Single layer drug

in adhesives.

Micro reservoir Multi-layer drug

controlled in adhesives.
TDDS.

Matrix diffusion
controlled Vapour patch.
TDDS.

Polymer
Adhesive
membrane
diffusion
permeation
controlled TDDS.
controlled TDDS.
 ❖ Single layer Drug in Adhesive
➢ The adhesive layer of this system also contains the
drug.
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.
 ❖ Multi layer Drug in Adhesive
Here 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.
This patch also has a temporary liner-layer and a
permanent backing.
 ❖ Vapour Patch
Here the adhesive layer not only
serves to adhere the various layers
together but also to release
vapour.
Commonly used for releasing essential
oils for up to 6 hours and are used in
cases of decongestion mainly.

Also used to improve the quaof sleep

and reduces cigarette smoking
conditions.
❖ Polymer Membrane permeation
controlled TDDS:
❖ Polymer Membrane permeation controlled TDDS:

➢ Drug reservoir is embedded between an impervious

backing layer and a rate controlling polymeric
membrane → microporous or non-porous.

➢ Rate of drug release is affected by:

•composition of polymer
•permeability coefficient
• thickness
Example:- Transderm Nitro,Transderm scop.
Transderm Scop (transdermal scopolamine) is an anticholinergic drug patch
applied to the skin used to prevent nausea and vomiting caused by motion
sickness or from anesthesia given during surgery.
❖Adhesive dispersion type systems
❖ Adhesive dispersion type systems

Drug reservoir :

• Dispersing drug in an adhesive polymer.

• Spread the medicated polymer by melting the
adhesive on to impermeable metallic plastic
baking.
•The drug reservoir is then covered by a non
medicated rate controlling adhesive polymer.

Eg :Isosorbide dinitrate releasing TDDS

(Frandol tape)-
Isosorbide dinitrate (ISDN) is
commonly used for the therapy of stable
angina pectoris.
❖Matrixdiffusion controlled
systems
 ❖Matrix diffusion controlled
systems

Homogeneously dispersing the drug particles in

a hydrophilic or lipophilic polymer matrix.

It is then pasted on to an occlusive base plate in a

compartment fabricated from a drug impermeable
plastic backing layer.

Adhesive polymer is then spread along the

circumference to form a strip of adhesive rim
Eg:Nitro Dur.
❖ Micro-reservoirtype
controlled systems
 ❖ Micro-reservoir type controlled systems

Combination of reservoir & matrix diffusion type

drug delivery systems.

Drug reservoir is formed by first suspendingthe

drug solids in an aqueous solution of a water
soluble polymer.

Then dispersing the solution homogeneouslyin a lipophilic

polymer to form thousands of microscopic
spheres of drug reservoirs

Example: Nitro Dur.

 ❖ Poroplastic type systems

It is made utilizing the concept of the water

coagulation of cellulose triacetate solution in
organic acids at low temp.

The water may be exchanged subsequently for

another vehicle by a diffusional exchange
process.
 ❖ Physico chemical evaluation:

❑ Interaction studies:

❖ Interaction between drug & excipient effect,

bioavailability & stability of the drug.

❖ Studies are carried out by thermal analysis,FT-IR

UV& chromatographic techniques.
❑ Thickness of patch:

Thickness measured using digital

micrometer

Determine the average thickness

And standard deviation to ensure the

thickness of prepared patch.
❑ Weight uniformity:

Weigh 10 randomly selected patches

Calculate the average weight

individual weight should not deviate

significantly from average weight
❑ Folding endurance:

Specific area of strip is cut & repeatedly

folded at the same place till it breaks

Number of times the film could be folded

without breaking gives folding endurance
❑ Percentage moisture content:

Prepared patches are weigh

individually Kept in desicator

containing fused Cacl2

at room temperature

After 24 hrs films are reweighed

Determine percentage moisture content by

given formula:
Percentage moisture content=
(initial weight –final weight/final weight)*100
❑ Water vapour permeability evaluation:

❖ Determined by natural air circulation method

WVP= W/A

W=Amount of vapour permeated through patch

A=Surface area of exposed samples.

❑ Flatness study:
Three longitudinal strips are to be cut from the
centre & other two from each side of patches

Length of each strip is measured

Variation in length is measuerd by determinig

percentage constriction

➢ Zero constriction is equilent to 100% flatness

% constriction=(initial length-final
length/initial length)*100
❑ Percentage elongation break test:

➢ Noting the length just before the break point.

➢ Elongation percentage=

(final length-initial length/initial length )*100

❑ Drug content determination:

An accuratly weighed portion of film is dissolved

in 100 ml suitable solvent.

shaken continuously for 24 hrs in shaker incubator

whole solution is sonicated

Solution is then filtered through a filter medium

Drug in solution estimated spectroscopically.

❑ Content uniformity test:

10 patches are selected &content is determined

for individual patches

If 9 of 10 patches have content 85%-115% patches

passes the test

If 3 patches have content 75%-125%,additional

20patches are tested

Drug content of 20 patches -85%-115%,pass test.

 ❖ In vitro evaluation:
❑ Invitro release studies:
To study the drug release , paddle over disc method is
used.
Procedure:
Dry films of known thickness is cut , weighed & fixed
over a glass plate with an adhesive

Placed the glass plate in 500ml phosphate buffer (ph7.4)

maintained at 32+-5c

Paddle set at a distance of 2.5 cm from glass plate &

operated at 50rpm

5ml samples are withdrawn at appropriate time intervals

upto 24 hrs &analyzed by UV spectrophotometer.
❑ Invitro skin permeation studies:

Study carried out using diffusion cell

Procedure:
Skin of male wristar rats (200-250g) are taken.

Hair removed from abdominal region & demal

side,cleaned with distilled water

Equilibrated for an hour in phosphate buffer&

Placed on magnetic stirrer with small magnetic needle

for uniform distribution of the diffusant.
Temperatue of the cell was maintained at 32+-50c

The isolated rat skin is mounted between the

compartments of diffusion cell.

Equal volume of fresh samples are replaced

Samples are filterd & analyzed

spectrophotometrically

o Permeability coefficient= flux/initial drug load

o Flux - slope of the curve between steady

state values of the amount of drug permeated
vs time .
 ❖ In vivo evaluation:

❑ Animalstudies:
Animal studies are preferred at small scale.

Most common species used are mouse,guinea

pig,rabbit,hairless rat, dog, rhesus monkey etc.

❑ Human models:

Clinical trials are conducted to asses efficacyrisk

involved,side effects,patient compliance etc.
❑ Skin irritation test:

Skin irritation &senzitised test can be performed on

healthy rabbit.

Procedure:
Dorsal surface of rabbit is cleaned & removed the hair

Clean the surface by rectified spirit & representative

formulation can be applied over skin.

Patch is to be removed after 24 hrs

skin is observed & classified into 5 grades on the basis

severity of skin injury.
 ❖ Stability studies :

Conducted according to ICH giudlines by storing

TDDS samples at 40+-0.50c & 75
+-5% RH for 6 months.

Samples were withdrawn at 0,30,60,90,&180

days.

Analyze suitably for dug content.

Peel adhesion test
Thumb crack test
Rolling ball test
Quick test
Probe tack test
Shear strength properties
 Antideppe
Vitamin
ressent
B12 patch
patch
Antihypert Easy
ensive breath
patch patch

Patch for Patch for

hyper
severe activity
pain disorder

Nicotine Types of Patch for

patch transdermal patches hormone
available today therapy
Fentanyl transdermal
patch is used to treat
chronic pain in opioid-
tolerant people.
An insulin patch.
Sufentanil patch for chronic cancer pain.
Varenicilin patch for smoking cessation.
Seligiline patch for deppression in elderly and
coccaine addiction.
Dexamethasone iontophoretic delivery for the
treatment of tennis elbow.
An iontophoretic sumatriptan patch for
migrain treatment.
Transdermal glyceryl trinitrate for acute
stoke therapy.