WO2012067141A1 - 二室式容器兼用注射器、並びに注射器充填済みアリピプラゾール - Google Patents
二室式容器兼用注射器、並びに注射器充填済みアリピプラゾール Download PDFInfo
- Publication number
- WO2012067141A1 WO2012067141A1 PCT/JP2011/076385 JP2011076385W WO2012067141A1 WO 2012067141 A1 WO2012067141 A1 WO 2012067141A1 JP 2011076385 W JP2011076385 W JP 2011076385W WO 2012067141 A1 WO2012067141 A1 WO 2012067141A1
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- WIPO (PCT)
- Prior art keywords
- stopper
- plunger rod
- rear end
- outer cylinder
- bypass
- Prior art date
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Classifications
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- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
-
- 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
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
-
- 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
-
- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
- A61M5/31586—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by rotationally moving or pivoted actuator, e.g. an injection lever or handle
-
- 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
- A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
-
- 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
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31501—Means for blocking or restricting the movement of the rod or piston
- A61M2005/31508—Means for blocking or restricting the movement of the rod or piston provided on the piston-rod
-
- 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
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
Definitions
- the present invention relates to a container-use syringe that can be filled and stored in advance with a chemical solution, removed from the package at the time of use, and used immediately.
- the present invention also relates to an aripiprazole filled with a syringe formed by filling a container-use syringe with aripiprazole.
- the present invention claims priority based on Japanese Patent Application No. 2010-256188 filed in Japan on November 16, 2010, the contents of which are incorporated herein by reference.
- the container / syringe Since the container / syringe is pre-filled with a chemical solution, it can be taken out of the package and used immediately without complicated operations in a medical institution. In this way, it is excellent in convenience and greatly contributes to the reduction of the work of medical personnel such as doctors and nurses, so that the container-use syringe is employed in many hospitals.
- a two-chamber container-use syringe in which a preparation and a liquid agent are separated and filled is known as a kind of this container-use syringe.
- a front stopper is inserted on the front end side of the outer cylinder, and an end stopper is inserted on the rear end side of the outer cylinder, and the outer cylinder is inserted by a middle stopper inserted in the center of the outer cylinder.
- the interior is divided into two chambers. Further, a bypass portion formed so that a part of the inner peripheral surface of the outer cylinder bulges outward is formed at a portion of the outer cylinder on the tip side of the middle stopper.
- a powdery preparation is sealed in the front chamber on the distal end side of the middle stopper, and the distal end is sealed with a front stopper.
- a liquid agent is sealed in the rear chamber on the rear end side of the middle stopper, and the rear end is sealed by the end stopper.
- a plunger rod is connected to the rear end of the end stopper.
- the end stopper When using the two-chamber container / syringe having such a configuration, the end stopper is advanced in the outer cylinder by pushing the plunger rod into the outer cylinder. Then, the pressing force due to the advancement of the end stopper is transmitted to the middle stopper via the liquid agent, so that the middle stopper also advances together with the advancement of the end stopper.
- the middle stopper reaches the bypass portion, the two front and rear chambers of the middle stopper are in communication with each other through the bulging portion of the bypass portion.
- the liquid medicine in the rear chamber flows into the front chamber, and the liquid medicine and the preparation in the front chamber are mixed to prepare an injection.
- aripiprazole used as an active ingredient of a pharmaceutical composition has the following structural formula: And is known as an atypical antipsychotic useful for the treatment of schizophrenia (see, for example, Patent Document 1).
- aripiprazole-containing syringe that is, aripiprazole filled with a syringe, for example, a cake-like composition obtained by suspending a pharmaceutical composition with a dispersion medium and freeze-drying the suspension To prepare.
- Patent Document 3 discloses two chambers in which a solution is freeze-dried in a syringe to prepare a freeze-dried product, which is then sealed with a rubber stopper, and an injection solution is sealed in another compartment in the syringe.
- a syringe in the form of a so-called double chamber syringe is disclosed.
- the middle stopper must not remain in the bypass section until all of the liquid medicine in the rear chamber has flown into the front chamber in order to properly mix the liquid medicine and the preparation. Don't be.
- the plunger rod is pushed too early, or if the plunger rod is pushed too hard without confirming the end of the flow of liquid into the front chamber, all the liquid flows into the front chamber.
- the middle stopper moves to the tip side from the bypass part in a state where it cannot be fully cut. Thereby, the situation which the liquid agent in a back chamber remains without mixing with a formulation arises.
- the present invention has been made in view of such problems, and an object of the present invention is to provide a two-chamber container-use syringe that can reliably and appropriately mix a liquid agent and a preparation in accordance with its properties. To do. Another object of the present invention is to provide aripiprazole filled with a syringe that can reduce undissolved residue during resuspension.
- the two-chamber container-use syringe according to the present invention has a cylindrical shape centering on the axis, and has an outer cylinder having a bypass portion in which a part of the inner peripheral surface bulges outward, and a tip of the outer cylinder
- a hub luer lock provided in the outer cylinder a finger grip provided at a rear end of the outer cylinder, a front stopper inserted in a distal end side of the bypass section in the outer cylinder, and the bypass section in the outer cylinder
- a middle stopper which is inserted into the rear end side and seals the preparation together with the front stopper, and an end stopper which is inserted into the rear end side of the middle stopper in the outer cylinder and seals the liquid agent together with the middle stopper
- a plunger rod inserted through the finger grip and connected to the end stopper from the rear end side; and the axis line on the inner peripheral surface of the finger grip Ri to include a female
- the plunger rod is rotated in accordance with the screwing of the male screw portion and the female screw portion.
- the plunger rod gradually moves forward according to the pitch of the male screw portion and the female screw portion. Therefore, since it is possible to avoid the forward speed of the plunger rod from becoming excessive, the middle stopper can be retained in the bypass portion. Accordingly, the flow rate of the liquid agent into the anterior chamber can be easily adjusted to be constant, and the preparation can be efficiently mixed with the liquid agent.
- the two-chamber container-use syringe according to the present invention is such that when the middle stopper that moves forward by pushing in the plunger rod enters the bypass portion, the tip of the male screw portion is behind the female screw portion. It is preferable that the end can be reached and screwed together.
- the middle stopper moves forward and completely enters the bypass part, and the liquid agent is introduced into the preparation through the bypass part to mix them.
- the inflow of the liquid into the preparation can be adjusted by the pitch of the male screw part and the female screw part, so that the inflow rate at which the preparation is easy to dissolve can be obtained. Therefore, only when the middle stopper reaches the bypass part and introduces the liquid into the preparation, the plunger rod only needs to be rotated according to the threaded engagement of the male thread part and the female thread part. It is only necessary to push in the plunger rod until reaching. Therefore, it is possible to avoid complicated handling of the two-chamber container-use syringe.
- any configuration may be used as long as the front end of the male screw portion reaches the rear end of the female screw portion before and after the front end of the middle stopper reaches the bypass portion.
- the two-chamber container-use syringe according to the present invention is formed in the female screw portion, and is formed on the rear end side of the male screw portion on the outer peripheral surface of the plunger rod, and a guide groove extending parallel to the axis. And a guide plate guided according to the guide groove.
- the plunger rod When the plunger rod is rotated and moved forward according to the screwing of the male screw portion and the female screw portion, the male screw portion of the plunger rod passes through the female screw portion of the finger grip. The screwing with the part is released. Thereby, a plunger rod will be in the state which can be pushed in. At this time, for example, by stopping the guide plate of the plunger rod and the guide groove formed in the female screw portion at a position where the plunger rod can be fitted and pushing the plunger rod, the plunger rod is extended by the guide groove. Guide along the direction. Thereby, the plunger rod can be switched reliably from rotation to rectilinear advance, and by eliminating the air bubbles in the outer cylinder and administering the medicinal solution to the patient reliably by moving the plunger rod rectilinearly.
- the two-chamber container-use syringe according to the present invention is formed at the rear end of the finger grip, and at least of the middle stopper that moves forward by rotating the plunger rod in accordance with the female screw portion and the male screw portion. It is preferable to further include a first protrusion with which the guide plate abuts so as to be able to get over when a part of the guide plate passes the bypass portion.
- the two-chamber container-use syringe according to the present invention is configured to rotate the plunger rod in accordance with the female screw portion and the male screw portion, so that the guide plate gets over the first protrusion, and then the male screw portion and It is preferable that the screwing with the female screw portion is released.
- the plunger rod to be pushed in after a part of the middle stopper has passed the bypass portion by rotating the plunger rod in accordance with the screwing of the male screw portion and the female screw portion and moving forward. That is, since the plunger rod is rotated only when the liquid agent is introduced into the preparation and then the plunger rod is pushed in, the handling of the two-chamber container-use syringe can be simplified.
- the medical staff may sense in advance that the rotation of the plunger rod is completed by the contact of the guide plate with the first protrusion before the screwing of the male screw part and the female screw part is released. it can.
- the two-chamber container-use syringe according to the present invention is a second protrusion formed at a rear end of the finger grip and abutting at a position where the guide plate over the first protrusion can be fitted into the guide groove. It is preferable to further comprise.
- the medical staff recognizes that the plunger rod can be pushed in by the guide plate coming into contact with the second protrusion. That is, the operation switching of the plunger rod can be reliably performed by the contact of the guide plate with the second protrusion. Since the guide plate and the guide groove can be fitted in this state, the plunger rod can be advanced along the guide plate by pushing the plunger rod thereafter.
- the two-chamber container-use syringe according to the present invention is particularly suitable when the preparation contains aripiprazole. That is, aripiprazole is difficult to dissolve in the liquid, but the two-compartment container combined syringe with the above configuration can dissolve the preparation appropriately in the liquid, so even if aripiprazole is used as the preparation, The aripiprazole can be suspended in the liquid preparation.
- the syringe-filled aripiprazole comprises aripiprazole, an outer cylinder having a cylindrical shape centering on the axis, and having a bypass portion in which a part of the inner peripheral surface bulges outward, and the outer cylinder
- a hub luer lock provided at the front end
- a finger grip provided at the rear end of the outer cylinder
- a front stopper inserted on the front end side of the bypass portion in the outer cylinder, and the bypass in the outer cylinder
- a middle stopper that seals the aripiprazole together with the front stopper inserted into the rear end side of the part, and an end stopper that seals the liquid agent together with the middle stopper inserted into the rear end side of the middle stopper in the outer cylinder
- a plunger roller inserted through the finger grip and connected to the end stopper from the rear end side.
- a female screw portion formed on the inner peripheral surface of the finger grip so as to be twisted around the axis, and a
- the plunger rod When using such a syringe-filled aripiprazole according to the present invention, the plunger rod is rotated according to the screwing of the male screw portion and the female screw portion. As a result, the plunger rod gradually moves forward according to the pitch of the male screw portion and the female screw portion. Therefore, since it is possible to avoid the forward speed of the plunger rod from becoming excessive, the middle stopper can be retained in the bypass portion. As a result, the flow rate of the liquid agent into the anterior chamber can be easily adjusted to be constant, and undissolved residue during resuspension can be reduced.
- the two-chamber type syringe for use in the present invention it is possible to prevent the plunger rod from being excessively advanced, thereby preventing the middle stopper from moving too far forward and coming off the bypass portion. can do. Accordingly, the middle stopper can be easily retained in the bypass portion, and the inflow speed of the liquid agent is determined by the pitch of the male screw portion and the female screw portion, so that the liquid agent and the preparation can be appropriately mixed. Moreover, according to the aripiprazole filled with a syringe, it is possible to reduce undissolved residue and non-uniform dispersion during resuspension.
- a two-chamber container-use syringe (aripiprazole filled with a syringe) 100 includes an outer cylinder 10, a hub luer lock 20, a front stopper 30, a middle stopper 40, an end stopper 50, and a finger grip. 60 and a plunger rod 70.
- the preparation S and the liquid L that are prepared by mixing to prepare the injection M are filled in a separated state.
- the two-chamber container-use syringe 100 of this embodiment is particularly suitable for administering a preparation S that is difficult to dissolve in the liquid L. Even in such a case, the preparation S can be easily and reliably added to the liquid L. Can be dissolved and suspended. In particular, when aripiprazole is used as the preparation S that is difficult to dissolve in the liquid L, the true value of the two-chamber container-use syringe 100 of the present embodiment is exhibited.
- This aripiprazole ie 7- ⁇ 4- [4- (2,3-dichlorophenyl) -1-piperazinyl] butoxy ⁇ -3,4-dihydrocarbostyril or 7- ⁇ 4- [4- (2,3-dichlorophenyl) -1-Piperazinyl] butoxy ⁇ -3,4-dihydro-2 (1H) -quinolinone is an atypical antipsychotic useful for the treatment of schizophrenia and has the following structural formula.
- the outer cylinder 10 is formed from transparent glass and has a substantially cylindrical shape extending along the axis O.
- the substantially central portion of the outer cylinder 10 in the direction of the axis O is configured such that the outer circumferential surface of the outer cylinder 10 and a part of the circumferential surface of the inner circumferential surface bulge radially outward over a predetermined dimension in the direction of the axis O.
- the position of the bypass portion 11 in the direction of the axis O can be set as appropriate according to the design.
- the cylindrical portion on the front end side of the bypass portion 11 in the outer cylinder 10 is a front end side cylindrical portion 12, and the cylindrical portion on the rear end side of the bypass portion 11 is a rear end side cylindrical portion 13. That is, in the outer cylinder 10, the front end side cylindrical portion 12 is disposed on the front end side with the bypass portion 11 as a boundary, and the rear end side cylindrical portion 13 is disposed on the rear end side. In other words, in the outer cylinder 10, the front end side region is the front end side cylindrical portion 12, and the rear end side region is the rear end side cylindrical portion 13, and between these front end side region and the rear end side region. This area is the bypass section 11.
- a front end side ring-shaped protrusion 14 that protrudes radially outward over the entire circumferential direction is formed on the outer periphery of the front end of the outer cylinder 10.
- a rear end side ring-shaped protrusion 15 protruding outward in the radial direction over the entire circumferential direction is also formed on the outer periphery of the rear end of the outer cylinder 10.
- the hubble lock 20 is formed from a transparent synthetic resin having appropriate rigidity, and has a multistage cylindrical shape with an axis O as the center.
- the hub luer lock 20 includes a base end portion 21 that has a cylindrical shape, a cylindrical portion 22 that is coupled to the distal end side of the base end portion 21 so as to be reduced in diameter by one step, and a cylindrical portion that is further on the distal end side of the cylindrical portion 22. And a luer tip 23 having a smaller diameter than the portion 22.
- a fitting hole 24 that opens to the rear end side of the hub luer lock 20 is formed inside the base end portion 21, and there is a front side of the fitting hole 24, that is, inside the cylindrical portion 22.
- a bottom hole-shaped bypass chamber 25 is formed.
- a location corresponding to the bottom of the bypass chamber 25 is a front end face 25a with which the front end of the front stopper 30 abuts.
- the front end face 25a is formed in a conical shape that gradually decreases in diameter toward the front side.
- an introduction hole 23a penetrating along the axis O is formed inside the luer tip 23.
- the introduction hole 23a has one end opened at the tip of the luer tip 23 and the other end on the bypass chamber 25. Is opened in the center of the front end face 25a.
- An injection needle 27 (not shown in FIG. 1, refer to FIG. 7B) extending along the axis O is attached to one end side, that is, the distal end side of the introduction hole 23a in a communicating state.
- a cap 110 is fitted into the luer tip 23.
- the fitting hole 24 is a hole formed for attaching the hub luer lock 20 to the outer cylinder 10, and has an inner diameter that is substantially the same as the outer diameter of the outer cylinder 10. By fitting the fitting hole 24 to the distal end of the outer cylinder 10, the hub luer lock 20 is attached to the distal end side of the outer cylinder 10.
- a ring-shaped groove 24 a that is recessed in an annular shape around the axis O is formed at the front end portion of the inner peripheral wall of the fitting hole 24.
- the bypass chamber 25 is a bottomed hole whose inner diameter is one step smaller than the fitting hole 24, and a bypass groove 26 is formed on the inner peripheral wall thereof.
- the bypass groove 26 includes a straight groove 26a and an annular groove 26b.
- a plurality of straight grooves 26 a are formed at equal intervals in the circumferential direction so as to extend in parallel with the axis O on the inner wall surface of the bypass chamber 25, and the front end side of these straight grooves 26 a is the inner wall surface of the bypass chamber 25.
- the annular groove 26 b is an annular groove extending in the circumferential direction about the axis O, and is formed near the boundary between the bypass chamber 25 and the fitting hole 24 on the inner wall surface of the bypass chamber 25. Yes.
- the annular groove 26b is connected to the rear end of each of the plurality of linear grooves 26a, whereby each linear groove 26a is connected via the annular groove 26b.
- the front stopper 30, middle stopper 40 and end stopper 50 are molded from medical rubber having corrosion resistance against the preparation S, solution L and injection M, respectively, and have an outer diameter slightly larger than the inner diameter of the outer cylinder 10. It has a substantially cylindrical shape centered on the axis O that it has.
- the front stopper 30 is inserted in the distal end side of the bypass portion 11 in the outer cylinder 10, that is, in the distal end side cylindrical portion 12.
- the middle stopper 40 is inserted into the rear end side of the bypass portion 11 in the outer cylinder 10, that is, the rear end side cylindrical portion 13.
- the middle stopper 40 in the present embodiment is arranged so that the front end of the middle stopper 40 is positioned at the boundary between the rear end side cylindrical portion 13 and the bypass portion 11 which is the front end of the rear end side cylindrical portion 13. .
- the powdery preparation S is sealed so as to be sandwiched between the front stopper 30 and the middle stopper 40 in the outer cylinder 10. That is, the preparation S is filled in the front chamber F defined by the inner peripheral surface of the outer cylinder 10, the rear end surface of the front stopper 30, and the front end surface of the middle stopper 40.
- the end stopper 50 is inserted into the middle stopper 40 in the rear end side cylindrical portion 13 of the outer cylinder 10 at a further rear end side with a gap in the axis O direction from the middle stopper 40.
- a liquid liquid L is sealed so as to be sandwiched between the end stopper 50 and the middle stopper 40. That is, the liquid agent L is filled in the rear chamber B defined by the inner peripheral surface of the outer cylinder 10, the rear end surface of the middle stopper 40 and the front end surface of the end stopper 50.
- a female screw hole (not shown) is formed at the rear end of the end stopper 50 into which a connecting portion 76 of a plunger rod 70 described later is screwed.
- the finger grip 60 includes a fitting portion 61, a flange portion 62, and a cylindrical portion 63.
- the fitting part 61 has a substantially cylindrical shape centered on the axis O, and the inner peripheral side thereof is a fitting hole 61a into which the rear end of the outer cylinder 10 is fitted.
- a ring-shaped groove 61b On the inner periphery of the rear end of the fitting hole 61a, a ring-shaped groove 61b that is recessed in an annular shape about the axis O is formed.
- FIG. 1 when the finger grip 60 is attached to the rear end of the outer cylinder 10, the rear end-side ring-shaped protrusion 15 of the outer cylinder 10 is fitted into the ring-shaped groove 61b.
- the finger grip 60 is firmly fixed and integrated with the outer cylinder 10.
- the flange portion 62 protrudes in the diametrical direction around the axis O from the rear end of the fitting portion 61, that is, near the boundary between the fitting portion 61 and the cylindrical portion 63, and is substantially rectangular when viewed in the direction of the axis O direction. I am doing.
- the flange portion 62 has a role of facilitating handling of the two-chamber container-use syringe 100 of the medical staff by supporting the fingers of the medical staff when the two-chamber container-use syringe 100 is used. Yes.
- the cylindrical portion 63 has a substantially cylindrical shape centered on the axis O, and extends further rearward from the rear end of the fitting portion 61.
- the inner diameter of the cylindrical portion 63 is one step smaller than the inner diameter of the fitting portion 61, and the rear end of the outer cylinder 10 abuts on a step portion at the boundary between the cylindrical portion 63 and the fitting portion 61.
- a female screw portion 64 that is twisted about the axis O is formed on the inner peripheral surface of the cylindrical portion 63.
- the female screw portion 64 is composed of two female screws that are twisted in a clockwise direction (hereinafter referred to as a screw rotation direction) from the rear end side to the front end side of the finger grip 60, and each female screw is a cylinder.
- the inner circumferential surface of the portion 63 extends so as to make one turn over 360 °, for example.
- the inner peripheral surface of the cylindrical portion 63 that is, the female screw portion 64 is recessed toward the radially outer side of the female screw portion 64 (the radially outer side of the axis O) and extends in parallel to the axis O.
- a guide groove 65 is formed. The guide groove 65 extends over the entire region of the cylindrical portion 63 and the female screw portion 64 in the axis O direction, and is spaced apart by 180 ° in the circumferential direction of the female screw portion 64, that is, the diameter of the female screw portion 64. A pair is provided so as to face each other.
- first protrusions 66 and second protrusions 67 are provided at the rear end of the cylindrical portion 63, respectively.
- the pair of first protrusions 66 are provided at an interval of 180 ° in the circumferential direction of the cylindrical portion, that is, so as to oppose each other in the diameter direction of the cylindrical portion.
- the cylindrical portion is provided at intervals of 180 ° in the circumferential direction, that is, so as to oppose the diametrical direction of the cylindrical portion.
- the first protrusion 66 is formed on the rear end surface 63a of the cylindrical portion 63 on the rear side in the screw rotation direction of the pair of guide grooves 65 so as to protrude from the rear end surface 63a to the rear side of the axis O.
- the second protrusion 67 is formed on the rear end surface 63a of the cylindrical portion 63 on the front side in the screw rotation direction of the pair of guide grooves 65 so as to protrude from the rear end surface 63a to the rear side of the axis O. . That is, the first protrusion 66 and the second protrusion 67 are adjacent to the guide groove 65 so as to sandwich the guide groove 65 from the circumferential direction of the axis O.
- the surface of the first protrusion 66 facing the rear side in the screw rotation direction is a gently inclined surface 66a that gradually inclines from the rear end surface 63a toward the rear side of the axis O as it goes to the front side in the screw rotation direction.
- the surface of the first protrusion 66 facing the front side in the screw rotation direction is a steeply inclined surface 66b that gradually inclines toward the front side of the axis O toward the front side in the screw rotation direction.
- the steeply inclined surface 66b is steeper than the gently inclined surface 66a.
- the surface of the second protrusion 67 facing the rear side in the screw rotation direction is a vertical surface 67a that extends perpendicularly from the rear end surface 63a of the cylindrical portion 63 connected to the guide groove 65 to the rear side of the axis O.
- the second protrusion 67 is formed higher than the first protrusion 66, that is, the top of the vertical surface 67 a of the second protrusion 67 is further rearward in the axis O direction than the top of the first protrusion 66. positioned.
- the plunger rod 70 is a member that is connected to the end stopper 50 and moves the end stopper 50 to the front side of the outer cylinder 10. As shown in FIGS. 3 to 5, the plunger rod 70 is provided with a long rod portion 71 extending along the axis O and a distal end side of the rod portion 71, and is attached to the end stopper 50. A connecting portion 76 having a male screw shape to be connected and a push-in portion 77 provided on the rear end side of the rod portion 71 and pressed by a medical worker when pushing the end stopper 50 are provided.
- a male screw portion 73 that is twisted about the axis O is formed on the outer peripheral surface of the rod portion 71.
- the male thread portion 73 is composed of two male threads that are twisted clockwise (screw rotation direction) from the rear end side toward the front end side of the plunger rod 70.
- Such a male screw portion 73 is formed over a predetermined range in the axis O direction on the tip side of the central portion of the rod portion 71 in the axis O direction.
- the rod portion 71 is formed with a pair of cutout portions 74 formed so as to cut out a predetermined range in the circumferential direction over substantially the entire area in the axis O direction.
- the pair of cutout portions 74 are formed at an interval of 180 ° in the circumferential direction of the rod portion 71.
- the male screw portion 73 is divided into two portions in the circumferential direction of the rod portion 71 by the notches 74 and 74.
- the notch 74 has a rib 74a that protrudes outward in the axis O radial direction from the bottom surface of the notch 74, that is, the surface facing the outside in the axis O radial direction of the notch 74, and extends in parallel to the axis O. Is formed.
- the strength of the rod portion 71 is maintained by the rib 74a.
- two ribs 74a are arranged in parallel in the direction of the axis O in each notch 74.
- region in which the male thread part 73 was formed in this rod part 71 is made into the rod front-end
- the region on the rear end side is also a rod rear end portion 71b whose outer peripheral surface has a cylindrical shape.
- the outer diameters of the rod front end portion 71 a and the rod rear end portion 71 b are formed to be the same as or slightly smaller than the inner diameter of the female screw portion 64 in the cylindrical portion 63 of the finger grip 60. Accordingly, the rod front end portion 71a and the rod rear end portion 71b can be inserted through the female screw portion 64 in the direction of the axis O.
- a pair of guide plates 75 are formed on the outer peripheral surface of the rod rear end portion 71b with an interval of 180 ° in the circumferential direction of the rod portion 71.
- These guide plates 75 have a shape protruding in a rectangular shape radially outward of the rod portion 71 in a cross section orthogonal to the axis O, and extend over a predetermined range in parallel to the axis O.
- the plunger rod 70 is connected to the end stopper 50 by screwing the connecting portion 76 at the tip of the plunger rod 70 into the female screw hole of the end stopper 50.
- the rod tip portion 71 a of the rod portion 71 passes through the female screw portion 64 of the finger grip 60.
- the medical staff presses the pushing portion 77 of the plunger rod 70 from the rear end side with the finger placed on the flange portion 62 of the finger grip 60.
- This pressing force is transmitted to the middle stopper 40 through the end stopper 50 and the liquid agent L. That is, the middle stopper 40 moves in the rear end side cylindrical portion 13 of the outer cylinder 10 as the plunger rod 70 advances by the pressing force. Go forward.
- the male of the plunger rod 70 When a part of the middle stopper 40 (in this embodiment, a half on the front end side in the axis O direction of the middle stopper 40) enters the bypass portion 11, the male of the plunger rod 70 The front end of the screw portion 73 abuts on the rear end of the female screw portion 64 of the finger grip 60. Note that the male screw portion 73 may contact the female screw portion 64 when the front end of the middle stopper 40 reaches the rear end of the bypass portion 11, or the front end of the middle stopper 40 reaches the rear end of the bypass portion 11. The male screw portion 73 may reach the female screw portion 64 immediately before the operation.
- the male screw portion 73 and the female screw portion 64 serve as a stopper for the advancement of the plunger rod 70, and thereafter the plunger rod 70 is pressed.
- the plunger rod 70 cannot advance.
- the male screw portion 73 and the female screw portion 64 abut on each other in this manner, the male screw portion 73 and the female screw portion 64 can be screwed together. Therefore, when the plunger rod 70 is rotated forward in the screw rotation direction in this state, the plunger rod 70 is engaged with the male screw portion 73 and the female screw portion 64, and moves forward according to the pitch. As the plunger rod 70 advances, the end stopper 50 also advances. Then, as shown in FIG. 6C, when the entire length of the middle stopper 40 in the direction of the axis O enters the bypass part 11, the front chamber F and the bypass part 11 pass through the bulging area of the outer cylinder 10 to the outside. The rear chamber B communicates with each other.
- the state in which the guide plate 75 comes into contact with the first protrusion 66 so as to be able to climb over is that although the resistance of the plunger rod 70 is caused to rotate by the contact of the guide plate 75 with the gently inclined surface 66a of the first protrusion 66, This means that the guide plate 75 is in contact with the first protrusion 66 by moving the plunger rod 70 strongly, so that the first protrusion 66 can be moved forward in the screw rotation direction.
- Such a contact state can be realized by molding the plunger rod 70 and the finger grip 60 with a flexible material such as synthetic resin.
- the guide plate 75 gets over the first protrusion 66 as shown in FIG. 8 by strongly rotating the plunger rod 70 in the abutting state, the guide plate 75 then moves to the vertical surface 67a of the second protrusion 67. It contacts from the screw rotation direction rear side. This prevents the guide plate 75 from moving forward in the screw rotation direction, that is, the plunger rod 70 cannot be further rotated forward in the screw rotation direction. Even if the plunger rod 70 is rotated in the reverse direction of the screw rotation direction, the rotation is prevented by the guide plate 75 coming into contact with the steeply inclined surface 66b of the first protrusion 66.
- the male screw portion 73 passes through the region where the female screw portion 64 is present, that is, the screw between the male screw portion 73 and the female screw portion 64.
- the match is released.
- the guide plate 75 is positioned between the first projection 66 and the second projection 67, the circumferential positions of the guide plate 75 and the guide groove 65 of the finger grip 60 coincide, that is, the guide plate. 75 and the guide groove 65 can be fitted. As a result, the plunger rod 70 can be pushed straight again.
- the plunger rod 70 is pushed in, the guide plate 75 of the plunger rod 70 is fitted into the guide groove 65 of the finger grip 60, and the plunger rod 70 moves forward so as to be guided by the guide groove 65. Further, the pressing force generated by pushing the plunger rod 70 at this time is transmitted to the front stopper 30 through the end stopper 50, the middle stopper 40 and the injection M, and the front stopper 30 advances in the outer cylinder 10. I will do it.
- the front stopper 30 moves forward, when the front stopper 30 enters the bypass chamber 25, the front chamber F in which the injection M is present communicates with the introduction hole 23a of the luer tip 23 via the bypass groove 26. It becomes. Thereby, the air bubbles remaining in the outer cylinder 10 are discharged to the outside so that the injection M can be introduced into the injection needle 27 and the injection M can be administered to the patient. Thereafter, when the injection M is administered, the plunger rod 70 is further pushed to introduce the injection M in the front chamber F into the injection needle 27 through the bypass groove 26 and the introduction hole 23a. When the plunger rod 70 is completely pushed in, as shown in FIG. 7B, the entire injection M is administered to the patient via the injection needle 27, and the front end of the middle stopper 40 and the front stopper 30 are The front chamber F disappears due to contact with the end. This completes the administration of the injection M to the patient.
- the plunger rod 70 when the plunger rod 70 is rotated in accordance with the screwing of the male screw portion 73 and the female screw portion 64, the plunger rod 70 and the male screw portion 73 and It gradually moves forward according to the pitch of the female screw portion 64. Thereby, it can avoid that the advance speed of the plunger rod 70 becomes excessive, and the middle stopper 40 can be stopped in the bypass part 11. Therefore, since the state where the front chamber F and the rear chamber B communicate with each other can be ensured, the liquid L and the preparation S can be mixed appropriately (or completely).
- aripiprazole when aripiprazole is employed as the preparation S, it is difficult to dissolve in the liquid L, but the preparation S is appropriately (or completely) dissolved in the liquid L in the two-chamber container-use syringe 100 of the present embodiment. be able to. Therefore, even when aripiprazole that is difficult to dissolve in the liquid L is used as the preparation S, the aripiprazole can be easily suspended in the liquid L.
- the middle stopper 40 moves forward through the end stopper 50 and the liquid L by pushing the plunger rod 70, the male screw portion 73 becomes the female screw portion when a part of the middle stopper 40 enters the bypass portion 11. 64 abuts. As a result, even if the plunger rod 70 is further pressed, the plunger rod 70 does not advance thereafter, and the middle stopper 40 does not advance accordingly. Therefore, it is possible to avoid the middle stopper 40 from being excessively advanced to the distal end side of the bypass portion 11 by applying too much force to the plunger rod 70.
- the two-chamber container-use syringe 100 of the present embodiment has a male screw portion 73 when a part of the middle stopper 40 that moves forward by pushing the plunger rod 70 enters the bypass portion 11 as described above.
- a male screw portion 73 when a part of the middle stopper 40 that moves forward by pushing the plunger rod 70 enters the bypass portion 11 as described above.
- the front end of the male screw portion 73 may reach the front end of the female screw portion 64 immediately before the front end of the middle stopper 40 enters the bypass portion 11.
- the plunger rod 70 only needs to be rotated according to the screwing of the male screw part 73 and the female screw part 64 only when the middle stopper 40 reaches the bypass part 11 and introduces the liquid L into the preparation S.
- the part of the middle stopper 40 reaches the bypass portion 11, only the operation of pushing the plunger rod 70 may be performed. Therefore, the handling of the two-chamber container-use syringe 100 can be simplified.
- the plunger rod 70 when the plunger rod 70 is rotated and advanced in accordance with the screwing of the male screw portion 73 and the female screw portion 64, the male screw portion of the plunger rod 70 is obtained.
- the threaded engagement between the male threaded portion 73 and the female threaded portion 64 is released.
- the guide plate 75 of the plunger rod 70 comes into contact with the second protrusion 67 of the finger grip 60 and cannot be rotated any more, so that the screwing of the male screw portion 73 and the female screw portion 64 is released. Health care workers can easily recognize.
- the plunger rod 70 can be pushed.
- the guide rod 75 of the plunger rod 70 and the guide groove 65 formed in the female threaded portion 64 are stopped at a position where they can be fitted, so that the plunger rod 70 is pushed when the plunger rod 70 is pushed. 70 can be guided along the extending direction of the guide groove 65. Therefore, the plunger rod 70 can be moved straight, and the same operation as a normal syringe is possible.
- the middle stopper 40 that moves forward in the outer cylinder 10 exceeds the bypass portion 11.
- the guide plate 75 of the plunger rod 70 comes into contact with the first projection 66 so as to be able to climb over.
- a medical worker can easily recognize that the front chamber F is sealed again by a part of the middle stopper 40 exceeding the bypass portion 11.
- an injection M in which the preparation S is completely dissolved in the liquid L can be prepared by shaking the two-chamber container-use syringe 100 by the medical staff.
- the plunger rod 70 is rotated in accordance with the screwing of the female screw portion 64 and the male screw portion 73, so that the guide plate 75 gets over the first protrusion 66 and then the male screw.
- the portion 73 and the female screw portion 64 are configured to be unscrewed.
- the plunger rod 70 it is possible to perform an operation of pushing the plunger rod 70 after a part of the middle stopper 40 exceeds the bypass portion 11.
- the plunger plate 70 is stopped from rotating by the guide plate 75 coming into contact with the second protrusion 67. This position is a switching position between the advance by rotation and the advance by straight movement.
- the plunger rod 70 can be rotated only when the liquid L is introduced into the preparation S, and thereafter, the operation can be switched to pushing the plunger rod 70. Handling of the two-chamber container / use syringe 100 can be simplified.
- the guide plate 75 comes into contact with the second protrusion 67 by rotating the plunger rod 70, the guide plate 75 of the plunger rod 70 is fitted into the guide groove 65 of the finger grip 60. It becomes possible. Therefore, after that, the plunger rod 70 can be moved straight by pushing the plunger rod 70 in.
- the two-chamber container-use syringe 100 of the present embodiment causes the plunger rod 70 to advance straight during use, and allows the middle stopper 40 to enter the bypass portion 11 to surely flow the liquid L into the preparation S side.
- the purpose is to sufficiently dissolve or suspend the preparation S.
- the plunger rod 70 is merely moved straight, it is difficult to adjust the force for pressing the plunger rod 70, and there is a risk that the middle stopper 40 may pass through the bypass portion 11.
- the medical worker can sense the position where the middle stopper 40 enters the bypass portion 11 by the contact of the male screw portion 73 with the female screw portion 64. Further, the subsequent advancement of the plunger rod 70 is performed by the rotation according to the screwing of the male screw portion 73 and the female screw portion 64, so that the speed adjustment can be easily performed, and the advance speed becomes a certain speed or more. It won't be faster. Thereby, it can avoid that the middle stopper 40 passes through the bypass part 11.
- the two-chamber container-use syringe 100 of this embodiment is preferably applied when the preparation S is special and it takes time to dissolve.
- the medical staff It is conceivable that it is impossible to sense that the male screw part 73 and the female screw part 64 are unscrewed, and the plunger rod 70 is rotated many times at that position. Further, when the medical staff notices that the screwing has been released and hurries and pushes the plunger rod 70, the plunger rod 70 can move straight forward, and thus the injection M is pushed momentarily. If the stopper is dropped into the bypass chamber 25 and the sealing of the tip of the outer cylinder 10 is released, and the syringe is shaken, the liquid L and the injection M may jump out of the injection needle 27.
- the guide plate 75 abuts on the second protrusion 67 and the rotation of the plunger rod 70 is stopped, so that the medical worker can sense that the screwing is released. .
- the medical staff must not push the plunger rod 70 easily, and the formulation S and the liquid L are sufficiently shaken and dissolved and suspended sufficiently on the spot. 70 can recognize that the plunger rod 70 must be operated with great care, such as discharging bubbles and administering to a patient.
- the two-chamber container-use syringe (aripiprazole filled with a syringe) 100 which is an embodiment of the present invention, has been described in detail, but is not limited to these unless departing from the technical idea of the present invention, Some design changes are possible.
- the pitch of the male screw portion 73 and the female screw portion 64 can be designed as appropriate, whereby the advance speed of the plunger rod 70 can be adjusted, and the dissolution of the preparation S by the liquid L is suspended or suspended. The speed can be adjusted freely.
- the edge part of the circumferential direction is respectively formed in the taper shape or the taper shape.
- a finger grip 60 of a modified example for example, the one shown in FIGS. 9A and 9B may be used.
- the finger grip 60 of this modification is different in configuration from the embodiment in which the flange portion 62 is provided on the rear end side of the cylindrical portion 63 and the cylindrical portion 63 itself protrudes rearward from the flange portion 62. .
- the cylindrical portion 63 is buried on the fitting portion 61 side.
- the bulk powder of aripiprazole hydrate was suspended in the dispersion medium so as to be 30% by weight.
- the concentration of other additives in the obtained suspension was about 1.248% by weight sodium carboxymethyl cellulose, about 6.24% by weight mannitol, about 0.111% by weight sodium dihydrogen phosphate monohydrate. %.
- the pH of the suspension was adjusted to about 7 by adding an aqueous sodium hydroxide solution.
- This suspension was preliminarily pulverized with a high-shear rotating homogenizer (Claremix, M Technique), and repeatedly wet-pulverized with a high-pressure homogenizer (Niro) at 550 bar.
- the average primary particle size of the obtained suspension was 2 to 3 ⁇ m.
- This lyophilized cake was placed as a preparation S in the front chamber (the space between the front stopper 30 and the middle stopper 40) of the two-chamber container-use syringe 100 of the embodiment.
- the rear chamber (the space between the middle stopper 40 and the end stopper 50) was filled with 2.0 mL of purified water as the liquid L.
- the two-chamber container-use syringe 100 was disassembled, and the amount of the drug remaining in the two-chamber container-use syringe 100 was quantified, and the average was about 19 mg. Since the suspension was shaken well and resuspended uniformly, this amount of drug is the amount remaining in the dead space in the syringe.
- a general plunger rod that only pushes the end stopper 50 in one direction in the discharge direction (one that does not have the male screw portion 73) attached thereto is used as a two-compartment container-use syringe of a comparative example.
- the purified water was immediately allowed to flow into the anterior chamber as described above. Thereafter, the suspension was left for 5 seconds without shaking, and the suspension was discharged from the introduction hole 23a of the luer tip 23 as it was. After discharging, the two-chamber container-use syringe was disassembled, and the amount of drug remaining in the two-chamber container-use syringe was quantified, and the average was about 195 mg. It was found that about 176 mg, which is the difference from the above remaining amount, remained in the syringe as undissolved.
- the screw-type plunger rod 70 of this embodiment was attached to the end stopper 50, and purified water was quickly flowed into the anterior chamber while turning the screw as described in this embodiment. Thereafter, the suspension was left for 5 seconds without shaking, and the suspension was discharged from the introduction hole 23a of the luer tip 23 as it was. After discharge, the two-chamber container-use syringe 100 was disassembled, and the amount of drug remaining in the two-chamber container-use syringe 100 was quantified, and the average was about 62 mg. It was found that about 43 mg, which is the difference from the above remaining amount, remained in the syringe as an undissolved residue.
- the operation of the plunger rod 70 is different before and after the resuspension process, which can prompt the user to recognize the resuspension process and forget to shake. The risk of dose reduction can be further reduced.
- the two-chamber type container combined use syringe which can mix a liquid agent and a formulation reliably and appropriately according to the property can be provided. Moreover, according to the present invention, it is possible to provide aripiprazole filled with a syringe that can reduce undissolved residue during resuspension.
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Abstract
Description
また、本発明は、容器兼用注射器にアリピプラゾールを充填してなる注射器充填済みアリピプラゾールに関する。本発明は、2010年11月16日に日本に出願された特願2010-256188号に基づき優先権を主張し、その内容をここに援用する。
この二室式容器兼用注射器では、外筒の先端側にフロントストッパーが、外筒の後端側にエンドストッパーが挿入されており、外筒内の中央部に挿入されたミドルストッパーによって該外筒内部が前後二室に分割されている。また、この外筒におけるミドルストッパーよりも先端側の部分には、外筒の内周面の一部が外側に膨出するようにして形成されたバイパス部が形成されている。さらに、ミドルストッパーの先端側の前室には、粉末状の製剤が封入されており、その先端はフロントストッパーで封止されている。一方、ミドルストッパーの後端側の後室には液剤が封入されており、その後端はエンドストッパーによって封止されている。なお、このエンドストッパーの後端にはプランジャーロッドが接続されている。
で表され、統合失調症の治療に有用な非定型抗精神病薬として知られている(例えば、特許文献1参照)。
このアリピプラゾールを含有する容器兼用注射器、即ち、注射器充填済みアリピプラゾールを使用する際には、例えば、医薬組成物を分散媒によって懸濁させ、該懸濁液を凍結乾燥して得られるケーキ状組成物を調製する。そして、該ケーキ状組成物を使用時に所望の分散媒(注射用液)と混合させ再懸濁させ、該再懸濁液を患者に筋肉内注射又は皮下注射する(例えば、特許文献2参照)。
また、特許文献3には、注射器内で溶液を凍結乾燥させて凍結乾燥物を調製した後、ゴム栓で密封し、さらに、注射器内の別の隔室に注射用液を封入させた二室式容器兼用注射器、いわゆるダブルチャンバーシリンジの形態のものが開示されている。
しかしながら、プランジャーロッドの押し方が早過ぎる場合や、液剤の前室への流入の終了を確認せずにプランジャーロッドを強く押し過ぎてしまった場合には、全ての液剤が前室に流入し切れない状態でミドルストッパーがバイパス部よりも先端側に移動してしまう。これにより、後室内の液剤が製剤と混合されずに残存する事態が生じる。
一方、上記注射器充填済みアリピプラゾールにおいては、再懸濁の際の溶け残りが問題となっていた。
また、この発明は、再懸濁の際の溶け残りを低減させることができる注射器充填済みアリピプラゾールを提供することを目的とする。
即ち、本発明に係る二室式容器兼用注射器は、軸線を中心とした筒状をなし、内周面の一部が外側に膨出してなるバイパス部を有する外筒と、該外筒の先端に設けられたハブルアーロックと、前記外筒の後端に設けられたフィンガーグリップと、前記外筒内における前記バイパス部の先端側に挿入されたフロントストッパーと、前記外筒内における前記バイパス部の後端側に挿入されて前記フロントストッパーとともに製剤を封止するミドルストッパーと、前記外筒内における前記ミドルストッパーの後端側に挿入されて前記ミドルストッパーとともに液剤を封止するエンドストッパーと、前記フィンガーグリップを挿通して前記エンドストッパーに後端側から接続されるプランジャーロッドと、前記フィンガーグリップの内周面に前記軸線回りに捩れるように形成された雌ネジ部と、前記プランジャーロッドの外周面に前記雌ネジ部と螺合可能に形成された雄ネジ部とを備える。
そして、上記のように雄ネジ部の先端が雌ネジ部後端に当接した後は、プランジャーロッドを回転させることによって、該プランジャーロッドが雄ネジ部と雌ネジ部との螺合に従って徐々に前進する。このプランジャーロッドの前進に伴ってミドルストッパーが前進してバイパス部内に完全に進入すると、バイパス部を介して液剤が製剤に導入され両者の混合が行われる。なお、液剤の製剤への流入は、雄ネジ部及び雌ネジ部のピッチによって調整され、製剤が溶解し易い流入速度とすることができる。
したがって、ミドルストッパーがバイパス部に到達して液剤を製剤に導入する際にのみプランジャーロッドを雄ネジ部及び雌ネジ部の螺合に従って回転させればよいため、ミドルストッパーの一部がバイパス部に到達するまではプランジャーロッドを押し込む作業のみを行えばよい。よって、二室式容器兼用注射器の取り扱いが煩雑になることを回避することができる。
なお、ミドルストッパーがバイパス部に進入する際とは、ミドルストッパーの先端がバイパス部の後端に到達した際の他、ミドルストッパーの一部がバイパス部に進入した際や、ミドルストッパーの先端がバイパス部の後端に到達する直前のことを意味している。即ち、ミドルストッパーの先端がバイパス部に到達する前後に雄ネジ部の先端が雌ネジ部の後端に到達する構成であればよい。
即ち、アリピプラゾールは液剤に溶解し難いが、上記構成の二室式容器兼用注射器においては製剤を液剤に対して適切に溶解させることができるため、製剤としてアリピプラゾールを採用した場合であっても容易に該アリピプラゾールを液剤に対して懸濁させることが可能となる。
また、注射器充填済みアリピプラゾールによれば、再懸濁の際の溶け残りや不均一な分散を低減することができる。
図1に示すように、二室式容器兼用注射器(注射器充填済みアリピプラゾール)100は、外筒10と、ハブルアーロック20と、フロントストッパー30と、ミドルストッパー40と、エンドストッパー50と、フィンガーグリップ60と、プランジャーロッド70とを備えている。この二室式容器兼用注射器100においては、混合されることで注射薬M(図7A参照)が調製される製剤S及び液剤Lが分離した状態で充填されている。
このアリピプラゾール、即ち7-{4-[4-(2,3-ジクロロフェニル)-1-ピペラジニル]ブトキシ}-3,4-ジヒドロカルボスチリル又は7-{4-[4-(2,3-ジクロロフェニル)-1-ピペラジニル]ブトキシ}-3,4-ジヒドロ-2(1H)-キノリノンは、精神分裂病の治療に有用な非定型抗精神病薬であって、以下の構造式を有するものである。
直線溝26aは、バイパスチャンバー25の内壁面において軸線Oと平行に延びるように周方向に等間隔を空けて複数が形成されており、これら直線溝26aの先端側は、バイパスチャンバー25の内壁面から前端面25aに延びてルアー先23の内部に形成された導入孔23aにそれぞれ接続されている。
また、ミドルストッパー40は、外筒10におけるバイパス部11の後端側、即ち、後端側円筒部13に挿入されている。特に本実施形態におけるミドルストッパー40は、後端側円筒部13の先端となる該後端側円筒部13とバイパス部11との境界に該ミドルストッパー40の先端が位置するように配置されている。そして、外筒10内においてフロントストッパー30とミドルストッパー40とに挟み込まれるようにして粉末状の製剤Sが封止されている。即ち、外筒10の内周面、フロントストッパー30の後端面及びミドルストッパー40の先端面によって画成された前室F内に製剤Sが充填されている。
このように、二室式容器兼用注射器100においては、ミドルストッパー40によって仕切られた前室F及び後室B内に、製剤S及び液剤Lが分離して封止されている。
嵌着部61は、軸線Oを中心とした略円筒形状をなしており、その内周側が上記外筒10の後端が嵌め込まれる嵌着孔61aとされている。この嵌着孔61aの後端内周には、軸線Oを中心として環状に凹むリング状溝61bが形成されている。図1に示すように、フィンガーグリップ60を外筒10の後端に取り付けた際には、このリング状溝61bに対して外筒10の後端側リング状突起15が嵌り込むことによって、当該フィンガーグリップ60が外筒10に対して強固に固定一体化される。
なお、第二突起67の方が第一突起66よりも高く形成されており、即ち、第二突起67の垂直面67aの頂部の方が第一突起66の頂部よりも軸線O方向後方側に位置している。
なお、ロッド部71には、周方向の所定範囲を軸線O方向のほぼ全域にわたって切り欠くようにして形成された一対の切欠部74が形成されている。これら一対の切欠部74は、ロッド部71の周方向に180°間隔をあけて形成されている。これにより、割型によるロッド部71の成形が可能とされている。
なお、切欠部74には、該切欠部74の底面、即ち、切欠部74における軸線O径方向外側を向く面から当該軸線O径方向外側に突出して軸線Oに平行に延在するリブ74aが形成されている。このリブ74aによってロッド部71の強度が保持されている。また、リブ74aは、それぞれの切欠部74において軸線O方向に2つが並設されている。このように先端側のリブ74aと後端側のリブ74aとを分断した構成によって、バイパス部11の膨出部分に残留した液剤Lの一部が、先端側のリブ74aを伝って後端側のリブ74aに到達することで医療従事者の手に付着してしまうことを回避している。
これらロッド先端部71a及びロッド後端部71bの外径は、フィンガーグリップ60の円筒部63における雌ネジ部64の内径と同一か僅かに小さい程度に形成されている。これにより、ロッド先端部71a及びロッド後端部71bは、雌ネジ部64を軸線O方向に挿通可能とされている。
最初に、図6Aに示すように、プランジャーロッド70の先端における接続部76をエンドストッパー50の雌ネジ穴に捩じ込むことにより、プランジャーロッド70をエンドストッパー50に接続する。この状態においては、ロッド部71のロッド先端部71aがフィンガーグリップ60の雌ネジ部64を挿通している。
これにより、プランジャーロッド70の直進の押し込みが再び可能な状態となる。
その後、注射薬Mの投与を行う際には、プランジャーロッド70をさらに押し込むことにより、前室Fの注射薬Mをバイパス溝26及び導入孔23aを介して注射針27に導入する。そして、プランジャーロッド70を完全に押し込んだ際には、図7Bに示すように、全注射薬Mが注射針27を介して患者へ投与されて、ミドルストッパー40の先端とフロントストッパー30の後端とが当接して前室Fが消滅する。以上により、患者への注射薬Mの投与が終了する。
これにより、ミドルストッパー40がバイパス部11に到達して液剤Lを製剤Sに導入する際にのみプランジャーロッド70を雄ネジ部73及び雌ネジ部64の螺合に従って回転させればよいため、ミドルストッパー40の一部がバイパス部11に到達するまではプランジャーロッド70を押し込む作業のみを行えばよい。よって、二室式容器兼用注射器100の取り扱いを簡便にすることができる。
また、このように螺合が解除されることにより、プランジャーロッド70が押し込み可能な状態となる。この際、プランジャーロッド70のガイド板75と雌ネジ部64に形成されたガイド溝65とが嵌合可能な位置に停止されることにより、プランジャーロッド70を押し込んだ際に該プランジャーロッド70をガイド溝65の延在方向に沿って案内することができる。したがって、プランジャーロッド70を直進させることができるようになり、通常のシリンジと同様の操作が可能となる。
これによって、プランジャーロッド70を回転させることによりミドルストッパー40の一部がバイパス部11を越えた後には、プランジャーロッド70を押し込む作業を行うことが可能となる。また、ガイド板75が第一突起66を乗り越えた後は、該ガイド板75が第二突起67に当接することによりプランジャーロッド70の回転が止められる。この位置が、回転による進行と直進による進行との切替位置となる。
このように、液剤Lを製剤Sに導入する際にのみプランジャーロッド70を回転させ、その後はプランジャーロッド70を押し込む作業に切り替えることができる。二室式容器兼用注射器100の取り扱いを簡便にすることができる。
例えば、雄ネジ部73及び雌ネジ部64のピッチは適宜設計することが可能であり、これによってプランジャーロッド70の前進速度を調整することができ、液剤Lによる製剤Sの溶解は又は懸濁速度を自由に調整することができる。
アリピプラゾール水和物原末を分散媒体に30重量%となるように懸濁した。なお、得られた懸濁液中の他の添加剤の濃度は、カルボキシメチルセルロースナトリウム約1.248重量%、マンニトール約6.24重量%、リン酸2水素ナトリウム1水和物約0.111重量%とした。また、懸濁液のpHは水酸化ナトリウム水溶液を添加することにより約7に調整した。この懸濁液を、高せん断回転型ホモジナイザー(クレアミックス、エム・テクニック社)にて予備粉砕し、高圧ホモジナイザー(Niro社)にて550barにて繰り返し湿式粉砕した。得られた懸濁液の平均一次粒子径は2~3μmであった。
(a)熱処理:懸濁液が充填されたカップを約4時間、棚温度を約-40℃で維持し凍結した。
(b)一次乾燥:チャンバ圧を約13Pa、棚温度を約-5℃へ上昇させ約40時間、一次乾燥を継続した。
凍結乾燥後、カップの底を押し、強固な凍結乾燥ケーキを取り出した。
後室の精製水がバイパス11を介して前室に流入するまでエンドストッパー50を押し込み、精製水が前室に流入した後に十分に振とうし、凍結乾燥ケーキを再懸濁した。再懸濁後の懸濁液は、溶け残りによる粉の塊等は見られなかった。この懸濁液を、エンドストッパー50をさらに押すことにより、二室式容器兼用注射器100先端の吐出口であるルアー先23の導入孔23aから懸濁液を吐出させた。吐出後、二室式容器兼用注射器100を分解し、該二室式容器兼用注射器100内に残った薬物量を定量したところ、平均約19mgであった。懸濁液はよく振とうし、均一に再懸濁されたことから、この薬物量はシリンジ内のデッドスペースでの残存量ということになる。
エンドストッパー50に、吐出方向に一方向に押すのみの一般的なプランジャーロッド(雄ネジ部73が形成されてないもの)を付けて比較例の二室式容器兼用注射器とし、エンドストッパー50を押し、上記同様に前室に精製水を速やかに流入させた。その後、全く振とうすることなく、5秒放置し、そのままルアー先23の導入孔23aから懸濁液を吐出させた。吐出後、二室式容器兼用注射器を分解し、該二室式容器兼用注射器内に残った薬物量を定量したところ、平均約195mgであった。上記残存量との差である約176mgが溶け残りとしてシリンジ内に残存したことがわかった。
エンドストッパー50に、本実施形態のネジ式のプランジャーロッド70を取り付け、本実施形態で説明したようにネジを回しながら前室に精製水を速やかに流入させた。その後、全く振とうすることなく、5秒放置し、そのままルアー先23の導入孔23aから懸濁液を吐出させた。吐出後、二室式容器兼用注射器100を分解し、該二室式容器兼用注射器100内に残った薬物量を定量したところ、平均約62mgであった。上記残存量との差である約43mgが溶け残りとしてシリンジ内に残存したことがわかった。
Claims (8)
- 軸線を中心とした筒状をなし、内周面の一部が外側に膨出してなるバイパス部を有する外筒と、
該外筒の先端に設けられたハブルアーロックと、
前記外筒の後端に設けられたフィンガーグリップと、
前記外筒内における前記バイパス部先端側に挿入されたフロントストッパーと、
前記外筒内における前記バイパス部の後端側に挿入されて前記フロントストッパーとともに製剤を封止するミドルストッパーと、
前記外筒内における前記ミドルストッパーの後端側に挿入されて前記ミドルストッパーとともに液剤を封止するエンドストッパーと、
前記フィンガーグリップを挿通して前記エンドストッパーに後端側から接続されるプランジャーロッドと、
前記フィンガーグリップの内周面に前記軸線回りに捩れるように形成された雌ネジ部と、
前記プランジャーロッドの外周面に前記雌ネジ部と螺合可能に形成された雄ネジ部とを備える二室式容器兼用注射器。 - 前記プランジャーロッドを押し込むことにより前進する前記ミドルストッパーが前記バイパス部に進入する際に、前記雄ネジ部の先端が前記雌ネジ部の後端に到達して互いに螺合可能とされる請求項1に記載の二室式容器兼用注射器。
- 前記雌ネジ部に形成され、前記軸線に平行に延びるガイド溝と、
前記プランジャーロッドの外周面における前記雄ネジ部の後端側に形成され、前記ガイド溝に従って案内されるガイド板とをさらに備える請求項1又は2に記載の二室式容器兼用注射器。 - 前記フィンガーグリップの後端に形成され、前記プランジャーロッドを前記雌ネジ部及び前記雄ネジ部に従って回転させることにより前進する前記ミドルストッパーの少なくとも一部が前記バイパス部を越えた際に、前記ガイド板が乗り越え可能に当接する第一突起をさらに備える請求項3に記載の二室式容器兼用注射器。
- 前記プランジャーロッドを前記雌ネジ部及び前記雄ネジ部に従って回転させることで前記ガイド板が第一突起を乗り越えた後に、前記雄ネジ部と前記雌ネジ部との螺合が解除される請求項4に記載の二室式容器兼用注射器。
- 前記フィンガーグリップの後端に形成され、前記第一突起を乗り越えた前記ガイド板が前記ガイド溝に嵌合可能な位置において当接する第二突起をさらに備える請求項5に記載の二室式容器兼用注射器。
- 前記製剤が、アリピプラゾールを含む請求項1から6のいずれか一項に記載の二室式容器兼用注射器。
- アリピプラゾールと、
軸線を中心とした筒状をなし、内周面の一部が外側に膨出してなるバイパス部を有する外筒と、
該外筒の先端に設けられたハブルアーロックと、
前記外筒の後端に設けられたフィンガーグリップと、
前記外筒内における前記バイパス部の先端側に挿入されたフロントストッパーと、
前記外筒内における前記バイパス部の後端側に挿入されて前記フロントストッパーとともに前記アリピプラゾールを封止するミドルストッパーと、
前記外筒内における前記ミドルストッパーの後端側に挿入されて前記ミドルストッパーとともに液剤を封止するエンドストッパーと、
前記フィンガーグリップを挿通して前記エンドストッパーに後端側から接続されるプランジャーロッドと、
前記フィンガーグリップの内周面に前記軸線回りに捩れるように形成された雌ネジ部と、
前記プランジャーロッドの外周面に前記雌ネジ部と螺合可能に形成された雄ネジ部とを備える注射器充填済みアリピプラゾール。
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US10517951B2 (en) | 2012-04-23 | 2019-12-31 | Otsuka Pharmaceutical Co., Ltd. | Injectable preparation |
US11097007B2 (en) | 2012-04-23 | 2021-08-24 | Otsuka Pharmaceutical Co., Ltd. | Injectable preparation |
US11638757B2 (en) | 2012-04-23 | 2023-05-02 | Otsuka Pharmaceutical Co., Ltd. | Injectable preparation |
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JPWO2018180458A1 (ja) * | 2017-03-31 | 2020-02-06 | 武田薬品工業株式会社 | シリンジ |
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JP7393362B2 (ja) | 2018-11-27 | 2023-12-06 | デウン ファーマシューティカル カンパニー リミテッド | 二室式容器兼用注射器 |
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