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T ransdermal drug delivery system (TDDS) is one of the systems lying under the category of controlled drug delivery, in
which the aim is to deliver the drug through the skin in a predetermined and controlled rate. It has various advantages,
like prolonged therapeutic effect, reduced side-effects, improved bioavailability, better patient compliance and easy termination
of drug therapy. The stratum corneum is considered as the rate limiting barrier in transdermal permeation of most molecules.
There are three main routes of drug penetration, which include the appendageal, transcellular and intercellular routes. Skin age,
condition, physicochemical factors and environmental factors are some factors that are to be considered while delivering drug
through this route. Basic components of TDDS include polymer matrix, membrane, drug, penetration enhancers, pressure-
sensitive adhesives, backing laminates, release liner, etc.Transdermal patches can be divided into various systems like reservoir
system, matrix system and micro-reservoir system, which are used to incorporate the active ingredients into the circulatory
system via the skin.After preparation of transdermal patches, consistent methodology are adopted to test the adhesion properties,
physicochemical properties, in vitro drug release studies, in vitro skin permeation studies, skin irritation studies and stability
studies. According to the duration of therapy, various drugs are commercially available in the form of transdermal patches.
Key words: Matrix system, microreservoir system, penetration enhancer, pressure-sensitive adhesives, reservoir system,
stratum corneum,Transdermal drug delivery system
Skin and drug permeation layer toward the skin surface. The epidermis contains no
The objective of TDDS is to achieve systemic medication blood vessels; therefore, nutrients and waste products must
through topical application on intact skin; therefore, it is diffuse across the dermal–epidermal junction to maintain its
important to review the structural and biochemical features vitality. The epidermis consists of five layers, which, from the
of the human skin and those characteristics that contribute inside to the outside, are the stratum germinativum (basal
to the barrier function and the rate of drug access into the layer), stratum spinosum (spinous layer), stratum granulosum
body via the skin. (granular layer), stratum lucidum and stratum corneum (SC).
Because the SC cells are dead, the epidermis without the SC
Anatomically, the skin can be divided into two layers: is usually termed the viable epidermis. The SC is considered
epidermis and dermis or corium [Figure 1], penetrated by as the rate-limiting barrier in transdermal permeation of
hair shafts and gland ducts. The skin is one of the most most molecules. The SC comprises 15–20 layers of keratin-
extensive organs of the human body, covering an area of filled corneocytes (terminally differentiated keratinocytes)
about 2 m2 in an average human adult. The major skin layers, anchored in a lipophilic matrix. The lipids of this extracellular
from inside to outside, comprise the fatty subcutaneous matrix are distinctive in many respects: (1) they provide
layer (hypodermis), the dermis of connective tissue and the the only continuous phase (and diffusion pathway) from
stratified avascular cellular epidermis. This multilayered the skin surface to the base of the SC; (2) the composition
organ receives approximately one-third of all blood (ceramides, free fatty acids and cholesterol) is unique among
circulating through the body. Epidermis results from an active biomembranes and particularly noteworthy is the absence of
epithelial basal cell population and is approximately 150-μm phospholipids; (3) despite this deficit of polar bilayer-forming
thick. It is the outermost layer of the skin, and the process lipids, the SC lipids exist as multilamellar sheets; and (4)
of differentiation results in migration of cells from the basal the predominantly saturated, long-chain hydrocarbon tails
Figure 1: Cross-section view of human skin showing different cell layers and appendages
facilitate a highly ordered, interdigitated configuration and historically held view of the follicles providing approximately
the formation of gel phase membrane domains as opposed 0.1% of the SC appears to be valid for forearm skin.
to the more usual (and more fluid and permeable) liquid
crystalline membrane systems. In the dry state, the SC has Transcellular route
a thickness of 10–15 μm; upon hydration, the SC swells and Drugs entering the skin via the transcellular route pass
its thickness can reach 40 μm. The structure of the SC is through the corneocytes. Corneocytes containing highly
often depicted as a bricks and mortar arrangement, where hydrated keratin provide an aqueous environment from
the keratin-rich corneocytes (bricks) are embedded in the which hydrophilic drugs can pass. The transcellular pathway
intercellular lipid-rich matrix (mortar). requires not only partitioning into and diffusion through the
keratin bricks but also into and across the intercellular lipids.
Dermis is the foundation of a firm of connective tissue upon
which the epidermis is laid, and is of mesoderm origin. The Intercellular route
dermis or corium consists of a dense network of connective The intercellular route involves drug diffusion through the
tissue in which bundles of collagen fibers predominate, continuous lipid matrix. This route is a significant obstacle
mingled with elastic tissue in the superficial levels. The dermis for two reasons: (i) recalling the “bricks and mortar” model
contains fine plexuses of blood vessels, lymphatics, nerves, of SC, the interdigitating nature of the corneocytes yields a
hair follicles, sweat glands and sebaceous glands.[8,9,14,15] tortuous pathway for intercellular drug permeation, which
is in contrast to the relatively direct path of the transcellular
ROUTES OF PENETRATION route. (ii) The intercellular domain is a region of alternating
structured bilayers. Consequently, a drug must sequentially
There are critically three ways in which a drug molecule partition into and diffuse through repeated aqueous and
can cross the intact SC: via skin appendages (shunt routes), lipid domains. This route is generally accepted as the most
through the intercellular lipid domains or by a transcellular common path for small uncharged molecules penetrating
route [Figure 2]. Physiochemical properties of the molecule the skin.
govern the flux of a particular drug to permeate by a
combination of these routes.[5,9] RATIONALE FOR TRANSDERMAL DRUG
DELIVERY
The appendageal route
The transappendageal routes are also known as the shunt Given that the skin offers such an excellent barrier to
routes, and include permeation through the sweat glands and molecular transport, the rationale for this delivery strategy
across the hair follicles with their associated sebaceous glands. needs to be carefully identified. Clearly, there are several
Skin appendages provide a continuous channel directly across instances in which the most convenient of drug intake
the SC barrier. Recent studies have re-examined the long held methods (the oral route) is not feasible and when alternative
assumption that the follicles occupy approximately 0.1% of routes must be sought.
the surface area of the human skin. Otberg et al. showed
that the follicular number, opening diameter and follicular Although intravenous introduction of the medicament
volume are important considerations in drug delivery through avoids many of these shortfalls (such as gastrointestinal and
these appendages and, indeed, the forehead provides hepatic metabolism), its invasive and apprehensive nature
13.7 mm2/cm2 as the follicular infundibula, i.e. approximately (particularly for chronic administration) has encouraged the
13.7% of the surface area of the forehead is available as search for alternative strategies, and few anatomical orifices
follicles. Interestingly, the same study also showed that the have not been investigated for their potential as optional
drug delivery routes. Nevertheless, the transdermal mode
offers several distinct advantages: (1) the skin presents a
relatively large and readily accessible surface area (1–2 m2)
for absorption; and (2) the application of a patch-like device
to the skin surface is a non-invasive (and thus a patient
compliant) procedure that allows continuous intervention
(i.e., system repositioning, removal or replacement).
must be therapeutically “justified”: drugs with high oral the concentration of unionized drug in applied phase will
bioavailability and infrequent dosing regimens that are well determine the effective membrane gradient, which is directly
accepted by patients do not warrant such measures. Similarly, related to its pH.[17]
transdermal administration is not a means to achieve rapid
bolus-type drug inputs; rather, it is usually designed to offer Environmental factors
slow, sustained drug delivery over substantial periods of Sunlight
time and, as such, tolerance-inducing drugs or those (e.g., Because of to sunlight, the walls of blood vessels become
hormones) requiring chronopharmacological management thinner, leading to bruising, with only minor trauma in the
are, at least to date, not suitable. Nevertheless, there remains sun-exposed areas. Also, pigmentation, the most noticeable
a large pool of drugs for which TDD is desirable but presently sun-induced pigment change, is a freckle or solar lentigo.[18]
unfeasible. The nature of the SC is, in essence, the key to
this problem. The excellent diffusional resistance offered by Cold season
the membrane means that the daily drug dose that can be The cold season often results in itchy and dry skin. The skin
systemically delivered through a reasonable “patch-sized” responds by increasing oil production to compensate for the
area remains in the 10 mg range. This limitation imposes weather’s drying effects. A good moisturizer will help ease
the first criterion for a successful transdermal candidate: symptoms of dry skin. Also, drinking lots of water can keep
transdermal drugs must be pharmacologically potent, your skin hydrated and looking radiant.[18]
requiring therapeutic blood concentrations in the ng/ml
range, or less. The second criterion is that SC is very selective Air pollution
with respect to the type of molecule that can be transported Dust can clog pores and increase bacteria on the face and the
across this outer covering, and not all molecules that pass surface of skin, both of which lead to acne or spots, which
the “potency” test will have the necessary physicochemical affects drug delivery through the skin. Invisible chemical
properties.[9] pollutants in the air can interfere with the skin’s natural
protection system, breaking down the skin’s natural oils
FACTORS AFFECTING TRANSDERMAL DRUG that normally trap moisture in the skin and keep it supple.[18]
DELIVERY
BASIC COMPONENTS OF TDDS
Skin condition
The intact skin itself acts as a barrier, but many agents like • Polymer matrix/drug reservoir
acids and alkali cross the barrier cells and penetrate through • Membrane
the skin. Many solvents open the complex dense structure • Drug
of the horny layer: solvents like methanol and chloroform • Permeation enhancers
remove the lipid fraction, forming artificial shunts through • Pressure-sensitive adhesives (PSA)
which drug molecules can pass easily.[16] • Backing laminates
• Release liner
Skin age • Other excipients like plasticizers and solvents
It is seen that the skin of adults and young ones is more
permeable than that of the older ones. but there is no dramatic Polymer matrix/drug reservoir
difference. Children show toxic effects because of the greater Polymers are the backbone of TDDS, which control the
surface area per unit body weight. Thus, potent steroids, boric release of the drug from the device. A polymer matrix can
acid and hexachlorophene have produced severe side-effects. be prepared by dispersion of drug in a liquid or solid state
synthetic polymer base. Polymers used in TDDS should have
Physicochemical factors biocompatibility and chemical compatibility with the drug
Hydration of skin and other components of the system, such as penetration
Generally, when water saturates the skin, it swells tissues, enhancers and PSAs. Additionally, they should provide
softens wrinkles on the skin and its permeability increases consistent and effective delivery of a drug throughout the
for the drug molecules that penetrate through the skin.[17] product’s intended shelf-life, and should be safe.[13,19-21]
Temperature and pH of the skin The following criteria should be preferred in selecting the
The penetration rate varies if the temperature varies and polymer to be used in the transdermal system:
the diffusion coefficient decreases as the temperature falls;, (i) Molecular weight, glass transition temperature and chemical
however adequate clothing on the body prevents wide functionality of the polymer should be such that the specific
fluctuations in temperature and penetration rates. According drug diffuses properly and gets released through it.
to pH, only unionized molecules pass readily across the lipid (ii) The polymer should be stable, nonreactive with the
membrane, and weak acids and bases dissociate to different drug, easily manufactured and fabricated into the desired
degrees according to their pH and pKa or pKb values. Thus, product, and should be inexpensive.
164 Asian Journal of Pharmaceutics - July-September 2012
Rastogi and Yadav: Transdermal drug delivery system: An overview
(iii) The polymer and its degradation products must be Table 2: Polymers used in TDDS[21,22]
nontoxic or nonantagonistic to the host. Natural Synthetic Synthetic
(iv) The mechanical properties of the polymer should not polymers elastomers polymers
deteriorate excessively when large amounts of active Cellulose Polybutadiene, Polyvinylalcohol,
ingredients are incorporated into it.[21] derivatives, zein, hydrin rubber, polyvinylchloride,
gelatin, waxes, polysiloxane polyethylene,
The polymers utilized for TDDS are presented in Table 2. proteins and their silicone rubber, polypropylene,
derivatives, nitrile, acrylonitrile, polyacrylate,
natural rubber, butyl rubber rubber, polyurea,
Membrane
starch, chitosan, styrene–butadiene polyvinyl
A membrane may be sealed to the backing to form a pocket etc. rubber, neoprene, pyrrolidone,
to enclose the drug-containing matrix or used as a single etc. polymethyl
layer in the patch construction. The diffusion properties of methacrylate,
the membrane are used to control availability of the drug epoxy, ethyl
and/or excipients to the skin. For example, ethylene vinyl cellulose,
acetate, silicone rubber, polyurethrane, etc. are used as a hydroxy propyl
rate-controlling membrane.[5,21] cellulose,
polyamide, etc.
Drug
For successfully developing a TDDS, the drug should be Table 3: Ideal properties of drugs for TDDS[5,9,23]
chosen with great care. Transdermal patches offer many
Parameters Properties
advantages to drugs that undergo extensive first-pass
Dose Should be low (less than 20 mg/day)
metabolism, drugs with narrow therapeutic window or drugs
with a short half-life, which cause noncompliance due to Half-life 10 or less (h)
frequent dosing.[13,19] Some of the desirable properties of a Molecular weight <400 Da
drug and factors to be considered for transdermal delivery Partition Log P (octanol–water) between 1.0 and
coefficient 4.0
are shown in Tables 3 and 4.
Skin permeability >0.5 × 10-3 cm/h
coefficient
There are some examples of drugs that are suitable for
Liophilicity 10 < Ko/w < 1000
TDDS, like Nicardipine hydrochloride, Captopril, Atenolol,
Oral bioavailability Low
Metoprolol tartarate, Clonidine, Indapamide, Propranolol
Therapeutic index Low
hydrochloride, Carvedilol, Verapamil hydrochloride and
Melting point <200°C
Niterdipine, etc.
pH Between 5.0 and -9.0
Permeation enhancers
One long-standing approach for improving TDD uses Table 4: Factors to be considered for transdermal dose
penetration enhancers (also called sorption promoters or calculation[24]
accelerants), which increase the permeability of the SC so Physiochemical Pharmacokinetic Biological
as to attain higher therapeutic levels of the drug candidate. Solubility Half-life Skin toxicity
Penetration enhancers interact with structural components Crystallinity Volume of Site of application
of the SC thus modifying the barrier functions, leading distribution
to increased permeability. Three pathways are suggested Molecular Total body Allergic reaction
for drug penetration through the skin: polar, nonpolar weight clearance
and polar/nonpolar. The enhancers act by altering one of Polarity Therapeutic plasma Skin metabolism
concentration
these pathways. The key to altering the polar pathway is to
Melting point Bioavailability factor Skin permeability
cause protein conformational change or solvent swelling.
The key to altering the nonpolar pathway is to alter the
rigidity of the lipid structure and fluidize the crystalline Chemical enhancers
pathway (this substantially increases diffusion). The fatty Chemicals that promote the penetration of topically applied
acid enhancers increase the fluidity of the lipid portion drugs are commonly referred to as accelerants, absorption
of the SC. Some enhancers (binary vehicles) act on both promoters or penetration enhancers.[13] Chemical enhancers
polar and nonpolar pathways by altering the multilaminate act by:
pathway for penetrants.[9,13] The methods employed for • Increasing (and optimizing) the thermodynamic activity
modifying the barrier properties of the SC to enhance the of the drug when functioning as a co-solvent
drug penetration (and absorption) through the skin can • Increasing the partition coefficient of the drug to
be categorized as (1) chemical and (2) physical methods promote its release from the vehicle into the skin
of enhancement. • Conditioning the SC to promote drug diffusion
Asian Journal of Pharmaceutics - July-September 2012 165
Rastogi and Yadav: Transdermal drug delivery system: An overview
Weight uniformity
The prepared patches are to be dried at 60°C for 4 h before
testing. A specified area of patch is to be cut in different parts
d of the patch and weighed in a digital balance. The average
Figure 3: Types of transdermal patches: (a) Reservoir, (b) Matrix, weight and standard deviation values are to be calculated
(c) Drug-in-Adhesive, (d) Microreservoir system from the individual weights.[6]
Folding endurance
medicated adhesive polymer by solvent casting or melting A strip of the specific area is to be cut evenly and repeatedly
(in the case of hot melt adhesives) on an impervious backing folded at the same place till it breaks. The number of times
layer. On the top face of the reservoir, unmedicated adhesive the film can be folded at the same place without breaking
polymer layers are applied for protection purpose. gives the value of the folding endurance.[6]
Water vapor permeability evaluation Molecular weight of the adhesive polymer and the type and
WVP can be determined with the foam dressing method, amount of additives are the variables that determine the peel
wherein the air-forced oven is replaced by a natural air adhesion properties. A single tape is applied to a stainless
circulation oven.[6] The WVP can be determined by the steel plate or a backing membrane of choice and then the
following formula: tape is pulled from the substrate at a 180º angle, and the
force required for tape removal is measured.[6]
WVP = W / A (3)
Thumb tack test
Where, WVP is expressed in gm/m2 per 24 h, W is the amount It is a qualitative test applied for tack property determination
of vapor permeated through the patch, expressed in gm/24 h, of the adhesive. The thumb is simply pressed on the adhesive
and A is the surface area of the exposure samples, expressed and the relative tack property is detected.[6]
in m2.
Flatness test
Drug content Three longitudinal strips are to be cut from each film at
A specified area of the patch is to be dissolved in a suitable different portions, like one from the center, one from the
solvent in a specific volume. Then, the solution is to be left side and another from the right side. The length of each
filtered through a filter medium and analyze the drug content strip was measured and the variation in length because of
with the suitable method (UV or HPLC technique). Each value nonuniformity in flatness was measured by determining
represents an average of three different samples.[6] the percent constriction, with 0% constriction equivalent to
100% flatness.[6]
Uniformity of the dosage unit test
An accurately weighed portion of the patch is to be cut into Percentage elongation break test
small pieces and transferred to a specific volume using a The percentage elongation break is to be determined by
volumetric flask, dissolved in a suitable solvent and sonicate noting the length just before the break point. The percentage
for complete extraction of the drug from the patch and elongation can be determined from the below-mentioned
made up to the mark with the same. The resulting solution formula:
was allowed to settle for about 1 h and the supernatant was
suitably diluted to give the desired concentration with the Elongation percentage = (L1 - L2) / L2 × 100 (4)
suitable solvent. The solution was filtered using a 0.2-µm
membrane, filtered and analyzed by a suitable analytical Where, L1 is the final length of each strip and L2 is the initial
technique (UV or HPLC), and the drug content per piece was length of each strip.[6]
to be calculated.[6]
Rolling ball tack test
Polariscope examination This test measures the softness of a polymer that relates
This test is to be performed to examine the drug crystals to talk. In this test, a stainless steel ball of 7/16 inches in
from the patch by a polariscope. A specific surface area of diameter is released on an inclined track so that it rolls down
the piece is to be kept on the object slide and observed for and comes in contact with the horizontal, upward facing
the drug crystals to distinguish whether the drug is present adhesive. The distance the ball travels along the adhesive
as a crystalline form or an amorphous form in the patch.[6] provides the measurement of tack, which is expressed in
inches.[6]
Shear adhesion test
This test is to be performed for measurement of the Quick stick (peel-tack) test
cohesive strength of an adhesive polymer. It can be In this test, the tape is pulled away from the substrate at
influenced by the molecular weight, the degree of cross- 90º at a speed of 12 inches/min. The peel force required to
linking and the composition of the polymer and the type break the bond between the adhesive and the substrate is
and amount of tackifier added. An adhesive-coated tape measured and recorded as tack value, which is expressed in
is applied onto a stainless steel plate; a specified weight ounces or grams per inch width.[6]
is hung from the tape to affect it, pulling in a direction
parallel to the plate. Shear adhesion strength is determined Probe tack test
by measuring the time it takes to pull the tape off the In this test, the tip of a clean probe with a defined surface
plate. The longer the time taken for removal, greater is roughness is brought into contact with the adhesive. And,
the shear strength.[6] when a bond is formed between the probe and the adhesive,
the subsequent removal of the probe mechanically breaks it.
Peel adhesion test The force required to pull the probe away from the adhesive
In this test, the force required to remove an adhesive at a fixed rate is recorded as tack, and it is expressed in
coating from a test substrate is referred to as peel adhesion. grams.[6]
168 Asian Journal of Pharmaceutics - July-September 2012
Rastogi and Yadav: Transdermal drug delivery system: An overview
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How to cite this article: Rastogi V, Yadav P. Transdermal drug delivery
medicine. 3rd ed. Churchill Livingstone: Elsevier; 2007. p. 567-8.
system: An overview. Asian J Pharm 2012;6:161-70.
18. Jain NK. Controlled and Novel Drug Delivery. New Delhi: CBS Publishers
and Distributors; 2002. p. 107. Source of Support: Nil. Conflict of Interest: None declared.
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