DESC:FORM – 2

THE PATENTS ACT, 1970
(39 of 1970)

COMPLETE SPECIFICATION
(SECTION 10, RULE 13)

“AN ADRENALINE PREFILLED SYRINGE”

AGRAWAL, Pawan
Indian National
F 22, Akash Tower,
Opp: Premchand Nagar,
Judges Bunglow Road, Satellite,
Ahmedabad-380054,
Gujarat State, INDIA

AGARWAL, Zameer
Indian National
F 22, Akash Tower,
Opp: Premchand Nagar,
Judges Bunglow Road, Satellite,
Ahmedabad-380054,
Gujarat State, INDIA

The following specification particularly describes the nature of this invention and manner in which it is to be performed:-

FIELD OF INVENTION

The present invention relates to an Adrenaline prefilled syringe. In particular present invention relates to an Adrenaline prefilled syringe for retaining effectiveness and enabling aseptic administration of Adrenaline.

BACKROUND AND PRIOR ART

Adrenaline (also known as Adrenalin or Epinephrine) is a hormone and a neurotransmitter. Chemically, Adrenaline is one of a group of monoamines called the catecholamines. It is produced from the amino acids phenylalanine and tyrosine, in some neurons of the central nervous system, and in the chromaffin cells of the adrenal medulla. Adrenaline has many functions in the body such as regulating heart rate, blood vessel and air passage diameters, and metabolic shifts; Adrenaline release is a crucial component of the fight-or-flight response of the sympathetic nervous system.
Indications of Adrenaline
Adrenaline is used to treat a number of conditions as below:
Adrenaline affects the contractility and rate, of the heart thereby used in treating Cardiac arrest. Adrenaline is used for severe allergic reactions, which includes life-threatening angioedema and anaphylactic shock. It is used to treat anaphylaxis due to its vasoconstrictive effects. Adrenaline is also used as a bronchodilator for asthma. It is also used for the treatment of croup, superficial bleeding bronchospasm and hypoglycemia. In addition, Adrenaline is used as a vasoconstrictor to slow down the absorption and, therefore, prolong the action of the anesthetic agent.
Adrenaline is administered using syringes that are filled from the Adrenaline single or multi dose glass vials. Further conventional syringe are made up of polymers that requires more gliding force while injecting Adrenaline i.e. more force has to be applied to the plunger of the syringe to inject the drug making handling of the syringe cumbersome and inconvenient.

DISADVANTAGES OF THE PRIOR ART

Syringes generally used to administer Adrenaline suffer from at least one of the following disadvantages:

Conventional syringes are required to be filled from vials before administering drug to the patient. In doing so the drug comes in contact with particulate and microbial contaminants that contaminate the drug which further causes serious health complications.

In conventional syringe the drug is filled from vials which are required to handle separately. This leads to increase in medical wastage.

Conventional syringe does not provide easy gliding force to the syringe which makes the syringe inconvenient and cumbersome in handling.

Hence, there is an unmet need to provide an Adrenaline prefilled syringe for retaining effectiveness and enabling aseptic administration of Adrenaline.

OBJECTS OF THE INVENTION

The main object of the present invention is to provide an Adrenaline prefilled syringe for retaining effectiveness and enabling aseptic administration of Adrenaline.

Another object of the present invention is to provide an Adrenaline prefilled syringe that has no risk of microbial contamination.

Yet another object of the present invention is to an Adrenaline prefilled syringe that is free from risk of particulate contamination.

Yet another object of the present invention is to provide an Adrenaline prefilled syringe whereby there is considerable reduction in medical wastage.

Yet another object of the present invention is to provide an Adrenaline prefilled syringe that provides easy gliding force to the plunger of the syringe making it more convenient in handling.

BRIEF DESCRIPTION OF DRAWINGS:
Fig 1 : Stacked Needle type prefilled syringe
Fig 2 : Luer-lock type prefilled syringe

DESCRIPTION OF INVENTION

The embodiment of the present invention relates an Adrenaline prefilled syringe for retaining effectiveness and enabling aseptic administration of Adrenaline. The present syringe is prefilled and does not require filing the drug from vial and so there are no chances of exposure of Adrenaline to microbial or particulate contaminants; hence there is no risk of Adrenaline getting contaminated which further avoids the risk of serious health complications. The present syringe being prefilled does not require separate handling of syringe and vials and hence there is considerable reduction in medical wastage. Hence the present syringe enables aseptic drug delivery and being contamination free, its effectiveness is retained.

The stability tests have been performed to check the stability of an Adrenaline prefilled syringe containing Adrenaline which is shown in the Table A which shows that the said Adrenaline prefilled syringe is non toxic i.e. it do not impart any toxicity to the Adrenaline. Further Table A also shows that Adrenaline remains sterile in the said Adrenaline prefilled syringe. Moreover Table A also shows that the pH of the Adrenaline in an Adrenaline prefilled syringe remains within the acceptance range. Also the assay of Adrenaline from initial point to six months remains within the labeled criteria.
The said Adrenaline prefilled syringe is further Stacked Needle type Adrenaline prefilled syringe or Luer-lock type Adrenaline prefilled syringe.

The Stacked Needle type Adrenaline prefilled syringe mainly comprises of:

• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Needle,
• Rubber Needle Shield, and
• Plastic Needle Shield

Whereas the Luer-lock type Adrenaline prefilled syringe mainly comprises of:

• Barrel,
• Plunger Rod,
• Rubber Stopper,
• Plastic Luer Lock,
• Plastic Luer Tip, and
• Rubber Luer Tip.

Reference numerals for the said component parts of an Adrenaline prefilled syringe of each of the above said types are:

1 : An Adrenaline prefilled syringe
1A : Stacked Needle type Adrenaline prefilled syringe
1B : Luer-lock type Adrenaline prefilled syringe
2 : Barrel
3 : Rubber Stopper
4 : Plunger Rod
5 : Plastic Luer Lock
6 : Plastic Luer Tip
7 : Rubber Luer Tip
8 : Needle
9 : Rubber Needle Shield
10 : Plastic Needle Shield

Referring to Fig. 1, shows an Adrenaline prefilled syringe (1) specifically, Stacked Needle type Adrenaline prefilled syringe (1A) which mainly comprises of a Barrel (2) made of glass, wherein further the said barrel is a hollow tube for the drug to be filled and is open at one end, a Plunger Rod (4) with a Rubber Stopper (3) for filling or emptying the said Barrel (2), wherein the said Plunger Rod (4) with a Rubber Stopper (3) on top of it is inserted into the open end of the Barrel (2) wherein the diameter of the open end of the said Barrel (2) and the said Rubber Stopper (3) are such that that it forms a tight seal or a lock such that no leakage occurs from the lower end of the said Barrel (2) and the said plunger is pulled back to fill the barrel and is pushed forward for emptying, a needle (8) for administering the drug in the said syringe to the subject, a Rubber Needle Shield (9) and a Plastic Needle Shield (10) to cover the needle (8) and maintain its sterility.

Referring to fig. 2, shows an Adrenaline prefilled syringe (1) specifically, Luer-lock type Adrenaline prefilled syringe (1B) which mainly comprises of a Barrel (2) made of glass, wherein further the said barrel is a hollow tube for the drug to be filled and is open at one end, a Plunger Rod (4) with a Rubber Stopper (3) for filling or emptying the said Barrel (2), wherein the said Plunger Rod (4) with a Rubber Stopper (3) on top of it is inserted into the open end of the Barrel (2) wherein the diameter of the open end of the said Barrel (2) and the said Rubber Stopper (3) are such that that it forms a tight seal or a lock such that no leakage occurs from the lower end of the said Barrel (2) and the said plunger is pulled back to fill the barrel and is pushed forward for emptying, a Plastic Luer Lock (5) which is a screw lock mechanism to securely holds the needle (8) in place, a Plastic Luer Tip (6) and Rubber Luer Tip (7) to cover the needle (8) and maintain its sterility.

Siliconization of prefilled syringe containing Adrenaline

The said Adrenaline prefilled syringe (1) is silicon layered to facilitate the movement of rubber plunger through the Barrel (2) with easy gliding force wherein medical grade silicone oil is used as a lubricant. Silicone oil is sprayed using a diving or static nozzle depending on the siliconization process. Further, the said syringes are subjected to baking by hot air that is free from water vapor. This silicone-coated syringe is baked to a 70-75°C for 50-60 minutes which results in longer chains that gets closely adhered to the surface they coat. Baking silicone reduces both the concentration of silicone in the syringe and the chemical reactivity that improves stability of the product. It also reduces the frequency of the “break loose” effect thereby improving the gliding force of the plunger stopper. The distribution of the silicone inside the syringe is homogenous and uniform to generate a smooth sliding profile for the plunger stopper. The gliding force of the conventional syringe is 10 N whereas that of prefilled syringe containing Adrenaline made of glass is in the range of 3-5 N.

Hence siliconization of the said Adrenaline prefilled syringe imparts easy gliding force to the syringe making it less cumbersome and more convenient in handling.

Coating on Rubber Stopper (3):

The Rubber Stopper (3) of the said Adrenaline prefilled syringe (1) is coated with silicone oil or with fluorocarbon coating to avoid reaction of the said Rubber Stopper (3) with the Adrenaline filled in the syringe.

Having described what is considered the best form presently contemplated for embodying the present invention, various alterations, modifications, and/or alternative applications of the invention will be promptly apparent to those skilled in the art. Therefore, it is to be understood that the present invention is not limited to the practical aspects of the actual preferred embodiments hereby described and that any such modifications and variations must be considered as being within the spirit and the scope of the invention, as described in the attached claims.

The table for the experimental data of various tests mentioned in the description as conducted at Roselabs Bioscience is given below:

Table A:

,CLAIMS:WE CLAIM:

1. An Adrenaline prefilled syringe (1) wherein the said Adrenaline prefilled syringe are Stacked Needle type Adrenaline prefilled syringe (1A) or Luer-lock type Adrenaline prefilled syringe (1B)

wherein further Stacked Needle type Adrenaline prefilled syringe (1A) mainly comprises of a Barrel (2), which is a hollow tube for the drug to be filled and is open at one end, a Plunger Rod (4) with a Rubber Stopper (3) for filling or emptying the said Barrel (2), wherein the said Plunger Rod (4) with a Rubber Stopper (3) on top of it is inserted into the open end of the Barrel (2) wherein the diameter of the open end of the said Barrel (2) and the said Rubber Stopper (3) are such that that it forms a tight seal or a lock such that no leakage occurs from the lower end of the said Barrel (2) and the said plunger is pulled back to fill the barrel and is pushed forward for emptying, a needle (8) for administering the drug in the said syringe to the subject, a Rubber Needle Shield (9) and a Plastic Needle Shield (10) to cover the needle and maintain its sterility;

whereas the Luer-lock type Adrenaline prefilled syringe (1B) mainly comprises of a Barrel (2), which is a hollow tube for the drug to be filled and is open at one end, a Plunger Rod (4) with a Rubber Stopper (3) for filling or emptying the said Barrel (2), wherein the said Plunger Rod (4) with a Rubber Stopper (3) on top of it is inserted into the open end of the Barrel (2) wherein the diameter of the open end of the said Barrel (2) and the said Rubber Stopper (3) are such that that it forms a tight seal or a lock such that no leakage occurs from the lower end of the said Barrel (2) and the said plunger is pulled back to fill the barrel and is pushed forward for emptying, a Plastic Luer Lock (5) which is a screw lock mechanism to securely holds the needle in place, and Luer Lock tips.

2. An Adrenaline prefilled syringe (1) according to claim 1, wherein the said barrel (2) is made of glass.

Dated this 16th day of October 2013.

____________________________
Gopi J. Trivedi (Ms.)
Patent Attorney
At Y.J. Trivedi & Co.
Authorized Agent of the Applicant

To,
The Controller of Patents,
The Patent Office,
At Mumbai.