EP1772395B1 - Emballage de protection pour produits pharmaceutiques - Google Patents

Emballage de protection pour produits pharmaceutiques Download PDF

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Publication number
EP1772395B1
EP1772395B1 EP05090280A EP05090280A EP1772395B1 EP 1772395 B1 EP1772395 B1 EP 1772395B1 EP 05090280 A EP05090280 A EP 05090280A EP 05090280 A EP05090280 A EP 05090280A EP 1772395 B1 EP1772395 B1 EP 1772395B1
Authority
EP
European Patent Office
Prior art keywords
packaging
oxygen
protective
pharmaceutical products
primary
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.)
Revoked
Application number
EP05090280A
Other languages
German (de)
English (en)
Other versions
EP1772395A1 (fr
Inventor
Karsten Gröger
Reinhard Schmitz
Jens Flemming
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.)
Berlin Chemie AG
Original Assignee
Berlin Chemie AG
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
Family has litigation
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Application filed by Berlin Chemie AG filed Critical Berlin Chemie AG
Priority to DE502005011092T priority Critical patent/DE502005011092D1/de
Priority to EP05090280A priority patent/EP1772395B1/fr
Priority to AT05090280T priority patent/ATE501059T1/de
Publication of EP1772395A1 publication Critical patent/EP1772395A1/fr
Application granted granted Critical
Publication of EP1772395B1 publication Critical patent/EP1772395B1/fr
Revoked legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • B65D81/18—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 providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2069—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas in a special atmosphere
    • 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
    • B65D81/18—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 providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2007—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 providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under vacuum
    • 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
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants

Definitions

  • the present invention relates to a pharmaceutical protective packaging and more particularly to a packaging for protection against oxygen.
  • the EP 0 810 163 A1 discloses such a package.
  • antioxidants or free-radical scavengers such as ascorbic acid, tocopherol, butylhydroxyanisole or butylhydroxytoluene
  • antioxidants or free-radical scavengers such as ascorbic acid, tocopherol, butylhydroxyanisole or butylhydroxytoluene
  • inert gases protected fumigation
  • the object of the present invention is therefore to provide a pharmaceutical protective packaging which, independently of climatic external conditions, allows the storage of oxygen-sensitive medicaments over a relatively long period of time.
  • a pharmaceutical protective packaging consisting of a primary packaging and an outer packaging, with the features of the main claim.
  • Advantageous embodiments are characterized in the dependent claims.
  • the object is achieved according to the invention by providing a pharmaceutical protective packaging in which the oxygen content within the primary packaging is less than 1% by volume.
  • Preferred according to the invention is a pharmaceutical protective packaging according to the invention, wherein the oxygen content within the primary packaging is less than 0.5% by volume.
  • Particularly preferred according to the invention is a pharmaceutical protective packaging according to the invention, wherein the oxygen content within the primary packaging is less than 0.1% by volume.
  • the packing prefferably evacuated, the pressure being less than 50 mbar.
  • the packing contains a protective gas selected from argon, nitrogen or carbon dioxide.
  • the pack contains an oxygen absorber.
  • the pharmaceutical protective packaging is structurally designed in such a way that it consists of at least two interconnected spaces, wherein a moisture and / or gas absorbing substance is located in one of the spaces.
  • the pharmaceutical protective packaging according to the invention also contains an oxygen indicator.
  • the oxygen indicator is arranged in an externally visible region of the protective packaging.
  • Another object of the present invention is the use of a protective packaging according to the invention for oxygen-sensitive active ingredients.
  • the active substance contains at least one oxygen-sensitive group which is selected from alcohol, phenol, aldehyde, enol, ether, amine, ketol, aromatic, heteroaromatic, peptide, protein, amino acid, carboxylic acid, fatty acid, fatty acid ester, Sterol and steroid.
  • oxygen-sensitive group which is selected from alcohol, phenol, aldehyde, enol, ether, amine, ketol, aromatic, heteroaromatic, peptide, protein, amino acid, carboxylic acid, fatty acid, fatty acid ester, Sterol and steroid.
  • the active ingredient is selected from vitamins such as vitamins A, B and E group, ascorbic acid, antibiotics such as amphotericin B, thyroid hormones such as levothyroxine, liothyronine, cysteine, tryptophan, nepadutant, sorbic acid , omega-3 fatty acids, omega-4 fatty acids, lipids phospholipids, ethyl oleates, cholesterol
  • a blister pack which are produced by deep drawing in a known manner.
  • aluminum foils are used, which are coated with conventional, heat-sealable plastics and also plastic films, which are suitable for the sealing process, as is known in the art.
  • plastic films which are suitable for the sealing process, as is known in the art.
  • aluminum-aluminum packaging which are also mechanically closed or heat-sealable equipped. These aluminum-aluminum packages can also be used as outer packaging for blister packs.
  • the package can be evacuated.
  • the ambient air is removed from the packaging and thus the harmful oxygen.
  • the oxygen content is only about 0.5% by volume.
  • the evacuation of the package can be done by, for example, blistering the packages in a vacuum. But it can also be a conventional blister pack placed in an outer packaging, such as an aluminum-aluminum packaging and then evacuated and sealed in the usual way.
  • the oxygen content can also be reduced by applying a protective gas to the packaging.
  • a protective gas for this purpose, it may be necessary to rinse the pack beforehand, if appropriate also several times with the protective gas, in order to lower the oxygen content in accordance with the invention.
  • an aluminum-aluminum packaging can be used as outer packaging, wherein the outer packaging may also be acted upon together with the inner packaging with the protective gas.
  • Suitable inert gases are inert gases which do not react with oxygen-sensitive groups of the active substances to be stored.
  • shielding gases include, but are not limited to, argon, nitrogen or carbon dioxide.
  • Other noble gases and inert gases are suitable. Of course, mixtures of these gases can also be used.
  • oxygen absorbers are known.
  • iron-containing absorbers may be used which may be suitably coated or coated.
  • oxygen absorbers are sold, for example, under the trademarks Ageless or Pharmakeep by Mitsubishi Gas Chemical Company, Inc.
  • the pharmaceutical protective packaging such that at least two interconnected spaces are present. These spaces are interconnected by channels or otherwise, so that there may be a pressure and / or gas exchange between these spaces. If one now fills one of the rooms with the medicament to be stored and the other room with the oxygen absorber, then the reduction of the content of oxygen within the protective packaging according to the invention occurs.
  • such an arrangement may be useful in the case of using a shielding gas or in evacuation.
  • an oxygen indicator can be added to the packaging.
  • These oxygen indicators are known and used in the form of tablets which show a color change at a certain oxygen content.
  • These oxygen indicators may contain substances that show a color change on the addition of oxygen. This is the case with pyrogallol, for example, with a color change to red.
  • other indicators may be used according to the invention.
  • it is therefore provided to add an indicator to the package, for example. If, as described above, the pharmaceutical protective package has, for example, several rooms, then the indicator can be placed in one of these rooms.
  • the indicator is placed in the outer packaging, for example in an aluminum-aluminum outer packaging, in which case advantageously the aluminum package may contain a viewing window through which the possible color change can be observed.
  • Such oxygen indicators are available, for example, under the trade designation Ageless-eye from Mitsubishi Gas Chemical Company, Inc.
  • the pharmaceutical protective packaging according to the invention can be used for drugs which tend to decompose on exposure to oxygen.
  • drugs usually contain a slightly reactive group, which is then altered by reaction with oxygen.
  • reactive groups include, for example, alcohols, phenols, aldehydes, enols, ethers, amines, ketols, aromatics, heteroaromatics, peptides, proteins, amino acids, carboxylic acids, fatty acids, fatty acid esters, sterols and steroids. This list is not exhaustive and can be extended by the expert without further ado.
  • drugs containing such reactive groups include, among others, vitamins such as ascorbic acid, tocopherols, vitamins of A, B and E groups, antibiotics such as amphotericin B, thyroid hormones such as levothyroxine, liothyronine, tryptophan , Sorbic acid, omega-3 fatty acids, omega-4 fatty acids, nepadutant, phospholipids, ethyl oleates, cholesterols, as well as other steroid hormones and the like.
  • vitamins such as ascorbic acid, tocopherols, vitamins of A, B and E groups
  • antibiotics such as amphotericin B
  • thyroid hormones such as levothyroxine, liothyronine, tryptophan , Sorbic acid, omega-3 fatty acids, omega-4 fatty acids, nepadutant, phospholipids, ethyl oleates, cholesterols, as well as other steroid hormones and the like.
  • Other suitable drugs
  • Tables 2 and 3 show the evaluation of an experiment at the storage condition 40 ° C / 75% rel.
  • F. Levothyroxine [%] was determined after a storage period of x months.
  • a conventional blister (Table 2) was used and stored in an aluminum transfer bag of the same blister in the presence of an oxygen absorber in the aluminum transfer bag.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Food Science & Technology (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Apparatus For Radiation Diagnosis (AREA)
  • Glass Compositions (AREA)
  • Materials For Medical Uses (AREA)

Claims (11)

  1. Emballage de protection pour des produits pharmaceutiques, caractérisé en ce qu'il est constitué par un emballage primaire et par un emballage extérieur, l'emballage primaire contenant un emballage-coque et l'emballage extérieur contenant une pellicule d'aluminium, la teneur en oxygène au sein de l'emballage primaire s'élevant à une valeur inférieure à 1 % en volume.
  2. Emballage de protection pour des produits pharmaceutiques selon la revendication 1, caractérisé en ce que l'emballage primaire ou l'emballage extérieur ou les deux contiennent un agent absorbant l'oxygène.
  3. Emballage de protection pour des produits pharmaceutiques selon l'une quelconque des revendications précédentes, caractérisé en ce que l'emballage primaire est constitué par au moins deux espaces reliés l'un à l'autre, une substance absorbant l'humidité et/ou les gaz étant présente dans un des espaces.
  4. Emballage de protection pour des produits pharmaceutiques selon l'une quelconque des revendications précédentes, caractérisé en ce que l'emballage primaire ou l'emballage extérieur contient un indicateur d'oxygène.
  5. Emballage de protection pour des produits pharmaceutiques selon la revendication 1, caractérisé en ce que la teneur en oxygène au sein de l'emballage primaire s'élève à une valeur inférieure à 0,5 % en volume.
  6. Emballage de protection pour des produits pharmaceutiques selon la revendication 1, caractérisé en ce qu'on crée un vide dans l'emballage, si bien que la pression s'élève à une valeur inférieure à 50 mbar.
  7. Emballage de protection pour des produits pharmaceutiques selon la revendication 1, caractérisé en ce que l'emballage contient un gaz de protection choisi parmi l'argon, l'azote ou le dioxyde de carbone.
  8. Utilisation d'un emballage de protection selon l'une quelconque des revendications 1 à 7, pour des substances actives sensibles à l'oxygène.
  9. Utilisation selon la revendication 8, caractérisée en ce que la substance active contient au moins un groupe sensible à l'oxygène, qui est choisi parmi un alcool, un phénol, un aldéhyde, un énol, un éther, une amine, un cétol, un composé aromatique, un composé hétéroaromatique, un peptide, une protéine, un acide aminé, un acide carboxylique, un acide gras, un ester d'acide gras, un stérol et un stéroïde.
  10. Utilisation selon la revendication 9, caractérisée en ce que la substance active est choisie parmi des vitamines, des vitamines des groupes A, B et E, l'acide ascorbique, des antibiotiques, l'amphotéricine B, des hormones thyroïdiennes, la lévothyroxine, la liothyronine, la cystéine, le tryptophane, le népadutant, l'acide sorbique, des acides gras oméga 3, des acides gras oméga 4, des lipides, des phospholipides, des oléates d'éthyle, du cholestérol.
  11. Utilisation selon la revendication 10, caractérisée en ce que la substance active est la lévothyroxine ou le sel de sodium de la lévothyroxine.
EP05090280A 2005-10-05 2005-10-05 Emballage de protection pour produits pharmaceutiques Revoked EP1772395B1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE502005011092T DE502005011092D1 (de) 2005-10-05 2005-10-05 Pharmazeutische Schutzverpackung
EP05090280A EP1772395B1 (fr) 2005-10-05 2005-10-05 Emballage de protection pour produits pharmaceutiques
AT05090280T ATE501059T1 (de) 2005-10-05 2005-10-05 Pharmazeutische schutzverpackung

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP05090280A EP1772395B1 (fr) 2005-10-05 2005-10-05 Emballage de protection pour produits pharmaceutiques

Publications (2)

Publication Number Publication Date
EP1772395A1 EP1772395A1 (fr) 2007-04-11
EP1772395B1 true EP1772395B1 (fr) 2011-03-09

Family

ID=36110769

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05090280A Revoked EP1772395B1 (fr) 2005-10-05 2005-10-05 Emballage de protection pour produits pharmaceutiques

Country Status (3)

Country Link
EP (1) EP1772395B1 (fr)
AT (1) ATE501059T1 (fr)
DE (1) DE502005011092D1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2450117A (en) * 2007-06-13 2008-12-17 Reckitt Benckiser Healthcare A water- and oxygen-occlusive blister tablet pack
DE102009043634B4 (de) * 2009-09-29 2012-08-09 Messer Austria Gmbh Vorrichtung und Verfahren zum Transportieren feuchtigkeitsempfindlicher Produkte
SG11201906890TA (en) 2017-02-03 2019-08-27 Berlin Chemie Ag Oral thyroid therapeutic agent
DE102017122807B4 (de) 2017-09-29 2023-02-09 Berlin-Chemie Ag Orales Schilddrüsentherapeutikum

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL9101862A (nl) * 1991-11-07 1993-06-01 Sara Lee De Nv Werkwijze en inrichting voor het vervaardigen van een gevuld en gesloten vacuuempak.
US5293996A (en) * 1992-05-14 1994-03-15 Motorola, Inc. Container having an observation window
US5799463A (en) * 1996-05-28 1998-09-01 Mitsubishi Gas Chemical Company, Inc. Method for preservation of article
DK0922219T3 (da) * 1996-07-19 2005-05-23 Fresenius Kabi Ab Farveblanding omfattende en pyrogallolforbindelse, et jern(II)salt og en organisk syre
US7219799B2 (en) * 2002-12-31 2007-05-22 Possis Medical, Inc. Packaging system with oxygen sensor

Also Published As

Publication number Publication date
ATE501059T1 (de) 2011-03-15
EP1772395A1 (fr) 2007-04-11
DE502005011092D1 (de) 2011-04-21

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