WO2001022913A1 - Contenant pour perfusion et procede de stockage d'un medicament lyophilise - Google Patents

Contenant pour perfusion et procede de stockage d'un medicament lyophilise Download PDF

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Publication number
WO2001022913A1
WO2001022913A1 PCT/JP2000/006590 JP0006590W WO0122913A1 WO 2001022913 A1 WO2001022913 A1 WO 2001022913A1 JP 0006590 W JP0006590 W JP 0006590W WO 0122913 A1 WO0122913 A1 WO 0122913A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
drug
storage chamber
small container
freeze
Prior art date
Application number
PCT/JP2000/006590
Other languages
English (en)
Japanese (ja)
Inventor
Seizo Sunago
Jiro Fujisaki
Osamu Takahata
Original Assignee
Fujisawa Pharmaceutical Co., Ltd.
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 Fujisawa Pharmaceutical Co., Ltd. filed Critical Fujisawa Pharmaceutical Co., Ltd.
Priority to EP00962838A priority Critical patent/EP1243245A4/fr
Publication of WO2001022913A1 publication Critical patent/WO2001022913A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2031—Separating means having openings brought into alignment

Definitions

  • the present invention relates to an infusion container and a method for accommodating a lyophilized drug, and more particularly, to a method for storing a lyophilized drug and its lysate in a separated state, and storing the lyophilized drug in a container immediately before use.
  • the present invention relates to an infusion container for aseptically mixing a lysis solution and supplying it as an infusion solution, and a method for storing a lyophilized drug in the infusion solution container.
  • a large amount of the drug is appropriately freeze-dried in advance, and a predetermined amount (corresponding to one container unit) is subdivided from the freeze-dried drug to obtain an infusion container.
  • a predetermined amount corresponding to one container unit
  • freeze-dry a predetermined amount of drug in a specific small container in advance, as in Patent Nos. 25511881 and 27671016. After freeze-drying, the freeze-dried drug was taken out of the small container and put into the drug storage room of the infusion container.
  • one of the main objects of the present invention is to provide an infusion container capable of easily storing a lyophilized drug in a drug storage room of the infusion container.
  • Another main object of the present invention is to provide an infusion container capable of storing a drug freeze-dried in a small freeze-drying container in a drug storage chamber of the infusion container without loss due to residue. Disclosure of the invention
  • the present invention includes a drug storage chamber for storing a drug, and a solution storage chamber for storing a solution and connected to the drug storage chamber, wherein the drug storage chamber has a mouth portion opened and freeze-dried.
  • the present invention provides an infusion container, which accommodates a small container containing a drug, is separated from the solution storage chamber during storage, and is communicable when used.
  • the drug previously freeze-dried in the small container is stored in the drug storage chamber together with the small container. Therefore, there is no need to take out the drug from the small container for freeze-drying the drug, and the process of storing the drug becomes extremely easy, and further, the loss of the drug due to the residue can be eliminated.
  • the small container for freeze-drying a drug can store about 0.5 to 4.0 milliliters in a liquid state in which the drug is dissolved (before freeze-drying), and freezes the drug by opening the mouth. It is necessary to have a small container that allows drying and passage of the solution and that can be stored in the medicine storage room of the infusion container (eg, mouth area: 2 to 3 cm 2 * height: 1.0) ⁇ : L. 5 cm), and it is preferable that this small container can be positioned in the medicine storage room of the infusion container.
  • a means for positioning the small container in the medicine storage chamber is to provide a locking part for locking a part of the small container in the medicine storage chamber.
  • a specific example of the locking part is a small container.
  • a vertical groove on the side wall and / or a concave groove on the bottom wall respectively Formed on the container main body of the medicine storage chamber so as to be engaged with these vertical grooves and / or concave grooves. it can.
  • the small container has an open mouth as described above, the small mouth may be provided with a lid having an opening for allowing the solution to pass therethrough.
  • the small container is made of a synthetic resin such as polyethylene, polypropylene, polyvinyl chloride, or cyclic polyolefin or a metal such as aluminum or stainless steel, and is preferably made of polyethylene, polypropylene, or cyclic polyolefin.
  • freeze-dried drug stored in the drug storage chamber of the infusion container of the present invention together with the small container include the following active ingredients.
  • Antibiotics include cefazolin sodium, ceftizoxime sodium, cefotiam hydrochloride, cefmenoxime hydrochloride, cefacetril sodium, cefamandole sodium, cephalorizine, cefataxime sodium, cefotenone sodium, cefoperazone sodium, cefoperone sodium Cefem antibiotics such as gin sodium, ceftezole sodium, cefviramid sodium, cefumesol sodium, cefuroxy sodium, cefoclesulfate, etc., as well as ambicilin sodium, carbenicillin sodium, sulbenicillin sodium Benicillin antibiotics, such as ticarcillin sodium, and vancomycin hydrochloride.
  • Antitumor agents include mitomycin C, fluorouracil, tegafur, and shirababine.
  • Antiulcer agents include famotidine, ranitidine hydrochloride and cimetidine.
  • solutions stored in the solution storage chamber of the infusion container of the present invention examples include, but are not limited to, physiological saline, glucose solution, or amino acid solution to which cysteine, tritophan, etc. are added.
  • the cap member specifically includes, for example, a pierceable plug and a lid arbitrarily attached to the plug.
  • a drug-deterioration preventing agent storage chamber is formed on the upper part of the cap member that seals the mouth of the drug storage chamber (specifically, on the lid described above).
  • You may comprise so that a desiccant and / or an oxygen scavenger can be accommodated as a chemical-alteration inhibitor.
  • the desiccant is intended to stabilize a drug that is denatured by moisture, and includes those containing silica gel, zeolite, or the like as a component.
  • the oxygen scavenger prevents deterioration of the easily oxidizable drug, and examples thereof include those using active iron oxide, amorphous copper, or the like.
  • the desiccant and the oxygen scavenger are appropriately used depending on the type of the drug stored in the drug storage chamber, and may be used alone or simultaneously.
  • the solution storage chamber in the present invention is formed by fusing a sheet of a relatively soft synthetic resin such as polyethylene, polypropylene, or polyvinyl chloride into a bag, or by blowing these synthetic resins into a flexible bag. It is preferably a container.
  • the above-mentioned medicine storage chamber may also be formed of such a flexible container, and both containers may be integrally formed (double bag system).
  • a small container having a vertical side wall and a bottom or bottom wall for locking the container itself in the drug storage chamber by locking the container itself in the drug storage chamber.
  • a small container for freeze-drying a drug having a groove and a z- or concave groove.
  • the present invention provides a medicine storage chamber for storing a medicine
  • a solution is stored therein, and the inside is partitioned with the inside of the medicine storage chamber so as to be communicable when used, and the solution storage chamber is connected to the medicine storage chamber.
  • a small container with an open mouth is filled with a solution in which the drug is dissolved, freeze-dried by a conventional method, and the freeze-dried drug is taken out of the small container without removing the small container.
  • a method for storing a freeze-dried medicine for an infusion container, characterized by being housed in the medicine storage room, is provided.
  • FIG. 1 is a longitudinal sectional view showing an embodiment of an infusion container according to the present invention.
  • FIG. 2 is a longitudinal sectional view in a direction different by 90 ° from FIG.
  • FIG. 3 is a sectional view taken along line AA of FIG.
  • FIG. 4 is a partially exploded perspective view mainly illustrating an open state of the communication hole.
  • FIG. 5 shows the small container for freeze-drying of the drug of FIG. 1, (A) is a plan view, (B) is a partial longitudinal sectional view, and (C) is a bottom view.
  • FIG. 6 is a perspective view of the small container for freeze-drying a drug of FIG. BEST MODE FOR CARRYING OUT THE INVENTION
  • FIG. 1 is a longitudinal sectional view showing an embodiment of an infusion container according to the present invention, and FIG. Longitudinal sectional view in different directions, Fig. 3 is A-A sectional view of Fig. 2, Fig.
  • FIG. 4 is a partially exploded perspective view mainly illustrating an open state of the communication hole
  • FIG. 5 shows the small container for freeze-drying the drug of FIG. 1
  • A) is a plan view
  • B) is a partial longitudinal sectional view
  • C is a bottom view.
  • FIG. 6 is a perspective view of the small container for freeze-drying a drug of FIG.
  • the infusion container 10 shown in FIGS. 1 and 2 is mainly composed of a drug storage chamber 1 for storing a lyophilized drug (not shown) and a lysis solution storage chamber 2 for storing a lysing solution (not shown). ing.
  • the medicine storage chamber 1 is a wide-mouthed container, the bottom of which is connected to the container body 8 connected to the solution storage chamber 2, and the medicine freeze-drying small containers 15 and 15 stored in the container body. It comprises a freeze-dried drug that has been freeze-dried in a container in advance and is stored as it is, and a cap member 3.
  • the container body 8 has, at its upper end, an opening 1a to which the cap member 3 can be attached, and at the bottom 6, a communication hole 5 to be described later.
  • the rigidity is increased compared to the solution storage chamber 2.
  • the solution storage chamber 2 is blow-molded from a transparent polypropylene in a liquid-tight and flat bag shape (thickness: 0.2 to 0.5 hall), and has sufficient flexibility and elasticity.
  • a flange-shaped mouth 2 b connected to a port 1 b formed at the lower end of the medicine storage chamber 1 is formed.
  • a suspension hole 23 as a suspension support is formed.
  • a communication hole 5 (5a, 5b) for communicating between the drug storage chamber 1 and the solution storage chamber 2 is formed at the bottom 6 of the drug storage chamber 1 which is connected to the solution storage chamber 2 in a liquid-tight manner.
  • a pair of protrusions 7 c and 7 d are formed as protrusions 7 that protrude into the medicine storage chamber 1 and cover and seal the communication holes 5.
  • These projections 7c and 7d are a pair of side-by-side towers, especially provided with fin-like ribs 7f7g to provide strength against torsion, and their common bottom part 7c
  • a fan-shaped notch (or opening) 7a.7b is formed in e.
  • the fan-shaped communication holes 5a and 5b formed in the bottom portion 6 of the medicine storage chamber 1 are formed to face each other at the center of the bottom portion 6, and the center angles are all about 90 °.
  • the fan-shaped notches 7a and 7b are formed corresponding to the communication holes 5a and 5 described above. Therefore, by the rotation of the projections 7c and 7d, the notches 7a and 7b of the bottom 7e and a pair of fan-shaped communication holes 5a and 5b formed in the bottom 6 of the medicine storage chamber 1 are formed.
  • 7h is a ridge as one of the protrusions 7 formed on the bottom portion 7e.
  • the protruding portions 7c and 7d are inserted (engaged) into the engaging holes 20d and 20e formed in the rubber plug 20 of the cap member 3 described later, respectively.
  • the cap member 3 and the rubber plug 20 are formed by combining the former Y-shaped socket 31 formed on the ceiling portion with the Y-shaped recessed portion 2 formed on the upper surface portion of the latter. By locking the cap 2, the rotation of the cap member 3 can be reliably transmitted to the rubber plug 20.
  • the communication holes 5a and 5b are closed in a liquid-tight manner by the bottom portion 7e before use, but as shown in FIG.
  • the bottom portion 7e rotates through the through holes 20d and 20e and the protrusions 7c and 7d, and the communication holes 5a * 5b are cutout 7a-7b as shown in Fig. 4.
  • the medicine storage chamber 1 and the solution storage chamber 2 can communicate with each other.
  • the lower surface of the rubber stopper 20 (particularly the stopper body 20a described later) is provided on the lower surface of the rubber stopper 20 to facilitate rotation when the freeze-dried drug is dissolved in the dissolving solution.
  • Ultra-high molecular weight polyethylene film is laminated (to reduce frictional resistance to 1a).
  • a ring-shaped packing 33 is interposed between the rubber stopper 20, the mouth la of the medicine storage chamber 1, and the cap member 3 to improve liquid tightness.
  • the protrusion 7 is a mixture of 10 to 30% of polypropylene and 90 to 70% of polyethylene, and the drug storage chamber 1 is formed of 100% of polypropylene, and both are freeze-dried. Until the medicine and the dissolving solution are mixed, the tree is adhered (temporarily fixed), and the communication holes 5a and 5b are sealed tightly.
  • Two protrusions 1 1 and 1 2 are formed on the outer circumference at equal angular intervals, while the inner surface of the cap member 3 restricts relative movement with the protrusions 1 1 and 1 2 within a range of 90 °. Grooves 3 4-35 are formed.
  • a pair of paragraph portions 40 and 41 are provided 180 around the outer periphery of the container body 8 to facilitate holding the cap member 3 described later when the cap member 3 is rotated. They are formed at intervals (see Fig. 2).
  • a rubber stopper (plug) 20 of the cap member 3 is rotatably inserted into the mouth 1 a of the medicine storage chamber 1 to make the medicine storage chamber 1 airtight.
  • the rubber stopper 20 is composed of a chlorinated butyl rubber stopper body 20a, which is selected to improve the stability with a large amount of a drug (solid), and a center of the stopper body approximately at the center. Double structure with a small rubber stopper part 20b that prevents liquid leakage after penetration of the puncture needle corresponding to the cutout hole 3b as the chemical solution take-out part 4 of the lid part 3a of the cap member 3 Consists of This small rubber stopper portion 20b is made of isoprene rubber with good resilience, and is partially exposed at the notch hole 3b.
  • the upper lid 9 is attached to the cap member 3 by welding, and the upper lid 9 is pulled open by breaking the weld by pulling the tension piece 9a, so that the small rubber plug is inserted through the cutout hole 3b. It is configured so that 20b appears.
  • the upper surface of the upper lid 9 is flat so that the infusion container 10 filled with the lyophilized drug and the lysing solution can stand on its own.
  • the lower surface of the rubber stopper 20 has a lower concave portion 20c for facilitating the penetration of the puncture needle, and an engaging hole 20d for engaging the tip of the protrusion 7c'7d. 20 e are formed.
  • the diameter of these engagement holes is 2 to 6 mm.
  • the small container 15 for freeze-drying of the drug is a small, substantially cylindrical container, the mouth of which is opened, and the side walls and the bottom wall have vertical grooves 36 37 and concave grooves (transverse grooves) 38 in a row, and are molded from polypropylene with an average thickness of 0.5 to 1.0 thigh.
  • the small container 15 contains the lyophilized drug as it is lyophilized in the small container, and is particularly positioned in the medicine storage chamber 1 as shown in FIGS. .
  • the small container 15 is put through the mouth 1 a, and the vertical grooves 36, 37 and the concave grooves 3 are formed. 8 are respectively engaged with the protrusions 7c and 7d as protrusions and the protrusion 7h.
  • the freeze-drying of the drug was performed by first filling a small container with a solution in which the drug was dissolved, and then in a freeze-dryer prepared separately by a conventional method.
  • the infusion container 10 has such a structure, when the cap member 3 is rotated during use, the rubber stopper 20 rotates with the rotation, and further, the engagement hole of the rubber stopper 20 is formed.
  • the protrusions 7c and 7d also rotate through 20d and 20e to break the resin bond (temporary fixation) with the bottom 6 of the drug storage chamber 1 and melt with the drug storage chamber 1.
  • Large communication holes 5 (5a and 5b) can be easily formed between the solution storage chambers 2 (particularly, see FIG. 4).
  • the solution is poured into the medicine storage chamber 1 through the communication hole 5.
  • the lysing solution enters through the mouth of the small container 15 for freeze-drying of drug contained in the drug storage chamber 1 and rapidly dissolves the freeze-dried drug in the small container 15 (usually, Easy to dissolve in dissolving solution, dissolves instantaneously).
  • the upper cover 9 is removed by the pulling piece 9a, the cutout hole 3b as the chemical solution outlet 4 is opened, and the puncture needle integrally connected to a drip device (not shown, the same applies hereinafter) is exposed.
  • a drip device not shown, the same applies hereinafter
  • the liquid medicine mixed with the liquid can be taken out to the other end of the infusion device as an infusion.
  • the communication operation between the medicine storage chamber 1 and the solution storage chamber 2 is very easily achieved by the rotation of the cap member 3.
  • the infusion container 10 has a flat shape due to the flat shape of the solution storage chamber 2 itself and its elasticity, so that it does not need to allow outside air to enter during drip (even if an air needle is not used). As a result, the solution can be discharged, and the chemical solution does not come into contact with the outside air until the end of the infusion, and the sterility in the container is guaranteed.
  • the container material other than the rubber stopper is an all-plastic container consisting only of polyethylene and polypropylene as described in the plastic container test for infusion in the Japanese Pharmacopoeia, it is usually performed in an infusion container (injection kit). It is not necessary to separate and discard glass and metal at the end of drip.
  • the protruding portion is located at the bottom of the medicine storage chamber.
  • the communication hole provided in the seal is sealed, and by rotating the cap member, the ridge engaging the rubber stopper via the rubber stopper can be separated from the bottom to open the communication hole.
  • the infusion solution can be easily and aseptically prepared and provided by connecting the drug storage room and the solution storage room.
  • the medicine freeze-dried in advance in the medicine freeze-drying small container is stored as it is in the medicine storage room together with the medicine freeze-drying small container. There is no need to take out the drug, which greatly facilitates the process of storing the drug, thereby eliminating drug loss due to the drug remaining in the small container for freeze-drying.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

On décrit un contenant pour perfusion qui comprend un espace (1) de stockage pour le médicament et un espace (2) de stockage pour du liquide de dilution qui sont continuellement reliés l'un à l'autre, l'espace (1) de stockage pour le médicament abritant un petit récipient (15) qui est ouvert au niveau d'une partie d'ouverture de ce dernier et qui renferme un médicament lyophilisé. L'espace (1) de stockage pour le médicament est formé pour être séparé de l'espace (2) de stockage lorsque le récipient est conservé et pour pouvoir communiquer avec ce dernier lorsqu'il est en utilisation, ceci permettant à un médicament lyophilisé à l'avance dans le petit récipient (15) de pouvoir être stocké intact dans l'espace (1) de stockage pour le médicament en même temps que le petit récipient (15) lui aussi intact, et ceci permettant de ne pas devoir sortir le médicament du petit récipient de lyophilisation du médicament. Par conséquent on dispose d'un procédé de stockage de médicament très simple et on élimine ainsi les pertes dues aux restes de médicament.
PCT/JP2000/006590 1999-09-30 2000-09-25 Contenant pour perfusion et procede de stockage d'un medicament lyophilise WO2001022913A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP00962838A EP1243245A4 (fr) 1999-09-30 2000-09-25 Contenant pour perfusion et procede de stockage d'un medicament lyophilise

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP11/279388 1999-09-30
JP27938899 1999-09-30

Publications (1)

Publication Number Publication Date
WO2001022913A1 true WO2001022913A1 (fr) 2001-04-05

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Application Number Title Priority Date Filing Date
PCT/JP2000/006590 WO2001022913A1 (fr) 1999-09-30 2000-09-25 Contenant pour perfusion et procede de stockage d'un medicament lyophilise

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EP (1) EP1243245A4 (fr)
WO (1) WO2001022913A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2485254C (en) * 2011-08-22 2013-12-25 Eulysis Uk Ltd A container having a recessed closure for drying and storing one or more active agents

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2551881B2 (ja) * 1991-06-26 1996-11-06 株式会社大塚製薬工場 凍結乾燥用容器および充填容器入り凍結乾燥薬剤の製造方法
EP0809994A1 (fr) * 1995-02-13 1997-12-03 Fujisawa Pharmaceutical Co., Ltd. Recipient pour transfusions
JPH1080465A (ja) * 1996-07-19 1998-03-31 Material Eng Tech Lab Inc 医療用容器
JP2767016B2 (ja) * 1992-07-14 1998-06-18 株式会社大塚製薬工場 凍結乾燥用容器
JPH10165480A (ja) * 1996-12-13 1998-06-23 Material Eng Tech Lab Inc 凍結乾燥物入り容器及びその製造方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3441179A (en) * 1967-05-29 1969-04-29 Ways & Means Inc Mixing container
FR2767514B1 (fr) * 1997-08-22 1999-11-05 Dominique Mounier Flacon melangeur mettant en contact deux composants isoles avant leur prelevement et leur injection a l'aide d'une seringue

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2551881B2 (ja) * 1991-06-26 1996-11-06 株式会社大塚製薬工場 凍結乾燥用容器および充填容器入り凍結乾燥薬剤の製造方法
JP2767016B2 (ja) * 1992-07-14 1998-06-18 株式会社大塚製薬工場 凍結乾燥用容器
EP0809994A1 (fr) * 1995-02-13 1997-12-03 Fujisawa Pharmaceutical Co., Ltd. Recipient pour transfusions
JPH1080465A (ja) * 1996-07-19 1998-03-31 Material Eng Tech Lab Inc 医療用容器
JPH10165480A (ja) * 1996-12-13 1998-06-23 Material Eng Tech Lab Inc 凍結乾燥物入り容器及びその製造方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1243245A4 *

Also Published As

Publication number Publication date
EP1243245A4 (fr) 2006-10-18
EP1243245A1 (fr) 2002-09-25

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