Vol. 1 No.

4 2012
Online Available at www.thepharmajournal.com

THE PHARMA INNOVATION

Transdermal Drug Delivery System: A Review

Dipen Patel*1, Sunita A. Chaudhary1, Bhavesh Parmar1, Nikunj Bhura1

1. Arihant School of Pharmacy and Bio-Research Institute, Gandhinagar, Gujrat, India

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. The main disadvantage to transdermal delivery systems
stems from the fact that the skin is a very effective barrier; as a result, only medications whose
molecules are small enough to penetrate the skin can be delivered in this method. A wide variety
of pharmaceuticals are now available in transdermal patch form.
Keyword: transdermal drug delivery system, bioavability, Iontophoresis, Electroporation,
ultrasound, microscopic projection

INTRODUCTION: Transdermal patch (Skin many other substances, however, are too large
patch) uses a special membrane to control the rate
to pass through the skin.
at which the liquid drug contained in the reservoir
within the patch can pass through the skin and Patches applied to the skin eliminate the need
into the bloodstream. Some drugs must be for vascular access by syringe or the use of
combined with substances, such as alcohol, that pumps. Transdermal patches were developed in
increase their ability to penetrate the skin in order
the 1970s and the first was approved by the
to be used in a skin patch. Drugs administered
through skin patches include scopolamine (for FDA in 1979 for the treatment of motion
motion sickness), nicotine (for quitting smoking), sickness. It was a three-day patch that delivered
estrogen (for menopause and to prevent scopolamine. In 1981, patches for nitroglycerin
osteoporosis after menopause), nitroglycerin (for were approved, and today there exist a number
angina), and lidocaine to relieve the pain of of patches for drugs such as clonidine, fentanyl,
shingles (herpes zoster). Molecules of insulin and
lidocaine, nicotine, nitroglycerin, oestradiol,
oxybutinin, scopolamine, and testosterone.
There are also combination patches for
Corresponding Author’s Contact information:
Dipen Patel * contraception, as well as hormone replacement.
Arihant School of Pharmacy and Bio-Research Institute, Depending on the drug, the patches generally
Gandhinagar, Gujrat, India last from one to seven days.
E-mail: [email protected]

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

The major advantages provided by transdermal to manage or dangerous needles to dispose of,
drug delivery include the following: improved and there are few or no gastrointestinal effects
bioavailability, more uniform plasma levels, from the drug itself. Peak plasma levels of the
drug are reduced, leading to decreased side
longer duration of action resulting in a reduction
effects. In addition, transdermal delivery is useful
in dosing frequency, reduced side effects and for those drugs that have a high first pass effect
improved therapy due to maintenance of plasma through the liver, have poor oral uptake, need
levels up to the end of the dosing interval frequent administration, or that interact with
compared to a decline in plasma levels with stomach acid. The first pass effect results in the
conventional oral dosage forms. Transdermal destruction of a significant amount of the drug.
patches have been useful in developing new Drugs absorbed through the skin, however, enter
the general circulation directly avoiding the liver,
applications for existing therapeutics and for
with less total drug absorption occurring
reducing first-pass drug-degradation effects.
Patches can also reduce side effects; for  Topical patches are a painless, non-
invasive way to deliver substances
example, oestradiol patches are used by more
directly into the body.
than a million patients annually and, in contrast  Topical patches are a better way to deliver
to oral formulations, do not cause liver damage. substances that are brokendown by the
of two major sub-categories - therapeutic and stomach acids, not well-absorbed from the
cosmetic), aroma patches, weight loss patches, gut, orextensively degraded by the liver.
and Non-medicated patch markets include  Topical patches over a controlled, steady
thermal and cold patches, nutrient patches, skin delivery of medication over longperiods
of time.
care patches (a category that consists patches  Topical patches have fewer side effects
that measure sunlight exposure. than oral medications orsupplements.
 Topical patches are easier to use and
remember.
Definition  Topical patches over an alternative to
A transdermal patch or skin patch is a medicated people who cannot, or prefer not to take
adhesive patch that is placed on the skin to medications or supplements orally.
deliver a specific dose of medication through the  Topical patches are cost-effective.
skin and into the bloodstream.  People prefer topical patches.

Limitation
 TDDS cannot deliver ionic drugs.
 TDDS cannot achieve high drug levels in
blood/plasma.
 It cannot develop for drugs of large
molecular size.
Advantages of transdermal patches  TDDS cannot deliver drugs in a pulsatile
fashion.
The advantages of transdermal delivery are
obvious even delivery of a therapeutic level of  TDDS cannot develop if drug or
drug is painless, the patient does not need to formulation causes irritation to skin.
inject himself, there are no bulky delivery devices

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

Limitation of TDDS can be overcome to some manufacturers of the Fentanyl patch, Alza
extent by novel approaches such as Iontophoresis, Pharmaceuticals (a division of major medical
electroporation and ultrasound. manufacturer Johnson & Johnson) and Sandoz,
subsequently issued a recall of their versions of
the patch due to a manufacturing defect that
Popular uses allowed the gel containing the medication to leak
 The highest selling transdermal patch in out of its pouch too quickly, which could result in
the United States is the nicotine patch, overdose and death. As of 2010, Sandoz no
which releases nicotine in controlled longer uses gel in its transdermal fentanyl patch;
doses to help with cessation of tobacco instead, Sandoz-branded fentanyl patches use a
smoking. The first commercially available matrix/adhesive suspension (where the
vapour patch to reduce smoking was medication is blended with the adhesive instead
approved in Europe in 2007. of held in a separate pouch with a porous
membrane), similar to other fentanyl patch
 Two opioid medications used to provide manufacturers such as Mylan and Janssen.
round-the-clock relief for severe pain are
often prescribed in patch form: Fentanyl In 2007, Shire and Noven Pharmaceuticals,
(marketed as Duragesic) and manufacturers of the Daytrana ADHD patch,
Buprenorphine (marketed as BuTrans). announced a voluntary recall of several lots of the
patch due to problems with separating the patch
 Estrogen patches are sometimes from its protective release liner. Since then, no
prescribed to treat menopausal symptoms further problems with either the patch or its
as well as post-menopausal osteoporosis. protective packaging have been reported.
Other transdermal patches for hormone
delivery include the contraceptive patch In 2009, the FDA announced a public health
(marketed as Ortho Evra or Evra). advisory warning of the risk of burns during MRI
scans from transdermal drug patches with
 Nitroglycerin patches are sometimes metallic backings. Patients should be advised to
prescribed for the treatment of angina in remove any medicated patch prior to an MRI scan
lieu of sublingual pills. and replace it with a new patch after the scan is
 The anti-hypertensive drug Clonidine is complete.
available in transdermal patch form under Skin burns have occurred with metal containing
the brand name Catapres-TTS. transdermal patches at the time of shock therapy
 Emsam, a transdermal form of the MAOI from external as well as internal cardioverter
selegiline, became the first transdermal defibrillators (ICD).
delivery agent for an antidepressant
approved for use in the U.S. in March
2006.

Adverse events
In 2005, the FDA announced that they were
investigating reports of death and other serious The main components to a transdermal patch are
adverse events related to narcotic overdose in Liner - Protects the patch during storage. The
patients using Duragesic, the fentanyl transdermal liner is removed prior to use. Drug - Drug
patch for pain control. The Duragesic product solution in direct contact with release liner.
label was subsequently updated to add safety Adhesive - Serves to adhere the components of
information in June 2005. In 2008, two the patch together along with adhering the patch

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

to the skin. Membrane - Controls the release of Formulation factors include

the drug from the reservoir and multi-layer
(1)Physical chemistry of transport (2) Vehicles
patches. Backing - Protects the patch from the and membrane used (3) Penetration enhancers
outer environment
used (4) Method of application (5) Device used
Conditions in which Transdermal patches are
used
Care taken while applying transdermal patch
Transdermal patch is used when:
(1)The part of the skin where the patch is to be
(1)When the patient has intolerable side applied should be properly cleaned. (2) Patch
effects (including constipation) and who is should not be cut because cutting the patch
unable to take oral medication (dysphagia) destroys the drug delivery system. (3) Before
and is requesting an alternative method of
applying a new patch it should be made sure that
drug delivery. the old patch is removed from the site. (4) Care
(2) Where the pain control might be improved should be taken while applying or removing the
by reliable administration. This might be patch because anyone handling the patch can
useful in patients with cognitive impairment absorb the drug from the patch. (5) The patch
or those who for other reasons are not able to should be applied accurately to the site of
self-medicate with their analgesia. administration.
(3) It can be used in combination with other
enhancement strategies to produce synergistic
Mechanism of Action of Transdermal Patch
effects.
The application of the transdermal patch and the
Conditions in which Transdermal patches are not flow of the active drug constituent from the patch
used to the circulatory system via skin occur through
The use of transdermal patch is not suitable various methods.
when:
(1)Cure for acute pain is required.
(2) Where rapid dose titration is required.
(3) Where requirement of dose is equal to or
less than 30 mg/24 hrs.

Factors affecting transdermal bioavaibility

Two major factors affect the bioavaibility of the
drug via transdermal routes: 1. Iontophoresis

(1)Physiological factors (2) Formulation factors Iontophoresis passes a few milliamperes of

current to a few square centimeters of skin
Physiological factors include through the electrode placed in contact with the
(1)Stratum corneum layer of the skin (2) formulation, which facilitates drug delivery
Anatomic site of application on the body (3) Skin across the barrier. Mainly used of pilocarpine
condition and disease (4) Age of the patient (5) delivery to induce sweating as part of cystic
Skin metabolism (6) Desquamation (peeling or fibrosis diagnostic test. Iontophoretic delivery of
flaking of the surface of the skin) (7) Skin lidocaine appears to be a promising approach for
irritation and sensitization (7) Race rapid onset of anesthesia.

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

2. Electroporation together, along with the entire system to the skin,

but is also responsible for the releasing of the
Electroporation is a method of application of
short, high-voltage electrical pulses to the skin. drug. The adhesive layer is surrounded by a
temporary liner and a backing.
After electroporation, the permeability of the skin
for diffusion of drugs is increased by 4 orders of
magnitude. The electrical pulses are believed to
form transient aqueous pores in the stratum
corneum, through which drug transport occurs. It
is safe and the electrical pulses can be
administered painlessly using closely spaced
electrodes to constrain the electric field within the
nerve-free stratum corneum.
3. Application by ultrasound
Application of ultrasound, particularly low
frequency ultrasound, has been shown to enhance
transdermal transport of various drugs including
macromolecules. It is also known as 2. Multi-layer Drug-in-Adhesive
sonophoresis. Katz et al. reported on the use of
The multi-layer drug-in adhesive patch is similar
low-frequency sonophoresis for topical delivery
to the single-layer system in that both adhesive
of EMLA cream.
layers are also responsible for the releasing of the
4. Use of microscopic projection drug. The multi-layer system is different however
Transdermal patches with microscopic that it adds another layer of drug-in-adhesive,
projections called microneedles were used to usually separated by a membrane (but not in all
facilitate transdermal drug transport. Needles cases). This patch also has a temporary liner-layer
ranging from approximately 10-100 µm in length and a permanent backing.
are arranged in arrays. When pressed into the
skin, the arrays make microscopic punctures that
are large enough to deliver macromolecules, but
small enough that the patient does not feel the
penetration or pain. The drug is surface coated on
the microneedles to aid in rapid absorption. They
are used in development of cutaneous vaccines
for tetanus and influenza.
Various other methods are also used for the
application of the transdermal patches like
thermal poration, magnetophoresis, and
photomechanical waves. However, these methods
3. Reservoir
are in their early stage of development and
required further detail studying. Unlike the Single-layer and Multi-layer Drug-in-
adhesive systems the reservoir transdermal
Types of Transdermal Patch
system has a separate drug layer. The drug layer
1. Single-layer Drug-in-Adhesive is a liquid compartment containing a drug
The adhesive layer of this system also contains solution or suspension separated by the adhesive
the drug. In this type of patch the adhesive layer layer. This patch is also backed by the backing
not only serves to adhere the various layers

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

layer. In this type of system the rate of release is Drugs used in the Transdermal Patch
zero order.
Brand Drug Manufacturer Indication
Name s

Nicotin Nicotine Novartis Pharmacol

ellR ogical
smoking
cessation

Matrife Fentanyl Nycomed Pain relief

nR patch

Ortho Norelgostr ORTHO-McNEIL Postmenstr

EvraTM omin/ ual
Ethinyl syndrome
4. Matrix Estradiol
The Matrix system has a drug layer of a semisolid
NuPatc Diclofenac Zydus Cadila Anti-
matrix containing a drug solution or suspension.
h 100 diethylami Inflammat
The adhesive layer in this patch surrounds the
ory
drug layer partially overlaying it. ne

Neupro Rigotine UCB and Schwarz early-stage

R
Pharma idiopathic
Parkinson’
s disease

Alora Estradiol TheraTech/Proctol Postmenstr

and Gamble ual
syndrome

Nicode Nicotine Alza/GlaxoSmithK Smoking

rmR line cessation
5. Vapour Patch
Estrade Estradiol Alza/Norvatis Postmenstr
In this type of patch the adhesive layer not only rm ual
serves to adhere the various layers together but
also to release vapour. The vapour patches are syndrome
new on the market and they release essential oils
for up to 6 hours. The vapours patches release Climar Estradiol 3M Postmenstr
essential oils and are used in cases of a Pharmaceuticals/B ual
decongestion mainly. Other vapour patches on erlex
syndrome
the market are controller vapour patches that Labs
improve the quality of sleep. Vapour patches that
reduce the quantity of cigarettes that one smokes Androd Testostero TheraTech/GlaxoS Hypogona
in a month are also available on the market. erm ne mithKline dism in
males

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

Nitrodi Nitroglyce Roberts Angina males

sc rin Pharmaceuticals pectoris
Oxytrol oxybutyni Watson Pharma Overactive
R
Transd Scopolami Alza/Norvatis Motion n bladder
erm- ne sickness
Prostep Nicotine Elan Corp./Lederle Smoking
ScopR
Labs cessation
Nuvell Estrogen/P Ethical Hormone
e TS roge Holdings/Schering replaceme
sterone nt therapy Evaluation of Transdermal Patches
 Physicochemical evaluation
Deponi Nitroglyce Schwarz-Pharma Angina  In vitro evaluation
t rin pectoris  In vivo evaluation
1. Physicochemical Evaluation:
Nitro- Nitroglyce Key Angina
dur rin Pharmaceuticals pectoris Thickness: The thickness of transdermal film is
determined by travelling microscope, dial gauge,
Catapre Clonidine Alza/Boehinger Hypertensi screw gauge or micrometer at different points of
s TTSR Ingelheim on the film.
Uniformity of weight: Weight variation is
FemPat Estradiol Parke-Davis Postmenstr studied by individually weighing 10 randomly
ch ual selected patches and calculating the average
syndrome weight. The individual weight should not deviate
significantly from the average weight.
Minitra Nitroglyce 3M Angina Drug content determination: An accurately
n rin Pharmaceuticals pectoris weighed portion of film (about 100 mg) is
Climad Estradiol Ethical Postmenstr dissolved in 100 mL of suitable solvent in which
erm Holdings/Wyeth- ual drug is soluble and then the solution is shaken
Ayerest continuously for 24 h in shaker incubator. Then
syndrome
the whole solution is sonicated. After sonication
and subsequent filtration, drug in solution is
Durage Fentanyl Alza/Janssen Moderate/s
estimated spectrophotometrically by appropriate
sicR Pharmaceutical evere
dilution.
pain
Content uniformity test: 10 patches are selected
Estrade Estradiol Alza/Norvatis Postmenstr and content is determined for individual patches.
rm ual If 9 out of 10 patches have content between 85%
to 115% of the specified value and one has
syndrome content not less than 75% to 125% of the
specified value, then transdermal patches pass the
Transd Nitroglyce Alza/Norvatis Angina test of content uniformity. But if 3 patches have
erm- rin pectoris content in the range of 75% to 125%, then
NitroR additional 20 patches are tested for drug content.
If these 20 patches have range from 85% to
Testod Testostero Alza Hypogona 115%, then the transdermal patches pass the test.
erm ne dism in
TTSR Moisture content: The prepared films are
weighed individually and kept in a desiccators

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

containing calcium chloride at room temperature the elongation of the film. The weight just
for 24 h. The films are weighed again after a sufficient to break the film is noted. The tensile
specified interval until they show a constant strength can be calculated using the following
weight. The percent moisture content is equation.
calculated using following formula. Tensile strength= F/a.b (1+L/l)
% Moisture content = Initial weight – Final F is the force required to break; a is width of film;
weight X 100 b is thickness of film; L is length of film; l is
Moisture Uptake: Weighed films are kept in a elongation of film at break point.
desiccator at room temperature for 24 h. These
Tack properties: It is the ability of the polymer
are then taken out and exposed to 84% relative to adhere to substrate with little contact pressure.
humidity using saturated solution of Potassium
Tack is dependent on molecular weight and
chloride in a desiccator until a constant weight is composition of polymer as well as on the use of
achieved. % moisture uptake is calculated as tackifying resins in polymer.
given below.
Thumb tack test: The force required to remove
% moisture uptake = Final weight – Initial weight
thumb from adhesive is a measure of tack.
X 100
Rolling ball test: This test involves measurement
Flatness: A transdermal patch should possess a of the distance that stainless steel ball travels
smooth surface and should not constrict with along an upward facing adhesive. The less tacky
time. This can be demonstrated with flatness the adhesive, the further the ball will travel.
study. For flatness determination, one strip is cut
from the centre and two from each side of Quick stick (Peel tack) test: The peel force
patches. The length of each strip is measured and required breaking the bond between an adhesive
variation in length is measured by determining and substrate is measured by pulling the tape
percent constriction. Zero percent constriction is away from the substrate at 90? at the speed of 12
equivalent to 100 percent flatness. inch/min.
% constriction = I1 – I2 X 100 Probe tack test: Force required to pull a probe
away from an adhesive at a fixed rate is recorded
I2 = Final length of each strip as tack.
I1 = Initial length of each strip
Folding Endurance: Evaluation of folding
2. In vitro release studies:
endurance involves determining the folding
capacity of the films subjected to frequent The Paddle over Disc: (USP apparatus 5/ PhEur
extreme conditions of folding. Folding endurance 2.9.4.1) This method is identical to the USP
is determined by repeatedly folding the film at the paddle dissolution apparatus, except that the
same place until it break. The number of times transdermal system is attached to a disc or cell
the films could be folded at the same place resting at the bottom of the vessel which contains
without breaking is folding endurance value. medium at 32 ±5°C.
Tensile Strength: To determine tensile strength, The Cylinder modified USP Basket: (USP
polymeric films are sandwiched separately by apparatus 6 / PhEur 2.9.4.3) This method is
corked linear iron plates. One end of the films is similar to the USP basket type dissolution
kept fixed with the help of an iron screen and apparatus, except that the system is attached to
other end is connected to a freely movable thread the surface of a hollow cylinder immersed in
over a pulley. The weights are added gradually to medium at 32 ±5°C.
the pan attached with the hanging end of the The reciprocating disc: (USP apparatus 7) In
thread. A pointer on the thread is used to measure this method patches attached to holders are

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

oscillated in small volumes of medium, allowing magnets,which are rotated at a speed of 600rpm.
the apparatus to be useful for systems delivering The system is controlled by thermostated water
low concentration of drug. In addition paddle through a water jacket surrounding the two
over extraction cell method (PhEur 2.9.4.2) may compartments.
be used. Franz diffusion cell: the cell is composed of two
compartments: donor and receptor. The receptor
In vitro permeation studies: The amount of drug
available for absorption to the systemic pool is compartment has a volume of 5-12ml and
greatly dependent on drug released from the effective surface area of 1-5 cm2. The diffusion
polymeric transdermal films. The drug reached at buffer is continuously stirred at 600rpm by a
skin surface is then passed to the dermal magnetic bar. The temperature in the bulk of the
microcirculation by penetration through cells of solution is maintained by circulating thermostated
epidermis, between the cells of epidermis through water through a water jacket that surrounds the
receptor compartment.
skin appendages. Usually permeation studies are
performed by placing the fabricated transdermal Flow-through diffusion cell: flow through
diffusion cells have the advantage that they can
patch with rat skin or synthetic membrane in
between receptor and donor compartment in a be used when the drug has lower solubility in the
receptor compartment. This cell can be fully
vertical diffusion cell such as Franz diffusion cell
or keshary-chien diffusion cell. The transdermal automated and connected directly to HPLC. They
have large capacity donor chamber to aloe
system is applied to the hydrophilic side of the
membrane and then mounted in the diffusion cell appropriate loading of the applied compound and
a low volume (0.3ml) receiving chamber that
with lipophillic side in contact with receptor
fluid. The receiver compartment is maintained at ensures rapid removal of penetrant at relatively
specific temperature (usually 32±5°C for skin) low pumping rates.
and is continuously stirred at a constant rate. The In vivo Studies: In vivo evaluations are the true
samples are withdrawn at different time intervals depiction of the drug performance. The variables
and equal amount of buffer is replaced each time. which cannot be taken into account during in
The samples are diluted appropriately and vitro studies can be fully explored during in vivo
absorbance is determined spectrophotometrically. studies. In vivo evaluation of TDDS can be
Then the amount of drug permeated per carried out using animal models human
centimeter square at each time interval is volunteers.
calculated. Design of system, patch size, surface
Animal models: Considerable time and resources
area of skin, thickness of skin and temperature are required to carry out human studies, so animal
etc. are some variables that may affect the release studies are preferred at small scale. The most
of drug. So permeation study involves common animal species used for evaluating
preparation of skin, mounting of skin on transdermal drug delivery system are mouse,
permeation cell, setting of experimental hairless rat, hairless dog, hairless rhesus monkey,
conditions like temperature, stirring, sink rabbit, guinea pig etc. Various experiments
conditions, withdrawing samples at different time
conducted leadus to a conclusion that hairless
intervals, sample analysis and calculation of flux animals are preferred over hairy animals in both
i.e., drug permeated per cm2 per sec
in vitro and in vivo experiments. Rhesus monkey
Horizontal-type skin permeation system: this is one of the most reliable models for in vivo
has been widely used for the evaluation of drug evaluation of transdermal drug delivery in man.
permeation across skin. The cell is divided in Human models: The final stage of the
receptor and donor compartments with a low development of a transdermal device involves
solution volume (3.5ml) for each compartment collection of pharmacokinetic and
and a small membrane area (0.64cm2). They are pharmacodynamic data following application of
continuously stirred by matched set of star-head

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Dipen Patel*, Sunita A. Chaudhary, Bhavesh Parmar, Nikunj Bhura

the patch to human volunteers. Clinical trials 9. Panner Selvam R, Kumar Singh A and Sivakumar T.
have been conducted to assess the efficacy, risk Transdermal drug delivery systems for
involved, side effects, patient compliance etc. antihypertensive drugs - A review. International
Phase I clinical trials are conducted to determine Journal of Pharmaceutical And Biomedical Research
mainly safety in volunteers and phase II clinical 2010; 1(1): 1-8.
trials determine short term safety and mainly 10. Gaur PK, Mishra S, Purohit S and Dave K.
Transdermal Drug Delivery System: A Review. Asian
effectiveness in patients. Phase III trials indicate
Journal of Pharmaceutical and Clinical Research 2009;
the safety and effectiveness in large number of
2(1): 14-20.
patient population and phase IV trials at post
marketing surveillance are done for marketed
patches to detect adverse drug reactions. Though
human studies require considerable resources but
they are the best to assess the performance of the
drug.

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