PLASTIC PRE-FILLED SYRINGE
FIELD OF THE INVENTION:
The present invention relates to a plastic pre-filled syringe and more particularly to an improved plastic pre-filled syringe which is made up of Poly- Carbonate medical grade of plastic by which we will get stability of formulation. BACKGROUND OF THE INVENTION:
Today, pre-filled syringes are available in various shapes, sizes and materials. The pre-filled syringes available in the market are generally made of glass and plastic materials. Generally, pre-filled syringes have used type I borosilicate glass barrels, rubber piston, nozzle caps and silicone lubricants. Silicone lubricant improves piston release and travel forces. The application of silicone oil is inconsistent, which results in variability in functional properties. The silicone oil in glass barrels can transfer to the drug product, which cause protein aggregation and a possible source of immunogenicity risk and product returns.
In a pre-filled syringe, the drug and diluent may be in constant contact with the components like the piston and nozzle cap for months or years. With increasing prevalence of protein and peptide based drugs which can bind to the surface of glass surfaces and be more capable of degradation from silicone oils. Additionally, glass is breakable and requires more care when filling and handling. Furthermore, glass is more expensive compared to plastic. Thus, glass pre-filled syringe presents design and manufacturing challenges.
Plastic syringe offers a true benefit over glass syringe. Plastic syringe provides robustness against breakability and lightweight, while delivering for many products an enough stability performance level. The further advantages are simple disposal, ease of manipulation, economy of space during storage, dosage precision, cost reductive and reduce medical waste.
Plastic syringes were made from polypropylene grade of polymers earlier. But the plastic grade used in these syringes usually fails to get the stability of the drug during storage like glass as explained above and which does not have the clarity like glass.
US 6331174 Bl discloses pre-filled, low particle, sterile, disposable syringe for injecting preparation with a fill volume of less than 5ml. The body of the syringe is however made of plastic material like polypropylene, so we will not get the stability of formulation as we get in the present invention.
US 6027481 discloses pre-fillable syringe which is made of a low extractable ion glass, which is particularly suited for being pre-filled with substances sensitive to pH shift such as for example water for injection. The problems have been associated with this type of syringes when pre-filled with substances sensitive to pH shift and stored over an extended period of time, including shifts in pH outside the acceptable range of 5-7 for water for injection.
US 5782815 discloses glass cartridge for an injection syringe capable of being pre-filled with pharmaceutical liquid. The glass cartridge comprises a barrel made of a glass tube such as a boro-silicate glass. Further, during process where liquid chemicals are poured into a formed injection syringe and sterilization by pressure steaming is performed, or during a long period of storage time thereafter, metal ions from the inner surface of the glass barrel wall eluted in pharmaceutical liquid. So we will not get the stability of formulation.
However, several disadvantages have been associated with this type of syringes used in the references described above. The syringes used above are made of glass and other plastic material like polypropylene. The syringe used above is pre-filled so drug and diluent may be in contact with for a long period of time and the material used can react with the drug stored, which cause pH shift and protein aggregation. Moreover, the polypropylene is not biodegradable so it is not environment friendly and it will not help in reducing the medical waste. Though, glass is biodegradable but the process is very expensive and it is breakable also.
So we have made syringes of new material called polycarbonate medical grade of plastic, by which we will get good stability of formulation compared to glass and polypropylene. Additionally, polycarbonate is biodegradable so it is environment friendly. Furthermore, it is cost reductive and reduce the medical waste.
OBJECTS OF THE INVENTION:
The main object of the invention is to provide a pre-filled syringe which is made of polycarbonate medical grade of plastic.
Another object of this invention is to provide a polycarbonate pre-filled syringe by which we will get stability of formulation. It is an additional object of this invention is to provide a plastic pre-filled syringe which will be one of the most 100% sterile drug delivery system.
It is still another object of this invention is to provide a plastic pre-filled syringe which is cost reductive compared to glass pre-filled syringes.
It is yet another object of this invention is to make pre-filled syringe which is biodegradable so it will help in cutting of the medical waste by 50%.
SUMMARY OF THE INVENTION:
The present invention discloses a pre-filled syringe which is made up of polycarbonate medical grade of plastic. The main purpose of this invention is to provide a pre-filled, disposable syringe that has durability, lightweight as compared to glass syringe, is an effective structure against pH shift and protein aggregation; due to its effective structure we will get stability of the drug during storage. This syringe also gives 100% sterile drug delivery system and along with that it will be cost reductive as compared to glass pre-filled syringe. Moreover, the syringe used is made of polycarbonate medical grade of plastic which is biodegradable so it would even help in cutting the medical waste. In the preferred embodiment, the prefillable syringe of the present invention includes a cylindrical barrel made of polycarbonate medical grade of plastic with an open front end, a plunger, disposed within the barrel and movable with respect thereto, a stopper which seals front end of the barrel and the luer tip.
BRIEF DESCRIPTION OF THE DRAWINGS:
Fig. 1 shows a longitudinal section of a preassembled unit consisting of the body of the syringe and luer tip.
Fig. 2 shows a longitudinal section of a fully assembled, pre-filled, disposable syringe used for medicinal purpose.
DETAILED DESCRIPTION:
The nature of the invention and the manner in which it is performed is clearly described in the specification. The invention has various components and they are clearly described in the following pages of the complete specification.
The present invention relates to a pre-filled syringe which is made of polycarbonate medical grade of plastic, by which we will get stability of formulation. The polycarbonate material is better alternative to polypropylene. Polycarbonates are a particular group of thermoplastic polymers and they have tendency to easily worked, moulded and thermoformed, so they are widely used in modern chemical industry. The main advantage of polycarbonate over other type of plastics is unbeatable strength combined with lightweight. Moreover, it is stain resistance and non-toxic. Additionally, polycarbonate has better clarity than polypropylene and it is biodegradable.
Some polycarbonate grades are used in medical application which is known as polycarbonate medical grade of plastic. In present invention, syringes are made up of this polycarbonate medical grade of plastic by which we will get stability of the formulation. We would be manufacturing plastic pre-filled syringes in 1 ml, 2 ml, 2.5 ml, 5 ml & 10 ml.
Referring to fig. 1, the syringe 1 consist of barrel 2 and luer tip 5 both made of polycarbonate medical grade plastic. The syringe manufactures delivers the preassembled unit as shown in fig. 1 (i.e., without plunger) to the pharmacist, who then attach the plunger at the time of use. Referring to fig. 2, syringe 1 of the present invention includes a cylindrical barrel 2 made of polycarbonate, in which, a plunger 3 is provided on one end while the other end have a luer tip which forms one chamber between two ends and the pharmaceutical liquid is filled in this chamber. The luer tip is also made of polycarbonate material which keeps the syringe sterile during storage. The plunger can be moved within barrel by plunger rod which is fixed to the plunger. The stopper 4 which closes the barrel is situated in the barrel removed from the plunger. The steps include at the time of use are: (i) remove the luer tip 5 (ii) attach the needle (iii) screw the plunger 3 into stopper 4 (iv) shake the syringe and push the plunger slowly for vaccination.
Although the preferred embodiment as well as the preparation and use have been specifically described, it should be understood that variations in the preferred embodiment could be achieved by a person skilled in the art without departing from the spirit of the invention. The invention has been described with reference to specific embodiments which are merely illustrative and not intended to limit the scope of the invention as defined in the claims.