WO2011117878A1 - Seringue pré-remplie en plastique - Google Patents

Seringue pré-remplie en plastique Download PDF

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Publication number
WO2011117878A1
WO2011117878A1 PCT/IN2010/000308 IN2010000308W WO2011117878A1 WO 2011117878 A1 WO2011117878 A1 WO 2011117878A1 IN 2010000308 W IN2010000308 W IN 2010000308W WO 2011117878 A1 WO2011117878 A1 WO 2011117878A1
Authority
WO
WIPO (PCT)
Prior art keywords
plastic
syringe
plunger
polycarbonate
filled
Prior art date
Application number
PCT/IN2010/000308
Other languages
English (en)
Inventor
Pawan Trilokchand Agrawal
Zameer Pawan Agarwal
Original Assignee
Pawan Trilokchand Agrawal
Agarwal Zameer Pawan
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pawan Trilokchand Agrawal, Agarwal Zameer Pawan filed Critical Pawan Trilokchand Agrawal
Publication of WO2011117878A1 publication Critical patent/WO2011117878A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula

Definitions

  • 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.
  • 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.
  • 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.
  • the drug and diluent may be in constant contact with the components like the piston and nozzle cap for months or years.
  • the components like the piston and nozzle cap for months or years.
  • protein and peptide based drugs which can bind to the surface of glass surfaces and be more capable of degradation from silicone oils.
  • glass is breakable and requires more care when filling and handling.
  • glass is more expensive compared to plastic.
  • 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.
  • 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.
  • the polypropylene is not biodegradable so it is not environment friendly and it will not help in reducing the medical waste.
  • glass is biodegradable but the process is very expensive and it is breakable also.
  • polycarbonate medical grade of plastic by which we will get good stability of formulation compared to glass and polypropylene.
  • polycarbonate is biodegradable so it is environment friendly. Furthermore, it is cost reductive and reduce the medical waste.
  • 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%.
  • 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.
  • the syringe used is made of polycarbonate medical grade of plastic which is biodegradable so it would even help in cutting the medical waste.
  • 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.
  • 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.
  • 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.
  • polycarbonate medical grade of plastic Some polycarbonate grades are used in medical application which is known as polycarbonate medical grade of plastic.
  • 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.
  • 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.
  • 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.

Abstract

L'invention concerne des seringues pré-remplies, jetables, pour injecter un volume de remplissage inférieur ou égal à 10 ml, en plastique polycarbonate de qualité médicale. Le corps de la seringue qui comprend un cylindre, un piston plongeur et un embout Luer est transparent comme le plastique polycarbonate de qualité médicale et est résistant aux agrégations de protéines, aux risques d'immunogénicité et aux renvois de produit.
PCT/IN2010/000308 2010-03-20 2010-05-13 Seringue pré-remplie en plastique WO2011117878A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN782MU2010 2010-03-20
IN782/MUM/2010 2010-03-20

Publications (1)

Publication Number Publication Date
WO2011117878A1 true WO2011117878A1 (fr) 2011-09-29

Family

ID=44672507

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2010/000308 WO2011117878A1 (fr) 2010-03-20 2010-05-13 Seringue pré-remplie en plastique

Country Status (1)

Country Link
WO (1) WO2011117878A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015173260A1 (fr) * 2014-05-12 2015-11-19 Formycon Ag Seringue en plastique préremplie contenant un antagoniste de vegf
WO2017085253A1 (fr) 2015-11-18 2017-05-26 Formycon Ag Seringue en plastique préremplie contenant un antagoniste du facteur de croissance de l'endothélium vasculaire (vegf)
WO2017087798A1 (fr) 2015-11-18 2017-05-26 Formycon Ag Conditionnement pharmaceutique prérempli comprenant une formulation liquide d'un antagoniste du vegf
WO2017087871A1 (fr) 2015-11-18 2017-05-26 Sio2 Medical Products, Inc. Emballage pharmaceutique pour formulations ophtalmiques
WO2018218013A2 (fr) 2017-05-24 2018-11-29 Sio2 Medical Products, Inc. Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques
WO2018217995A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf
WO2019191269A1 (fr) 2018-03-27 2019-10-03 Sio2 Medical Products, Inc. Récipients, contenants et surfaces revêtues de revêtements faisant barrière à l'eau
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
WO2022204675A1 (fr) * 2021-03-26 2022-09-29 Saint-Gobain Performance Plastics Corporation Matériau multicouche et son procédé de fabrication et d'utilisation

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6065270A (en) * 1996-12-18 2000-05-23 Schott Glaswerke Method of producing a filled plastic syringe body for medical purposes
US6090081A (en) * 1997-05-22 2000-07-18 Daikyo Seiko, Ltd. Sealing stopper for a syringe and a prefilled syringe
US6626870B1 (en) * 2000-03-27 2003-09-30 Artix Laboratories, Inc. Stoppering method to maintain sterility
CN1882368A (zh) * 2003-10-01 2006-12-20 贝克顿·迪金森公司 可萃取物低的热塑性注射器和针尖盖帽
WO2007103998A2 (fr) * 2006-03-08 2007-09-13 Gilero, Llc Couvercle anti-contamination pour un raccord pour passage de fluide

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6065270A (en) * 1996-12-18 2000-05-23 Schott Glaswerke Method of producing a filled plastic syringe body for medical purposes
US6090081A (en) * 1997-05-22 2000-07-18 Daikyo Seiko, Ltd. Sealing stopper for a syringe and a prefilled syringe
US6626870B1 (en) * 2000-03-27 2003-09-30 Artix Laboratories, Inc. Stoppering method to maintain sterility
CN1882368A (zh) * 2003-10-01 2006-12-20 贝克顿·迪金森公司 可萃取物低的热塑性注射器和针尖盖帽
WO2007103998A2 (fr) * 2006-03-08 2007-09-13 Gilero, Llc Couvercle anti-contamination pour un raccord pour passage de fluide

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3492495A1 (fr) 2014-05-12 2019-06-05 Formycon AG Seringue en plastique préremplie contenant un antagoniste de vegf
WO2015173260A1 (fr) * 2014-05-12 2015-11-19 Formycon Ag Seringue en plastique préremplie contenant un antagoniste de vegf
EP3828202A1 (fr) 2014-05-12 2021-06-02 Formycon AG Seringue en plastique préremplie contenant un antagoniste de vegf
US10925927B2 (en) 2015-11-18 2021-02-23 Formycon Ag Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
WO2017085253A1 (fr) 2015-11-18 2017-05-26 Formycon Ag Seringue en plastique préremplie contenant un antagoniste du facteur de croissance de l'endothélium vasculaire (vegf)
WO2017087798A1 (fr) 2015-11-18 2017-05-26 Formycon Ag Conditionnement pharmaceutique prérempli comprenant une formulation liquide d'un antagoniste du vegf
WO2017087871A1 (fr) 2015-11-18 2017-05-26 Sio2 Medical Products, Inc. Emballage pharmaceutique pour formulations ophtalmiques
US11666632B2 (en) 2015-11-18 2023-06-06 Formycon Ag Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US11654046B2 (en) 2015-11-18 2023-05-23 Sio2 Medical Products, Inc. Pharmaceutical package for ophthalmic formulations
US11298405B2 (en) 2015-11-18 2022-04-12 Formycon Ag Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
US10905786B2 (en) 2017-03-27 2021-02-02 Regeneron Pharmaceuticals, Inc. Sterilisation method
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
WO2018217995A1 (fr) 2017-05-24 2018-11-29 Formycon Ag Conditionnements pharmaceutiques pré-remplis stérilisables comprenant une formulation liquide d'un antagoniste du vegf
WO2018218013A2 (fr) 2017-05-24 2018-11-29 Sio2 Medical Products, Inc. Conditionnement pharmaceutique stérilisable pour formulations ophtalmiques
US11433186B2 (en) 2017-12-13 2022-09-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
WO2019191269A1 (fr) 2018-03-27 2019-10-03 Sio2 Medical Products, Inc. Récipients, contenants et surfaces revêtues de revêtements faisant barrière à l'eau
US11439758B2 (en) 2019-06-05 2022-09-13 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
WO2022204675A1 (fr) * 2021-03-26 2022-09-29 Saint-Gobain Performance Plastics Corporation Matériau multicouche et son procédé de fabrication et d'utilisation

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