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A Review on Topical Drug Delivery System Patches

Article · January 2022


DOI: 10.35629/7781-0701292302

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International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

A Review on Topical Drug Delivery System Patches


1Pavan*. R. Patel, 2DrAnandK. Patel,3DrVishnuM.Patel,
A.P.M.C College of Pharmaceutical Educationand Research, Himmatnagar, Gujarat
A.P.M.C College of Pharmaceutical Educationand Research, Himmatnagar, Gujarat
A.P.M.C College of Pharmaceutical Educationand Research, Himmatnagar, Gujarat

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Submitted: 02-01-2022 Accepted: 12-01-2022
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ABSTRACT easily penetrate the skin can be delivered by this
Topicaldrug delivery systems have been shown to method. This review article describes introduction,
overcome difficulties in drug delivery, especially physiology of skin, criteria for drug selection of
orally. A topical patch is a drug-containing topical patch, which conditions topical patches are
adhesive patch that is attached to the skin, and a used/not used, advantages, disadvantages, Factor
specific dose of drug can be delivered to the blood affecting topical drug delivery system, Components
through the skin. It promotes the healing of an of Topical Drug Delivery System, a general clinical
injured area of the body. Advantages of the drug considerations in the use of tdds, methods of
delivery route through the skin compared to other preparation of tdds, evaluation parameter.
routes such as oral, topical, intravenous, etc. is a
patch that allows a controlled release of medication INTRODUCTION
into the patient, usually through a porous Topical products are classified according
membrane that covers a drug reservoir or by body to those that are applied to produce local and
heat melting thin layers of medication embedded in systemic effects. These systems are commonly
an adhesive.The main disadvantage of thetopical used for localized skin infections when other routes
delivery system is that the skin is a very effective of administration have failed. See in Figure 11,2.
barrier, so only drugs with small molecules that can

Fig. 1. :-Local and Systemic Actions

Effectively administered low-dose drug an ideal factor to be considered in a topical drug


molecules are confined to a small area anywhere on delivery system to achieve and maintain consistent
the body. The stratum corneum is lipid in nature, systemic therapeutic levels throughout the duration
made up of 40% fat,40% protein and only 20% of administration. Drugs that are administered
water. The lipophilic properties of the drug make it passively through the skin must have appropriate
most suitable for topical use, the delivery of which lipophilicity and a molecular weight of less than
is facilitated by solubility in the intercellular lipids 500 Da. The topical drug reaches the area at
surrounding the cells of the stratum corneum. optimal concentrations reducing side effects and
However, hydrophilic drugs are difficult to increasing bioavailability and patient compliance3.
transport to the stratum corneum due to their low In topical drug use, the skin is one of the
water content. These molecules are absorbed into main and easily accessible organs of the human
the skin through “pores” or openings in hair body. The stratum corneum forms a major barrier
follicles and sebaceous glands that limit the to penetration of drugs into and through the skin.
absorption of the drug. Percutaneous absorption is However, this layer makes it selective for the
DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 292
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

distribution system. An important aspect of topical lipid/water partition and it is a non-electrolyte, the
drug use is making the skin the target organ for absorption of the drug is improved through the
diagnosis and treatment. This review is more skin. Dermatological products come in a variety of
concerned with all the details regarding formulations and their consistency, although the
conventional and current advances in topical drug most common dermatological products are semi-
delivery4,5,6. solid dosage forms7.
TOPICAL DRUG CLASSIFICATION SYSTEM
TOPICAL DRUG DELIVERY (TCS)
A topical drug delivery system is a local Based on qualitative(Q1) &
drug delivery system for the delivery of topical quantitative(Q2) composition, Semi solid
drugs through the skin for the treatment of skin products(Q3), TCS provides a framework for
disorders. These systems are commonly used for classifying topical drug products. Topical drug
local skin infections. Formulations are available in products are classified into 4 classes, as seen in
different forms, from solid to semi-solid to liquid. Figure 28.
If the drug substance in solution has a favorable

Fig. 2:-Classification of Topical Drug Products Based on Qualitative & Quantitative Composition

ANATOMY AND PHYSIOLOGY OF SKIN parts: living cells or cells of the squamous layer
The skin is most extensive part of the body. Human (existing epidermis) and squamous cells. dead cells
body covering an area in skin about 2 m2. Human of the corneal layer.5 called the stratum corneum.
skin three distinct layer. Each layer has perform Viable epidermis further classified into four
own function and own importance to maintain the distinct layers, as shown in Fig.39.
integrity of skin.  The stratum lucidum
 Cellular epidermis  The stratum granulosum
The epidermis is a constantly renewing  The stratum spinosum
squamous epithelium that covers the entire outer  The stratum basale
surface of the body and is mainly made up of two

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 293
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

Fig. 3: Schematic Diagram Of Anatomy Of Cellular Epidermis

 Stratum corneum: hydrated. It is flexible but relatively waterproof.


It is the outermost layer of the skin, also The architecture of the stratum corneum (Figure 4)
known as the stratum corneum. It is a flow can be modeled as a structure in the form of a wall
restriction barrier that restricts the movement of of protein bricks and lipid mortar. It is made up of
chemicals in and out. The barrier nature of the keratinocytes (corneal cells) bound together by
stratum corneum is highly dependent on its desmomes (protein-rich appendages of cell
constituents: 7580% protein, 515% lipid and 510% membranes).The corneal cells are embedded in a
ondansetron on a dry weight basis. lipid matrix that plays an important role in
The stratum corneum is about 10mm thick determining the permeability of this substance
when dry, but will swell several times when fully through the skin10.

Fig. 4: Schematic Diagram Of Micro-Structure Of Stratum Corneum

 Viable epidermis: various layers such as the lucidum layer, the seed
It lies below the stratum corneum and layer, the organism layer and the substrate layer. In
varies in thickness from 0.06mm on the eyelids to the basal layer, cell mitosis continuously renews
0.8mm on the palms. Going inside, it consists of the epidermis and this proliferation compensates
DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 294
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

for the loss of dead keratinocytes from the surface histological changes on their own, undergoing
of the skin. As the cells produced by the basal layer keratinization to form the outermost layer of the
migrate outward, they undergo morphological and stratum corneum11. shown in Fig. 5.

Fig. 5: Schematic Diagram Of Different Layers Of Viable Epidermis

 Dermis:  Drugs should be selected for their short half-


The dermis is the layer of skin just 3-5 life.
mm below the epidermis and is made up of a  In topicalpatches, the dose should be chosen to
matrix of connective tissue, containing blood be low.(<20mg/ml)
vessels, lymph and nerves. The skin's blood supply  Drugs should be chosen with lower molecular
has an essential function in regulating body weight (<400 daltons)
temperature. It also delivers nutrients and oxygen  Drugs should be selected in the partition
to the skin, and removes toxins and waste. The coefficient(logP) between 1.0-4.
capillaries reach within 0.2 mm of the skin surface  The drug should be chosen in an oral form
and facilitate the escape of most of the molecules to with low bioavailability.
penetrate the skin barrier. Thus, the blood supply  Drugs should be selected with a low
maintains very low topical concentrations, and the therapeutic index.
difference in concentrations across the epidermis
 The drug should be selected as non-irritating
provides the essential driving force for and non-sensitizing to the skin.
topicalpenetration.for topical drug delivery system,
 Drugs must be selected in their affinity for the
this layer is generally considered to be mainly
lipophilic and hydrophilic phases.
composed of water and thus providing a minimal
barrier to the use of most polar drugs,, although the
WHICH CONDITIONS TOPICAL PATCHES
skin barrier may be important. important when
ARE USED:
using highly lipophilic molecules12.
Topicalpatches are used when:
 Hypodermis:
The dermis or subcutaneous fatty tissue  When a patient experiences side effects that
are intolerable and cannot take oral
supports the dermis and epidermis. It serves as a fat
storage area. This layer provides temperature medications (dysphagia) and an alternative
regulation, nutritional support, and mechanical medication approach is needed.
protection. It carries major blood vessels and  Where pain control can be improved by
nerves to the skin and may contain sensory reliable management. This can be helpful in
pressure organs. In order for a drug to be delivered patients with dementia or who for other
through the skin, it must penetrate all three layers reasons are unable to self-medicate with their
and reach the circulatory system11. pain medication.

CRITERIA FOR DRUG SELECTION OF WHICH CONDITIONS TOPICAL PATCHES


TOPICAL PATCH 13-15 ARE NOT USED:
The use of topicalpatches is not appropriate when:
(1)Treatmentof acute pain is necessary.

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 295
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

(2) When rapid dose titration is required.  A wide field of application compared to other
(3) When the required dose is equal to or less than routes.
30 mg/24 hours16,17.  Dispensing drugs to a specific location

ADVANTAGES18,19 DISADVANTAGES18,19
 Avoid first-pass metabolism.  Possibility of local skin irritation at the site of
 It is easy to use and easy to apply. application.
 Easy withdrawal of medicine.  Drug-induced contact dermatitis may occur.
 Drugs are selectively distributed to a specific  Some drugs with low permeability are difficult
location. to penetrate through the skin.
 Gastrointestinal incompatibility should be  Drugs with larger particles are difficult to
avoided. penetrate.
 Provide the use of drugs with short biological  Possibility of an allergic reaction.
half-lives and narrow therapeutic windows.  Drugs with very low plasma concentrations
 Improve patient compliance.Self-medication. may be used to action
 It gives effect at low dose and by continuous
drug delivery. FACTORS EFFECTING TOPICAL
 Avoid drug concentration fluctuations and PERMEABILITY:20,21
risks.

COMPONENTS OF TOPICAL DRUG  The molecular weight and chemical function of


DELIVERY SYSTEM:22-27 the polymer should be such that the specific
 Polymer matrix/ Drug reservoir drug diffuses properly and is released through
 Drug it.
 Permeation enhancers.  Polymers must be durable.
 Pressure sensitive adhesive (PSA).  Polymer must be non-toxic.
 Backing laminate.  Polymers must be easy to manufacture.
 Release liner.  Polymers must be cheap.
 Other excipients like plasticizers and solvents  The polymer and its degradation products must
[5]
. be non-toxic or non-antagonistic to the host.
 A large amount of active ingredients are
 Polymer Matrix/ Drug Reservoir incorporated in it.
Macromolecular control is the release of drugs
from the device. The following criteria must e
met for a polymer to e used in topical patches.

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 296
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

Types of polymer: -
Natural polymers: Synthetic Elastomers: Synthetic polymers:
Cellulose derivative, Waxes, Hydrin rubber, Polyvinyl alcohol, polyvinyl
Gelatin, Proteins, Gum, Shellac, silicone chloride, polyethylene,
starch, Natural rubber. rubber, Nitrile, polypropylene, polyamiode,
Acrylonitrile, polyurea, epoxy.
Neoprene.

 Drug  Pressure sensitive adhesive (PSA)


The drug solution in direct contact with the PSA maintains close contact between the
memrane releases patch and the skin surface. It must adhere to
Physiochemical properties: maximum finger pressure, has a strong and long-
 The drug must have a molecular weight of less lasting effect of tacho, and has a strong holding
than 1000 Daltons. force. These include polyacrylate, polyisobutylene
 The drug must have affinity for both the and silicone adhesives. The choice of an adhesive
lipophilic and hydrophilic phases. is based on many factors, including the design of
 The drug must have a low melting point. the patch and the formulation of the drug. PSA
Biological properties must be physicochemically and biologically
 The drug should have a strong effect at a daily compatible and must not interfere with drug
dose of several mg/day. release. The PSA can be located on the face of the
 The half-life (t1/2) of the drug should be device (as in a reservoir system) or on the rear of
short.The drug should not cause skin irritation the device and extend to the periphery (as in the
or allergic reactions. case of the matrix system).
 Drugs that are degraded in the gastrointestinal  Backing laminate.
tract, or inactivated by first-pass effects by the The main function of the support plate is
liver, are suitable candidates for topical to provide support. The buffer layer must be
administration. chemically resistant and compatible with the
excipients, as prolonged contact between the buffer
 Tolerance is not developed below the level of
layer and the excipients can cause leaching of the
release close to topical administration.
additives or may lead to diffusion of the excipients
 Drugs that must be used for a long time or
and drugs. or diaper enhancer. They must have a
cause unwanted effects in non-target tissues
low steam transmission rate. They must have
may also be formulated for topical
optimum elasticity, flexibility and tensile strength.
administration.
Examples of some supporting materials are
aluminum vapor coating, plastic film
 Permeation enhancer:-
(polyethylene, polyester) and thermal backing.
A penetration enhancer or promoter is an
 Release liner
agent that has no inherent therapeutic properties but
During storage, the release liner prevents
is able to transport drug absorption from the drug
loss of drug that has migrated into the binder and
delivery system to the skin.11 The topical drug
contamination. It is therefore considered part of the
flow can be written as:J = D Xdc / dxwhere D is
primary packaging material rather than part of the
the diffusion coefficient and is a function of the
dosage form for medicinal use. The release liner is
size, shape and flexibility of the diffusing molecule
composed of a backing that can be non-stick (tissue
as well as of the membrane resistance; C is the
paper) or non-stick (polyethylene and polyvinyl
concentration of the diffuse species; x is the spatial
chloride) and a non-stick coating consisting of
coordinate.Although the solution for J for different
silicon or teflon. Other materials used for TDDS
boundary conditions and film heterogeneity can be
release liners include a polyester foil and a metal
very complex, the basic concepts of flux
lamination.
improvement can be found in the above equation.
METHODS OF PREPARATION OF TDDS 28,29
The concentration gradient is thermodynamically
 Asymmetric TPX membrane method.
derived, and the diffusion coefficient is related to
 Circular Teflon mould method.
the size and shape of the entry and the energy
 Mercury substrate method.
required to create a hole for diffusion.
 By using “IPM membranes” method.
 By using “EVAC membranes” method.

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 297
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

 Preparation of TDDS by using Proliposomes. covered with an inverted funnel to control


 By using free film method. solvent evaporation.

 Asymmetric TPX Membrane Method:This  By Using “IPM Membranes” Method:In a


method was discovered by Berner and John in mixture of water and polymers (propylene
1994 . By this method, a prototype patch can glycol polymers containing Carbomer 940),
be prepared using a heat-sealable polyester the drug was dispersed and stirred for 12 h in a
film (1009.3 m type) with a diameter of 1 cm magnetic stirrer. The dispersion shall be
concave as support membrane. The drug was neutralized and made viscous by the addition
dispersed on a concave film, covered by an of triethanolamine. If the solubility of the drug
asymmetrical TPX [poly (4-methyl-1- in aqueous solution is very low, a solution gel
pentene)] film, and sealed with an adhesive. is obtained using pH 7.4 buffer. The resulting
gel will be incorporated into the IPM
Preparation:They are prepared using either membrane.
a dry or wet reverse process. In this TPX is
dissolved in a mixture of solvents (cyclohexane)  By Using “EVAC Membranes” Method:To
and solvent-free additives at 60 °C to form a prepare TDS, a membrane consisting of a gel
polymer solution. The polymer solution was containing 1% carbopol, polyethylene (PE)
maintained at 40 °C for 24 h and poured onto a and ethylene vinyl acetate copolymer (EVAC)
glass dish. The molded film was then evaporated at is required as the flow control membrane. If
50 °C for 30 s, after which the glass plate should be the drug is insoluble in water, use propylene
immediately immersed in a coagulation bath glycol to prepare the gel. The drug was
(temperature kept at 25 °C). After soaking for 10 dissolved in propylene glycol, carbopol resin
min, the film can be removed, air-dried in a was added to the above solution and
recirculating oven at 50 °C for 12 h. neutralized with 5% w/w sodium hydroxide
solution. The drug (in gel form) is placed on a
 Circular Teflon Mould Method:It was sheet of carrier layer that covers the indicated
discovered by Baker and Heller in 1989. A area. A flow control film will be placed on the
polymer solution in various proportions is used gel and the edges will be heat sealed to achieve
as an organic solvent. Then this solution is a watertight device.
divided into two parts. In one part, the
calculated amount of drug is dissolved, and in  Preparation of TDDS by Using
the other part, activators of different Proliposomes:By an assisted method using
concentrations are dissolved, after which the film deposition technique,proliposomeswere
two parts are mixed. Then a plasticizer (eg, prepared. The drug/lecithin ratio should be
diNbutyl phthalate) is added to the drug 0.1:2.0 to be considered as the optimized ratio
polymer solution. The total solution should be compared to previous references. To prepare
stirred for 12 hours and then poured into a proliosomes in a 100 ml round-bottom flask,
round Teflon mold. The mold should be placed take 5 mg of mannitol powder, then maintain
on a level surface and covered with an inverted at 60-70°C and rotate the flask at 80-90 rpm
funnel to control solvent evaporation in a and mannitol is dried under vacuum for 30
laminar flow fume hood model with an air min. . After drying, the temperature of the
velocity of 0.5 m/s.The solvent was allowed to water bath was adjusted to 20-30 °C. The drug
evaporate for 24 h. A dry film was then formed and lecithin were dissolved in a suitable
that was kept for an additional 2 h at 25 ± 0.5 mixture of organic solvents, an amount of 0.5
°C in a desiccator containing silica gel prior to ml of the organic solution was added. round
evaluation to eliminate the effects of aging. bottom flask at 37 °C, after complete drying, a
second portion (0.5 ml) of solution should be
 Mercury Substrate Method: In this method, added. After the final loading, the vial
the drug and plasticizer are dissolved in a containing the proliposome was joined in a
polymer solution. It is stirred for 10 to 15 min freeze dryer and then the loaded mannitol
to produce a homogeneous dispersion, after powder (proliposome) was placed in a
which it is poured onto a flat mercury surface, desiccator overnight and then sieved through a
100 mesh. The resulting powder was

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 298
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

transferred to the vial. glassware and stored at standard deviation values should be calculated
cryogenic temperature until properties can be from the individual weights.
determined.
 Thickness of patch
 By using Free Film Method:In this process, a The thickness of the loaded patch was
cellulose acetate-free film is first prepared by measured for different points by use of digital
casting it onto a mercury surface. And 2% w/w micrometer and the mean thickness and standard
polymer solution was prepared using deviation of the patch were determined to ensure
chloroform. Plasticizers should be added at a the thickness of the prepared patch.
concentration of 40% by weight/weight of
polymer. Then, 5 ml of the polymer solution
was poured into a glass ring placed over the  Flatness Test:
mercury surface in a glass petri dish. The Three longitudinal strips should be cut
solvent evaporation rate can be controlled by from each film into different sections such as one
placing an inverted funnel over the Petri dish. from the center, another from the left side and
Film formation was observed by observing the another from the right side. The length of each
surface of the mercury after the solvent had strips was measured and the change in length due
completely evaporated. The dry film will be to non uniform flatness was measured by
separated and stored between wax paper sheets determining the percent constriction, with 0%
in a desiccator until use. By this process, we constriction equivalent to 100% flatness.
can prepare freestanding films of different
thicknesses, which can be prepared by varying  A Percentage Moisture Uptake:
the volume of the polymer solution. A Weighed films should be stored in a
desiccator at room temperature for 24 h containing
EVALUATION PARAMETER OF TOPICAL saturated solution of potassium chloride to
PATCH:30-47 maintain 84% RH. After 24 h, the films should be
 A Drug Excipients Interaction Studies of reweighed and the percentage of moisture uptake
patch determined according to the formula below.
Drugs and excipients must be compatible Percentage moisture uptake = [initial weight-final
to make a stable product and it is imperative to weight/ final weight] × 100.
detect any possible physical and chemical
interactions. Interaction studies are usually  A Moisture Loss:
performed using thermal analysis, FTIR studies, Prepared films should be weighed individually and
UV techniques and chromatography comparing stored in a desiccator containing calcium chloride
their physicochemical characteristics such as at 40 °C. After 24 h, the films should be reweighed
assays, fusion fusion, characteristic wave numbers and the percentage moisture loss determined
and absorption maxima, etc. according to the formula below.
% Moisture Loss = [Initial wt – Final wt/ Final wt]
× 100
 Drug Content of patch
A specific area of the patch must be  Water Vapor Transmission Rate (WVTR)
dissolved in the appropriate solvent for a specific Studies of patch
volume. The solution should then be filtered Glass vials of equal diameter are used as a
through a filter media and analyzed for drug transmission cells. These transmission cells were
content by an appropriate method (UV or HPLC thoroughly washed and dried in an oven at 100 °C
technique). Each value represents the mean of three for a period of time. Approximately 1 g of
samples. anhydrous calcium chloride was placed into the
cells and the corresponding polymeric films were
 Weight Uniformity of patch attached to the edge. Cells were accurately weighed
Prepared patches should be dried at 60°C and stored in a sealed desiccator containing a
for 4 hrs prior before testing. A specific area of the saturated solution of potassium chloride to
patch should be cut into different parts of the patch maintain a relative humidity of 84 %. Cells were
and weighed in a digital balance. The mean and removed and weighed after storage. The amount of

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 299
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

water vapor passed by found using following  Skin Irritation Study of patch
formula. Skin sensitization and irritation tests can
Water Vapor Transmission Rate = Final Weight – be performed on healthy rabbits (mean weight 1.2-
Initial WeightTime X Area 1.5 kg). The dorsal surface (50 cm2) of the rabbit
It is expressed in grams of moisture should be cleaned and hair removed from the clean
gained/hrs/cm.sq. dorsal surface by scraping and cleaning the surface
using disinfected alcohol and representative
 Swellability of patch formulations may be used for application. onto the
The 3.1 cm2 patch were weighed and placed in10 skin. The patch should be removed after 24 hours
ml of double distilled water petri dish and allowed and the skin should be observed and graded into 5
to imbibe. Patch weight increase were determined grades based on the severity of the skin damage.
at preset time intervals, until observed constant
weight.  In-vitro drug release studies of patch
Degree of swelling (S) = Wt– Wo/Wo× 100 The paddle-over-disk method (USP V
Where S is the percentage of swelling, device) can be used to assess drug release from
Wt is the weight of the patch at time t, and Wo is prepared patches. The dry film of known thickness
the weight of the patch at time 0. shall be cut into a defined shape, weighed and fixed
to the glass plate with an adhesive. Then place the
 Folding Endurance of patch: glass dish in 500 ml of dissolution medium or
A specific area strip should be cut evenly and phosphate buffer (pH 7.4) and the apparatus
repeatedly folded in the same place until it breaks. equilibrated at 32 ± 0,5 °C. The stirrer isset from
The number of times the film can be folded in the the glass plate 2.5 cm and operates at 50 rpm.
same position without breaking gives value to its Samples (aliquots 5 ml) can be sampled over an
folding endurance. appropriate period of up to 24 h and analyzed by
UV spectrophotometer or high performance liquid
 Polariscope Examination of patch chromatography (HPLC). The test shall be carried
This test should be done to check for drug crystals out in triplicate and an average value may be
in the patch with a polariscope. A specific surface calculated.
area of the patch should be kept on a slide and
observed for drug crystals to distinguish whether  Stability Studies of patch
the drug is crystalline or amorphous in the patch. Stability studies should be performed
according to ICH guidelines by storing TDDS
 Tensile Strength: samples at 40 ± 0.5 °C and 75 ± 5% RH for 6
The tensile strength of the film was months. Samples were taken at 0, 30, 60, 90 and
determined using a universal strength tester. The 180 days and analyzed for suitable drug content.
sensitivity of the device is 1 g. It includes two force
sensing handles. The bottom is fixed and the top is REFERENCES
movable. Film of the test size (4 × 1 cm2) was fixed [1]. R Asija, R Sharma, A Gupta.Emulgel: A
between these cell clamps and a gradually force novel approach to topical drug delivery.
was applied until the film broke. The tensile Journal of Biomedical and Pharmaceutical
strength of the patch is taken directly from the dial Research, 2: 91-94, 2013.
readings in kg. The tensile strength is expressed by [2]. C T Ueda, V P Shah, K Derdzinski, G
following. Ewing, G Flynn, H Maibach, A Yacobi.
Tensile strength of patch =Tensile load at break / United States Pharmacopeial Convention,
Cross section area 750-64, 2010.
[3]. J Kaur, J Kaur, S Jaiswal, G Gupta. Recent
 Probe Tack test of patch advances in topical drug delivery system.
In this test, the tip of a clean probe with a Pharmaceutical Research, 6: 6353-69, 2016.
defined surface roughness is exposed to the [4]. D Bhowmik, H Gopinath, B P Kumar, S
adhesive and when a bond is formed between the Duraivel, K P S Kumar. Recent Advances
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mechanically break it. The force required to The Pharma Innovation Journal, 1: 12-31,
remove the probe from the adhesive at a fixed rate 2012.
is recorded as adhesive and expressed in grams.

DOI: 10.35629/7781-0701292302 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 300
International Journal of Pharmaceutical Research and Applications
Volume 7, Issue 1 Jan-Feb 2022, pp: 292-302 www.ijprajournal.com ISSN: 2249-7781

[5]. S Babiuk, M Baca-Estrada, L A Babiuk, C [17]. Shah S, Topical Drug Delivery Technology
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