EP0295104A1 - Improvements in the use of vials - Google Patents

Improvements in the use of vials Download PDF

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Publication number
EP0295104A1
EP0295104A1 EP19880305283 EP88305283A EP0295104A1 EP 0295104 A1 EP0295104 A1 EP 0295104A1 EP 19880305283 EP19880305283 EP 19880305283 EP 88305283 A EP88305283 A EP 88305283A EP 0295104 A1 EP0295104 A1 EP 0295104A1
Authority
EP
European Patent Office
Prior art keywords
vial
stopper
compartment
plug
upper compartment
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.)
Withdrawn
Application number
EP19880305283
Other languages
German (de)
English (en)
French (fr)
Inventor
Masamichi Sudo
Tamotsu C/O Daikyo Gomu Seiko Ltd. Okuda
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.)
DAIKYO GOMU SEIKO Ltd
Original Assignee
DAIKYO GOMU SEIKO 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 DAIKYO GOMU SEIKO Ltd filed Critical DAIKYO GOMU SEIKO Ltd
Publication of EP0295104A1 publication Critical patent/EP0295104A1/en
Withdrawn legal-status Critical Current

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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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents
    • B65D25/082—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of contents the partition being in the form of a plug or the like which is removed by increasing or decreasing the pressure within the container
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D51/00—Closures not otherwise provided for
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
    • 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
    • A61J1/2041—Separating means having removable plugs

Definitions

  • This invention relates to an improved method of mixing two substances using a compartmented vial and in particular it relates to an improvement using a compartmented vial capable of holding two substances, in particular medicaments, separately in two compartments until required for an injection, for example, wherein the two substances are then required to be mixed in the vial before use.
  • Medicaments used in injections are generally classified into powdered forms, freeze-dried forms, liquid forms etc.
  • the vessels available for storing such medicaments include glass or plastic ampoules and vials. At the present time, glass vessels have widely been used.
  • a powdered or freeze-dried medicament is generally dissolved by adding to it a dissolving fluid stored in another vessel, possibly by means of a syringe.
  • a liquid medicament in one vessel may be injected into another vessel containing another liquid medicament, resulting in the mixing of the two liquids.
  • Such operations wherein means, such as syringes, are required, to transport a liquid from one vessel to another can give rise to mishaps.
  • a vessel has been proposed in which two different types of medicaments, for example a main ingredient and a dissolving fluid, are stored in two separate compartments of a single vessel, divided by a partition wall. In use, this partition wall can be removed to allow the two medicaments to mix.
  • Such a vessel has already been used in Europe as a means for preventing mishaps.
  • two medicaments for example a liquid medicament 6 and a solid medicament 7, are separately stored in an upper compartment A and a lower compartment B of a container 1.
  • the compartments A, B are separated by an intermediate plug 2.
  • the vial 1 has a mouth which is sealed by a rubber stopper 3′ comprising a cap E′ and a body F′ protruding from a lower side of the cap E′.
  • the body F′ is longer than that of an ordinary stopper for a vial such that an upper part of body still protrudes from the mouth C of the vial 1 when it has been sealed.
  • the stopper 3′ contains a narrow recess D′.
  • An end of the body F′ furthest from the cap E′ has a greater circumference than the end of the body F′ adjacent the cap E′.
  • Only the lower end of the body of the stopper is inserted into the mouth C of the container 1 to seal it.
  • the part of the rubber stopper 3′ in contact with the mouth C is fastened by an aluminum cap 4′ in such a manner that the rubber stopper 3′ projects out from the mouth C, and the alumunium cap 4′ and the protruding part of the rubber stopper 3′ are further covered by an over cap 5′ made of a plastics material.
  • this over cap 5′ is removed and the stopper 3′ is manually pushed downwards (see Fig. 5), thus raising the pressure in compartment A which eventually displaces the intermediate plug 2 allowing communication between the two compartments A and B (US patent Nos. 4,089,432, 4,180,173, 4,274,543).
  • a rod is fitted to the lower side of a rubber stopper and in use the rod is pushed downwards to force the intermediate plug out of position, thereby allowing the two medicaments to mix.
  • Method (II) is hard to put to practical use, since the shape of the rubber stopper is extremely complicated and therefore both difficult and expensive to manufacture in order that the rod can be operated successfully. Furthermore inserting a syringe needle into such a stopper is not easy.
  • Method (I) has now been put to practical use because of the simplicity of the shape of the rubber stopper and the intermediate plug.
  • Method (I) has the disadvantage that, as shown in Fig. 4 and Fig. 5, the recess D′ of the rubber stopper 3′ is so narrow that when a syringe needle pierces the rubber stopper 3′ there is a danger that the inner wall of the body of the rubber stopper is scraped thus generating rubber scraps.
  • Such rubber scraps tend to clog the needle such that it does not function. Therefore, needle piercing needs to be carried out with great care in such a manner that the stopper is pierced vertically.
  • this is often not easy to do.
  • a further problem is that in order that the intermediate plug is caused to be displaced and falls into compartment B, a force higher than the resistance to movement of the intermediate plug 2 is required, as represented by the following formula (1): (Manual Thrusting Force Value - Sliding Resistance Value of Rubber Stopper Movement Resistance Value of Intermediate Plug) (1)M
  • the rubber stopper C When the rubber stopper C is pushed downwards by a strong force as shown in Fig. 5, the rubber stopper itself tends to distort because of the unsupported length protruding from the vial thus making it difficult to handle.
  • Another problem arising herein is the sliding resistance value of the rubber stopper 3′.
  • the primary function required of a rubber stopper 3′ is that it efficiently seals the vial container 1 and the secondary function is that it slides into a sealing position when pushed into the vial container 1. Since these primary and secondary functions are effected at the same time contradictory conditions are simultaneously required.
  • the gap between the inner surface of the mouth of the vial and the outer surface of the stopper body is required to be minimised such that the inner diameter of the vial is actually less than the rubber stopper diameter, so as to maximise the sealing quality.
  • the gap is required to be maximised.
  • the sliding resistance value of the rubber stopper 3′ itself should be approximately equal to the movement resistance value of the intermediate plug 2.
  • the following relationship is given: Manual Thrusting Force Value > Movement Resistance Value of Intermediate Plug + Sliding Resistance Value of Rubber Stopper
  • the sliding resistance value of the rubber stopper 3′ is the smaller, the manual thrusting force is the smaller and accordingly, handling of the compartmented vial is improved.
  • a method of storing and mixing substances for use in an injection comprising the steps of (i) placing the substances separately in an upper and a lower compartment (A, B) of a compartmented vial container, in which the two compartments are joined by a neck portion having a smaller internal diameter than that of the compartments, in which neck portion is positioned a displaceable plug to separate and seal the compartments from each other, (ii) sealing the container with a stopper positioned in a mouth opening at an end of the upper chamber away from the neck portion said mouth opening having a larger internal diameter than of said neck, (iii) displacing the plug from the neck portion to allow the substances in the two compartments to combine to form a mixture, characterised in that the plug is displaced by injecting air with a syringe through the stopper into the upper compartment to raise the pressure in the upper compartment such that the plug is forced downwards out of the neck into the lower compartment.
  • a vial 1 has two compartments A and B which are separated by a displaceable intermediate plug 2 such that medicaments 6 and 7 may be stored completely independent from each other.
  • Vial 1 has an open mouth C which can be sealed by inserting a rubber stopper 3 of a known type.
  • the stopper 3 has a wide recess D beneath a designated needle piercing area.
  • the stopper 3 has a head portion E, a part of the lower surface of which seals against mouth C of the vial 1.
  • the stopper 3 also has a body portion F protruding from the lower surface of the head portion E, which, in use, is inserted into the mouth C of the vial 1, and which closely contacts the inner surface of the mouth C of vial 1.
  • the rubber stopper 3 isfastened in position to the vial 1 by a flip-off aluminum cap 4.
  • a flip-off plastic cover is fitted over the aluminium cap 4.
  • Joining the compartment A and B is a constricted neck having an internal diameter less than the mouth C of vial 1.
  • Compartment A can then be charged with another medicament and the rubber stopper 3 is fixed in the mouth C of the vial 1 as shown in Fig. 1.
  • a syringe needle 8 pierces the rubber stopper 3 as shown in Fig. 2 into recess D and air contained in the body 9 of the syringe is forced into compartment A by depressing plunger 10. This results in an increase in the internal pressure in compartment A, which forces displacement of the intermediate plug 2 out of the neck and into compartment B, allowing communication between compartments A and B and thus the mixing of the two medicaments 6 and 7.
  • medicament 6 is dissolved in a solvent 7 to form a liquid medicament which is then taken up into the syringe.
  • Operation of the vial container is ordinarily carried out by introducing air into the vial 1 of an amount at least corresponding to that to be taken into the syringe, the liquid medicament being sucked into the body of the syringe assisted by this pressurization. Otherwise, the pressure in the vial 1 is negative whilst charging the syringe which makes operations difficult.
  • the method of the present invention therefore, it is possible to effect a syringe charging operation by the same procedure as the mixing operation and moreover, the fear of scraping the inner wall of the body portion of the stopper during insertion of the needle is removed as the rubber stopper is fixed in position and the recess D in the body portion is of a broad diameter.
  • mixing in the vial can be effected only by depressing the plunger of a syringe and then raising the plunger for the purpose of charging without the necessity of manual thrusting or pressing the rubber stopper, so a safety system which can be easily handled and without any mis-haps is available.
  • the pressure in compartment A was measured when the needle of a syringe, in which the plunger had been set to a maximum scale mark, pierced the piercing area of the rubber stoppersample 3, and the plunger depressed gradually by means of a push-pull gauge (made by Imamura Seisakusho Co.) to feed air into the upper compartment A until the intermediate plug 2 was displaced from the neck of vial A into the lower compartment B.
  • a push-pull gauge made by Imamura Seisakusho Co.
  • the sample body was held at 40°C for 4 weeks, after which the rubber stopper and the water in the upper compartment A were removed and dried at 90°C for 1 hour.
  • the intermediate plug was then forced to be displaced into compartment B and 5 ml of alcohol added to the contents of compartment B to adequately dissolve the calcium chloride thus preparing a solution, 50 ⁇ l of which was taken as a sample and subjected to measurement of the amount of water therein using a Karl Fischer's meter.
  • the permeability ratio was calculated by the following formula (2): A sample giving 0% by the above described formula (2) was estimated as "good".

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • 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)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
EP19880305283 1987-06-12 1988-06-09 Improvements in the use of vials Withdrawn EP0295104A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP8969087U JPS63197542U (it) 1987-06-12 1987-06-12
JP89690/87 1987-06-12

Publications (1)

Publication Number Publication Date
EP0295104A1 true EP0295104A1 (en) 1988-12-14

Family

ID=13977756

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19880305283 Withdrawn EP0295104A1 (en) 1987-06-12 1988-06-09 Improvements in the use of vials

Country Status (2)

Country Link
EP (1) EP0295104A1 (it)
JP (1) JPS63197542U (it)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003053812A1 (es) * 2001-12-20 2003-07-03 Rosa Elena Serra Galdos Dispositivo de envasado complejo
EP2003064A1 (en) 2007-06-13 2008-12-17 Baxter International Inc. Packaging system and method of alerting a practitioner
US20170208861A1 (en) * 2016-01-21 2017-07-27 Pacific Vial Mfg., Inc. Method of making a disposable vial for packing tobacco to be smoked

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2660171A (en) * 1950-12-07 1953-11-24 Jr Fairleigh S Dickinson Vial
BE568541A (it) * 1958-08-01 1958-06-30
FR2390341A1 (fr) * 1977-05-09 1978-12-08 Asicomo As Fermeture de receptacle et procede pour la realiser

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2660171A (en) * 1950-12-07 1953-11-24 Jr Fairleigh S Dickinson Vial
BE568541A (it) * 1958-08-01 1958-06-30
FR2390341A1 (fr) * 1977-05-09 1978-12-08 Asicomo As Fermeture de receptacle et procede pour la realiser

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003053812A1 (es) * 2001-12-20 2003-07-03 Rosa Elena Serra Galdos Dispositivo de envasado complejo
ES2201892A1 (es) * 2001-12-20 2004-03-16 Rosa Elena Serra Galdos Sistema de envasado complejo.
US6951275B2 (en) * 2001-12-20 2005-10-04 Rosa Elena Serra Galdos Complex packaging device
EP2003064A1 (en) 2007-06-13 2008-12-17 Baxter International Inc. Packaging system and method of alerting a practitioner
WO2008153581A1 (en) * 2007-06-13 2008-12-18 Baxter International Inc. Packaging system and method of alerting a practitioner
US9463138B2 (en) 2007-06-13 2016-10-11 Baxter International Inc. Packaging system
US10702452B2 (en) 2007-06-13 2020-07-07 Baxter International Inc. Packaging system and methods of alerting a practitioner
US20170208861A1 (en) * 2016-01-21 2017-07-27 Pacific Vial Mfg., Inc. Method of making a disposable vial for packing tobacco to be smoked
US10492525B2 (en) 2016-01-21 2019-12-03 R.Y.L. Inc. Method of making a disposable vial for packing tobacco to be smoked
US10512281B2 (en) 2016-01-21 2019-12-24 R.Y.L. Inc. Method of making a disposable vial for packing tobacco to be smoked
US10602772B2 (en) * 2016-01-21 2020-03-31 R.Y.L. Inc. Method of making a disposable vial for packing tobacco to be smoked

Also Published As

Publication number Publication date
JPS63197542U (it) 1988-12-20

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