FORM 2
THE PATENT ACT, 1970
(39 OF 1970)
AND
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
1 TITLE OF THE INVENTION: Needle - free Dispensing Pin
2 APPLICANT (S)

(a) Name: Ms. Kaudanya Anju Gupta,
(b) Nationality: Indian
(c) Address: 802/A wing, 8th floor President Park, Plot No. 77 & 77A, Sector 29, Opp. Rajiv Gandhi Udyan, Vashi, Navi Mumbai
APPLICANT (S)
(d) Name: Mr. Iyer Natrajan S.
(e) Nationality: Indian
(f) Address: 403 Kaveri, K. Raheja Residential Complex, Balkum Pipe road, Thane (W) - 400 008, India
3 PREAMBLE TO THE DESCRIPTION
" | COMPLETE
The following specification
particularly describes the invention and the manner in which it is to be performed. :
4 DESCRIPTION (Description shall start from next page)
See the attachment
5 CLAIMS (not applicable for provisional specification. Claims should start with
the preamble - "I/We claim" on separate page)
See the attachment
6 DATE AND SIGNATURE (to be given at the end of last page of specification)
See the attachment
7 ABSTRACT OF THE INVENTION (to be given along with complete specification
on separate page)
See the attachment
Note-
* Repeat boxes in case of more than one entry
* To be signed by the applicant(s) or by authorized registered patent agent.
* Name of the applicant should be given in full, family name in the beginning.
* Complete address of the applicant should be given staling the postal index no. / code State ad country.
* Strike out the column which is/are not applicable.

FIELD OF INVENTION:
This invention i.e. Needle - free Dispensing Pin is a further development of Indian patent no- 1871/MUM/2009
This field of invention is related to administration of injectable drugs especially cytotoxic and cytostatic drugs, which is made safe for the administrator as well as the patient.
The present invention acts as sterile barrier, which filters air while reconstitution process. The device is made needle free, which is a precautionary measure taken for avoiding needle stick injuries.
BACKGROUND OF INVENTION:
Over the ages, safe administration of cytotoxic and cytostatic drug has been a serious concern to the healthcare practitioners worldwide. Several medical devices had been made to avoid such health related issues of while administration of these toxic drugs. Most of the devices are vial adaptors having two lumens: one as the syringe vent and the second as the air vent comprising of a sterile filter.
There are different type of vial adaptor used having multiple functions such as air pressure balancing and withdrawal of fluids with or without using needles syringes. Certain vial adaptors had complex assembly like having multiple check valve or luers. This in turn increases the cost of the product and manufacturing as well as sterilizing complexities. Also as these vial adaptors are so featured

that they can only be used for reconstitution or withdrawal of fluids from the vials. Hence they can only be used for vials, this restricts their usage. Though the vial adaptors have a provision of both liquid and air flow, however, if the venting of the vial does not have the same or better flow capacity than the withdrawal flow rate of the reconstituted medicament by the syringe, air bubbles may be drawn into the syringe with the medicament. Moreover these are complex devices features different types of check valves.
The current invention is a simple, cost effective device, which is meant to use as air pressure balancer while restitution or withdrawal of fluids along with maintaining sterile conditions. This can be used for vials as well as for i.v. bags. This is a simple device, which can be easily sterilized by using ethylene dioxide. Thus process and cost of manufacturing is reasonably low. Moreover, this simple device is made needle free so as to prevent needle stick injuries.
Most of the healthcare unit does not have provision for aseptic drug reconstitution for the injectables. Mostly, sterile disposable syringes are used for reconstitution and dilution of the reconstituted drug in I.V. fluid bags. This process of reconstitution has higher chances of needlestick injuries caused to healthcare workers. The percutaneous injuries caused due to needlesticks are of serious concern. According to Centers For Disease Control and Prevention, These needlesticks forms a source of transmission of blood borne diseases like HIV (Human immunodeficiency virus), HBV (Hepatitis B virus), HCV {Hepatitis C virus). Millions of healthcare professionals worldwide are infected by such diseases due to these needlesticks. According to WHO reports, out of 35-million healthcare workers, 2-million experience percutaneous exposure to infectious diseases each year. It also reports that 37.6% of Hepatitis B, 39% of Hepatitis C and 4.4% of HIV/AIDS in Health-Care Workers around the world are due to needlestick injuries. These incidences intensify the urge

for inventing needless devices, for the safety of healthcare professionals. Moreover, maintenances of high sterility and less contamination of drug product, which are to be injected, during reconstitution, should also be the prime concern.

DESCRIPTION OF INVENTION:
When a lyophiliized or dry powder is reconstituted using a syringe, there occurs an air pressure difference in the vial thus causing difficulty in reconstitution. Therefore a provision for maintaining this air pressure balance has to be provided. However, when the air pressure is created in the vial it generates drug aerosols, which gets released in the immediate atmospheric environment. These drug aerosols are usually hazardous for the health care practitioners especially when the drugs are of oncological products. These drug aerosols may be cytotoxic or cytostatics in nature. Repeated exposure to such hazardous chemicals may cause many harmful effects like- skin rashes, infertility, miscarriage, birth defect and possibly leukemia or other cancers to die health care practitioners according to The National Institute for Occupational Safety and Health (NIOSH). Thus a provision of a mere passage for air is not sufficient. The passage has to be guarded with certain materials mat only filtered air can pass through, thus retaining the drug particulates (FIG- 1). It is found mat 0.2 micron or 0.45 micron hydrophobic air venting filter captures aerosolization while reconstituting or dispensing cytotoxic medications from multi-dose vials.
FIG: 1 shows a needle free dispensing pin (1), piercing through a rubber vial stopper (2) attached to the vial (3).
FIG-2 shows a dispensing pin (1), a vial (3) and syringe (4), consisting of dry powder to be reconstituted.
FIG-3 shows dispensing pin (1) and IV. fluid bag (5) consists IV. fluid.

FIG-4 shows the difference in air pressure while reconstitution of the product. p' represents the air pressure inside the vial which is higher than pa which represents the air pressure outside the vial. Therefore, the total air pressure difference is given by,
∆ = pJ- pa.
When a fluid is withdrawn from the vials or i.v. bags, a negative air pressure builds up in the container. Thus a provision of air to enter the system is necessary which in turn would balance the air pressure and allow the fluid to flow in a faster rate. As maintaining the sterility of the drug is an important aspect for injectables, it becomes necessary to provide sterile air entry. Thus a filter fitted needle can be used to provide the required sterile conditions (FIG-5,6).
FIG- 5, 6 shows the difference in air pressure when the liquid is withdrawn from the vial or the i.v. bag. p' represents the air pressure in the container which is lower than pa which represents the air pressure outside the container. Therefore, the total air pressure difference is given by,
∆p = pa-p
Filters of 0.2 micron and 0.45 micron retain the aerosolized drug particles in the vial while allowing sterile bacteria and endotoxin free air passage. Thus providing the required safety for both the patient and the administrators.
Currendy there are two procedures available for protecting the administrator from the hazardous aerosols of the cytotoxic drugs. The first method that is used is so-called glove box where the administrator inserts his hands into the gloves through which the access to the syringe containing the diluents or reconstitution solvent and the vial containing the drug is gained as they are

placed in an enclosed box. This procedure is tedious and time consuming. The second method is use of vial adaptors having a spike for piercing the elastomeric stopper, a vent lumen with filter for providing air passage and a fluid lumen where syringe is attached to withdrawal of fluids. There are certain disadvantages with these vial adaptors like these are relatively expensive and there no guarantee that the filter would always be efficient in blocking the aerosol particles to get is contact with the outer environment especially when the filter is wet when the diluent is introduced into the vial, thus causing outward flow of gas which in turn might cause entrain the drug particles into the filter. Due to wet filters, the particles might stick to the filter media, which eventually might cause its blockage. These disadvantages are overcome by our invention, as the device is used only for air filtration and thus does not comes in contact with liquid flow. Also, this device is to be disposed after every use, the efficiency of the filter media is thus maintained.
Numerous drugs have to be admixed quickly, all at the same time. The patients need their medicines, treatment regimes to be started as quickly as possible. Also, busy practitioners require simple convenient and safe procedures for administration of medicaments. Considering these aspects, it is made simple, convenient and safe device for the benefit of mankind.
The current invention is a device having a filter for maintaining sterile airflow while reconstitution and withdrawal procedures (FIG-4, 5). Access pores for injecting fluid into or removing fluid from a system, such as a drug vial generally involves a pierceable rubber stopper formed using elastomeric material e.g. butyl rubber, natural rubber etc are placed in the opening of the vial. A metal crimped closes the sealing area of the rubber bung and the vial sitting area. The closure has opening or axis port, through which stopper and

vial opening may be accessed. 0.2 p or 0.45p filter is inserted into die access port (FIG- 7). The cannula pierces the rubber stopper to make fluid connection with the interior of the vial.
Use of a sterile venting device provides safety for the patient medications by eliminating bacteria, dust particles, etc during equalization of pressure. Retaining the aerosolized particles while reconstituting the drug again provides safe environment for die doctors and healthcare personnel.
FIG- 7 shows a cross sectional view of the needle - free dispensing pin.
The device consists of three parts — (FIG-7)
1. A hollow cap (6).
2. A hydrophobic filter media (8).
3. A V-shaped body (7) along with a small cannula (9).
The device has a cap (6), i.e. is hollow (11), which supports the filter media (8) and allows the aerosol free air to pass outside as well as allows the air from die atmosphere to pass in the sealed container. The hydrophobic sterile filter media (8) is sealed to the hollow cap (6) through its outer diameter thus providing an impervious joint. V-shaped curved walls known as 'the body' (7) of the device. The body is molded along with a small, hollow pipe, which is known as 'the cannula' (9) of the device. Due to this V- shaped body of the device, the inner cross sectional area increases and thus allowing proper filtration and retention of drug particulates by avoiding any congestion or blockage of the filter media. Due to V-shape structure, the body part accurately fits into the hollow cap. The cannula has a small sharp opening (10). The cannula (9) pierces the elastometric rubber vial stopper, thus making a sterile connection between the inner

environment of the container and the immediate outer atmosphere. Basically, the filter media (8) is enclosed in a plastic case, which is hollow. The diameter of the opening (11) in the hollow cap (6) is larger than the diameter of the opening (10) in the cannula (9) as shown in FIG- 8, 9. As the filter (8) has an impervious joint, it restricts the free movement of the filter media (8) and thus allowing an efficient filtration process. The top view (FIG-8) shows a wide hollow cap (6), which is the outer opening (11) through which the filter media (8) is visible. The bottom view (FIG-9) shows a small opening (9), i.e. the sharp cannula (9) of the device. The device maintains the sterility throughout the process thus preventing the entry of foreign particles.
The device consists of 0.2 (i or 0.45 (J. nominal stoke absolute filter. The sealing between the sterile filter and the hollow cap is made impervious (FIG- 7). The filter used in this device is hydrophobic in nature with available pores sizes of 0.2 μ. or 0.45 p, pore sizes and it is sterilizable. This device can be used for large volume as well as small volume parenteral for providing safe conditions. This device works on a very simple principle and does not require high level of skill. This device does not have any dynamic moving parts like non-returning valve, springs, etc.the same device can be used for different types of parental preparations. For handling special types of wings i.e. the hollow cap (6) is provided to transmit uniform force along the periphery from all the sides while insertion. The materials used are of food grade, sterilizable with ethylene oxide.

Process Of Manufacturing:
There are two molds made for the device. One mold made for molding the hollow cap (6) and the second mold is for molding the body (7) along with die cannula (9). The mold temperature is approximately 200°C - 250°C. The material used for the manufacturing of the dispensing pins is of medical grade plastic. Medical grade plastics have outstanding dimension stability. It has high chemical resistant and an excellent resistance to sterilization process. Sterilization is basically done by ethylene oxide. The filter media (8) is sealed from its outer diameter with the hollow cap (6) to make an impervious joint. The sealing of hollow cap (6) and the body (7) is done by press fitting and heating.

SUMMARY:
This invention relates to a safe and effective device to protect the healthcare personnel from exposure to harmful drug aerosols and to maintain the sterility of the drug. This is a simple sterile device, which is used for air pressure balance in a sealed vial or i.v. bags. This simple unit is basically a sterile hydrophobic filter, which is to be fitted to a sterile device. While reconstitutions of sterile dry powders or lyophilized powders, drug aerosols get generated in the vial and tend to enter the immediate atmosphere outside the vial along with the air. This might be very hazardous for the administrators, especially if the drug is an oncological product. Hence the air in the vial should be released, while retaining the aerosolized drug particles. Therefore a hydrophobic filter is fitted in the vent lumen for air filtration. Thus providing a safe environment for the physicians and other healthcare practitioners.
As the sterility of the drug is a prime aspect for injectables, thus provision of sterile air into the containers in very important. Thus a vent lumen having a hydrophobic filter pore size sufficient enough for maximum particle retention capacity fulfills this aspect. The device consists of a hydrophobic filter with pore size of 0.2 microns or 0.45 microns, which effectively retains the aerosolized particles in the vial whereas filtering sterile, bacterial and endotoxin free air into the sealed container. This in turn provides sterile medication for the patient. This device acts as a sterile barrier, and filters air while reconstitution or withdrawal of liquids from a sealed container.
The device is made simple and convenient so as to avoid chaos and tedious
procedures to maintain the sterility of the drug, while dispensing the drug by
the busy doctors or healthcare practitioners.
OBJECT OF THE INVENTION:
1. One of the objects of the present invention is to provide safe, economical and simple apparatus for compounding dry powder injectables, liquids injectables and i.v. fluids.
2. The present invention provides sterilizable filter, which can by using ethylene oxide.
3. One of the objects of the present invention is to provide ease of assembling and disassembling of filter module.
4. The present invention also delivers consistent operation in terms of maintaining sterile air filtration s.
5. This unit helps in administration of medicaments safely to the patient without getting exposed to harmful fumes.
6. This device is used to maintain the air pressure balance between inside and outside the vial.
7. This unit is available in two types of filters i.e. 0.22μm and 0.45 μm filtration medias.
8. This device helps in maintaining sterile environment for the medicaments.
9. This device also provides bacterial and endotoxin free air filtration.
10. An easy to use device, which protects patients and healthcare professionals with hydrophobic barrier.

REFERENCES:
1. International Publication no: - WO 2007/079048 A2
2. US Patent No:-5833213
3. International Patent No: - WO 2008/036101 A2
4. US Patent No: - 4743243
5. US Patent No: - 5451374
6. US Patent No: - 4645073
7. National Institute For Occupational Safety and Health (NIOSH) http://www.cdc.gov/niosh

We Claim:
1. 'Needle - Free Dispensing Pins' is a needle free device used for
balancing air pressure while reconstituting and withdrawal of liquids
from vials and i.v. bags, the device consists of:
a hollow cap,
a sterile disc filter of 0.2 microns or of 0.45 microns.
a V- shaped tapering body along with sharp cannula.
2. 'Needle - Free Dispensing Pins' of claim 1 wherein said filter media of pore size 0.2 microns or 0.45 microns.
3. 'Needle — Free Dispensing Pins' of claim 1 wherein said the hollow cap and the body may have various geometric shapes like square, hexagonal, triangle.
4. 'Needle — Free Dispensing Pins' of claim 1 wherein said filter media are hydrophobic in nature.
5. 'Needle — Free Dispensing Pins' of claim 1 wherein said the filter media is fitted in tongue and groove arrangement thereby fiction is avoided.
6. 'Needle - Free Dispensing Pins' of claim 1 wherein said is a sterile connector between the inner environment of the drug container and the outer atmosphere.
7. 'Needle — Free Dispensing Pins' of claim 1 wherein said the wings i.e the hollow cap is provided to transmit uniform force along the periphery of the device from all the sides while insertion into the container.
8. 'Needle — Free Dispensing Pins' of claim 1 wherein said at least one hydrophobic filter is present between the sharp cannula and the outer opening i.e. the hollow cap.
9. 'Needle — Free Dispensing Pins' of claim 1 wherein said the V-shaped body of the device provides a large the surface area for filtration.

10. 'Needle - Free Dispensing Pins' of claim 1 wherein said the outer diameter of hollow cap is larger than the outer diameter of the cannula..
11. 'Needle - Free Dispensing Pins' of claim 1 wherein said the V-shaped walls of the body of the device which is molded with the cannula makes an obtuse angle.

12. 'Needle — Free Dispensing Pins' of claim 1 wherein said the cross sectional shape of the body of the device is generally concave inside and is of frustoconical shape.
13. 'Needle - Free Dispensing Pins' of claim 1 wherein said at least one the hydrophobic filter is enclosed within the hollow cap and the body of the device.
14. 'Needle — Free Dispensing Pins' of claim 1 wherein said the device can be dismantled into three parts i.e. the hollow cap, a hydrophobic filter and the body molded along with the sharp cannula of the device.

15. 'Needle — Free Dispensing Pins' of claim 1 wherein said the device has sharp cannula.
16. 'Needle — Free Dispensing Pins' of claim 1 wherein said the device is made of rigid material.
17. 'Needle — Free Dispensing Pins' of claim 1 wherein said there are two separate molds made. One for the hollow cap and the other for the body along with the sharp cannula.
18. 'Needle - Free Dispensing Pins' of claim 1 wherein said the filter paper
is sealed by its outer diameter to the hollow cap thus making an
impervious joint.
19. 'Needle - Free Dispensing Pins' of claim 1 wherein said the material of
the device is made of medical grade plastic.
20. 'Needle - Free Dispensing Pins' of claim 1 wherein said the hollow cap
and the body is sealed by press fitting and heating.

21. 'Needle — Free Dispensing Pins' of claim 1 wherein said the material of the dispensing pins has high chemical resistance and an excellent resistance to sterilization.