This presentation is about the industrial pharmacy

1. TRANSDERMAL
DRUG
DELIEVERTY
SYSTEM
(Patches)
Ashoq Kumar_________21
Hitish Nath___________47
Khadim Hussain_______54
Maqsood Korai________66
Zeeshan Abbas________133

2. Patches
Contents:
• Introduction
• Selection
• Significance
• Types
• Basic components
• Manufacturing process
• Equipments
• Examples
• Advantages
• Disadvantages
• General consideration
• References

3. Transdermal Drug Delivery System
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.
Transdermal patches in the pharmaceutical
industry are like stickers that you stick on your
skin.
It's a convenient way to deliver medication
without having to take pills or injections. The
patch slowly releases the medication over time,
providing a steady dose. It's used for various
purposes like pain relief, hormone therapy, and
nicotine replacement.
INTRODUCTION

4. Selection of Drugs for Transdermal Drug Delivery System
• Non irritant , Potent, Non ionic
• Narrow Therapeutic Effect
• Low mol weight i-e 400-1000 dalton
• MP< 200celcius
• Water solubility > 1mg/ml
• Dose<20 mg/day
• pH between 5-9
• Preferably for drug undergo extensive first pass metabolism
• Half Life < 10 hrs
• Log P 1-3
• Less oral bioavailability

5. The Significance of Drug Delivery Patches
These patches have transformed the way pharmaceuticals are administered, providing numerous
advantages, including:
Patient Compliance:
• Patches are non-invasive and painless, making them more acceptable to patients.
• They eliminate the need for frequent dosing, which can be burdensome for patients with chronic
conditions.
Steady Drug Release:
• The controlled and continuous release of medication through the skin ensures a more stable and
predictable therapeutic effect.
Reduction in Side Effects:
• Patches can minimize side effects by maintaining optimal drug levels in the bloodstream.
Enhanced Pharmacokinetics:
• Patches allow for a consistent plasma concentration of the drug, reducing the risk of underdosing or
overdosing.

6. Transdermal Drug Delivery Systems
Transdermal drug delivery systems are designed to support the passage of drug substances
from the surface of the skin, through its various layers, into the systemic circulation.
Physically, these systems are sophisticated patches.
There are two basic types of transdermal dosing systems:
1. Those that allow the skin to control the rate of drug absorption.
2. Those that control the rate of drug delivery to the skin.
The first type is useful for drugs for which a wide range of plasma concentration is effective, but
not toxic.
For these drugs, transdermal dosage forms may be developed of various size and
concentrations, with physician increasing the dose or transdermal application until the
desired effect is obtained.
However, for many drugs, it is important to control the predictable rate of drug delivery and
percutaneous absorption.
In these instances, effective transdermal drug delivery systems deliver uniform quantities
of drug to the skin over a period of time.
The amount of drug delivered per unit of time may varied with different types of skin and
thus, the drug delivery system, and not the skin, controls the amount of drug entering the
circulation.

7. 1. Design and Formulation:
Experts carefully select the active ingredients and determine the optimal adhesive and backing materials.
2. Adhesive Application:
The adhesive layer is applied to the backing material using specialized coating machines.
This ensures precise and consistent distribution of the adhesive.
3. Cutting and Shaping:
Once the adhesive is applied, the patches are cut into the desired shape and size using rotary die-cutting
machines. This step ensures uniformity and accuracy.
4. Quality Control:
Quality checks are conducted throughout the production process to ensure the patches meet safety and
efficacy standards.
These checks include testing for proper drug release, adhesion strength, and overall product integrity.
5. Packaging and Distribution:
After passing the quality control checks, the patches are carefully packaged using packaging machinery. This
ensures proper sealing and protection during transportation and storage.

8. TYPES OF TRANSDERMAL PATCHES
There are various types of Transdermal Patches:
1. Single layer drug in adhesive
In this type, the adhesive layer contains the drug. The adhesive layer not only serves to
adhere the various layers together but also responsible for releasing the drug to the skin.
The adhesive layer is surrounded by a temporary liner and a backing.
2. Multi-layer drug in adhesive
This type is also similar to the single layer but it contains an immediate drug release layer and
other layer will be a controlled release along with the adhesive layer.
The adhesive layer is responsible for the releasing of drug.
This patch also has a temporary liner-layer and a permanent backing
.
3. Vapour patch
In this type of patch, the role of adhesive layer not only serves to adhere the various layers
together but also serves as release vapour.
These are new to the market, commonly used for releasing of essential oils in decongestion.
Various other types of vapor patches are also available in the market which are used to
improve the quality of sleep and reduces the cigarette smoking conditions.

9. 4. Reservoir system
In this system the drug reservoir is embedded between an impervious backing layer
and rate controlling membrane. The drug releases only through the rate controlling
membrane, which can be micro porous or non porous.
In the drug reservoir compartment, the drug can be in the form of a solution,
suspension, gel or dispersed in a solid polymer matrix.
Hypoallergenic adhesive polymer can be applied as outer surface polymeric
membrane which is compatible with drug.
5. Matrix system
i. Drug-in-adhesive system
ii. Matrix-dispersion system
6. Micro-reservoir system
In this type, the drug delivery system is a combination of reservoir and matrix-
dispersion system.
The drug reservoir is formed by first suspending the drug in an aqueous solution of
water soluble polymer and then dispersing the solution homogeneously in a lipophilic
polymer to form thousands of unreachable, microscopic spheres of drug reservoirs.
This thermodynamically unstable dispersion is stabilized quickly by immediately cross-
linking the polymer in situ by using cross linking agents.

10. Figure: Representative designs of transdermal drug
delivery systems.

11. 1. Polymer matrix
2. Drug substance
Following are some of the desirable properties of a drug suitable for transdermal delivery:
i. Physicochemical properties
ii. Biological properties
3. Penetration enhancers
a. Solvents
b. Surfactants
c. Miscellaneous chemicals
4. Drug reservoir components
BASIC COMPONENTS OF TDDS
Figure: Different layers of TDDS.

12. 5. Backing laminates
The primary function of the backing laminate is to provide support. They should be able to prevent drug from
leaving the dosage form through top. They must be impermeable to drugs and permeation enhancers; should
have a low moisture vapor transmission rate; must have optimal elasticity, flexibility, and tensile strength; must
be chemically compatible with the drug, enhancer, adhesive and other excipients; must be relatively
inexpensive and allow printing and adhesive lamination.
Type backing membranes are composed of a pigmented layers, an aluminum vapor coated layer, a plastic film
(polyethylene, polyvinyl chloride, polyester) and a heat seal layer.
6. Rate controlling membrane
Rate controlling membranes in transdermal devices govern drug release from the dosage form.
Membranes made from natural polymeric material such as chitosan show great promise for use as rate
controlling membranes.
Recently composite polyhydroxyethyl methacrylate membranes have been evaluated as rate controlling
barriers for transdermal application.
.

13. 7. Adhesive layer
The fasting of all transdermal devices to the skin using a pressure sensitive adhesive that can
be positioned on the face or in the back of device is necessary.
It should not cause irritation, sensitization or imbalance in the normal skin flora during its
contact with the skin. It should adhere to the skin aggressively.
The three major classes of polymers evaluated for potential medical applications in TDDS
include:
•Polyisobutylene type pressure sensitive adhesives.
•Acrylic type pressure sensitive adhesives.
•Silicone type pressure sensitive adhesives
8. Release liners
The release liner has to be removed before the application of transdermal system, and it
prevents the loss of the drug that has migrated into the adhesive layer during storage. It also
helps to prevent contamination.
It is composed of a base layer, which may be non-occlusive or occlusive, and a release
coating layer made of silicon or Teflon.
Other materials include polyesters, foil and metallized laminates.

16. Specialized Equipment for Patch Production
The manufacture of drug delivery patches relies on a range of specialized equipment designed to ensure
precision and consistency in the production process. Some of the key equipment used includes:
Coating and Laminating Machines: These machines are used for applying drug formulations onto the
backing materials and laminating them together. They must provide precise control over coating thickness
and uniformity.
Die-Cutting Machines: Die-cutting machines are employed to cut the laminated material into individual
patches. These machines are essential for maintaining consistent patch size and shape.
Quality Control Equipment: Various quality control instruments, such as spectrophotometers and mass
spectrometers, are used to ensure that the patches meet stringent quality standards.
Packaging Machinery: Specialized packaging equipment is employed to ensure the aseptic and secure
packaging of the patches. This equipment often includes blister packing machines and vacuum sealing
devices.

19. While every patch is created similarly, there are a lot of factors that must be considered for each type. Let's explore the process in
more detail.
FOLLOWING A FOUR-STEP PROCESS
STEP 1: MIX THE INGREDIENTS TOGETHER
People in lab coats and masks on assembly line, When working from a developed formula, the first step of the manufacturing
process is to create a consistent mixture of all the “ingredients” in a large vessel.
The active pharmaceutical formula is mixed together with excipients (inactive substances) to form a batch of a liquid adhesive matrix.
Our manufacturing process relies on absolute precision when it comes to ingredients, viscosity, temperature, pH, and time. These
variables are all meticulously tracked in order to achieve the optimum state of uniformity. Depending on the medication, the active
drug substance may be mixed separately from the adhesive material and sealed together in the following step.
STEP 2: COAT AND DRY THE MIXTURE
With tablets and traditional pills, the coating step normally adds flavor, color, and/or durability. But because transdermal patches are
applied to the skin, transdermal patch manufacturers use the coating step to apply the mixture to a polymer release liner.
That adhesive matrix we mixed together in step one is applied evenly to a substrate that will protect the adhesive and drug
formulation. The liner is then removed before application to the skin.
Our coating machines carefully meter the mixture onto the release liner and can be programmed to meet any substance
requirement. Tapemark’s machines can coat liners at widths from 3 –22 inches. We work with formulas at temperatures ranging from
100–350 degrees Fahrenheit and have the capacity to churn out liners at a speedy 65 feet per minute.
This coated liner then passes through state-of-the-art drying channels, which dry the entire matrix at specific predetermined speeds,
temperatures, airflows, and humidity levels.

21. STEP 3: SEAL THE LAMINATE
Immediately after drying is complete, the entire laminated material is sealed with an impermeable backing film. In
this step, the active pharmaceutical ingredient that was mixed with the adhesive substance is formed together
with a protective backing material. The backing seals the entire matrix together, essentially creating a single,
enormous transdermal patch.
Note that for some types of transdermal patches, there are extra layers that are added before the laminate is fully
sealed. These may be rate-controlling membranes, drug reservoirs, or monitoring devices.
STEP 4: CUTTING
Gloves lifting circle cut transdermal patch
The final step is to cut the patches down to the appropriate size and shape. This is done by slicing the bulk
product into narrower rolls of laminate, and then sending these through a die-cutting machine to achieve the final
shape of the patch. The shape of your patch is ultimately decided by what will maximize effectiveness and comfort
for patients.
Once the final patches are converted into individual units, they are ready to be heat-sealed into their pouches for
shipment.

22. Examples of Transdermal Systems in Use
1. Transdermal Scopolamine Systems
2. Transdermal Nitroglycerine Systems
3. Transdermal Clonidine Systems
4. Transdermal Estradiol Systems
5. Other Transdermal Therapeutic Systems:
i. A Testosterone Transdermal Systems [Testoderm (Alza)]
ii. A Salicylic Acid Transdermal System [Trans-Ver-Sal (Tsumura Medical)]
6. Others TDDSs under study:
i. Isosorbide Nitrate, propranolol and mepindolol and cardiovascular drugs
ii. Levonorgestrel / estradiol for contraception.
some common examples
ALLERGY
PATCH
Vit C,D,E
Patch
STRESS
RELIEF
PATCH,
SMART
MEMORY
PATCH,
MMUNE
BOOSTER
PATCH
IGF-1 &
MGF
PATCH,
HANGOVE
R PATCH –
HO PATCH,
CHONDROI
TIN PATCH,
GLUCOSA
MINE
CREATIN
PATCH
ANTI-
OXIDANT
PATCH
ANTI-
INFLAMMA
TORY
PATCH

23. Advantages of TDDS
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.
1. Avoid gastrointestinal drug absorption difficulties caused by gastrointestinal pH, enzymatic activity and drug
interactions with food, drink or other orally administered drugs.
2. Substitute for oral administration of medication when that route is unsuitable, as in instances of vomiting and
/ or diarrhea.
3. Avoid the first pass effect, that is, the initial pass of a drug substance through the systemic and portal
circulation following gastrointestinal absorption, thereby possibly avoiding the drug deactivation by
digestive and liver enzymes.
4. Avoid the risks and inconveniences of parenteral therapy and the variable absorption and metabolism
associated with oral therapy.
5. Provide the capacity for multi–day therapy with a single application therapy improving patient compliance
over use of other dosage forms requiring more frequent dose administration.
6. Extend the activity of drugs having short half-lives through the reservoir of the drug present in the therapeutic
delivery system and its controlled release characteristics.
7. Provide capacity to terminate the effect rapidly (if clinically desired) by removal of drug application from the
surface of the skin.
8. Provide ease of rapid identification of the medication in emergencies (e.g. nonresponsive, unconscious, or
comatose patients).

24. Disadvantages of TDDS
1. Unsuitable for drugs that irritate or sensitize the skin.
2. Only relatively potent drugs are suitable candidates.
3. Technical difficulties are associated with the adhesion of systems to different skin types and under various
environmental conditions.
4. The development of rate-controlling drug delivery features which are not economically feasible and
therapeutically effective for many drug substances.

25. General considerations in the use of TDDS
Some general points applicable to the use of transdermal patches include the following:
1. The site selected for the application should be clear, dry and hairless (but not shaved).
[Nitroglycerin patches are generally applied to the chest, estradiol to the buttocks or the
abdomen, scopolamine behind the ear and nicotine to the upper trunk or upper outer
arm.] Because of the possible occurrence of skin irritation, the site of application for
replacement patches is rotated. Skin sites generally are not reused for a week.
2. The transdermal patch should not be applied to skin that is oily, irritated, cut or abraded. (This
is to assure the intended amount and rate of transdermal drug delivery and absorption.)
3. The patch should be removed from its protective package, being careful not to tear or cut it.
The patch's protective backing should be removed to expose the adhesive layer, and it
should be applied firmly with the palm or heel of the hand until securely in place (about 10
seconds).
4. The patches should be worn for the period of time stated in the product's instructions.
Following that period the patch should be removed and a fresh patch applied as directed.
The used patch should be folded in half with the adhesive layer together so that it cannot
be reused.
5. Patches generally may be left on when showering, bathing or swimming. Should a patch
prematurely dislodge, an attempt may be made to reapply it, or it may be replaced with a
fresh patch.
6. The patient should be instructed to clean the hands thoroughly before and after applying the
patch. Care should be taken not to rub the eyes or touch the mouth during handling the
patch.
7. As with all medications, if the patient exhibits sensitivity or intolerance to the drug, or if undue
skin irritation results, the patient should seek re-evaluation.

26. References
1:- Transdermal drug delivery systems: A review"
by Prajapati
et al., published in the International Journal of
Pharmaceutical Sciences and Research.
2:- Transdermal Drug Delivery Systems" by
Jonathan Hadgraft and Richard H. Guy.
3:- Google scholar
4:- Youtube

27. THANK
YOU