EP0459182B1 - Containers for lyophilized pharmaceutical products - Google Patents

Containers for lyophilized pharmaceutical products Download PDF

Info

Publication number
EP0459182B1
EP0459182B1 EP19910107365 EP91107365A EP0459182B1 EP 0459182 B1 EP0459182 B1 EP 0459182B1 EP 19910107365 EP19910107365 EP 19910107365 EP 91107365 A EP91107365 A EP 91107365A EP 0459182 B1 EP0459182 B1 EP 0459182B1
Authority
EP
European Patent Office
Prior art keywords
bottle
cap
containers
pharmaceutical products
stopper
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.)
Expired - Lifetime
Application number
EP19910107365
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0459182A3 (en
EP0459182A2 (en
Inventor
Alberto Federighi
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.)
Farmigea SpA
Original Assignee
Farmigea SpA
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 Farmigea SpA filed Critical Farmigea SpA
Publication of EP0459182A2 publication Critical patent/EP0459182A2/en
Publication of EP0459182A3 publication Critical patent/EP0459182A3/en
Application granted granted Critical
Publication of EP0459182B1 publication Critical patent/EP0459182B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
    • 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
    • A61J1/2044—Separating means having slits

Definitions

  • This invention is referred to containers for lyophilized pharmaceutical products to be administered in drops, such as eye drops.
  • the packages of these pharmaceutical products usually consist of a dropper and a couple of bottles that contain respectively the lyophilized product and the solvent.
  • Extemporary prepared lyophilized eye drops are a kind of product that has to be used in a relatively short time, once it is prepared so as to prevent decay.
  • the pharmaceutical product For the purpose of giving the user a product the expiration date of which starts from the day of the reconstitution of the eye drops, the pharmaceutical product has to be prepared extermporarily following the instructions that are written on the ticket that is enclosed with the product.
  • the user can instill the eye drops by squeezing the body of the plastic dropper applied on the glass bottle, after removing the top's cap. After the use, the cap has to be put on again and the bottle put away.
  • the main defect of the prior art lies in the fact that the product has to be instilled by squeezing the body of a plastic dropper that is fixed on the glass bottle very weekly. This operation has to be carried out very delicately as the dropper has an elonged shape. Consequently, a week couple of forces acting with respect to the dropper's connection on the bottle is enough to displace the dropper from its seat.
  • EP-A-0 138 681 relates to an assembly for preparing and dispensing a solution, which comprises a first bottle containing a liquid component, with an elongated head and a second bottle containing a second component; a stopper for this second bottle presenting a recess, whose shape is homologous of the head of the first bottle and in which said head must be screwed.
  • the bottom of the recess is constituted by a membrane of deformable material comprising an axial orifice which is hermetically closed, in absence of deformation of the membrane.
  • Said assembly has the drawback that impurities or bacteric polluting agents can infiltrate inside said recess of the stopper during assembling operations; which operations are not so simple because the bottle must be well screwed to deform the bottom of the recess and to avoid losses of liquid.
  • this invention proposes to realize containers for lyophilized pharmaceutical products to be administrated in drops, consisting of two bottles of which the first one initially containing the lyophilised product is made of rigid material and provided with hermetically sealed cap that can be partially ripped open and with a rubber stopper interposed between the cap of the first bottle and its own open edge, the second bottle being designed for containing initially the solvent made of compressible material and being provided with a spout ; characterized in that the rubber stopper is in form of a washer and in that said stopper has a small hole designed for receiving the spout of the second bottle penetrating inside the first bottle .
  • a bottle usually made of glass, contains the lyophilized product 2 and it is hermetically sealed by a cap 3, the centre of which is punched to the end of a tang or lever 4 for tearing it open.
  • FIG. 6 A different embodiment is shown in fig. 6. This differs from the sample of fig. 1 for the presence of a further cap 11, preferably made of plastic material, that covers cap 3 superiorly and that substitutes the tang 4 for opening the bottle.
  • Cap 11 has a larger diameter than that of cap 3 on which it is centrally punched, so the user can easily push the protruding edge of cap 11 upwards. Cap 11 will rip off the central part of cap 3 uncovering in this way the hole 5 in a similar way as previously described and illustrated in figs. 1 and 2.
  • the stopper 7 consists of a simple rubber washer as shown in fig. 4.
  • the spout 9 of a plastic bottle 8 that originally contains the solvent 10 has to be introduced into the hole 6. Then, the two bottles be turned upside-down as a whole, with bottle 1 on top and bottle 8 underneath.
  • bottle 8 is finally filled with the eye drop solution; bottle 1 can be taken off of bottle 8 and the product is ready to be used.
  • this invention has several advantages. First of all the dropper that was present for the known eye drops containers has been eliminated together with its paper coverings for preserving the sterility.
  • the diameter of hole 6 of the stopper 7 is designed so as to let the solvent be sprayed inside the bottle with a thin and quite vigorous jet that creates a considerable turbulence that facilitates the solving of the lyophilized product. Moreover, a further re-mixing takes place as the solution passes back into bottle 8 from bottle 1.

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)
  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Closures For Containers (AREA)
  • Medicinal Preparation (AREA)
EP19910107365 1990-05-29 1991-05-07 Containers for lyophilized pharmaceutical products Expired - Lifetime EP0459182B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT5305990U 1990-05-29
IT5305990U IT220400Z2 (it) 1990-05-29 1990-05-29 Contenitori di prodotti farmaceutici liofilizzati

Publications (3)

Publication Number Publication Date
EP0459182A2 EP0459182A2 (en) 1991-12-04
EP0459182A3 EP0459182A3 (en) 1993-01-20
EP0459182B1 true EP0459182B1 (en) 1996-09-11

Family

ID=11279627

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19910107365 Expired - Lifetime EP0459182B1 (en) 1990-05-29 1991-05-07 Containers for lyophilized pharmaceutical products

Country Status (5)

Country Link
EP (1) EP0459182B1 (es)
AT (1) ATE142587T1 (es)
DE (1) DE69121966T2 (es)
ES (1) ES2092524T3 (es)
IT (1) IT220400Z2 (es)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013134760A3 (en) * 2012-03-09 2015-06-18 Invivo Therapeutics Corporation Protective packaging with product preparation features incorporated

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5619419B2 (ja) 2006-09-29 2014-11-05 インファ ソシエテ アノニム 薬学的組成物用調剤システム及び静脈内投与用キット
WO2016162814A1 (en) 2015-04-10 2016-10-13 Dompe' Farmaceutici S.P.A. Method for manufacturing a dispensing device for eye drops
MA41906A (fr) * 2015-04-10 2018-02-13 Dompe Farm Spa Dispositif de distribution de gouttes oculaires
ITUA20162072A1 (it) 2016-06-30 2017-12-30 Platinum Corp Srl Dropper a volume controllato
CA3134973A1 (en) * 2019-03-27 2020-10-01 Fluidigm Canada Inc. Lyophilized antibody panel

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4230112A (en) * 1978-08-07 1980-10-28 Smith Philip E Syringe-type liquid container dispenser adapter
US4284201A (en) * 1980-07-10 1981-08-18 Anchor Cap & Closure Corporation Of Canada Ltd. Child proof cap
FR2552404B1 (fr) * 1983-09-26 1987-12-24 Merck Sharp & Dohme Ensemble de preparation et de delivrance d'une solution, bouchon obturateur pour cet ensemble et procede de fabrication de ce bouchon

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013134760A3 (en) * 2012-03-09 2015-06-18 Invivo Therapeutics Corporation Protective packaging with product preparation features incorporated

Also Published As

Publication number Publication date
IT220400Z2 (it) 1993-09-21
IT9053059V0 (it) 1990-05-29
DE69121966D1 (de) 1996-10-17
DE69121966T2 (de) 1997-03-20
EP0459182A3 (en) 1993-01-20
ES2092524T3 (es) 1996-12-01
EP0459182A2 (en) 1991-12-04
ATE142587T1 (de) 1996-09-15
IT9053059U1 (it) 1991-11-30

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