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WO2011128912A2 - Contenant pour des produits à reconstituer administrés par voie orale - Google Patents

Contenant pour des produits à reconstituer administrés par voie orale Download PDF

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Publication number
WO2011128912A2
WO2011128912A2 PCT/IN2011/000249 IN2011000249W WO2011128912A2 WO 2011128912 A2 WO2011128912 A2 WO 2011128912A2 IN 2011000249 W IN2011000249 W IN 2011000249W WO 2011128912 A2 WO2011128912 A2 WO 2011128912A2
Authority
WO
WIPO (PCT)
Prior art keywords
vessel
container
constituent
reconstitution
oral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IN2011/000249
Other languages
English (en)
Other versions
WO2011128912A3 (fr
Inventor
Rajesh Kumar Mishra
Bikram Bhowmik
Anahita Karande
Amiya Ranjan Pradhan
Shripad Jathar
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.)
Abbott Healthcare Pvt Ltd
Original Assignee
Abbott Healthcare Pvt 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 Abbott Healthcare Pvt Ltd filed Critical Abbott Healthcare Pvt Ltd
Publication of WO2011128912A2 publication Critical patent/WO2011128912A2/fr
Publication of WO2011128912A3 publication Critical patent/WO2011128912A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • B65D25/085—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 dislodged by means of a plunger rod or the like pushing the plug down
    • 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

  • the present invention relates to containers for oral reconstitution products and more particularly, to containers for oral pharmaceutical reconstitution products.
  • Oral antimicrobial drugs in dry powder suspension formulations such as Cefixime, Cefpodoxime, Amoxycilin, Diclooxacilin, the combinations thereof and the like, need 'to be reconstituted before use' as the ingredients or composition of the product are not stable in liquid form throughout the shelf life.
  • the pharmaceutical products such as dry syrups and oral powders are packed in either plastic or glass bottle for reconstitution.
  • Dosage preparation in such cases becomes tedious and cumbersome.
  • steps need to be followed: boiling the water, cooling it, opening the bottle, reconstituting the powder with the cooled water, shaking the container and finally dispensing the prepared suspension.
  • the first few steps of boiling and cooling water in itself may take about 15- 20 minutes. Further, there is a substantial probability of medical errors (under and over dosing) and contamination.
  • a tamper-evident band of the cap of the bottle requires low tear initiation strength, therefore they are normally made up of polyethylene e.g. either low density poly ethylene, linear low density poly ethylene or high density poly ethylene.
  • polyethylene e.g. either low density poly ethylene, linear low density poly ethylene or high density poly ethylene.
  • the use of these materials renders the cap opaque. Therefore, a separate transparent cup needs to be provided with the bottles for measuring the dosage. The additional cup adds to the cost of packaging and there is a chance of misplacing the measuring cup.
  • United States Patent 4102451 ('2451) to Clarke, et al describes a dual compartment mixing vial having a center seal isolating one compartment from the other which is provided with a stopper at its open end which embodies a rod that is slidably positioned therethrough.
  • the rod upon being pushed downwardly, abuts the center seal of the vial and causes it to be displaced, thereby permitting the contents of the two compartments to intermix within the closed vial.
  • An activating cap is provided for preventing accidental movement of the rod and to facilitate intentional movement of it.
  • the mixing vial of '2451 is specifically for use with a syringe.
  • the design is complex as the vial has to provide for insertion of the syringe needle.
  • the rod for pushing the center seal downwards needs to be pushed with a substantial force.
  • the rod needs to be sufficiently strong to transmit the force without piercing the center seal.
  • An objective of the invention is to provide a simple and cost-effective container for oral reconstitution products, which obviates the conventional cumbersome process of oral reconstitution dosage preparation and reduces the time required for the same.
  • the present invention provides a container for oral reconstitution products comprising a vessel having a bottom chamber for storing a first constituent and a top chamber for storing a second constituent, a sealing plug snugly fitted at a neck of the vessel between the top and the bottom chamber for separating the first constituent from the second constituent, a cage insert for pushing the sealing plug out of the neck of the vessel, and an over cap screwed over male threads on a mouth of the vessel for sealably closing the vessel.
  • the container is simple in construction, is cost-effective and saves time by doing away with the conventional method of reconstitution dosage preparation.
  • Fig. 1 shows a container for oral reconstitution products, in accordance with an embodiment of the invention.
  • Fig. 1a is an isometric view and
  • Fig. 1 b is a sectional view of the assembled container, and
  • Fig. 1c is an exploded isometric view of the container.
  • Fig. 2 shows a container for oral reconstitution products, in accordance with another embodiment of the invention.
  • Fig. 2a is an isometric view and
  • Fig. 2b is a sectional view of assembled container, and
  • Fig. 2c is an exploded isometric view of the container.
  • Figs. 3a-6a illustrate the process of using the container for preparing an oral dosage, in accordance with an embodiment of the invention.
  • Figs. 3b-6b illustrate the process of using the container for preparing an oral dosage, in accordance with another embodiment of the invention.
  • Various embodiments of the invention provide a simple and cost-effective container for oral pharmaceutical reconstitution products.
  • FIG. 1 shows container 100, in accordance with an embodiment of the invention.
  • container 100 includes a vessel 102 having a bottom chamber 104 and a top chamber 106, a sealing plug 108, a cage insert 112, and an over cap 114 screwed over male threads on a mouth 116 of vessel 102 for sealably closing vessel 102.
  • Vessel 102 creates two different chambers for two different constituents of drug products.
  • the material of construction of vessel may be one of poleolefins, polypropylene, polyvinyl chloride, polyethylene terepthalate, poly carbonate, acrylic, vinyl acetate, polystyrene and the like.
  • Bottom chamber 104 is a base of container 100 and stores a first constituent.
  • Top chamber 106 stores a second constituent. The first and the second constituent intermix to form a desired reconstitution composition.
  • Sealing plug 108 is snugly fitted at a neck 110 of vessel 102 between top chamber 106 and bottom chamber 104 and separates the first constituent from the second constituent. Sealing plug 108 seals the opening of the bottom chamber 104 where the first constituent is filled and does not allow the second constituent to get mixed unless pushed by cage insert 112.
  • Sealing plug 108 provides a perfect sealing (or leak proof partition) between the two chambers and also minimizes the moisture transmission rate.
  • the material of construction of sealing plug 108 is one of thermoplastic elastomer (such as styrene, polycarbonate, polyethylene, polypropylene, polyvinylchloride, polyurethane, polyesters, polyamides and the like), thermosetting elastomer (such as butyl rubber, ethylene propylene diene monomer, silicone, natural rubber, neoprene, polybutadiene, flouroelastomer, styrene butadiene rubber and the like) and the like.
  • thermoplastic elastomer such as styrene, polycarbonate, polyethylene, polypropylene, polyvinylchloride, polyurethane, polyesters, polyamides and the like
  • thermosetting elastomer such as butyl rubber, ethylene propylene diene monomer, silicone, natural rubber, ne
  • Cage insert 112 is for pushing sealing plug out of the neck of the vessel so that the first constituent can mix with the second constituent.
  • Cage insert tip 112b has a hollow circular section which allows exerting an even force on the periphery of the sealing plug 108. Further, a steady movement of cage insert 108 is enables by tight interference of its outer surface with the inside surface of vessel 102.
  • the material of construction of cage insert 108 may be one of polyolefins, polystyrene, polyvinyl chloride, polyethylene terepthalate and the like.
  • over cap 114 has a tamper evident tear band 118. Tamper evident tear band 118 of over cap 114 acts as a stopper to the downward movement of cage insert 112.
  • Tamper evident tear band 118 needs to be removed before screwing over cap 114. Only after removing tamper evident tear band 118, over cap 114 can be rotated.
  • the material used for over cap 114 is one of low density poly ethylene, linear low density poly ethylene, high density poly ethylene, and the like and preferably polypropylene or by mixing with other additives. Polypropylene allows transparency and additional cup is not required.
  • tamper evident band puller 118a has been provided at the opening of tamper evident tear band 118 to facilitate easy opening.
  • Fig. 2 shows container 200, in accordance with another embodiment of the invention.
  • sealing plug 108 and cage insert 112 are replaced with a sealing plug 208 and a cage insert 212, repectively.
  • Sealing plug 208 is in the form of a ring and is attached to cage insert 212 or is a part thereof so that the sealing plug does not fall on the bottom of container 200 once it is intentionally pushed by a user (figure 6).
  • Cage insert 212 has grooves for sealing plug 208 to snugly fit into. The length or the height of cage insert 212 is adapted so that sealing plug 208 is snugly fit into neck 110.
  • Bottom chamber 104 is filled with the first constituent and sealing plug 108 is inserted into vessel 102 and is snugly fitted at neck 110 of vessel 102.
  • Cage insert 112 is then inserted into vessel 102 so that cage insert tip 112b is just above sealing plug 108.
  • the second constituent is filled in top chamber 106 and over cap 114 is put over mouth 116 to close and seal vessel 102.
  • An o-ring 120 is already fitted on a groove 120a on cage insert 112, which arrests the movement of cage insert 112.
  • a liner 122 is provided in over cap 114 for sealing over cap with a top 112a of cage insert 112.
  • container 100 Use and operation of container 100 will be explained with reference to figures 3 to 6.
  • tamper- evident tear band 118 is removed by tearing it apart by pulling away tamper evident puller 118a.
  • over cap 114 is screwed clock-wise as shown in figure 4.
  • Over cap 114 moves downwards and pushes cage insert 112 downwards, which in turn pushes sealing plug 108 out of neck 110 and opens up a channel for the first and second constituents to intermix so that the reconstitution takes place and the desired composition is formed.
  • Container 100 may be shaken well before dispensing the composition.
  • over cap 114 is made of polypropylene and has graduation marks and is used as a measuring cup. Subsequently, over cap 114 is unscrewed from vessel 102 and may be filled with the desired dispensing quantity of the composition formed.
  • vessel 102 is a dual-chambered single container body and is manufactured using known methods such as injection molded, injection blow moulded or extrusion blow moulded or injection stretch blow molded.
  • the first and second constituents may be in liquid, solid or powdered form. Further, in various embodiments, it may be apparent that any of the constituents may be kept in either of the top or bottom chambers.
  • material 1 and material 2 are mixed.
  • material 3-5 are added and mixed and passed through 0.5mm screen.
  • the first constituent is then ready to be filled into one of the chambers of the container.
  • Material 1 and material 2 are dissolved in hot water (material 3) to form the second constituent which is then filled in the other chamber of the container.
  • Other examples are oral antimicrobial drugs in dry powder such as cefodoxine, dry powder suspension formulations such as cefixime, cefpodoxime, amoxycilin, diclooxacilin, combinations thereof and the like.
  • sealing means such as o-rings, liners, and the like may be provided at appropriate locations in the construction of the various embodiments described above to save the constituents from getting exposed to the atmosphere before the means for sealing is broken and during the process of administration.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (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)
  • Closures For Containers (AREA)

Abstract

La présente invention concerne un contenant simple, peu coûteux et permettant de gagner du temps destiné à des produits pharmaceutiques oraux, ledit contenant évitant le processus classique ennuyeux de préparation de la dose reconstituée pour administration par voie orale. Le contenant comprend un corps à deux chambres formé d'une chambre inférieure pour stocker un premier constituant et d'une chambre supérieure pour stocker un second constituant, un bouchon d'étanchéité ajusté serré au niveau d'un goulot du contenant entre les chambres supérieure et inférieure pour séparer le premier constituant du second constituant, un élément rapporté formant cage servant à pousser le bouchon d'étanchéité hors du goulot du contenant et un surbouchon vissé sur les filets mâles formés sur une ouverture du contenant pour fermer hermétiquement le contenant. Le contenant est simple du point de vue de sa construction, peu coûteux et permet de gagner du temps puisqu'il évite le procédé classique de préparation de la dose reconstituée.
PCT/IN2011/000249 2010-04-12 2011-04-11 Contenant pour des produits à reconstituer administrés par voie orale Ceased WO2011128912A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1198MU2010 2010-04-12
IN1198/MUM/2010 2010-04-12

Publications (2)

Publication Number Publication Date
WO2011128912A2 true WO2011128912A2 (fr) 2011-10-20
WO2011128912A3 WO2011128912A3 (fr) 2011-12-15

Family

ID=44629184

Family Applications (1)

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PCT/IN2011/000249 Ceased WO2011128912A2 (fr) 2010-04-12 2011-04-11 Contenant pour des produits à reconstituer administrés par voie orale

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Country Link
WO (1) WO2011128912A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2934422A4 (fr) * 2012-12-23 2016-07-20 Vadim Zelikman Porteur de gomme gellane pour un médicament, moyen et procédé
WO2017013550A1 (fr) 2015-07-20 2017-01-26 Abbott Healthcare Pvt. Ltd. Contenant de mélange
CN106619536A (zh) * 2017-03-15 2017-05-10 深圳立健药业有限公司 一种头孢克肟干混悬颗粒的制备方法

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4102451A (en) 1977-05-25 1978-07-25 Eli Lilly And Company Mixing vial

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4727985A (en) * 1986-02-24 1988-03-01 The Boc Group, Inc. Mixing and dispensing apparatus

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4102451A (en) 1977-05-25 1978-07-25 Eli Lilly And Company Mixing vial

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2934422A4 (fr) * 2012-12-23 2016-07-20 Vadim Zelikman Porteur de gomme gellane pour un médicament, moyen et procédé
WO2017013550A1 (fr) 2015-07-20 2017-01-26 Abbott Healthcare Pvt. Ltd. Contenant de mélange
CN106619536A (zh) * 2017-03-15 2017-05-10 深圳立健药业有限公司 一种头孢克肟干混悬颗粒的制备方法

Also Published As

Publication number Publication date
WO2011128912A3 (fr) 2011-12-15

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