MICRONEEDLES OVERVIEW: TRANSDERMAL DELIVERY

AND APPLICATIONS
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Langhneja Dixit, Dr Jaydeep Patel

Email : langhnejadixit@gmail.com, jaydeepbkmgpc@gmail.com

ABSTRACT

Transdermal route explore for drug delivery because of advantage to bypass first pass effect and sustained
release and reduced toxicity. transdermal delivery is challenging due to to strong barrier of skin mainly
stratum corneum. First generation and second generation TDDS include transdermal patches, chemical
enhancers, iontoporesis, etc recently micron scale needles use for increasing skin permeability for
macromolecule, called miceoneedles. These are third generation TDDS . microneedle transdermal delivery
having advantages over other transdermal drug delivery due to it delivers a drug to the dermal tissue directly
overcoming problems associated to transfer through the epidermis.also it is painless due to no contact with
nerve fibres, more convenient, safe, and deliver efficiently drugs, macromolecule, vaccines, protein,
peptides, DNA, RNA directly to the target tissue,but it may also lead to risk of mechanical failures, which
should be prevented in the clinical application of microneedles. There is also a limited choice of appropriate
biomaterials, lack of mechanical strength, poor control of drug delivery, and limitation of drug loading dose.
Morphologically those are solid, coated, dissolving, or hollow type’s microneedles having different
applications in a different area of the field. Several important milestones have been achieved through the use
of micro-electro-mechanical systems (MEMS) technologies and those developed specifically to optimize
MN for transdermal drug delivery. In this article material, types, fabrication process, advantages
/applications of microneedle were focused to give fundamental knowledge of microneedle to promote its
clinical use. biomedical applications of microneedles such as disease treatment, immunobiological
administration, disease diagnosis and cosmetic field, are highlighted in detail.

(keywords: transdermal, microneedles, fabrication, coated, solid, hollow, photolithography, etching,

RIE reactive ion etching)

LIST OF CONTENT
1. Introduction
2. Types of microneedles
2.1. Solid microneedles
2.2. Coated microneedles
2.3. Dissolving microneedles
2.4. Hollow microneedles
3. The material used for microneedles
3.1. Metal material
3.2. Inorganic material
3.3. Polymer material
4. The fabrication process for microneedles
4.1. Microneedles molds fabrication
4.2. Microneedles masters fabrication
4.3. Laser cutting
4.4. Photolithography
4.5. Etching
5. Fabrication microneedles from various materials
6. Advantages
7. Application

1) INTRODUCTION

Injection of the painful hypodermic needle is most common when oral administration of a drug is difficult
due to poor drug absorption or for enzymatic degradation in the gastrointestinal tract or liver.
Therefore an approach that is more patient compliance and offers good control release over the time period
in drug delivery through the skin using a patch.
Skin is the largest organ and also the first barrier of the body mainly consists of epidermis, dermis, and
hypodermis.
  The epidermis is the outer layer of skin having 0.2 mm thickness protect from harmful chemicals invasion
1.
and water loss from the skin.

The middle layer is called the dermis which is made of mostly elastin and collagen hair follicles, nerve
2.
endings, sweat glands, etc.

The hypodermis is adipose tissue of the deeper skin which is composed of reticular structure of connective
3.
tissue and connects the dermis to the muscles or bones.

Hypodermic needles for the vaccine delivery give a weaker immunological response than skin.
Also transdermal drug delivery avoids haptic first-pass metabolism therefore it is a safe administered non-
4.
invasive and painless process of drug delivery.

in 1976 new technology name microneedles were first introduced to overcome limits of conventional
transdermal delivery, and a great variety of microneedles have been successfully fabricated then after
5.
having a length ranging from 25 micrometers to 2000 micrometers.

Microneedle has Sharper tips then hypodermic needle that is easily cross Satnam corneum for micron-scale
drug delivery channels without touching nerve fiber and blood vessels so that drug delivery to the dermal
site is enhanced.
Microneedles can be used for delivering a low permeable drug, oligonucleotides, DNA vaccines, insulin,
and hormones through the skin. Also widely studied for blood sampling, signal monitoring, gene
transferring, and biosensor.

it is more like combining the technique of a transdermal patch and a hypodermic syringe.
They are easy to administer for the non-skilled person so self-administration possible also so increase
6.
compliance for disposal of waste due to it is not hazardous.

Microneedles of various types and different materials play different roles in drug delivery patterns and also
in the research field.

2) TYPES OF MICRONEEDLES

Due to its various design and composition microneedles can be categorized in mainly four types for
convenient, non-invasive, safety concern, painless, and effective transdermal drug delivery. By design these
are in plane/out plane microneedles which are parallel or adjective to substrate surface.

Microneedle makes pores on the skin to enable the drug to penetrate through the epidermis to the dermal
tissue directly. Also, it is convenient for patients than a regular hypodermic needle because it does not hurt
7.
nerves.

Based on morphology the four types are

1. solid microneedles,
2. coated microneedles,
3. dissolving microneedles,
4. hollow microneedles

These microneedles have different drug delivery mechanisms like poke and patch, coat and poke, poke and
8.
release, poke and flow approach.

2.1 Solid microneedles 

9.
1971 this kind of microneedles was first to introduce for skin pretreatment.

Solid microneedles first penetrate into the skin that makes micron size channels then after the drug is
delivered through it so its poke and patch approach for delivery through the skin. Also, the scarp and patch
8.
approach can be used in solid microneedle which is a variation approach made from poke and patch type.

Having advantage of safe drug delivery, toxic and infectious substance blocked because the micron size
channel closed after microneedles are removed,
There is required iontophoresis for increase delivery of charged drug having disadvantage that may it causes
10.
skin irritation.
 11.
Solid microneedles can be fabricated from stainless steel, metal, silicon, and some polymers.
We will study the fabrication process of microneedle later on.

 2.2 coated microneedles

Where the solid microneedles have a drawback due to is complex administration process because it needs
two steps for delivering the drug to the skin,
in coated microneedles have solved that problem in this the tips of microneedles are coated with drug and
8.
work via coat and poke approach having a single step for drug delivery through the skin.

For coating dipping, gas jet drying, inkjet printing or spraying methods, layer by layer coating techniques,
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etc used. Out of these dry coating gives a better result than liquid formulations.

Also, DNA coated microneedles had the ability to persist in the skin two weeks after application.
These microneedles having great potential for delivering vaccines as it does not only increase memory T
13.
cell generation and gene expression but also induce an immune response.

This approach had the drawback that only used when the dose of the drug is low if there is a high dose then
the thickness of array will be increased and there is a decrease in drug delivery efficiency. Also, a high
amount of drug loss while coating.

 2.3 dissolving microneedles

14.
The type of microneedles was first introduced by Miyano et al in 2005.
These microneedles having pork and release approach of drug delivery through the skin as a drug was
8.
dissolved uniformly in microneedle made from biodegradable material.

A polymer such as polyvinyl alcohol most commonly used as it is dissolved fully in 4 minutes after
15.
penetrates into the skin, free and fixed drying both processes can use separately for drying after freezing.

16.
It not only induced a stronger immune response but also increase the stability of vaccines.

Microneedles had advantages like higher drug loading than other types of microneedles also convenient and
17.
easy to make.
Also dissolving microneedles fabricated by common methods such as micro-molding, photopolymerization,
and lithography, etc.

That is also beneficial in terms of waste management due to it is completely biodegradable the hazardous
18.
waste can be reduced that overcomes problem associated with other microneedles.

This should have enough mechanical strength for skin penetration, control drug release or sustain drug
release properties, a fabrication process that avoids damaging sensitive molecules, and safe and nontoxic
material. Fabricated mostly by micro-molding (solvent casting method). A heat-sensitive substance can
19.
encapsulate in microneedles and solidify in favorable conditions.

 2.4 Hollow microneedles

In this type of microneedle, there is a hollow channel in an array of the microneedle. It delivers the amount
of fluid at different flow rates due to different pressure control mechanisms like a syringe, pump,
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pressurized gas, etc in a controlled manner.

The most pressing dose given by hollow microneedles then others described previously due to its "poke and
flow" approach for delivery.
8.
So it is advantageous for patients to customize controlled doses that can be given.

There is one disadvantage of poke and flow approach is infusion rate normally very low it can be overcome
by adding hyaluronidase to the solution which is infusions, that break hyaluronic acid into the collagen fiber
21.
of the skin and increase the flow rate.

Metal or silicon most common materials for making hollow microneedles through microelectronic system
22.
(MSME) techniques.
Various MSME techniques like lithographic, micromachines, molding method, x-ray photolithography, etc.
23., 24. 25.
These are also able for blood extraction, and blood analysis.

Figure 1 types of microneedles

3) Materials Used For Microneedles

Depend on various applicability of microneedle material used to fabricate microneedles divided into three
7.
categories metal material, inorganic material, and polymer material.

 3.1 Metal material

most widely used in the preparation of microneed les for transdermal delivery with the advantage of
26.
mechanical strength and toughness. ex.: stainless steel, titanium, palladium, nickel.
It is used for making solid, coated, and hollow microneedles but the efficiency of delivering drugs depends
27., 7.
on the shape, size, and pore of array.
Metal material use may be unsafe due to the breakage of array inside the skin so various other materials are
required to develop.

 3.2 Inorganic material

Mostly used in inorganic material for microneedles are silicon, ceramics, and glass.
Solid, coated, and hollow type microneedles can make from inorganic material. They should be
28.
biocompatible and enough strength that is not broken inside the skin while application.

 3.3 Polymer material

The most promising and efficient result comes from polymer microneedles then metal and inorganic
materials. The polymer material is used to make all types of microneedles. Almost all dissolving
29.
microneedles are made from a polymer material.
30. 31.
A polymer such as carboxymethyl cellulose (CMC) , polyvinyl alcohol (PVA), chitosan , sodium
32.
alginate, PVP, hyaluronic acid, polyglycolic acid (PGA), etc can be used to prepare microneedles . From
7.
this CMC, PVP sodium alginate is used for fabricating dissolving microneedles.

4) The Fabrication Process For Microneedles

Early-stage for fabricating microneedles deep reactive ion etching (RIE) and lithography were used in
silicon wafers.
after that different microfabrication procedures are used for making microneedle from polymer, metal, glass,
silicone micrometer scale that provide unique design facilities of different shapes and sizes to fulfill
33.
effective application criteria.

The progression of microelectronics industries being advantageous to prepare highly accurate, reproducible,
and easily scalable for the industry at a minimum cost of price.

Lithography depended approach used for making large size arrays of microneedles that easily penetrates
34.
into the skin and other tissue.

These fabrication methods are mostly completed in just one or two steps also some techniques fabricate only
33.
in a single molding step that makes it inexpensive at larger-scale production.

The most usual technique to fabricate microneedles is lithography, wet and dry etching, laser cutting, and
35.
molding.

4.1 Microneedle Molds Fabrication

Materials like silicone, metal, and polymer were used to make micro-molds from previously defined metal
33.
and polymer needles.
1) Silicone micro molds: made by using inductively coupled plasma RIE, for producing Hollow channel for
silicon microneedle by directly etching the entire silicon wafer.
36.
This mold was used for producing straight-walled solid and hollow microneedles.

2) metal micro molds: these solid silicone microneedle Masters were electroplated by NiFe plating bath for
coating and another side of array was protected by being electroplated after the TiCu layer deposited.
after completing that process silicon master removed by reactive ion etching gives micro mold of NiFe to
37.
fabricate solid polymer microneedles

3) Polymer micro mold: number of methods used to fabricate polymer micro mold.
One of that method in which polydimethylsiloxane (PDMS) micro mold derived from a polymer or silicon
Masters.
First of all silicone oil was coated on Masters and then Deeping into PDMS layer having sufficient
thickness.
Remove entrusted air bubble by vacuum and place at 90°C for an hour, then cooled it and carefully peeling
off the mold.
38.
Molds these models can use for preparing both metal and polymer solid microneedles. Molds can also be
39.
prepared by UV lithography.

 4.2 Microneedles Masters Fabrication

Masters made by subsequent fabricated micro molds from previously made microneedles structure were
etched from silicon or polymer materials.
33.
Preparing symmetrically defined needles solid silicone microneedles used as master.
For preparing asymmetrical microneedle master su-8 epoxy where lithographically define on the silicon
35.
wafer. Al or Cu deposited by an electron beam to coat the surface and lithographically patterned.

4.3 Laser Cutting

Mostly metallic microneedles are made through this method in which metallic sheets cut and give micron
size geometry needles by an infrared laser. Computer software such as AutoCAD was used to predesign the
35.,40.
shape of needles. Finally, electropolishing gives results for sharpens of tips.

4.4 Photolithography

It is the technique to produce microneedle from silicon or polymer both solid and hollow type of
microneedles.
Silicon wafer was used as a substrate and polymer coated on the substrate called photoresist.
That photoresist were masked and exposed to UV radiation that manipulates the cross-link of polymer bond.
35.,41.
There is a final step known as etching, which can be wet or dry etching.

4.5 Etching
There are various methods for dry etching such as RIE (reactive ion etching) which is a chemical process
and ion beam etching for the physical etching process. The film deposited on the surface of the substrate
etched to form a complete structure of microneedles.
Wet etching having two-step processes dynamic And static, in dynamics step isotropic etching throughout
substrate and in static step structure the top of microneedles by aggressive etching at top of column
42.
compared to the lower portion.

Etching with KOH

5) Fabricating Microneedles From Various Material

 5.1 Silicon microneedle:

These are etched from the silicon wafer. About 2-inch silicon wafer taken first then chromium deposited on
it after that it is lithographically patterned.

Through reactive ion etching, chromium cover become completely undercut for desirable shape and form
42.
microneedles tips. KOH use as a Solution for etching with the protection layer of nitride and oxide.

For making hollow microneedles polymers were coated by spin method, then lithography pattern on the 2-
inch silicon wafer. After that inductive coupled plasma reactive ion etching was done using a modified
43.
process for getting holes in microneedle array and a straight-walled array of microneedles.

 5.2 Metal microneedles:

These microneedles were formed by the electrodeposition process.

For this silicon or polymer micro molds were used and a soft explosion of the Ti and Cu layer for coating,
44.
also nickel can use for electroplating by PDMS mold.

For hollow microneedles, the outer surface at the tip of the mold was protected by being electroplated by
coating powder tape. After that Ni or NiFe or other metals of required density layered for a wall of the
hollow microneedle.

For making solid microneedles the entire mold was field by plating.
If there were PDMS molds required for gently removing resulting microneedles.
In case of polyimide and polyethylene where used for mold, cleared by Deeping in an alkaline solution such
as NaOH.
Silicon molds were used KOH bath taken for removal.

 5.3 Polymer microneedles: 

Silicon wafer was first cleaned by H2SO4 and heating up to 150 °C to remove the impure substance. And
deposit oxide Coat to make it photoresist.
photolithographic makes a v-shaped groove on the wafer that is covered with su-8 uniformly make the
surface smoothed and bubble-free by applying heating and vacuum. Remove su-8 from wafer to obtain
42.
microneedle.
Also, it is made through PDMS micro-mould by melting polymers such as polyglycolic acid, polylactic
45.
acid, polylactic-co-glycolic acid, and place in vacuum and cooling and removing mold.

 5.4 Glass microneedle:

The most common technique for making glass microneedles is the drawn glass micropipette technique. In
this capillary of glass dragged into micropipette puller and then sloped it.

Pulling pipettes is a technique widely used for making Hollow glass microneedle.
Borosilicate glass pipettes are very heated and pulled through a micropipette puller.
By making this process with programmed parameters constant, uniform, and reproducible microneedles can
46.
be obtained.
Droplet born air blowing newest method for making microneedles, mostly polymer microneedles produce
through this technique. First that techniques introduced by Kim et al. it is a very convenient method of
preparing microneedles, also overcome the problem of inactivation of a drug into UV or heat in other
processes of fabrication. An only single drop of polymer used which has the advantage of controlled dose
47.
microneedles can make by drop size and concentration.

6) Advantages

Now a day’s transdermal delivery system becomes the third most useful drug delivery pathway after the oral
and injection delivery system.

1. microneedle drug delivery system enhances the drug delivery efficiency through the transdermal route
also so having various advantages over conventional delivery systems in terms of safety, painlessness,
48.
patient compliance.

49.
2. Increase the penetration of large size molecules.

48.
3. Without pain administration of active ingredient.

4. Bypass first-pass metabolism.

5. Microneedles take very little time for healing at the injection area then hypodermic needle then
50.
hypodermic.

6. Easily can administer.

50.
7. No needle phobia over here, increase patient compliance.

51.
8. Main required low-dose due to higher efficacious than other transdermal drug delivery.
9. Very low microbial infections can happen through it then hypodermic needle because it penetrates only
50.
the epidermis layer of skin.

52.
10. Specific tissue, cell, and area of skin can target.

11. Drug delivery through the control rate can be administered.

12. Silicon substrate use for microneedles preparation so very accurate, reproducible in thousand of
51.
microneedles in small size and at low cost can make.
7) APPLICATION

 • In Cancer therapies

There is a tremendous effort come out of transdermal delivery in superficial cancer treatment due to its
53.
target specificity and having minimum side effect as compared to another route of administration.
Different types of microneedles structure were used to treat epidermoid cancer and breast cancer that not
54.
only having high insertion capability but also having heat transfer abilities that remove tumors.
Skin is a first protective barrier also serving immune response, it has proven that immunotherapy is useful in
55.
skin cancer and microneedles are a promising candidate to this.

Microneedle system gives new ways for delivering a gene to the targeted skin cells, for example for plasmid
DNA and siRNA delivery for cancer treatment.
however, the microneedle system having an advantage for delivering drug, vaccines, DNA,siRNA to treat
56.
superficial cancer over the conventional delivery system.

 • Diagnosis

Interstitial fluid from the skin very useful biomarker for diagnosis of a disease condition such as blood
57.
glucose level continuously can measure.
Microneedles are used to extract interstitial fluid from the skin time to time analysis of metabolic by
painless and easy ways than after centrifugation takes place for removal of fluid from microneedles.
58.
Mohan et al. make microneedle arrays that measure alcohol continuously without high invasion.

 • Treatment of diabetes

In a diabetic patient of both type 1 and type 2 required frequent injection of insulin of both long-acting and
short-acting. The dose given by subcutaneous injection does not mimic the physiological release of insulin
57.
so that may it causes hypoglycemia or hyperglycemic condition.
in this area, microneedle having a vast advantage over the hypodermic needle due to its glucose sensitive
insulin release for this purpose glucose oxidase enzyme or glucose responsive vesicles were introduced.
59.
Also, some dissolving microneedles maintain the stability of insulin at normal temperature for one month.
Also, some support the structure of PVP or PVA uses to provide length to insert deeper tissue of the skin.

 • Anti-inflammatory and analgesic

Pain defines as acute which are almost lasts for weeks and chronic lasts more than a month.
Transdermal administration having a lower risk of systemic side effects so there are many microneedle
patches were fabricated to deliver lidocaine for both acute and chronic pain conditions. Some advantages
60.
such as triggered release of lidocaine by light-sensitive etching can be applied.

 • Immunobiologics

Immunobiology to cure infectious disease conventionally given through intramuscular, subcutaneous,

intradermal route. Vaccine delivered conventionally having the drawback of pain due to needles
penetrations, or phobia.
Microneedles having the advantage of delivering vaccines through transdermal route by safe and painless
50.
method.
liquid vaccines required to store in cold conditions also during transport and having a very short shelf life,
coated microneedles study by Hirschberg et al. reported that stability of vaccines at higher temperatures and
antigenicity maintenance coated microneedles gives good results. Controlled and completely delivered
61.
antibody result also obtained through dissolving microneedle by Li et al.

 • Biopharmaceuticals 

Growth hormones, proteins, peptide, oligonucleotide, such as DNA, RNA, insulin are mostly not
administered orally because they are very less stable in GIT and get degraded also absorption difficulties
occur. Therefore delivering biopharmaceuticals parenteral route was mostly used so there is much
applicability of microneedles for minimum invasion and better control over the release and safest delivery
can obtain.
Lee et al. developed dissolving microneedles matrix using CMC polymer by encapsulation in that project
they conclude microneedles where dissolved in a minute and deliver biotherapeutics due to
62.,63.
microencapsulation having good bioavailability and stability.

 • Drugs

active pharmaceutical ingredient very few were cross the epidermis layers of skin also physicochemical
properties like HLB value, solubility, molecular weight, size, shape affects the rate of transport to skin. This
all problems are overcome by the use of microneedles. Highly hydrophobic drugs showing higher area
under the curve and Cmax then compared to gel, cream and other formulation that needs penetrations
64.
enhancers which may cause irritation.

 • Fluid extraction

Microneedles are mostly used for drug delivery but there are various study reports suggested it is also used
for the diagnostic purpose by extracting blood and interstitial fluid for ex Vivo analysis. The sugar level of
interstitial fluid can measure by microneedle, taking a few microlitres from the skin having a great
correlation with blood glucose level. Also attached with biomarkers microneedle able to extract selective
57.
components for analysis.

8) Marketed preperation
Brand name Manufacturer Application
VaxMat TheraJect Inc., USA It is dissolvable microneedles and can deliver hundreds of
micrograms of drug rapidly through the stratum corneum into
the epidermal tissue.
MTS-Rollers Clinical Resolution Laboratory It is used for transdermal delivery of cosmetics in deeper skin
Inc., USA layers.

Macroflux Zosano Pharma Inc., USA Metallic microneedles for the delivery of peptides and vaccines.
Onvax Becton Dickinson, USA It is a skin micro abrader having plastic microneedles for
disruption of stratum corneum for the delivery of vaccines.
MicronJet NanoPass Inc., Israel It can be used with any standard syringe for painless delivery of
drugs, protein and vaccines approved for this delivery route.
Microstructured transdermal 3 M Corp., USA The technology can be used to administer drugs including
system technology (MTS) monoclonal antibodies in solid or liquid dosage form.

Soluvia® Becton Dickinson, USA It is a prefillable microinjection system for accurate

intradermal delivery of drugs and vaccines.
IDflu®/Intanza® Sanofi Pasteur, Lyon, France Prefilled with influenza vaccine for intradermal influenza
vaccination.

MicroHyala® CosMED It contains hyaluronic acid that is released in the skin to

Pharmaceutical Co. Ltd., treat wrinkle.
Japan
Darmaroller® Derma spark, Canada Used to treat acne, stretch mark, hair loss. Able to
enhance drug absorption (minoxidil, hyaluronic acid,
etc.).
Drugmat® TheraJect Inc., USA It delivers hundreds of micrograms of drug rapidly
through the stratum corneum into the epidermal tissue.

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Dixit
Langhneja

Contact

Address
Kadi,
Gujarat,
382715
Phone

769 896 2511

E-mail

langhnejadixit@gmail.com

Skills

Verbal and written communication

Very Good

Microsoft Office
Good
 MICRONEEDLES OVERVIEW 2020

Project Management
Good

Decision-making skill
Very Good

Problem-solving abilities
Good

Teamwork and flexibility

Very Good

Languages

Gujarati, Hindi, English

Very Good

[Job Title] with over [Number] years of successful experience in [Skill] and [Skill]. Recognized consistently for performance excellence and
contributions to success in [Industry] industry. Strengths in [Skill] and [Skill] backed by training in [Area of study].

Current Status

2019-06 -
Current
Pursuing M.pharm
B.K Mody Govt. pharmacy collage.,
Rajkot,
Gujarat

Majored in "PREPARATION AND EVALUATION OF NOVEL BILOSOMAL ITRACONAZOLE GEL FOR TOPICAL APPLICATION"
Minored in "MICRONEEDLES OVERVIEW: transdermal delivery and application"

Education

2019-05 -
Current
Master of Science:
Master of Pharmacy

B.K Mody Govt. Pharmacy Collage. -

Rajkot

18
 MICRONEEDLES OVERVIEW 2020

2014-03 -
2018-12
Bachelor of Science:
Bachelor of Pharmacy

B.K Mody Govt. Pharmacy Collage -

Rajkot

Graduated with 6.31 CPI.

2012-03 -
2014-03
HSC

S.V High School -

Kadi

High school study in biology completed with 55%.

2010-03 -
2012-04
SSC

Shri D.A. Patel Technical High School. -

KADI

SSC study in technical school completed with 84%.

Interests

Table tennis, Traveling, Current Affairs, Economy, Sci-fi

19