EP0459182A2 - Behälter für lyophilisierte pharmazeutische Produkte - Google Patents

Behälter für lyophilisierte pharmazeutische Produkte Download PDF

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Publication number
EP0459182A2
EP0459182A2 EP91107365A EP91107365A EP0459182A2 EP 0459182 A2 EP0459182 A2 EP 0459182A2 EP 91107365 A EP91107365 A EP 91107365A EP 91107365 A EP91107365 A EP 91107365A EP 0459182 A2 EP0459182 A2 EP 0459182A2
Authority
EP
European Patent Office
Prior art keywords
bottle
cap
spout
hole
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.)
Granted
Application number
EP91107365A
Other languages
English (en)
French (fr)
Other versions
EP0459182A3 (en
EP0459182B1 (de
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/de
Publication of EP0459182A3 publication Critical patent/EP0459182A3/en
Application granted granted Critical
Publication of EP0459182B1 publication Critical patent/EP0459182B1/de
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.
  • this invention proposes to realize containers for lyophilized pharmaceutical products to be administrated in drops, characterized in that they consist of two bottles of which the first one, initially containing the lyophilized product is made of rigid material and provided with a hermetically sealed cap that can be partially ripped open and with a rubber stopper interposed between the cap 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; the first bottle having a hole in the stopper designed for receiving the spout; the first bottle having a hole in the stopper designed for receiving the spout of the second 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 centally 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 cna also consist of a simple rubber washer as shown in fig. 4, or of a traditional rubber stopper, or otherwise it can be of the "stoppering" kind, that is already used in particular for lyophilized products.
  • 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 Behälter für lyophilisierte pharmazeutische Produkte Expired - Lifetime EP0459182B1 (de)

Applications Claiming Priority (2)

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

Publications (3)

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

Family

ID=11279627

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19910107365 Expired - Lifetime EP0459182B1 (de) 1990-05-29 1991-05-07 Behälter für lyophilisierte pharmazeutische Produkte

Country Status (5)

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

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008038126A3 (en) * 2006-09-29 2008-11-20 Infa Sa Packaging system for pharmaceutical compositions and kit for intravenous administration
WO2016162812A1 (en) * 2015-04-10 2016-10-13 Dompe' Farmaceutici S.P.A. Dispensing device for eye drops
US10442583B2 (en) 2015-04-10 2019-10-15 Dompe' Farmaceutici S.P.A. Method for manufacturing a dispensing device for eye drops
US11324630B2 (en) 2016-06-30 2022-05-10 Dompe' Farmaceutici S.P.A. Controlled volume dropper
EP3946274A4 (de) * 2019-03-27 2023-04-19 Fluidigm Canada Inc. Lyophilisierte antikörperplatte
US12496177B2 (en) 2017-02-13 2025-12-16 Boehringer Ingelheim Animal Health USA Inc. Liquid applicator for delivering vaccines

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130233736A1 (en) * 2012-03-09 2013-09-12 Invivo Therapeutics Corporation Protective packaging with product preparation features incorporated

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 (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008038126A3 (en) * 2006-09-29 2008-11-20 Infa Sa Packaging system for pharmaceutical compositions and kit for intravenous administration
US8721616B2 (en) 2006-09-29 2014-05-13 Infa S.A. Packaging system for pharmaceutical compositions and kit for intravenous administration
WO2016162812A1 (en) * 2015-04-10 2016-10-13 Dompe' Farmaceutici S.P.A. Dispensing device for eye drops
US10442583B2 (en) 2015-04-10 2019-10-15 Dompe' Farmaceutici S.P.A. Method for manufacturing a dispensing device for eye drops
EA037496B1 (ru) * 2015-04-10 2021-04-05 Домпе Фармачеутичи С.П.А. Приспособление для дозирования глазных капель
US11103379B2 (en) 2015-04-10 2021-08-31 Dompe' Farmaceutici S.P.A. Dispensing device for eye drops
US11324630B2 (en) 2016-06-30 2022-05-10 Dompe' Farmaceutici S.P.A. Controlled volume dropper
US12496177B2 (en) 2017-02-13 2025-12-16 Boehringer Ingelheim Animal Health USA Inc. Liquid applicator for delivering vaccines
EP3946274A4 (de) * 2019-03-27 2023-04-19 Fluidigm Canada Inc. Lyophilisierte antikörperplatte

Also Published As

Publication number Publication date
EP0459182A3 (en) 1993-01-20
ES2092524T3 (es) 1996-12-01
IT9053059V0 (it) 1990-05-29
IT9053059U1 (it) 1991-11-30
ATE142587T1 (de) 1996-09-15
DE69121966T2 (de) 1997-03-20
DE69121966D1 (de) 1996-10-17
IT220400Z2 (it) 1993-09-21
EP0459182B1 (de) 1996-09-11

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