal patch Nicotine
 transdermal patch for severe pain
 transdermal patch for harmone theorapy
 transdermal patch anti hypertensive
 transdermal patch anti depressant
 transdermal patch deficit hyper activity disorder
 transdermal patch vitamin b12
 transdermal patch easy breath

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Types of Transdermal
patches available today
 Transdermal patch Nicotine
Nicorette Patch helps to give up smoking by relieving
the desire to smoke, and some of the unpleasant effects
which smokers experience when they stop smoking.
To successfully become a non-smoker it is important to
understand how Nicorette Patch works.

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 Transdermal patch for severe pain
A transdermal analgesic or pain
relief patch is a medicated
adhesive patch used to relieve
minor to severe pain. There are
two primary types of analgesic
patches: patches containing
counterirritants, which are used
to treat mild to moderate pain,
and patches containing fentanyl,
a narcotic used to relieve
moderate to severe pain in
opioid-tolerant patients.

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 Transdermal patch for hormone therapy

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transdermal patch anti hypertensive
Hypertension is one of the largest deaths causing
disease for the mankind. Since it is a chronic disease
it necessitates long term treatment.
Depending on the release required over a period of
time, the concentrations of polymer, plasticizer and
penetrant were varied.

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Transdermal patch anti depressant
Is a transdermal patch containing the Selegiline, in small
doses, is most commonly used in the treatment
of Parkinson's disease. It is also effective in higher doses
for the treatment of major depressive disorder.
The patch "is a matrix containing three layers consisting
of a backing, an... adhesive drug layer, and a release liner
that is placed against the skin.

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 Transdermal patch deficit hyper
activity disorder
ADHD (attention deficit hyperactivity disorder) is
the most common behavioural disorder that starts
during childhood. However, it does not only affect
children - people of all ages can suffer from ADHD.
Psychiatrists say ADHD is a neurobehavioral
developmental disorder.

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 Transdermal patch Vitamin B12

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Transdermal patch Easy Breath
When you suffer from nasal congestion, it
affects your whole day. Breathe Right helps
you breathe better so you can sleep better
and feel better all day long.
When placed correctly, Breathe Right nasal
strips provide:
Nasal congestion relief due to the common
cold or allergies
Better breathing for people with a deviated
septum
Snoring relief due to night time nasal
congestion

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Photo Gallery
A 21mg dose Nicoderm CQ
patch applied to the left arm
Contraceptive
patch
Clonidine tablets and
transdermal patch

52. Please feel free to contact us
For more Information
Our website : www.psadhesive.com
Personal Email : psatechno@gmail.com
Cell : 00 91 9850242282
5217-06-2013
Background

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