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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

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Page 1: Needle free Injection-main project(7th sem)

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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

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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.

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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:

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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

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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

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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!

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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.

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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.

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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

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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.

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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.

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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

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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

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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

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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REFERENCES

Websites:

1) www.bioject.com

2) www.glidepharmaceuticals.com

3) Google

4) Google Scholar