Pressentation on Transdermal Patches

By Shrikant Athavale Prathith Consultants Pune India

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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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Designing

Polymer

Selection

The main polymers used

are

silicone,

polyisobutylene

and

acrylic ( most dominating )

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Designing

Release Control

solubilizes, and solubilizing adjuvants

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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

this patch anesthetizes skin to relieve pain

pains caused by injection or associated with periodical treatment

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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

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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

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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.



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3. Elastic Bandages and Patches for relief from Joint Pain,

Arthritis, Rheumatism etc.



4. Patches for relief from Headache, Fever, Anxiety, Sleep

Deprivation etc.



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5. Patches for Motion Sickness



6. Hydrogel Cosmetic Masks and Psoriasis Patches for lesions

due to dry and scale skin



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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

http://en.wikipedia.org/wiki/File:Nicoderm.JPG

http://en.wikipedia.org/wiki/File:Contraceptivepatch.jpg

http://en.wikipedia.org/wiki/File:Clonidine_pills_and_patch.jpg

Please feel free to contact us

For more Information

Our website : www.psadhesive.com

Personal Email : [email protected]

Cell : 00 91 9850242282

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Background

http://www.psadhesive.com/

mailto:[email protected]

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Pressentation on Transdermal Patches

Technology

Transcript of Pressentation on Transdermal Patches