WO2023172119A1 - Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament - Google Patents

Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament Download PDF

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Publication number
WO2023172119A1
WO2023172119A1 PCT/MX2022/050015 MX2022050015W WO2023172119A1 WO 2023172119 A1 WO2023172119 A1 WO 2023172119A1 MX 2022050015 W MX2022050015 W MX 2022050015W WO 2023172119 A1 WO2023172119 A1 WO 2023172119A1
Authority
WO
WIPO (PCT)
Prior art keywords
vial
cap
tip
vaccine
rubber
Prior art date
Application number
PCT/MX2022/050015
Other languages
English (en)
Spanish (es)
Inventor
Héctor SILVA CASTRO
Original Assignee
Silva Castro Hector
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 Silva Castro Hector filed Critical Silva Castro Hector
Priority to PCT/MX2022/050015 priority Critical patent/WO2023172119A1/fr
Publication of WO2023172119A1 publication Critical patent/WO2023172119A1/fr

Links

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
    • 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

Definitions

  • the vials that are made up of a container with a resilient rubber stopper or with elastic memory, so that the liquid or powder content inside the vial is reached by introducing the needle through the rubber of the stopper, reaching the product. to be extracted, to later remove the needle and the rubber section closes the micro-opening created by the needle when introduced into the vial.
  • vials have been developed with caps made of other materials, which may have leachate migration towards the vaccine and/or medication, reacting with the active ingredient and reducing its effectiveness and shelf life, which is why the need was found. to develop a vial, in which there is no contact of the vaccine and/or medication with the materials and leachates of the cap until the moment it is applied.
  • a disinfectant cap and a manufacturing method which may include a first section and a second section, the first section may include a first plate, a container, a first seal, a second seal and a disinfectant agent, the second section may include a sleeve holder.
  • the container may include a second plate, a side wall and an inner chamber, the inner chamber and the side wall being positioned between the first plate and the second plate, the second section being adjacent to the second plate and opposite the first plate, and the first needle port and the second needle port are collinearly aligned with the sleeve holder.
  • GB1054586 relates to a closure for a container comprising a laminate of natural rubber with a solid polymer held in place by a sealing ring, wherein the layers can be joined together by adhesive or co-vulcanization and Closing discs can be cut from laminate sheets.
  • US2629379 relates to a vial stopper with a closure that clearly indicates puncture marks, which helps prevent coring by showing where previous punctures have occurred, comprising a self-sealing rubber stopper having a disc self-sealing without crowns laminated on top of it.
  • US6146362 discloses an injection system and a tipless drug transfer tip to facilitate attachment of a syringe to a fluid line.
  • the system has a casing and a partition consisting of only two parts.
  • the drug transfer tip has a positive locking member to restrict retraction of the injection site once it is inserted to inject a medication.
  • the positive locking member preferably comprises an annular rim defined around the axis of the drug transfer tip.
  • the septum includes a pair of oppositely oriented and axially aligned conical recesses with apices adjacent separated by a thin membrane or intersecting at the time of manufacture, the housing has an inlet for receiving the septum and comprises a plurality of fingers with tabs extending inwardly to hold the septum therein, the septum is ideally suited for application in injection sites, Y-connectors, vial adapters, single-dose or multi-dose vials and blood collection tubes.
  • the septum walls or inwardly extending tabs engage firmly with the shaft of the tip to prevent inadvertent removal.
  • leachates are generated under exaggerated conditions of temperature and time in the presence of an appropriate solvent, growing evidence suggests that leachates may represent a safety risk by causing toxicity, carcinogenicity, immunogenicity and/or endocrine deregulation, These substances can also alter the physical-chemical properties of the product through the interaction with the active pharmaceutical ingredient or the excipients in the product vehicle, which negatively affects the quality of the final product, it is for this reason that it is necessary to develop a container for medicines , more specifically for vaccines, that remains completely sealed and with the vaccine in contact with a single material until its use, and also that it contains multi-dose vaccines inside and that it is opened only when it is going to be used, but also that can incorporate a rubber stopper through which a needle can be inserted multiple times to extract a dose of the vaccine to be applied with each puncture.
  • An objective of the present invention is to provide a completely sealed vial with a vaccine or medication inside, so that the vaccine or medication remains in contact with a single material until the moment of use, extending the shelf life.
  • Another objective of the present invention is to provide an adapter or cap for the vial, which can be attached to the vial at the time the vaccine is to be extracted, where when the adapter or cap is attached to the vial, the tip of the vial penetrates. .
  • Another objective of the present invention is to provide an adapter or cap to the vial, which allows the insertion on several occasions of an extraction needle, so that the multi-dose contained in the vial can be extracted, said cap being attached at the time of extract the vaccine or medication, in this way the contact time of our injection site with the vaccine will only last while the vaccine is applied in a short time and the rubber (membrane) will only be in contact during the extraction of the vaccine which is a short time.
  • Figure 1 shows a side view where the syringe needle is inserted into the rubber of the adapter or cap.
  • Figure 2 shows a side view where the syringe needle, adapter or cap is inserted, not illustrating the rubber.
  • Figure 3 is a side sectional view of the adapter or plug without the rubber section.
  • Figure 4 is a side sectional view of the adapter or plug with rubber section.
  • Figure 5 represents a longitudinal section showing a side view of the completely sealed vial.
  • Figure 6 is a side section of the extraction cap being installed on the tip of the vial, showing the conical walls of the cap punch and the tip of the vial, showing the female angle on the inside of the vial that makes a seal with the male angle plug punch
  • the vial (13) is made up of a plastic container or container, preferably polyethylene or any polymer, hermetically closed, with the vaccine or multi-dose medication or injectable water (14) previously confined inside, said vial It has a neck with a straight tip (15), said straight tip (15) is closed by a thin wall (16) and has an external thread (17).
  • the adapter or extraction plug (1) is made up of a unitary plastic body that integrally defines a lower ring (6) with internal thread, an upper ring (4) and an intermediate transition section (9) between the upper ring ( 4) and the lower ring (6), where the upper ring (4) defines inside a chamber (2) where a rubber or drilling rubber (10) is housed, so that a needle can be inserted on multiple occasions. extraction (18).
  • the intermediate section (9) defines an inner diameter reduction, its upper walls are diagonal, forming a funnel-type conical portion (3) that ends in a through hole or extraction channel (5), said funnel helps direct the needle, From the center of the lower face of said intermediate section (9), a tubular punch (8) projected downwards defined by a metal or plastic tube with a diagonal or beveled tip (11), said bevel defining a punch tip, so that when this adapter or cap (1) is screwed into the external thread (17) of the tip of the vial (13), the tip (11) of the punch (8) is introduced into the vial (13), tearing the upper wall (16). ) thin of the vial (13), said punch (8) projects beyond the height of the edge of the lower ring (6) protruding from said ring (6).
  • Said vial adapter or cap (1) has a resilient rubber (10) with elastic memory, so that once the extraction cap (1) is placed on the vial (13), this rubber (10) remains attached to the vial. vial until all predetermined vaccine doses that have been previously packaged in the vial have been removed.
  • the medication or vaccine (14) already comes into contact with the materials of the cap (1) but for a period of very short time, only while the doses are extracted and applied, so the vaccine or medication or injectable water, since it is not in contact for a long time with other materials other than the material with which the vial is manufactured, does not undergo decomposition. , nor are leachables generated, nor alterations that could affect its effectiveness.
  • the walls of the punch (8) have a slight inclination or conicity (20) of preferably 6 o and the interior walls of the tip (15) of the vial (13) have the same inclination or conicity of 6 or (21), in this way when the adapter (1) is assembled to the vial (13), this taper allows a firmer fit or union.
  • the vial (13) is taken and the adapter or cap (1) is screwed on, as the adapter or cap (1) is screwed onto the tip of the vial.
  • the beveled tip (11) is introduced into the tip (15) of the vial, tearing or breaking the wall (16), introducing the punch (8) into the tip of the vial (13), leaving the rubber or rubber (10) firmly attached to the vial (13), to subsequently introduce the needle (18) of a syringe (19) through the rubber portion (10) extracting the predetermined amount of a dose by removing the needle (18), to subsequently repeat this operation until all the doses are extracted from the vial (13).

Landscapes

  • 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

Selon l'invention, une fiole à bouchon biseauté d'extraction est accoupable au moment de son utilisation, ladite fiole comprenant un récipient complètement scellé pour que les vaccins, par exemple, contre la COVID-19 ou le médicament qui y est contenu soit en contact uniquement avec une matière, évitant que les agents extractibles ou lixiviables présents dans une seconde matière ne migrent pendant la durée de conservation altérant les propriétés du médicament ou du vaccin ou de l'eau injectable. L'adaptateur ou le bouchon comporte un poinçon intégré, ainsi, au moment d'administration de la dose du médicament ou de la fiole, on prend la fiole et on visse l'adaptateur ou le bouchon , à mesure que l'adaptateur ou le bouchon se visse sur le col de la fiole, la pointe biseautée pénètre dans le col de la fiole, déchirant ou rompant la paroi lors de l'introduction du poinçon dans le col de la fiole, laissant la gomme ou le caoutchouc fermement liée à la fiole, pour introduire par la suite l'aiguille d'une seringue dans la partie en gomme ou en caoutchouc extrayant la quantité prédéterminée d'une dose sortant de l'aiguille pour répéter ultérieurement cette opération jusqu'à extraction de toutes les doses de la fiole.
PCT/MX2022/050015 2022-03-09 2022-03-09 Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament WO2023172119A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/MX2022/050015 WO2023172119A1 (fr) 2022-03-09 2022-03-09 Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/MX2022/050015 WO2023172119A1 (fr) 2022-03-09 2022-03-09 Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament

Publications (1)

Publication Number Publication Date
WO2023172119A1 true WO2023172119A1 (fr) 2023-09-14

Family

ID=87935574

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/MX2022/050015 WO2023172119A1 (fr) 2022-03-09 2022-03-09 Ensemble fiole et bouchon-poinçon pour prolonger la durée de conservation d'un vaccin et/ou médicament

Country Status (1)

Country Link
WO (1) WO2023172119A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US20040210207A1 (en) * 2001-06-20 2004-10-21 Shai Amisar Safety dispensing system and method
US20180161243A1 (en) * 2016-12-13 2018-06-14 Shire Modular vial adapter
US20190217015A1 (en) * 2018-01-12 2019-07-18 Becton, Dickinson And Company Smart Vial Adapter and Method
WO2021022326A1 (fr) * 2019-08-03 2021-02-11 Noble House Group Pty. Ltd. Dispositif de prélèvement de sous-cultures

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4650475A (en) * 1985-07-18 1987-03-17 Carol Smith Method and apparatus for the injection of pharmaceuticals
US20040210207A1 (en) * 2001-06-20 2004-10-21 Shai Amisar Safety dispensing system and method
US20180161243A1 (en) * 2016-12-13 2018-06-14 Shire Modular vial adapter
US20190217015A1 (en) * 2018-01-12 2019-07-18 Becton, Dickinson And Company Smart Vial Adapter and Method
WO2021022326A1 (fr) * 2019-08-03 2021-02-11 Noble House Group Pty. Ltd. Dispositif de prélèvement de sous-cultures

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