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WO2002038138A2 - Emballage primaire pour systemes therapeutiques transdermiques ou pour timbres medicaux - Google Patents

Emballage primaire pour systemes therapeutiques transdermiques ou pour timbres medicaux Download PDF

Info

Publication number
WO2002038138A2
WO2002038138A2 PCT/EP2001/012618 EP0112618W WO0238138A2 WO 2002038138 A2 WO2002038138 A2 WO 2002038138A2 EP 0112618 W EP0112618 W EP 0112618W WO 0238138 A2 WO0238138 A2 WO 0238138A2
Authority
WO
WIPO (PCT)
Prior art keywords
tts
adhesive
plaster
cover
film
Prior art date
Application number
PCT/EP2001/012618
Other languages
German (de)
English (en)
Other versions
WO2002038138A3 (fr
Inventor
Frank Theobald
Wolfgang Laux
Original Assignee
Lts Lohmann Therapie-Systeme 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
Application filed by Lts Lohmann Therapie-Systeme Ag filed Critical Lts Lohmann Therapie-Systeme Ag
Publication of WO2002038138A2 publication Critical patent/WO2002038138A2/fr
Publication of WO2002038138A3 publication Critical patent/WO2002038138A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed

Definitions

  • the present invention relates to primary packaging for transdermal therapeutic systems (TTS) or medical plasters, as well as TTS or medical plasters, which are enclosed in or connected to such primary packaging.
  • TTS transdermal therapeutic systems
  • medical plasters as well as TTS or medical plasters, which are enclosed in or connected to such primary packaging.
  • Transdermal therapeutic systems are dosage forms which enable the administration of active substances to or through the skin of a patient.
  • the active substances or the active substance preparation which may contain additional auxiliary substances, are typically embedded in a polymer matrix, which may be self-adhesive or non-self-adhesive.
  • the procedure is generally such that the active substance-containing matrix polymer mass is coated on a carrier web and then provided with a cover film.
  • the cover film is connected to the matrix and remains on the TTS even during application; it thus covers the matrix layer to the outside (“back layer”).
  • the carrier web or film covers the matrix layer on its skin-side, usually pressure-sensitive adhesive surface and can be detached therefrom ("release l ner").
  • the carrier web serves as protection for the active substance matrix and at the same time as an application aid for the later application of the TTS on the skin.
  • the carrier web is often provided with a longitudinal or transverse division, which enables the TTS to be partially detached.
  • polymer material containing active ingredients can escape from the matrix layer come along the above-mentioned transverse or longitudinal divisions, which can lead to the TTS sticking to the inner wall of the primary packaging or the packaging material. This is particularly the case with those polymer matrices which have a high tendency to "cold flow". This means an undesired slow flow of the polymer matrix under any external force, in the simplest case of gravity.
  • the object of the present invention was therefore to provide packaging for TTS and other medical plasters which make it possible to package or package such TTS or plasters in such a way that the abovementioned dangers and disadvantages are avoided.
  • plasters made up and packaged in this way should be easy and safe to handle, especially during application.
  • the object is achieved by a primary packaging with the properties mentioned in claim 1 and by the embodiments described in the subclaims.
  • the use of primary packaging according to claim 1 makes it possible to use TTS or other medical plasters without having to assemble and pack a removable carrier film covering the skin-side adhesive surface.
  • the absence of such a carrier film avoids the disadvantages described above.
  • the primary packaging according to the invention is explained in more detail below with reference to the exemplary embodiment shown in FIG. 1.
  • a primary packaging according to the invention for transdermal therapeutic systems (TTS) or medical plasters (5) comprises a flat packaging material web (1) which is provided with adhesive at least in a partial area (2) and a hood-shaped cover (3) ,
  • the packaging material web (1) and the cover (3) are connected to one another in such a way that an interior (4) which is enclosed on all sides and is suitable for packaging a TTS or a plaster is formed.
  • the adhesive area (2) of the packaging material sheet (1) faces the interior (4) and serves to fasten the TTS or plaster (5) to be packaged.
  • the TTS or plaster (5) is connected to the adhesive area (2) via the back of its cover layer or backing layer (6).
  • This adhesive connection is detachable, so that the TTS or plaster can be detached from the packaging material web (1) before application.
  • the hood-shaped cover (3) protects the skin-side surface (9) of the adhesive matrix of the TTS or plaster (5) from being touched or damaged. Since the patch or TTS is attached to the packaging material web (1) via the adhesive layer (2), accidental contact of the surface (9) with the inside of the hood-shaped cover (3) can also be prevented.
  • the primary packaging according to the invention makes it possible to use TTS or medical Customize plasters without a backing layer covering the adhesive surface of the matrix and pack them securely for storage.
  • the disadvantages mentioned above are also eliminated.
  • the carrier web originally present, onto which the matrix mass is coated is subsequently removed. This can take place either immediately before or after the TTS provided with a covering film (6) has been applied to the adhesive-equipped plastic web (1).
  • the cover (3) is preferably a molded part produced by deep drawing, which is difficult to deform or largely resistant to deformation in order to ensure optimal protection of the TTS or plaster in the packaging.
  • hood-shaped covers produced differently can also be used.
  • the cover (3) consists of a film that is thermoformable and stable against deformation, or another plastic material that has these properties.
  • Suitable plastic materials for the production of the cover (3) are, for example, films made of rigid PVC, polystyrene, polyester, polystyrene / polyethylene, styrene-butadiene copolymers, polypropylene, polycarbonate or also composite films, eg. B. polyamide / polyethylene films.
  • the cover In the molded state, the cover preferably has an average thickness of 0.05 to 1 mm.
  • the cover (3) of the primary packaging is connected to the packaging material web (1) at its edge regions (8) in the final state after the packaging has taken place.
  • This connection is preferably produced by gluing, welding or heat sealing; it is also preferably detachable, so that the cover (3) before the application of the TTS contained in the packaging can be detached from the packaging material web (1).
  • the sealing is not carried out over the entire area in a partial area of the peripheral edge area (8), so that a grip aid for tearing open is formed.
  • the adhesive area (2) is preferably an adhesive film applied to the packaging material web (1), preferably a polymer film.
  • the following are particularly suitable as polymer materials: polyacrylates, polyisobutylenes, polyisoprenes, polyisoprene-styrenes and polydimethylsiloxanes, and hot-melt polymers which are solid at room temperature, for example hot-melt adhesives based on ethylene-vinyl acetate, polyacrylates, polyester or styrene-butadiene copolymers ,
  • the packaging material web (1) can either be provided with an adhesive over the entire surface or be provided with an adhesive film, but it can also be provided with adhesive or only with an adhesive film in a partial area or in individual partial areas, for example in a punctiform manner.
  • Suitable materials for the production of the packaging material web are in principle all sheet-like plastics known to the person skilled in the art, which are suitable for adequately shielding the packaged products against external influences, in particular against air and moisture access, eg. B. impermeable or coated paper or cardboard, polymer films, metal foils (eg aluminum), textile fabrics, or composite materials (packaging laminates), eg. B. plastic film coated paper.
  • the adhesive strength of the adhesive-equipped plastic web (1) based on the cover film (6) of a TTS (5) to be packaged, it is preferred that this is lower than the adhesive strength of the matrix (7) of the TTS on the skin. In this way, the removal of the cover film (6) from the packaging material web (1) of the packaging is made easier after the application of the TTS or plaster on the skin.
  • the packaging material web (1) of the primary packaging according to the invention can serve as an application aid while the TTS or plaster is being applied to a patient's skin. Accordingly, according to a further embodiment it is provided that the packaging material web (1) is designed as an application aid for the TTS (5) which is adhesively fastened thereon. This makes it possible to use a TTS or
  • the primary packaging according to the invention can be produced in a wide variety of geometric shapes, so that the floor plan of the interior (4) or the cover (3) corresponds to the floor plan of the plaster or TTS to be packaged;
  • the cover (3) can be round, square, elongated or rectangular in plan or in plan view.
  • embodiments are also provided in which two or more individual primary packagings are arranged next to one another or in row (s), it being possible for individual packaging units to be separated off before a plaster or TTS is removed.
  • the present invention further relates to TTS or medical plasters which are packaged in primary packaging with the aforementioned features according to the invention.
  • the invention relates to transdermal therapeutic systems (TTS) or medical plasters (5) which have a cover film (6) and a pressure-sensitive adhesive matrix (7) connected thereto, the TTS or plasters being used on the inside.
  • space (4) of a primary packaging according to claim 1 or one of the subclaims 2 to 10 is arranged.
  • the cover film (6) of the TTS or plaster is adhesive but detachably attached to the adhesive area (2) of the packaging material web (1).
  • the skin-side adhesive surface (9) of the matrix (7) of the TTS or plaster (5) is not, or at most partially, covered by a protective film or layer, ie preferably the TTS or plaster packaged in this way do not provide a carrier web on the skin-side adhesive surface (9) as described at the beginning.
  • a carrier web covering the surface of the matrix By dispensing with such a carrier web covering the surface of the matrix, the disadvantages mentioned at the outset, which are mainly caused by the “cold flow”, are avoided.
  • the absence of a carrier web covering the matrix does not rule out that the surface of the matrix (9) is partially covered with a film or layer. Since there is preferably no carrier web covering the matrix in the TTS or plasters packed according to the invention, the blocking phenomenon described at the outset is excluded.
  • the packaging material web (1) of the packaged TTS or plaster can be used as an application aid. This is particularly important with regard to the uncovered surface (9) of the matrix, because the application aid mentioned enables the plaster to be applied to the skin, wherein unintentional contact with the matrix (7) can be avoided.
  • the packaging material web (1) is detached from the cover film (6) and discarded. In this case, the packaging material web (1) thus takes over the function (as an application aid) of the carrier layer of the plaster or TTS that is no longer present.
  • the transdermal therapeutic system (TTS) or medical plaster (5) arranged in the primary packaging according to the invention, which has a cover film (6) and a pressure-sensitive adhesive matrix (7) connected to it, can be constructed very differently; for example, the matrix can also be made up of several layers.
  • the person skilled in the art is generally familiar with the materials suitable for the construction of the pressure-sensitive adhesive matrix or the covering film of a TTS or plaster.
  • Polyacryla pressure-sensitive adhesives, polymers based on isobutylene or ethylene-vinyl acetate, rubbers, synthetic rubbers, styrene-diene copolymers or hot-melt adhesives are suitable for the matrix layers.
  • the matrix contains one or more active ingredients and auxiliaries and additives known to those skilled in the art.
  • cover film (6) As materials for the cover film (6) are especially polyester, but also almost any other skin-compatible plastics, such as. B. polyvinyl chloride, ethylene vinyl acetate, vinyl acetate, polyethylene, polypropylene, cellulose derivatives and many others.
  • the distance between the adhesive surface (9) of the matrix (7) of the TTS or plaster (5) and the inside of the cover (3) located above is dimensioned so that contact of the surface (9) with the cover (3) is largely excluded. It is advantageous here if the cover (3) is made from a deformation-stable film or a dimensionally stable material.
  • the adhesive force of the surface (9) of the matrix (7) of the TTS or patch (5) on the skin should be as great as possible than the adhesive strength of the cover film (6) of the TTS or plaster (5) on the adhesive-equipped area (2) of the packaging material web (1). In this way, the packaging material web (1) can be removed from the TTS or plaster (5) after application.
  • FIG. 1 shows, by way of example and schematically, an embodiment of the primary packaging according to the invention with a TTS or medical plaster packaged therein (cross-section or longitudinal section).

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Composite Materials (AREA)
  • Mechanical Engineering (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention concerne un emballage primaire pour systèmes thérapeutiques transdermiques (transdermal therapeutic system : TTS) ou pour timbres médicaux. Cet emballage primaire comprend une bande de matériau d'emballage plane, qui est adhésive au moins dans une zone partielle, ainsi qu'un revêtement en forme de chapeau. Cette bande de matériau d'emballage et le revêtement sont connectés l'un à l'autre de façon à former un espace intérieur qui est entouré de tous côtés et qui est adapté à l'emballage d'un TTS ou d'un timbre. La zone adhésive de la bande de matériau d'emballage est orientée vers l'espace intérieur et sert à fixer le TTS ou le timbre devant être emballé.
PCT/EP2001/012618 2000-11-13 2001-10-31 Emballage primaire pour systemes therapeutiques transdermiques ou pour timbres medicaux WO2002038138A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE2000156234 DE10056234A1 (de) 2000-11-13 2000-11-13 Primärverpackung für transdermale therapeutische Systeme oder medizinische Pflaster
DE10056234.5 2000-11-13

Publications (2)

Publication Number Publication Date
WO2002038138A2 true WO2002038138A2 (fr) 2002-05-16
WO2002038138A3 WO2002038138A3 (fr) 2002-08-01

Family

ID=7663152

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2001/012618 WO2002038138A2 (fr) 2000-11-13 2001-10-31 Emballage primaire pour systemes therapeutiques transdermiques ou pour timbres medicaux

Country Status (2)

Country Link
DE (1) DE10056234A1 (fr)
WO (1) WO2002038138A2 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019988A1 (fr) 2002-08-28 2004-03-11 Hisamitsu Pharmaceutical Co., Inc. Patch adhesif
WO2010142587A1 (fr) * 2009-06-12 2010-12-16 Varta Microbattery Gmbh Emballage de vente et de stockage pour des piles boutons zinc-air

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040028931A1 (en) * 2002-06-26 2004-02-12 Bletsos Ioannis V. Coated sheet materials and packages made therewith
DE102005033543A1 (de) * 2005-07-14 2007-01-18 Grünenthal GmbH Ein einen Duftstoff aufweisendes transdermales therapeutisches System
DE102006011338A1 (de) * 2006-03-09 2007-09-13 Grünenthal GmbH Pflasterverpackung
DE102008006788A1 (de) 2008-01-30 2009-08-13 Lts Lohmann Therapie-Systeme Ag Mikro- und/oder nanostrukturierter Packstoff
DE202008004785U1 (de) * 2008-04-04 2009-08-13 Grünenthal GmbH Entsorgungsvorrichtung

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3204582A1 (de) * 1982-02-10 1983-08-25 Hassia Verpackung Gmbh, 6479 Ranstadt Verfahren zur kontinuierlichen herstellung von pflasterpackungen fuer die transdermale verabreichung von medikamenten
US4781293A (en) * 1987-12-23 1988-11-01 Pfizer Hospital Products Group, Inc. One step dressing delivery system
DE3806444A1 (de) * 1988-02-29 1989-08-31 Lohmann Therapie Syst Lts Primaerverpackung fuer flaechenstabilisierte verbandstoffe
DE3921434A1 (de) * 1989-06-30 1991-01-17 Lohmann Therapie Syst Lts Vorrichtung und verpackung von selbstklebenden substratabschnitten und ihre verwendung
DE4128248A1 (de) * 1991-08-26 1993-03-04 Varta Batterie Verkaufs- und vorratspackung fuer zink/luftzellen
WO1995000122A1 (fr) * 1993-06-24 1995-01-05 Cygnus Therapeutic Systems Emballage pour systeme a liberation transdermique
DK0783301T3 (da) * 1994-09-30 1999-08-02 Becton Dickinson Co Fremgangsmåde til udformning og pakning af iontoforetiske medikamentleveringsplastre og lignende med henblik på forøgelse a
JP3335569B2 (ja) * 1997-10-31 2002-10-21 花王株式会社 シート状パック包装体及びその製造方法
DE19902196C1 (de) * 1999-01-21 2000-06-15 Lohmann Therapie Syst Lts Vorrichtung zum Verpacken von haftklebenden Substratabschnitten und ihre Verwendung

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019988A1 (fr) 2002-08-28 2004-03-11 Hisamitsu Pharmaceutical Co., Inc. Patch adhesif
WO2010142587A1 (fr) * 2009-06-12 2010-12-16 Varta Microbattery Gmbh Emballage de vente et de stockage pour des piles boutons zinc-air
CN102803091A (zh) * 2009-06-12 2012-11-28 瓦尔达微电池有限责任公司 用于锌-空气纽扣电池的零售和存储包装

Also Published As

Publication number Publication date
WO2002038138A3 (fr) 2002-08-01
DE10056234A1 (de) 2002-05-29

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