EP1045799B1 - Primärverpackungseinheit für film- oder oblatenartige darreichungsformen - Google Patents

Primärverpackungseinheit für film- oder oblatenartige darreichungsformen Download PDF

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Publication number
EP1045799B1
EP1045799B1 EP99902517A EP99902517A EP1045799B1 EP 1045799 B1 EP1045799 B1 EP 1045799B1 EP 99902517 A EP99902517 A EP 99902517A EP 99902517 A EP99902517 A EP 99902517A EP 1045799 B1 EP1045799 B1 EP 1045799B1
Authority
EP
European Patent Office
Prior art keywords
packaging material
film
packaging
wafer
primary packaging
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
EP99902517A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP1045799A1 (de
Inventor
Karsten Cremer
Karin Ludwig
Dieter Anhäuser
Klaus Schumann
Peter Steinborn
Uwe Bungarten
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.)
LTS Lohmann Therapie Systeme AG
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 EP1045799A1 publication Critical patent/EP1045799A1/de
Application granted granted Critical
Publication of EP1045799B1 publication Critical patent/EP1045799B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • 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
    • B65D75/40—Packages formed by enclosing successive articles, or increments of material, in webs, e.g. folded or tubular webs, or by subdividing tubes filled with liquid, semi-liquid, or plastic materials
    • B65D75/42—Chains of interconnected packages
    • 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
    • B65D75/52—Details
    • B65D75/527—Tear-lines for separating a package into individual packages
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B9/00—Enclosing successive articles, or quantities of material, e.g. liquids or semiliquids, in flat, folded, or tubular webs of flexible sheet material; Subdividing filled flexible tubes to form packages
    • B65B9/02—Enclosing successive articles, or quantities of material between opposed webs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor
    • Y10T156/1089—Methods of surface bonding and/or assembly therefor of discrete laminae to single face of additional lamina
    • Y10T156/1092—All laminae planar and face to face
    • Y10T156/1093—All laminae planar and face to face with covering of discrete laminae with additional lamina
    • Y10T156/1095—Opposed laminae are running length webs

Definitions

  • the present invention relates to a method for producing a primary packaging unit for film-like or wafer-like dosage forms for oral Application. It affects in particular a method for producing a primary packaging unit, which from the film or wafer-like to be packed Dosage form and a section of each Upper and lower packaging material is formed.
  • Forms of administration in film or wafer form for oral administration are u. a. from the patent or published documents US 3 007 848, DE 24 32 925, DE 27 46 414, EP 219 762 are known. They differ from conventional fixed dosage forms such as tablets or capsules in particular through their geometric shape and by their manufacture. You together is a thin, flat shape, being distinguished by differences in flexibility, brittleness, smoothness or consistency either a film or foil-like, a paper-like or results in an oblate character. For the production were especially those in industrial film production applied extrusion and coating processes recommended.
  • rapidly decaying or quick-release variants for decay in the oral cavity immediately after application with release of an active ingredient where the term "rapidly disintegrating" in the sense of this invention to a disintegration time of a few seconds up to a few minutes under the influence of saliva should relate.
  • Both basic types can be designed so that they are in Dependence on the incorporated active ingredient for a local Therapy of the oral mucosa or for systemic drug application are suitable.
  • the packaging of these dosage forms in primary packaging units can not be easily with the for conventional pharmaceutical products such as capsules or tablets Carry out usual procedures, packaging materials or machines.
  • a modern one Primary packaging unit for single dosage solid dosage forms on the one hand the product is intended to withstand external influences protect, on the other hand a conscious and verifiable removal a single dose unit at the desired time of intake allow, taking the dose unit from the primary packaging unit must be such that the dosage form is not damaged.
  • Primary packaging units contain a plurality of dose units, each individually in a cavity between two packaging material web sections are sealed. The cavity is filled by hot or cold working before filling Bottom of packaging material with the help of an appropriate tool created. After filling the cavities, the top web of packaging material fed and sealed together with the bottom sheet.
  • a dose unit is removed from modern blister packs in that on the outside of the deformed points the packaging material lower web and thus on the tablet or Capsule, which is in the created by the deformation Cavity, with which finger pressure is exerted, which is sufficient to break through the top web of packaging material and push out the dose unit.
  • this is only then possible if the material of the packaging material upper web a certain Strength does not exceed.
  • Oral dosage forms in the form of films or wafers are generally much lighter and less compact than conventional tablets or capsules, particularly in the case of the quick-release variants.
  • the proposed dimensions of the film-like or wafer-like dose units are approximately 1 cm 2 (eg DE 27 46 414) to 3 cm 2 or more (eg DE 24 32 925) and a thickness of approximately 0.05 to 1 mm (e.g. DE 24 329 25).
  • dose units with a mass of about 5 to 100 mg result, whereby the typical and preferred configurations are more likely to be in the lower sector of this range. It has now been shown that it is more difficult to insert such thin films or wafers in blisters.
  • a primary packaging unit must additionally another feature is perforation between the compartments in which the individual Dose units are, and such a perforation that it enables, if necessary, the removal of a single dose unit first the compartment of this dose unit from the Remove the primary packaging unit in order to subsequently remove the To be able to open the compartment without further compartments to damage.
  • the perforation also has the advantage that with the appropriate design, if possible with only a few, small breakpoints also allowed, one compartment without first separating it from the primary packaging unit targeted opening without additional compartments open at the same time.
  • This primary packaging unit consists in the relatively small gas space of the compartments, in which the dose units are located. oxidation or Moisture sensitive products can therefore be used with suitable Choice of primary packaging materials largely before the harmful ones Protected against the effects of atmospheric oxygen and humidity become.
  • Another advantage of this primary packaging unit is in the low packaging material requirement and the handy, see space-saving format. For example, let in a folding box of 1 cm in height 10 or more primary packaging units with 10 dose units each accommodate.
  • Another advantage of this primary packaging unit exists in the possibility as a packaging material bottom sheet also use materials that are significantly thinner and cheaper are as such that are used to manufacture blister packs and are suitable for cold or hot working and a specific one Minimum thickness and, due to this, a minimum weight must have.
  • This primary packaging unit consists in the possibility of printing on it Visualize therapy schemes. For example, a packaging unit as a weekly pack with 7 dose units produce a medicine to be taken once a day, the individual compartments of the packaging unit with the names or abbreviations of the days of the week are printed. Based patients can use this printed therapy scheme control your earnings very easily. In a preferred one The packaging unit contains imprints.
  • the primary packaging unit contains sealing seams or sealing surfaces between the packaging material upper section and the - sub-web section, which are peelable. Peelable in the sense of this Invention encompasses all sealing seams or sealing surfaces that with moderate peel force, e.g. B. less than about 10 N / 15 mm, separated can be, usually the integrity of the Packaging material web sections are preserved.
  • special sealing media e.g. B. So-called "Peel-PE"
  • a special polyethylene which is usually contains another polymer such as polystyrene and special sealing conditions (pressure, time, temperature) used.
  • Another embodiment of the Primary packaging unit provides that next to each compartment outside of the sealing surfaces or sealing seams there is an unsealed edge on at least one side. This serves as handle tabs to the section of the packaging material easily grasp the bottom web and the packaging materials underneath To be able to separate the opening of a compartment.
  • these tabs or unsealed edges of different lengths for the Packaging material upper and lower web section. If one of the If it protrudes from both packaging material sections on the edge, it is special easy to grip and from the second packaging material web section to bend away, which then also makes it easier to grab is.
  • Packaging material webs for the production of such primary packaging units can be single-layered, but are usually be multilayered in order to be able to meet the requirements to modern packaging materials and in connection with film or wafer-like dosage forms must be provided.
  • Frequently occurring layers are e.g. B. Kraft paper for Generation of rigidity, plastic films for tensile strength and tightness of the packaging material, sealing wax for better Sealability, protective lacquers for impregnating the kraft paper, Aluminum for particularly high tightness, glue for the cohesion of individual layers, etc.
  • Optimized Packaging material laminates contain from an economic point of view no more layers and no greater layer thicknesses than for the respective purpose is necessary.
  • the upper and lower lanes can be attached different requirements are made.
  • a Primary packaging e.g. B. have a certain minimum stiffness should - and used a preferred for better manageability
  • Design of the primary packaging unit a packaging material web with a bending stiffness of at least x with a common minimum thickness of y ⁇ m - it is sufficient if this rigidity is mainly due to a the packaging material web is conveyed while the other packaging material web according to other economic or technical aspects can be optimized.
  • Another variant of the primary packaging unit with two differently constructed packaging material webs contains a transparent packaging material section, through which the dosage units of the dosage form can see through the intact package. It is the definition of top and bottom rail arbitrary; for the purpose of This invention aims at using a transparent and a non-transparent packaging material web is the transparent one Path can be defined as the upper path.
  • One of the advantages of this The variant is the simple visual inspection of the compartments or the dose units and their condition.
  • Another The advantage is that there is a transparent top sheet printing on the top of the lower web or of dose units. Since such prints, such as already described, advantages u. a. regarding the revenue control have a variant of Primary packaging unit a transparent Packaging material upper web section and either one on the top-printed Lower web section or printed on the top Dosage units.
  • Such packaging units are suitable for everyone film-like or wafer-like dosage forms that correspond to the stand are known in the art.
  • FIG. 1 A manufacturing process schematically shown in Fig. 1, for packaging units with square or rectangular dose units (5) consists of at least the following principal ones Process steps together, if necessary by further Steps for printing, additional shaping of the packaging unit or the like.
  • the first step is a top web of packaging material (1) and a bottom web (2) without cold or hot deformation via a deflection shaft (3) brought together, at the same time the film or wafer-like dosage form (4) with the help of roles or Pliers advantages (17) between the two packaging material webs to be led.
  • the film or wafer-like Dosage form already as a web product - single lane or multi-lane parallel at a distance from each other - with the desired one Width of the dose units (5) is supplied. Equally beneficial is smaller than the diameter of the deflection shafts the length of the dose units in the direction of travel of the webs choose.
  • dose units (5) from the sheet-like dosage form by a Cross cutting device (6) isolated, which immediately before the deflection shafts is positioned.
  • the two packaging material webs with the help of a heated sealing tool (7) sealed against each other in such a way, that the individual dose units (5) in compartments (8) be sealed and completely by sealing seams or sealing surfaces (9) are surrounded.
  • a further step are perforations through a punching device (12) stamped between the compartments (8).
  • the process step can be carried out by primary packaging units (11) a second cross cutting or punching device can be divided.
  • a manufacturing method according to the invention is shown schematically in Fig. 2.
  • the ones described here Process steps can be supplemented if necessary.
  • the procedure contains the provision of a laminate in one process step (13) from the web-like, film or wafer-like dosage form (4) and a carrier film (14), from which in one further step with a punching device (15) the dose units (5) are punched out without the carrier film (14) is punched through.
  • the punched laminate (13) with the help of rolls or Pliers advantages (17) over an edge or deflection shaft (18) see above deflected that the dose units (5) from the carrier film Loosen (14). If necessary, this can also be done additionally a scraper (16) can be used.
  • perforations between a punching device (12) the compartments (8) are stamped.
  • primary packaging units (11) by a second cross cutting or punching device can be separated.

Landscapes

  • Mechanical Engineering (AREA)
  • Engineering & Computer Science (AREA)
  • Packages (AREA)
  • Wrappers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Formation Of Insulating Films (AREA)
  • Exposure Of Semiconductors, Excluding Electron Or Ion Beam Exposure (AREA)
  • Application Of Or Painting With Fluid Materials (AREA)
  • Dry Development In Electrophotography (AREA)
  • Packaging For Recording Disks (AREA)
  • Non-Silver Salt Photosensitive Materials And Non-Silver Salt Photography (AREA)
EP99902517A 1998-01-10 1999-01-05 Primärverpackungseinheit für film- oder oblatenartige darreichungsformen Expired - Lifetime EP1045799B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19800682 1998-01-10
DE19800682A DE19800682B4 (de) 1998-01-10 1998-01-10 Verfahren zur Herstellung einer Primärverpackung für film- oder oblatenförmige Darreichungsformen
PCT/EP1999/000020 WO1999035051A1 (de) 1998-01-10 1999-01-05 Primärverpackungseinheit für film- oder oblatenartige darreichungsformen

Publications (2)

Publication Number Publication Date
EP1045799A1 EP1045799A1 (de) 2000-10-25
EP1045799B1 true EP1045799B1 (de) 2002-10-23

Family

ID=7854295

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99902517A Expired - Lifetime EP1045799B1 (de) 1998-01-10 1999-01-05 Primärverpackungseinheit für film- oder oblatenartige darreichungsformen

Country Status (24)

Country Link
US (1) US6655112B1 (xx)
EP (1) EP1045799B1 (xx)
JP (1) JP3947358B2 (xx)
KR (1) KR100515699B1 (xx)
AT (1) ATE226547T1 (xx)
AU (1) AU736498B2 (xx)
CA (1) CA2317491C (xx)
CZ (1) CZ293339B6 (xx)
DE (2) DE19800682B4 (xx)
DK (1) DK1045799T3 (xx)
ES (1) ES2188126T3 (xx)
HK (1) HK1030917A1 (xx)
HU (1) HU225551B1 (xx)
IL (1) IL137184A (xx)
MY (1) MY124591A (xx)
NO (1) NO325407B1 (xx)
NZ (1) NZ505340A (xx)
PL (1) PL195971B1 (xx)
PT (1) PT1045799E (xx)
SK (1) SK285576B6 (xx)
TR (1) TR200001897T2 (xx)
TW (1) TW385293B (xx)
WO (1) WO1999035051A1 (xx)
ZA (1) ZA99129B (xx)

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CN109621649B (zh) * 2018-11-23 2023-12-26 晋江市神奇生物科技有限公司 一种防霉干燥片及其生产工艺
CN109573135B (zh) * 2018-12-14 2024-04-26 龚涛 用于带覆膜包装的饼类食品切割机构、制造设备及切割方法
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CN111114888B (zh) * 2020-01-14 2024-04-26 上海小松包装机械有限公司 一种跟踪整列提升装置
CN112918723A (zh) * 2021-01-27 2021-06-08 福建华赢化工有限公司 一种防霉包的制作方法及制作装置

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NO20003528D0 (no) 2000-07-07
ATE226547T1 (de) 2002-11-15
KR20010033824A (ko) 2001-04-25
PL195971B1 (pl) 2007-11-30
DE59903158D1 (de) 2002-11-28
SK10222000A3 (sk) 2000-10-09
NO20003528L (no) 2000-08-25
TR200001897T2 (tr) 2000-12-21
IL137184A0 (en) 2001-07-24
DE19800682A1 (de) 1999-07-15
WO1999035051A1 (de) 1999-07-15
AU2277999A (en) 1999-07-26
JP2002500140A (ja) 2002-01-08
SK285576B6 (sk) 2007-04-05
TW385293B (en) 2000-03-21
HUP0101308A2 (hu) 2001-08-28
CA2317491A1 (en) 1999-07-15
NO325407B1 (no) 2008-04-21
CZ20002422A3 (cs) 2001-12-12
AU736498B2 (en) 2001-07-26
DE19800682B4 (de) 2004-07-08
US6655112B1 (en) 2003-12-02
NZ505340A (en) 2002-04-26
CA2317491C (en) 2008-06-17
PL341811A1 (en) 2001-05-07
ES2188126T3 (es) 2003-06-16
CZ293339B6 (cs) 2004-04-14
EP1045799A1 (de) 2000-10-25
HUP0101308A3 (en) 2002-10-28
PT1045799E (pt) 2003-03-31
HK1030917A1 (en) 2001-05-25
JP3947358B2 (ja) 2007-07-18
KR100515699B1 (ko) 2005-09-15
HU225551B1 (en) 2007-03-28
DK1045799T3 (da) 2003-02-24
IL137184A (en) 2004-02-19
MY124591A (en) 2006-06-30
ZA99129B (en) 2000-10-23

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