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STUDY OF NEEDLE FREE INJECTION
SEMINAR REPORT
In partial fulfillment of the requirements for the award of the degree of
BACHELOR OF TECHNOLOGY
IN
BIO-MEDICAL ENGINEERING
(West Bengal University of Technology)
Submitted by
NAME: KAUSHIK BANDOPADHYAY
ROLL NO: 08109031014
Under the guidance of
Mr. SUJAN KRISHNA SAMANTA
Asst. Professor, Department of Biomedical Engineering
NETAJI SUBHASH ENGINEERING COLLEGE
KOLKATA
DEPARTMENT OF BIOMEDICAL ENGINEERING
NETAJI SUBHASH ENGINEERING COLLEGE
TECHNO CITY, PANCHPOTA, GARIA, TECHNO CITY
KOLKATA: 700152, WEST BENGAL
2
CERTIFICATE
Certified that the seminar work entitled STUDY OF NEEDLE FREE INJECTION is a bonafide
work carried out by
KAUSHIK BANDOPADHYAY ROLL NO.08109031014
In partial fulfillment for the award for degree of BACHELOR OF TECHNOLOGY in BIO-
MEDICAL ENGINEERING of the WEST BENGAL UNIVERSITY OF TECHNOLOGY,
KOLKATA during the year 2011-2012. It is certified that all corrections/suggestions indicated
for Internal Assessment has been incorporated in the report deposited in the Department. The
seminar report has been approved as it satisfies the academic requirements in respect of seminar
Work prescribed for Bachelor of Technology Degree.
…………………………….. ………………………………………..
MR. SUJAN KRISHNA SAMANTA DR. SUKUMAR ROY
Seminar Coordinator HOD, BME, NSEC
Name of the Student: KAUSHIK BANDOPADHYAY
University Roll No.: 08109031014
Name of Examiners Signature with Date
1.
2.
3.
3
ACKNOWLEDGEMENT
I am greatly indebted to our seminar Guide Dr. Sukumar Roy, Department of Biomedical
Engineering, for providing us all possible help and support while doing this work. Without his
guidance the work would not get such a progress.
I am highly obliged to our co-guide Mr. Sujan Krishna Samanta, Assistant Professor, Department
of Biomedical Engineering for his timely help and guidance. We are also thankful to him for his
valuable lectures that he offered to us during project.
I am also thankful to Ms. Sumana Chatterjee, Lecturer Dept. of BME, for her active
cooperation.
I extend my thanks giving to all respected Faculty Members and our friends directly or indirectly
associated with my work, who contributed their personal level best which enabled me for a
successful completion of this seminar.
Signature:
4
CONTENTS
Chapter No. Chapter Page No.
I Introduction 6
II Relevance of this technology in today’s world 7
III Classifications of Needle Free Injections 8
IV Advantages of using Needle Free Injection Technology 14
V Raw materials used for manufacturing Needle free Injection 17
VI Manufacturing Process 17
VII Quality Control and Management 18
VIII Popular Brands present Internationally. 19
IX Limitations of this Technology 21
X Conclusion 22
XI References 23
5
LIST OF FIGURES
Chapter No. Fig No. Description Page No.
III 1.1 Nano-Patch 9
1.2 Application of Nano-Patch on skin surface 10
1.3 Operation Mechanism of Nano-Patch 11
1.4 Jet Pressured Needle Free Injection 12
1.5 Operation Mechanism of Jet Pressured 13
Needle free Injection
6
INTRODUCTION
As long as drugs have been known to cure diseases, people have searched for better methods of
delivering them. During the early nineteenth century researchers made a series of discoveries that
eventually led to the development of the hypodermic needle by Alexander Wood in 1853. This
device was used to give morphine to patients suffering from sleeping disorders. In subsequent
years, the hypodermic needle underwent significant changes which made them more efficient to
use, safer, and more reliable.
As technology advanced, procedures for delivering drugs metamorphosed. Today it has reached
a stage where conventional drug delivery using needles might become history. Thanks to the
invention of “Needle Free Injection Technology” which brings in a plethora of advantages,
enough to set conventional injections in the pages of history. Definitely a relief for millions as
this technology promises no pain, which is more than a psychological disease which sets many
at unease, even hyper reactive, irrespective of age, gender, geography. But it is not merely the
pain-less factor that for this technology has been conceived, deeper aspects such as effective and
efficient delivery of drugs, extensive inoculation during pandemics, cost effectiveness and many
more important objectives are behind which have led to formulation of this latest technology in
medical science. Such aspects will be extensively discussed as one surfs across the pages of this
project leading to enlightenment and relevance of this technology at this present moment and the
near future. Happy reading and discovery!
7
RELEVANCE OF THIS TECHNOLOGY IN TODAY’S WORLD.
People are given injections to protect them from influenza, tetanus, cholera, typhoid, and
other diseases. When a needle is inserted through the skin, the vaccine (or drug) it carries
provides systemic immunity. This is because the vaccine gets into the bloodstream and provokes
the body to create antibodies that are carried throughout the entire body.
In many countries, children may get over 13 vaccine injections by the age of 16.
Unfortunately, there are a variety of problems associated with the hypodermic needles used for
these injections. One of the most significant drawbacks is the relatively high cost of the needles.
The cost results in a lower vaccination rate, especially for children in developing countries.
Another problem with traditional needles is the lack of reusability. If a needle syringe is not
sterilized, reusing it can lead to the spread of disease. Additionally, many people have a fear of
needles which causes them to avoid treatment. These drawbacks have led to the development of
alternative delivery systems to needle injections.
Needle-free systems are designed to solve these problems making them safer, less
expensive, and more convenient. It is anticipated that these systems will increase the incidence of
vaccination and reduce the amount of prescribed antibiotics. Moreover, they should reduce the
number of needle stick accidents that have resulted in some health care workers contracting
diseases.
8
CLASSIFICATION OF NEEDLE FREE INJECTIONS
Needle free Injections can be classified into two types based on their mechanism of drug
delivery, namely: 1) Nano-patch, 2) Jet pressure Needle free Injection. The mechanism of their
operation will be described in details as every classification is introduced.
1) Nano-Patch:
This is the latest form of needle free drug delivery system where a patch containing
medicine called “Nano-Patch” is used. This drug delivery system is mainly used for
vaccination purpose, though delivery of routine medications are also performed. Nano-patch is
a specially designed surface having approximately 20,000 micro-projections per square
centimeter. The size of the patch is about the size of a stamp used in postal services. The base
membrane and the micro-projections are made up of some fine polymeric material like LDPE
(Low Density Poly-Ethylene) and the micro-projections hold the drug in extream minute
volume. Due to the presence of a high number of micro-projections a sufficient volume of drug
is delivered.
A team of 20 researchers led by Professor Mark Kendall, from the Australian Institute for
Bioengineering and Nanotechnology at The University of Queensland developed this Nano-
Patch. Intercell USA was the first medical organization to produce such needle less drug delivery
system with the help from the global design giant Ideo, USA.
Nano-Patch involves transcutaneous delivery of drugs, i.e delivery of drugs just beneath
the skin surface. It delivers the drug directly into the transcutaneous layer which is rich in
immune cells. And unlike the needle and syringe, which places the drug into the muscle having
far more less number of immune cells. As production of antibodies is directly proportional to the
amount of antigens the immune cells are exposed to, the Nano-Patch techniques scores far better
than the conventional Needle inoculations.
9
Fig 1.1
Methods of Application:
Drug delivery through Nano-Patch can be classified into two categories, namely 1) Sand-paper
aided delivery , 2) Iontophoresis enabled delivery.
1) Sand-paper aided delivery:
This is one of the methods of application of Nano-Patch before the patch is placed on the
surface of the skin. Scientists have developed a special type of sandpaper which can be placed
over the skin surface prior to the application of Nano-Patch. By pressing it onto the skin and
pulling it in a motion akin to removal of a tape from a package helps in removing a skin layer
of 25 microns thickness, just sufficient for the micro-projections of the patch to deliver the
drug at the immune cells’ layer. This is an extremely simple method and does not require
medical supervision or expertise for administration of the drug. Moreover, there is no
perception of pain when the sand paper is stripped off or when the Nano-Patch with its
microscopic projections are pressed onto the skin. The scratch indented by the sand paper is
10
invisible and to aid the proper positioning of Nano-Patch an ink mark is left behind by the sand
paper. Thus making the technology absolutely user friendly.
Fig 1.2
This diagram shows the entire procedure of application of the Nano-Patch. Figure1 shows the
Nano-Patch kit containing the Nano-Patch and the specially devised sand paper.
Figure2 shows how the entire set up is to be applied on the skin surface and then the sand paper
is to be pulled.
Figure3 shows that after the sandpaper is pulled off, the Nano-Patch can be applied.
2) Iontophoresis enabled delivery:
This is another type of application of Nano-Patch. In this method there is no need to
remove a thin layer of skin surface, rather the patch is directly applied on the skin surface and a
extremely small amount of electric discharge( a few microvolts) is applied over the patch to
drive the drug molecules into the skin surface. This method is less popular because it requires a
external device, i.e a driving electrode to push the micro sized drug molecules which are
present only in hospitals. This technique also demands medical supervision and expertise for
proper application of the electrical discharge.
11
Mechanism of Operation:
Fig 1.3
The nano-projections containing the drug( in case of normal treatment) or antigen( in
case of immunization) puncture the skin surface and delivers the drug/antigen into the
epidermis. The epidermis is rich of Langerhans cells, members of the immune system. Their
role is to pick up the antigens and physically move from epidermis to the nearest Lymph node.
Lymph nodes the hub of our immune system. Once there, Langerhans cells mature and display
the antigen to the passing naïve T-cells.
T-cells are specialised cells which specifically recognise one type of antigen. It’s like a
policeman with a picture of just one criminal. A naïve T-cell doesn’t have a picture yet. It
collects one from a Langerhans cell and other cells in the lymph nodes. With that the T-cell
matures, looking out for the antigen. Next time it sees it, it will be armed and ready.
T-cells, along with B-cells, protect you from getting the same disease twice. T-cells in
particular are needed to clear infections like HIV and malaria, and needle vaccines don’t
stimulate them enough. The nano-patch focuses on T-cells specifically. It gives them their first
look at the disease, without the pesky side-effect of getting traumatically ill.
12
2) Jet Pressured Needle Free Injection:
A UK based company, The Medical House (TMH) in collaboration with Bioject, a USA
based company developed the Jet pressured Needle free Injection in the year 2001. This device
was developed specifically for injecting Insulin and Human Growth hormone. Though these two
companies had collaborated, they fell apart a few years after signing the pact and each of them
later came up with revolutionary products: Vitajet , by Bioject and SQ-Pen by TMH. Both these
devices have been extremely popular since their inception due to the fact that patients
administered drugs without the depressing sight and pain of needle and their ease of use without
any medical supervision or expertise.
Variations of the above mentioned devices have been developed to make the technology
more user friendly and available at a cheaper cost so as to improve the life of millions suffering
from diabetes, the silent killer or malfunction of growth hormone. International Drug control and
Regulatory organizations such as NHS Drug Tariff, COP( Comfort Optimization Programme)
have their control over such devices and the companies manufacturing them obeys such
guidelines to manufacture safe and economically viable products.
Fig 1.4
13
Mechanism of Operation:
Needle-free injectors use jet pressure to inject the drug rapidly into the tissue at the correct
depth. The jet is achieved by forcing the drug through a specially designed nozzle, which is
completed in only 300 milliseconds. The drug delivery involved is Transcutaneous type as the
jet penetrates the tissue depositing the drug in the subcutaneous layer.
The air-forced needle-free injection systems are typically made up of three components
including an injection device, a disposable needle free syringe and an air cartridge. The
injection device is made of a durable plastic. It is designed to be easy to hold for self-
administration of medicine. The needle-free syringe is also plastic. It is sterilized and is the
only piece of the device that must touch the skin. The syringe is made to be disposed after
every use and pressurized metal air cartridges are included. Some devices have air hook-ups
that attach to larger containers of compressed air. Some air-forced systems use a re-usable
spring to generate the pushing force instead of pressurized air cartridges.
Fig 1.5
The diagram above shows the mechanism of drug delivery of a Needle and a Jet pressured
Needle Free Injection. Diagram on the left shows the needle based delivery where there is a
distinct puncture of the skin surface and the drug after delivery gets trapped for a while without
being diffused immediately. On the other hand, there is no puncture when the Jet Pressured
Needle free Injection is used , due to the specially developed nozzle the drug penetrates through
14
a skin pore and is immediately dispersed into the epidermis, thus enabling a faster transport to
the body.
ADVANTAGES OF USING NEEDLE FREE INJECTION TECHNOLOGY
Advantages galore as one delves into the Neddle Free Injection Technology. The biggest proof
of its credibility and effectivity is its acceptance among the patients and wide practice by medical
professionals and organizations. Though this is a pretty new concept in India, but in developed
nations this technology is in vogue. A comprehensive and exhaustive list of advantages of this
technology is listed below:
1) Painless Procedure
The word “Needle free” itself psychologically suggests a painless procedure and
certainly it does live up to its name and intriguing nature. Be it Nano-Patch or Jet Pressure or
Gas Powered Needle free Injection all of these provide pain less inoculation of drugs into the
body. Thus, causing a relief to millions, irrespective of age, gender or geography who are
needle-phobic.
2) Relief to patients who have to be administered with Transdermal Inoculation many times
a day
These are mainly people suffering from acute Diabetes. Such patients have to be
administered with insulin at regular intervals to keep a check on their blood sugar levels. This
is an extreme painful procedure as the patient has to undergo numerous injection pierces a
day and for the entire duration of his/her stay in the hospital. Needle free Injection
Technology thus comes as a blessing to such people.
3) Efficient use of Vaccine
Researchers have found that the amount of drug that is introduced inside our body
through conventional injections do not cause the right magnitude of effect which actually that
amount of drug should do. This means that a considerable amount of drugs do get wasted. As
evident from above diagrams some portion of the drugs do get trapped inside the muscles and
15
are eventually excreated from our body. Such a thing never occurs in Needle free injections.
A specific amount of drug is administered which gets totally used by our body as there is no
entrapment and immediate dispersion upon introduction.
4) Pandemic effective
During pandemics such as Cholera, diarrhea, dysentery availability of drugs and medical
professionals are not in abundance which leads to incomplete administration of drugs among
the patients thus leading to death of many. Such a mishap can be easily averted if a mass
amount of such Needle free Injections can be delivered to families where they themselves
can administered under minimum medical supervision.
5) Self administrable:
As previously mentioned, needle free injections can be administered without any medical
supervision or expertise, there is no need for patients to visits clinics or hospitals.
6) Less expensive:
In developed nations the cost of Needle free injections are less than conventional needle
injections. Though this is not a reality is developing countries, efforts are being made to
realize such a project.
7) Zero Contamination:
This is due to the fact that the needle free injections are for one time use only. Even if
one tries to reuse it( as it happens in case of conventional injections) one can’t because the
drug cannot be refilled into the device. Thus making the device absolutely fool proof from
sabotage by unscrupulous agents, thereby rendering cent percent safety and contamination
free inoculation.
16
8) Better drug diffusion:
Conventional injections deliver drugs into our muscles where it gets trapped for a period
of time before getting diffused into our body, thereby causing a delay in action of the drug.
Moreover there is also a possibility of the drug being trapped inside the muscles thus
resulting in wastage of the drug. Such things never happen in Needle free injections because
drugs are instantaneously transported into our system, thanks to the Langerhans cells and
Lymph nodes in our body which supports such a brilliant mechanism.
9) Zero disposal Hazard:
Conventional needle injections have mainly two types of disposal hazards. Firstly, injury
caused to the the person handling the sharps which mioght lead to devastating effects as
contamination is inevitable. Secondly there is a fear of reusability of the used sharps. Though
the second factor has been stopped but still unscrupulous activities thrives where used needle
injections are washed, rinsed packed and again sold into the market. Such possibilities would
never occur if needle free injections are used.
10) Ideal for Developing countries:
This is the one of the most propelling motives which has culminated in design of this
technology. Developing countries have a huge population but lacks proper medical facilities
and scarcity of trained medical personnel. Thus during any vaccination drive or treatment
during pandemics most of the mass are left untreated, thereby causing permanent impairment
or even death. To eradicate such an undesirable happening this technology gives the best
possible solution.
17
RAW MATERIALS USED FOR MANUFACTURING NEEDLE FREE INJECTIONS
Since these devices directly contact the body, they must be made from materials that are
pharmacologically inert. The materials also must be able to withstand high temperatures because
they are heat-sterilized. Jet pressured injection systems are available in different shapes as sizes.
The outer shell of the device is made from a high strength, lightweight thermoplastic such as
polycarbonate. Polycarbonates are polymers produced synthetically through various chemical
reactions. To make the polymer easier to mold, fillers are added. These fillers make plastics more
durable, lightweight, and rigid. Colorants are also incorporated into the plastic to modify the
appearance. Prior to manufacture, the plastics are typically supplied in pellet form with the
colorants and fillers already incorporated. Jet pressured systems typically use carbon dioxide or
helium gas to propel the medicine into the body.
MANUFACTURING PROCESS
There are numerous methods of producing each needle-free injection system. The following
process focuses on the production of an air-forced system. These systems are made through a
step by step procedure which involves molding the pieces, assembling them, and decorating and
labeling the final product. The individual pieces are typically produced off-site and assembled by
the needle free injection system manufacturer. All of the manufacturing is done under sterile
conditions to prevent the spread of disease.
Making the pieces
1) The first step requires the production of the component plastic pieces from plastic pellets.
This is done by a process called injection molding. Pellets of plastic are put into a large holding
bin on an injection molding machine. They are heated to make them flowable.
2 ) The material is then passed through a hydraulically controlled screw. As the screw rotates, the
plastic is directed through a nozzle which then injects it into a mold. The mold is made up of two
metal halves that form the shape of the part when brought together. When the plastic is in the
mold, it is held under pressure for a specified amount of time and then allowed to cool. As it
cools, the plastic inside hardens.
18
3) The mold pieces are separated and the plastic part falls out onto a conveyor. The mold then
closes again and the process is repeated. After the plastic parts are ejected from the mold, they
are manually inspected to ensure that no significantly damaged parts are used.
Assembling and labeling
The parts are next transported to an assembly line. In this production phase various
events occur. Machines apply markings that show dose levels and force measurements. These
machines are specially calibrated so each printing is made precisely. Depending on the
complexity of the device, human workers or machines may assemble the devices. This involves
inserting the various pieces into the main housing and attaching any buttons.
Packaging
After the assembly step, the injection devices are put into packaging. They are first
wrapped in sterile films and then put into cardboard or plastic boxes. Each part is packaged so
movement is minimal to prevent damage. For consumer products, an instruction manual is
included along with safety information. These boxes are then stacked on pallets and shipped via
truck to distributors.
QUALITY CONTROL AND MANAGEMENT
Quality control checks are done throughout the manufacturing process. Line inspectors
check the plastic components to assure they conform to predetermined specifications. Visual
inspections are the first test method, but measuring equipment is also used to check the
dimensions including size and thickness. Instruments that can be used include laser micrometers,
calipers and microscopes. Inspectors also check to make sure the printing and labeling is correct
and that all the parts are included in the final packages.
Since these devices can have various safety issues, their production is strictly controlled
by the Food and Drug Administration (FDA). Each manufacturer must conform to various
production standards and specifications. Announced and unannounced inspections may occur to
ensure that these companies are following good manufacturing practices. For this reason detailed
records must be kept related to production and design.
19
POPULAR BRANDS PRESENT INTERNATIONALLY
Biojectorr 2000
The Biojector 2000 is a durable, professional-grade injection system designed for
healthcare providers. The Biojector 2000 is the only needle-free system in the world cleared by
the FDA to deliver intramuscular injections. The system can also deliver subcutaneous
injections, and is being used for intradermal injections in clinical trials.
The Biojector 2000 uses sterile, single-use syringes for individual injections, which
prevent the cross-contamination that has been reported with fixed-nozzle jet injection systems.
More than 10 million injections have been administered successfully using the Biojector 2000,
with no reports of major complications. Because there is no needle, the Biojector provides
healthcare workers with an unparalleled level of protection against accidental needlestick
injuries. In high-risk situations, such as delivering injections to patients known to be infected
with HIV or hepatitis, the Biojector is an ideal injection system.
Vitajet 3
The Vitajet 3 is an easy-to-use, economical needle-free injection system for delivering
insulin. The system requires no maintenance or re-assembly. With disposable nozzles that are
replaced once-a-week, the Vitajet 3 offers the quality of a reusable medical product, with the
convenience and safety of a sterile disposable. The exclusive, easy-to-read Crystal Check
disposable transparent nozzle allows to inspect the dosage prior to injection and visually confirm
loading and full discharge of your insulin after each use.
The Vitajet 3 received the FDA marketing clearance for delivering subcutaneous
injections of insulin in 1996. Since then, the system has been used to deliver hundreds of
thousands of injections, safely, economically, and without the use of a needle.
Cool click
Bioject developed the cool.click needle-free injection system for delivering Saizen
recombinant human growth hormone. In some children, naturally occurring growth hormone is
20
absent or is produced in inadequate amounts. In these cases, Saizen or growth hormone
replacement must be injected to maintain normal growth.
Cool.click is a customised version of Bioject’s Vitajet 3 needle-free injection system. The
system includes customized dosage features to accurately deliver variable doses of Saizen and
was designed with bright colors to make the injector attractive and non-threatening to children.
The cool.click received FDA market clearance for delivering subcutaneous injections of Saizen
in June, 2000.
SeroJet
The SeroJet is a needle-free injection system for delivering Serostim recombinant human
growth hormone for treatment of HIV-associated wasting in adults. HIV-associated wasting is a
metabolic condition in which people infected with HIV lose body weight. If not treated, this
could result in increased morbidity and mortality.
Serono developed Serostim to treat this condition by utilizing the natural properties of
growth hormone in increasing lean body mass. SeroJet is a customised version of Bioject’s
Vitajet needle-free injection system. The system includes customised dosage features to
accurately deliver variable doses of Serostim. The SeroJet received FDA market clearance for
delivering subcutaneous injections of Serostim in March 2001.
Iject
Bioject has developed a second-generation gas-powered injector known as the Iject,
which is based on the design and performance of the B2000 and is intended to serve as a single-
use pre-filled device. The pressure profile of the Iject has been documented by in vitro testing to
be virtually the same as that of the B2000, and injection performance of the two devices is
therefore predicted to be equivalent.
The Iject is a pre-filled single-use disposable injection device configured to administer
0.5 to 1.00 ml subcutaneous or intramuscular injections. The device is distributed “ready to use.”
Thus, it requires no additional parts or modifications for function.
The device is primed by rotating the trigger sleeve 180 degrees, and an injection is administered
by advancing the trigger sleeve while the nozzle is held against the injection site. The Iject
needle-free injection system is an investigational device, subject to the US Food and Drug
Administration clearance for commercial distribution.
21
Biovalve’s Mini-Ject technology
The Mini-Ject represents the next generation in needle-free injection systems by
combining the features of accuracy reliability, a variety of pre-filled options, comfortable
administration, and full disposability, all within a patient friendly easy-to-use design. The Mini-
Ject can deliver a wide range of drugs, ranging from small molecules to large proteins, fragile
antibodies, and vaccines. Delivery can be targeted to intradermal, subcutaneous or intramuscular
depending on the clinical need. No other single-use needle-free delivery technology provides the
same level of performance as the Mini-Ject technology with the ability to target specific tissue
layers over such a broad range of drug volumes (0.1 mL to 1.3 mL) and viscosities.
Antares’ Medi-Jector Vision technology
Antares Pharma, one of the pioneers in the field of needle-free injection technology has
developed Medi-Jector Vision technology which is used to deliver insulin to diabetes sufferers. It
is a newest marketed version of the reusable, variable dose, spring-powered device for insulin
delivery. This technology is also being used to deliver human growth hormone. Its plastic,
disposable needle-free syringe allows the patient to see the dose prior to injection. It is marketed
in US and Europe for insulin administration since 1999.
LIMITATIONS OF THIS TECHNOLOGY
Like all technologies this technology too has its share of drawbacks. Though it is not aplenty but
one major drawback which is a clinical concern is that the high pressure delivery of drugs by the
Jet pressured needle free Injection can damage fragile molecules beneath our skin surface,
especially Monoclonal antibodies. This can be resolved if a specialized device is employed to
control the exact pressure of drug delivery. Though this problem is faced only by patients who
undergo multiple inoculations within a short period of time thus is not of a major concern for the
generally ill patients or patients for vaccination.
22
CONCLUSION
After delving into the depths of this technology and getting enlightened by the magnitude of its
acceptance and value one might ask: Is the future needle-free? The answer for developed
countries is a big Yes but for developing countries it is still questionable, though this technology
is designed appropriately for such nations. The reason for such an occurrence being technology
introduction in a country doesn’t solely depend on the prowess of the technology. Commercial
considerations, impediments from local business giants and various other factors are to be met.
Still there appears to be tremendous opportunity for needle-free technology to have major impact
in the industry. Although organizations such as WHO( World Health Organization) and CDC
(Centre for Disease Control) and groups like Gates Foundation have supported the development
of needle-free alternatives for drug delivery, it is likely that dramatic change may occur only
when a large pharmaceutical or biotechnology company adopts needle-free technology and
demonstrates its versatility, acceptance and value in major therapeutic area.
23
REFERENCES
Websites:
1) www.bioject.com
2) www.glidepharmaceuticals.com
3) Google
4) Google Scholar

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Needle free Injection-main project(7th sem)

  • 1. 1 STUDY OF NEEDLE FREE INJECTION SEMINAR REPORT In partial fulfillment of the requirements for the award of the degree of BACHELOR OF TECHNOLOGY IN BIO-MEDICAL ENGINEERING (West Bengal University of Technology) Submitted by NAME: KAUSHIK BANDOPADHYAY ROLL NO: 08109031014 Under the guidance of Mr. SUJAN KRISHNA SAMANTA Asst. Professor, Department of Biomedical Engineering NETAJI SUBHASH ENGINEERING COLLEGE KOLKATA DEPARTMENT OF BIOMEDICAL ENGINEERING NETAJI SUBHASH ENGINEERING COLLEGE TECHNO CITY, PANCHPOTA, GARIA, TECHNO CITY KOLKATA: 700152, WEST BENGAL
  • 2. 2 CERTIFICATE Certified that the seminar work entitled STUDY OF NEEDLE FREE INJECTION is a bonafide work carried out by KAUSHIK BANDOPADHYAY ROLL NO.08109031014 In partial fulfillment for the award for degree of BACHELOR OF TECHNOLOGY in BIO- MEDICAL ENGINEERING of the WEST BENGAL UNIVERSITY OF TECHNOLOGY, KOLKATA during the year 2011-2012. It is certified that all corrections/suggestions indicated for Internal Assessment has been incorporated in the report deposited in the Department. The seminar report has been approved as it satisfies the academic requirements in respect of seminar Work prescribed for Bachelor of Technology Degree. …………………………….. ……………………………………….. MR. SUJAN KRISHNA SAMANTA DR. SUKUMAR ROY Seminar Coordinator HOD, BME, NSEC Name of the Student: KAUSHIK BANDOPADHYAY University Roll No.: 08109031014 Name of Examiners Signature with Date 1. 2. 3.
  • 3. 3 ACKNOWLEDGEMENT I am greatly indebted to our seminar Guide Dr. Sukumar Roy, Department of Biomedical Engineering, for providing us all possible help and support while doing this work. Without his guidance the work would not get such a progress. I am highly obliged to our co-guide Mr. Sujan Krishna Samanta, Assistant Professor, Department of Biomedical Engineering for his timely help and guidance. We are also thankful to him for his valuable lectures that he offered to us during project. I am also thankful to Ms. Sumana Chatterjee, Lecturer Dept. of BME, for her active cooperation. I extend my thanks giving to all respected Faculty Members and our friends directly or indirectly associated with my work, who contributed their personal level best which enabled me for a successful completion of this seminar. Signature:
  • 4. 4 CONTENTS Chapter No. Chapter Page No. I Introduction 6 II Relevance of this technology in today’s world 7 III Classifications of Needle Free Injections 8 IV Advantages of using Needle Free Injection Technology 14 V Raw materials used for manufacturing Needle free Injection 17 VI Manufacturing Process 17 VII Quality Control and Management 18 VIII Popular Brands present Internationally. 19 IX Limitations of this Technology 21 X Conclusion 22 XI References 23
  • 5. 5 LIST OF FIGURES Chapter No. Fig No. Description Page No. III 1.1 Nano-Patch 9 1.2 Application of Nano-Patch on skin surface 10 1.3 Operation Mechanism of Nano-Patch 11 1.4 Jet Pressured Needle Free Injection 12 1.5 Operation Mechanism of Jet Pressured 13 Needle free Injection
  • 6. 6 INTRODUCTION As long as drugs have been known to cure diseases, people have searched for better methods of delivering them. During the early nineteenth century researchers made a series of discoveries that eventually led to the development of the hypodermic needle by Alexander Wood in 1853. This device was used to give morphine to patients suffering from sleeping disorders. In subsequent years, the hypodermic needle underwent significant changes which made them more efficient to use, safer, and more reliable. As technology advanced, procedures for delivering drugs metamorphosed. Today it has reached a stage where conventional drug delivery using needles might become history. Thanks to the invention of “Needle Free Injection Technology” which brings in a plethora of advantages, enough to set conventional injections in the pages of history. Definitely a relief for millions as this technology promises no pain, which is more than a psychological disease which sets many at unease, even hyper reactive, irrespective of age, gender, geography. But it is not merely the pain-less factor that for this technology has been conceived, deeper aspects such as effective and efficient delivery of drugs, extensive inoculation during pandemics, cost effectiveness and many more important objectives are behind which have led to formulation of this latest technology in medical science. Such aspects will be extensively discussed as one surfs across the pages of this project leading to enlightenment and relevance of this technology at this present moment and the near future. Happy reading and discovery!
  • 7. 7 RELEVANCE OF THIS TECHNOLOGY IN TODAY’S WORLD. People are given injections to protect them from influenza, tetanus, cholera, typhoid, and other diseases. When a needle is inserted through the skin, the vaccine (or drug) it carries provides systemic immunity. This is because the vaccine gets into the bloodstream and provokes the body to create antibodies that are carried throughout the entire body. In many countries, children may get over 13 vaccine injections by the age of 16. Unfortunately, there are a variety of problems associated with the hypodermic needles used for these injections. One of the most significant drawbacks is the relatively high cost of the needles. The cost results in a lower vaccination rate, especially for children in developing countries. Another problem with traditional needles is the lack of reusability. If a needle syringe is not sterilized, reusing it can lead to the spread of disease. Additionally, many people have a fear of needles which causes them to avoid treatment. These drawbacks have led to the development of alternative delivery systems to needle injections. Needle-free systems are designed to solve these problems making them safer, less expensive, and more convenient. It is anticipated that these systems will increase the incidence of vaccination and reduce the amount of prescribed antibiotics. Moreover, they should reduce the number of needle stick accidents that have resulted in some health care workers contracting diseases.
  • 8. 8 CLASSIFICATION OF NEEDLE FREE INJECTIONS Needle free Injections can be classified into two types based on their mechanism of drug delivery, namely: 1) Nano-patch, 2) Jet pressure Needle free Injection. The mechanism of their operation will be described in details as every classification is introduced. 1) Nano-Patch: This is the latest form of needle free drug delivery system where a patch containing medicine called “Nano-Patch” is used. This drug delivery system is mainly used for vaccination purpose, though delivery of routine medications are also performed. Nano-patch is a specially designed surface having approximately 20,000 micro-projections per square centimeter. The size of the patch is about the size of a stamp used in postal services. The base membrane and the micro-projections are made up of some fine polymeric material like LDPE (Low Density Poly-Ethylene) and the micro-projections hold the drug in extream minute volume. Due to the presence of a high number of micro-projections a sufficient volume of drug is delivered. A team of 20 researchers led by Professor Mark Kendall, from the Australian Institute for Bioengineering and Nanotechnology at The University of Queensland developed this Nano- Patch. Intercell USA was the first medical organization to produce such needle less drug delivery system with the help from the global design giant Ideo, USA. Nano-Patch involves transcutaneous delivery of drugs, i.e delivery of drugs just beneath the skin surface. It delivers the drug directly into the transcutaneous layer which is rich in immune cells. And unlike the needle and syringe, which places the drug into the muscle having far more less number of immune cells. As production of antibodies is directly proportional to the amount of antigens the immune cells are exposed to, the Nano-Patch techniques scores far better than the conventional Needle inoculations.
  • 9. 9 Fig 1.1 Methods of Application: Drug delivery through Nano-Patch can be classified into two categories, namely 1) Sand-paper aided delivery , 2) Iontophoresis enabled delivery. 1) Sand-paper aided delivery: This is one of the methods of application of Nano-Patch before the patch is placed on the surface of the skin. Scientists have developed a special type of sandpaper which can be placed over the skin surface prior to the application of Nano-Patch. By pressing it onto the skin and pulling it in a motion akin to removal of a tape from a package helps in removing a skin layer of 25 microns thickness, just sufficient for the micro-projections of the patch to deliver the drug at the immune cells’ layer. This is an extremely simple method and does not require medical supervision or expertise for administration of the drug. Moreover, there is no perception of pain when the sand paper is stripped off or when the Nano-Patch with its microscopic projections are pressed onto the skin. The scratch indented by the sand paper is
  • 10. 10 invisible and to aid the proper positioning of Nano-Patch an ink mark is left behind by the sand paper. Thus making the technology absolutely user friendly. Fig 1.2 This diagram shows the entire procedure of application of the Nano-Patch. Figure1 shows the Nano-Patch kit containing the Nano-Patch and the specially devised sand paper. Figure2 shows how the entire set up is to be applied on the skin surface and then the sand paper is to be pulled. Figure3 shows that after the sandpaper is pulled off, the Nano-Patch can be applied. 2) Iontophoresis enabled delivery: This is another type of application of Nano-Patch. In this method there is no need to remove a thin layer of skin surface, rather the patch is directly applied on the skin surface and a extremely small amount of electric discharge( a few microvolts) is applied over the patch to drive the drug molecules into the skin surface. This method is less popular because it requires a external device, i.e a driving electrode to push the micro sized drug molecules which are present only in hospitals. This technique also demands medical supervision and expertise for proper application of the electrical discharge.
  • 11. 11 Mechanism of Operation: Fig 1.3 The nano-projections containing the drug( in case of normal treatment) or antigen( in case of immunization) puncture the skin surface and delivers the drug/antigen into the epidermis. The epidermis is rich of Langerhans cells, members of the immune system. Their role is to pick up the antigens and physically move from epidermis to the nearest Lymph node. Lymph nodes the hub of our immune system. Once there, Langerhans cells mature and display the antigen to the passing naïve T-cells. T-cells are specialised cells which specifically recognise one type of antigen. It’s like a policeman with a picture of just one criminal. A naïve T-cell doesn’t have a picture yet. It collects one from a Langerhans cell and other cells in the lymph nodes. With that the T-cell matures, looking out for the antigen. Next time it sees it, it will be armed and ready. T-cells, along with B-cells, protect you from getting the same disease twice. T-cells in particular are needed to clear infections like HIV and malaria, and needle vaccines don’t stimulate them enough. The nano-patch focuses on T-cells specifically. It gives them their first look at the disease, without the pesky side-effect of getting traumatically ill.
  • 12. 12 2) Jet Pressured Needle Free Injection: A UK based company, The Medical House (TMH) in collaboration with Bioject, a USA based company developed the Jet pressured Needle free Injection in the year 2001. This device was developed specifically for injecting Insulin and Human Growth hormone. Though these two companies had collaborated, they fell apart a few years after signing the pact and each of them later came up with revolutionary products: Vitajet , by Bioject and SQ-Pen by TMH. Both these devices have been extremely popular since their inception due to the fact that patients administered drugs without the depressing sight and pain of needle and their ease of use without any medical supervision or expertise. Variations of the above mentioned devices have been developed to make the technology more user friendly and available at a cheaper cost so as to improve the life of millions suffering from diabetes, the silent killer or malfunction of growth hormone. International Drug control and Regulatory organizations such as NHS Drug Tariff, COP( Comfort Optimization Programme) have their control over such devices and the companies manufacturing them obeys such guidelines to manufacture safe and economically viable products. Fig 1.4
  • 13. 13 Mechanism of Operation: Needle-free injectors use jet pressure to inject the drug rapidly into the tissue at the correct depth. The jet is achieved by forcing the drug through a specially designed nozzle, which is completed in only 300 milliseconds. The drug delivery involved is Transcutaneous type as the jet penetrates the tissue depositing the drug in the subcutaneous layer. The air-forced needle-free injection systems are typically made up of three components including an injection device, a disposable needle free syringe and an air cartridge. The injection device is made of a durable plastic. It is designed to be easy to hold for self- administration of medicine. The needle-free syringe is also plastic. It is sterilized and is the only piece of the device that must touch the skin. The syringe is made to be disposed after every use and pressurized metal air cartridges are included. Some devices have air hook-ups that attach to larger containers of compressed air. Some air-forced systems use a re-usable spring to generate the pushing force instead of pressurized air cartridges. Fig 1.5 The diagram above shows the mechanism of drug delivery of a Needle and a Jet pressured Needle Free Injection. Diagram on the left shows the needle based delivery where there is a distinct puncture of the skin surface and the drug after delivery gets trapped for a while without being diffused immediately. On the other hand, there is no puncture when the Jet Pressured Needle free Injection is used , due to the specially developed nozzle the drug penetrates through
  • 14. 14 a skin pore and is immediately dispersed into the epidermis, thus enabling a faster transport to the body. ADVANTAGES OF USING NEEDLE FREE INJECTION TECHNOLOGY Advantages galore as one delves into the Neddle Free Injection Technology. The biggest proof of its credibility and effectivity is its acceptance among the patients and wide practice by medical professionals and organizations. Though this is a pretty new concept in India, but in developed nations this technology is in vogue. A comprehensive and exhaustive list of advantages of this technology is listed below: 1) Painless Procedure The word “Needle free” itself psychologically suggests a painless procedure and certainly it does live up to its name and intriguing nature. Be it Nano-Patch or Jet Pressure or Gas Powered Needle free Injection all of these provide pain less inoculation of drugs into the body. Thus, causing a relief to millions, irrespective of age, gender or geography who are needle-phobic. 2) Relief to patients who have to be administered with Transdermal Inoculation many times a day These are mainly people suffering from acute Diabetes. Such patients have to be administered with insulin at regular intervals to keep a check on their blood sugar levels. This is an extreme painful procedure as the patient has to undergo numerous injection pierces a day and for the entire duration of his/her stay in the hospital. Needle free Injection Technology thus comes as a blessing to such people. 3) Efficient use of Vaccine Researchers have found that the amount of drug that is introduced inside our body through conventional injections do not cause the right magnitude of effect which actually that amount of drug should do. This means that a considerable amount of drugs do get wasted. As evident from above diagrams some portion of the drugs do get trapped inside the muscles and
  • 15. 15 are eventually excreated from our body. Such a thing never occurs in Needle free injections. A specific amount of drug is administered which gets totally used by our body as there is no entrapment and immediate dispersion upon introduction. 4) Pandemic effective During pandemics such as Cholera, diarrhea, dysentery availability of drugs and medical professionals are not in abundance which leads to incomplete administration of drugs among the patients thus leading to death of many. Such a mishap can be easily averted if a mass amount of such Needle free Injections can be delivered to families where they themselves can administered under minimum medical supervision. 5) Self administrable: As previously mentioned, needle free injections can be administered without any medical supervision or expertise, there is no need for patients to visits clinics or hospitals. 6) Less expensive: In developed nations the cost of Needle free injections are less than conventional needle injections. Though this is not a reality is developing countries, efforts are being made to realize such a project. 7) Zero Contamination: This is due to the fact that the needle free injections are for one time use only. Even if one tries to reuse it( as it happens in case of conventional injections) one can’t because the drug cannot be refilled into the device. Thus making the device absolutely fool proof from sabotage by unscrupulous agents, thereby rendering cent percent safety and contamination free inoculation.
  • 16. 16 8) Better drug diffusion: Conventional injections deliver drugs into our muscles where it gets trapped for a period of time before getting diffused into our body, thereby causing a delay in action of the drug. Moreover there is also a possibility of the drug being trapped inside the muscles thus resulting in wastage of the drug. Such things never happen in Needle free injections because drugs are instantaneously transported into our system, thanks to the Langerhans cells and Lymph nodes in our body which supports such a brilliant mechanism. 9) Zero disposal Hazard: Conventional needle injections have mainly two types of disposal hazards. Firstly, injury caused to the the person handling the sharps which mioght lead to devastating effects as contamination is inevitable. Secondly there is a fear of reusability of the used sharps. Though the second factor has been stopped but still unscrupulous activities thrives where used needle injections are washed, rinsed packed and again sold into the market. Such possibilities would never occur if needle free injections are used. 10) Ideal for Developing countries: This is the one of the most propelling motives which has culminated in design of this technology. Developing countries have a huge population but lacks proper medical facilities and scarcity of trained medical personnel. Thus during any vaccination drive or treatment during pandemics most of the mass are left untreated, thereby causing permanent impairment or even death. To eradicate such an undesirable happening this technology gives the best possible solution.
  • 17. 17 RAW MATERIALS USED FOR MANUFACTURING NEEDLE FREE INJECTIONS Since these devices directly contact the body, they must be made from materials that are pharmacologically inert. The materials also must be able to withstand high temperatures because they are heat-sterilized. Jet pressured injection systems are available in different shapes as sizes. The outer shell of the device is made from a high strength, lightweight thermoplastic such as polycarbonate. Polycarbonates are polymers produced synthetically through various chemical reactions. To make the polymer easier to mold, fillers are added. These fillers make plastics more durable, lightweight, and rigid. Colorants are also incorporated into the plastic to modify the appearance. Prior to manufacture, the plastics are typically supplied in pellet form with the colorants and fillers already incorporated. Jet pressured systems typically use carbon dioxide or helium gas to propel the medicine into the body. MANUFACTURING PROCESS There are numerous methods of producing each needle-free injection system. The following process focuses on the production of an air-forced system. These systems are made through a step by step procedure which involves molding the pieces, assembling them, and decorating and labeling the final product. The individual pieces are typically produced off-site and assembled by the needle free injection system manufacturer. All of the manufacturing is done under sterile conditions to prevent the spread of disease. Making the pieces 1) The first step requires the production of the component plastic pieces from plastic pellets. This is done by a process called injection molding. Pellets of plastic are put into a large holding bin on an injection molding machine. They are heated to make them flowable. 2 ) The material is then passed through a hydraulically controlled screw. As the screw rotates, the plastic is directed through a nozzle which then injects it into a mold. The mold is made up of two metal halves that form the shape of the part when brought together. When the plastic is in the mold, it is held under pressure for a specified amount of time and then allowed to cool. As it cools, the plastic inside hardens.
  • 18. 18 3) The mold pieces are separated and the plastic part falls out onto a conveyor. The mold then closes again and the process is repeated. After the plastic parts are ejected from the mold, they are manually inspected to ensure that no significantly damaged parts are used. Assembling and labeling The parts are next transported to an assembly line. In this production phase various events occur. Machines apply markings that show dose levels and force measurements. These machines are specially calibrated so each printing is made precisely. Depending on the complexity of the device, human workers or machines may assemble the devices. This involves inserting the various pieces into the main housing and attaching any buttons. Packaging After the assembly step, the injection devices are put into packaging. They are first wrapped in sterile films and then put into cardboard or plastic boxes. Each part is packaged so movement is minimal to prevent damage. For consumer products, an instruction manual is included along with safety information. These boxes are then stacked on pallets and shipped via truck to distributors. QUALITY CONTROL AND MANAGEMENT Quality control checks are done throughout the manufacturing process. Line inspectors check the plastic components to assure they conform to predetermined specifications. Visual inspections are the first test method, but measuring equipment is also used to check the dimensions including size and thickness. Instruments that can be used include laser micrometers, calipers and microscopes. Inspectors also check to make sure the printing and labeling is correct and that all the parts are included in the final packages. Since these devices can have various safety issues, their production is strictly controlled by the Food and Drug Administration (FDA). Each manufacturer must conform to various production standards and specifications. Announced and unannounced inspections may occur to ensure that these companies are following good manufacturing practices. For this reason detailed records must be kept related to production and design.
  • 19. 19 POPULAR BRANDS PRESENT INTERNATIONALLY Biojectorr 2000 The Biojector 2000 is a durable, professional-grade injection system designed for healthcare providers. The Biojector 2000 is the only needle-free system in the world cleared by the FDA to deliver intramuscular injections. The system can also deliver subcutaneous injections, and is being used for intradermal injections in clinical trials. The Biojector 2000 uses sterile, single-use syringes for individual injections, which prevent the cross-contamination that has been reported with fixed-nozzle jet injection systems. More than 10 million injections have been administered successfully using the Biojector 2000, with no reports of major complications. Because there is no needle, the Biojector provides healthcare workers with an unparalleled level of protection against accidental needlestick injuries. In high-risk situations, such as delivering injections to patients known to be infected with HIV or hepatitis, the Biojector is an ideal injection system. Vitajet 3 The Vitajet 3 is an easy-to-use, economical needle-free injection system for delivering insulin. The system requires no maintenance or re-assembly. With disposable nozzles that are replaced once-a-week, the Vitajet 3 offers the quality of a reusable medical product, with the convenience and safety of a sterile disposable. The exclusive, easy-to-read Crystal Check disposable transparent nozzle allows to inspect the dosage prior to injection and visually confirm loading and full discharge of your insulin after each use. The Vitajet 3 received the FDA marketing clearance for delivering subcutaneous injections of insulin in 1996. Since then, the system has been used to deliver hundreds of thousands of injections, safely, economically, and without the use of a needle. Cool click Bioject developed the cool.click needle-free injection system for delivering Saizen recombinant human growth hormone. In some children, naturally occurring growth hormone is
  • 20. 20 absent or is produced in inadequate amounts. In these cases, Saizen or growth hormone replacement must be injected to maintain normal growth. Cool.click is a customised version of Bioject’s Vitajet 3 needle-free injection system. The system includes customized dosage features to accurately deliver variable doses of Saizen and was designed with bright colors to make the injector attractive and non-threatening to children. The cool.click received FDA market clearance for delivering subcutaneous injections of Saizen in June, 2000. SeroJet The SeroJet is a needle-free injection system for delivering Serostim recombinant human growth hormone for treatment of HIV-associated wasting in adults. HIV-associated wasting is a metabolic condition in which people infected with HIV lose body weight. If not treated, this could result in increased morbidity and mortality. Serono developed Serostim to treat this condition by utilizing the natural properties of growth hormone in increasing lean body mass. SeroJet is a customised version of Bioject’s Vitajet needle-free injection system. The system includes customised dosage features to accurately deliver variable doses of Serostim. The SeroJet received FDA market clearance for delivering subcutaneous injections of Serostim in March 2001. Iject Bioject has developed a second-generation gas-powered injector known as the Iject, which is based on the design and performance of the B2000 and is intended to serve as a single- use pre-filled device. The pressure profile of the Iject has been documented by in vitro testing to be virtually the same as that of the B2000, and injection performance of the two devices is therefore predicted to be equivalent. The Iject is a pre-filled single-use disposable injection device configured to administer 0.5 to 1.00 ml subcutaneous or intramuscular injections. The device is distributed “ready to use.” Thus, it requires no additional parts or modifications for function. The device is primed by rotating the trigger sleeve 180 degrees, and an injection is administered by advancing the trigger sleeve while the nozzle is held against the injection site. The Iject needle-free injection system is an investigational device, subject to the US Food and Drug Administration clearance for commercial distribution.
  • 21. 21 Biovalve’s Mini-Ject technology The Mini-Ject represents the next generation in needle-free injection systems by combining the features of accuracy reliability, a variety of pre-filled options, comfortable administration, and full disposability, all within a patient friendly easy-to-use design. The Mini- Ject can deliver a wide range of drugs, ranging from small molecules to large proteins, fragile antibodies, and vaccines. Delivery can be targeted to intradermal, subcutaneous or intramuscular depending on the clinical need. No other single-use needle-free delivery technology provides the same level of performance as the Mini-Ject technology with the ability to target specific tissue layers over such a broad range of drug volumes (0.1 mL to 1.3 mL) and viscosities. Antares’ Medi-Jector Vision technology Antares Pharma, one of the pioneers in the field of needle-free injection technology has developed Medi-Jector Vision technology which is used to deliver insulin to diabetes sufferers. It is a newest marketed version of the reusable, variable dose, spring-powered device for insulin delivery. This technology is also being used to deliver human growth hormone. Its plastic, disposable needle-free syringe allows the patient to see the dose prior to injection. It is marketed in US and Europe for insulin administration since 1999. LIMITATIONS OF THIS TECHNOLOGY Like all technologies this technology too has its share of drawbacks. Though it is not aplenty but one major drawback which is a clinical concern is that the high pressure delivery of drugs by the Jet pressured needle free Injection can damage fragile molecules beneath our skin surface, especially Monoclonal antibodies. This can be resolved if a specialized device is employed to control the exact pressure of drug delivery. Though this problem is faced only by patients who undergo multiple inoculations within a short period of time thus is not of a major concern for the generally ill patients or patients for vaccination.
  • 22. 22 CONCLUSION After delving into the depths of this technology and getting enlightened by the magnitude of its acceptance and value one might ask: Is the future needle-free? The answer for developed countries is a big Yes but for developing countries it is still questionable, though this technology is designed appropriately for such nations. The reason for such an occurrence being technology introduction in a country doesn’t solely depend on the prowess of the technology. Commercial considerations, impediments from local business giants and various other factors are to be met. Still there appears to be tremendous opportunity for needle-free technology to have major impact in the industry. Although organizations such as WHO( World Health Organization) and CDC (Centre for Disease Control) and groups like Gates Foundation have supported the development of needle-free alternatives for drug delivery, it is likely that dramatic change may occur only when a large pharmaceutical or biotechnology company adopts needle-free technology and demonstrates its versatility, acceptance and value in major therapeutic area.