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WO2011117877A1 - Seringue pré-remplie à chambre double - Google Patents

Seringue pré-remplie à chambre double Download PDF

Info

Publication number
WO2011117877A1
WO2011117877A1 PCT/IN2010/000307 IN2010000307W WO2011117877A1 WO 2011117877 A1 WO2011117877 A1 WO 2011117877A1 IN 2010000307 W IN2010000307 W IN 2010000307W WO 2011117877 A1 WO2011117877 A1 WO 2011117877A1
Authority
WO
WIPO (PCT)
Prior art keywords
chamber
dual chamber
syringe
filled plastic
plastic syringe
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IN2010/000307
Other languages
English (en)
Inventor
Pawan Trilokchand Agrawal
Zameer Pawan Agarwal
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2011117877A1 publication Critical patent/WO2011117877A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2448—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing

Definitions

  • the present invention relates to an improved pre-filled syringe and more particularly to a dual chamber pre-filled syringe for mixing of two substances in one device.
  • Dual chamber syringe technology assures highly efficient drug use through gentle product constitution.
  • the dual chamber syringe was designed specifically for sensitive drug requiring lyophilization to maintain their desired shelf life.
  • the actual active ingredient is lyophilized in one chamber, while the other chamber of the syringe contains a solvent that is mixed with the active substance immediately before application.
  • Dual chamber syringes are available in glass and plastic material. Generally, glass dual chamber syringes have used type I borosilicate glass barrels, rubber pistons, 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
  • 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 20040236273 Al discloses a dual chamber type pre-filled syringe which comprises a cylindrical member made of glass or plastic an interior area of which is portioned into a front chamber and a rear chamber by a plurality of plug members. The front chamber and the rear chamber containing an injection agent and its dissolving solution or the like. But the problem with this type of syringe is that, at the time of use there is a possibility of leakage of liquid out of the injection needle.
  • US 2006018138 discloses a combined container syringe which can be pre-filled with a drug, stored and immediately used after removal from the package at the time of usage.
  • This combined container syringe comprises a glass cylinder, a cylindrical tip, and a finger grip, and a drug is pre-filled therein and sealed by stopper. Because it is made of glass, there is a possibility of breakage during storage.
  • Dual chamber type pre-filled syringe described above in the references is made of glass or plastic which cause protein aggregation, immunogenicity and product returns.
  • plastic is not degradable so it is not environment friendly and it would not help in cutting the medical waste.
  • Glass is biodegradable but the process is very expensive and it is also breakable.
  • the problem associated with this type of pre-filled syringe described above is the leakage of liquid from the needle at the time of use and its working mechanism is also complicated.
  • the main object of the invention is to provide an improved designed dual chamber pre-filled syringe which makes the working mechanism simpler.
  • Another object of the present invention is to provide a dual chamber pre-filled syringe which is made of polycarbonate medical grade of plastic.
  • It is an additional object of this invention is to provide a dual chamber polycarbonate pre-filled syringe by which we will get the stability of drug during storage.
  • It is still another object of the invention is to provide a polycarbonate dual chamber pre-filled syringe which is biodegradable so it will reduce the medical waste as well as cost.
  • the present invention discloses a dual chamber type pre-filled syringe having two chambers where it makes easy for mixing of powder and liquid in one device only. Further, the present invention relates to a dual chamber type pre-filled syringe which is made of polycarbonate medical grade of plastic by which we will get stability of drug during storage.
  • the main purpose of this invention is to provide an improved designed dual chamber pre-filled syringe which makes the working mechanism of mixing of two substances simpler.
  • this syringe is made of polycarbonate medical grade of plastic which is biodegradable so it would help in reducing the medical waste.
  • the dual chamber type pre-filled syringe has major four parts: barrel 2, stopper 7a, stopper 7b and plunger 3.
  • the barrel 2 further includes front chamber 4, tunnel 6 and rear chamber 5.
  • front chamber 4 powder 8 is filled in total vacuum area and then stopper 7a is placed and further liquid 10 is filled in rear chamber 5 and other stopper 7b is placed.
  • 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 preassembled unit consisting of the body of the syringe which further consisting of front chamber, rear chamber and tunnel.
  • Fig. 3 shows a cross sectional view of a tunnel.
  • Fig. 4 shows a longitudinal section of a fully assembled, dual chamber syringe used for medicinal purpose.
  • Fig. 5 is a view like fig. 4 but showing the syringe in the mixing position.
  • Fig. 6 shows a longitudinal section of a syringe in the ready-to-use position.
  • 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 dual chamber type pre-filled syringe by which we can easily mix the powder and liquid in one device. Further, it is made of polycarbonate medical grade of plastic by which we will get stability of drug during storage.
  • the polycarbonate material is better alternative to glass and 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 nontoxic. 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 drug during storage.
  • body of syringe 1 consist of a cylindrical barrel 2 and luer tip 11 both made of polycarbonate medical grade of plastic.
  • the syringe manufactures delivers the preassembled unit as shown in fig. 1 to the pharmacist, who then attach the plunger at the time of use.
  • body of syringe 1 further consist of front chamber 4, rear chamber 5 and tunnel 6 between two chambers.
  • syringe 1 of the present invention comprises cylindrical barrel 2, in which a plunger 3 is provided on one end while the other end have a luer tip 11 which forms one chamber between them.
  • This chamber is further divided into two further chambers: front chamber 4 and rear chamber5 .
  • Front chamber 4 is filled with powder8 in total vacuum area along with nitrogen gas9 and rear chamber5 is filled with liquidlO.
  • stopper 7a is placed between front chamber 4 and rear chamber5 which covers half of the tunnel6.
  • stopper7a is placed at the top of barrel.
  • the wall thickness of chamber 4 would vary from chamber 5 just by 0.1 mm. The diameter of the stoppers would even vary just by 0.1 mm.
  • mixing position of the drug is shown.
  • the stopper 7a shifts to tunnel and by which the liquid gets slide down in the other chamber. After that mixing of the formulation is possible.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une seringue en plastique pré-remplie à chambre double préparée au moyen d'un polycarbonate de plastique de qualité médicale, comprenant deux chambres, l'une contenant la forme poudreuse d'une substance pharmaceutique à injecter et l'autre contenant le liquide dans lequel la substance pharmaceutique est dissoute. Une buté est disposée entre les deux chambres afin de maintenir séparés les contenus de ces dernières. Lorsqu'une pression est appliquée sur le piston-plongeur, la butée atteint un canal qui présente un espace permettant l'entrée du liquide dans l'autre chambre. Le liquide se mélange avec la poudre dans l'autre chambre et la formulation est prête à être injectée. La seringue en plastique pré-remplie à chambre double permet d'économiser du temps et de l'argent et de réduire les déchets médicaux.
PCT/IN2010/000307 2010-03-22 2010-05-13 Seringue pré-remplie à chambre double Ceased WO2011117877A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN777MU2010 2010-03-22
IN777/MUM/2010 2010-03-22

Publications (1)

Publication Number Publication Date
WO2011117877A1 true WO2011117877A1 (fr) 2011-09-29

Family

ID=44672506

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2010/000307 Ceased WO2011117877A1 (fr) 2010-03-22 2010-05-13 Seringue pré-remplie à chambre double

Country Status (1)

Country Link
WO (1) WO2011117877A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014099846A1 (fr) * 2012-12-20 2014-06-26 Merck Sharp & Dohme Corp. Seringues de mélange à chambre double et procédés d'utilisation de celles-ci
CN108421132A (zh) * 2018-03-11 2018-08-21 杨博 药物复原装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3016896A (en) * 1960-01-26 1962-01-16 Wilton E Van Sickle Disposable hypodermic syringe
US4599082A (en) * 1984-08-13 1986-07-08 Becton, Dickinson And Company Two-component syringe assembly
US5665068A (en) * 1991-06-26 1997-09-09 Arte Corporation Dual chamber prefillable syringe
US5788670A (en) * 1994-12-22 1998-08-04 Schott Glas Dual chamber prefillable syringe and a method for the assembly and filling of same
US6626870B1 (en) * 2000-03-27 2003-09-30 Artix Laboratories, Inc. Stoppering method to maintain sterility
US20060084909A1 (en) * 2004-07-12 2006-04-20 Chung Yuan Christian University Syringe with separate cavities
WO2006056452A1 (fr) * 2004-11-24 2006-06-01 Cilag Ag Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3016896A (en) * 1960-01-26 1962-01-16 Wilton E Van Sickle Disposable hypodermic syringe
US4599082A (en) * 1984-08-13 1986-07-08 Becton, Dickinson And Company Two-component syringe assembly
US5665068A (en) * 1991-06-26 1997-09-09 Arte Corporation Dual chamber prefillable syringe
US5788670A (en) * 1994-12-22 1998-08-04 Schott Glas Dual chamber prefillable syringe and a method for the assembly and filling of same
US6626870B1 (en) * 2000-03-27 2003-09-30 Artix Laboratories, Inc. Stoppering method to maintain sterility
US20060084909A1 (en) * 2004-07-12 2006-04-20 Chung Yuan Christian University Syringe with separate cavities
WO2006056452A1 (fr) * 2004-11-24 2006-06-01 Cilag Ag Dispositif servant a administrer une substance, notamment dans le domaine medical, et se presentant en particulier sous la forme d'une seringue en plastique a deux chambres

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014099846A1 (fr) * 2012-12-20 2014-06-26 Merck Sharp & Dohme Corp. Seringues de mélange à chambre double et procédés d'utilisation de celles-ci
CN108421132A (zh) * 2018-03-11 2018-08-21 杨博 药物复原装置
CN108421132B (zh) * 2018-03-11 2024-04-12 杨一博 药物复原装置

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