WO2005116552A1 - Dispositif pour revetir un film de support avec un principe actif pharmaceutique - Google Patents

Dispositif pour revetir un film de support avec un principe actif pharmaceutique Download PDF

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Publication number
WO2005116552A1
WO2005116552A1 PCT/EP2004/004585 EP2004004585W WO2005116552A1 WO 2005116552 A1 WO2005116552 A1 WO 2005116552A1 EP 2004004585 W EP2004004585 W EP 2004004585W WO 2005116552 A1 WO2005116552 A1 WO 2005116552A1
Authority
WO
WIPO (PCT)
Prior art keywords
carrier film
dryer
station
module
application
Prior art date
Application number
PCT/EP2004/004585
Other languages
German (de)
English (en)
Inventor
Clifton Zimmermann
Original Assignee
Optimags Dr. Zimmermann Gmbh
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 Optimags Dr. Zimmermann Gmbh filed Critical Optimags Dr. Zimmermann Gmbh
Priority to DE202004020631U priority Critical patent/DE202004020631U1/de
Priority to DE112004002828.0T priority patent/DE112004002828B4/de
Priority to PCT/EP2004/004585 priority patent/WO2005116552A1/fr
Publication of WO2005116552A1 publication Critical patent/WO2005116552A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C9/00—Apparatus or plant for applying liquid or other fluent material to surfaces by means not covered by any preceding group, or in which the means of applying the liquid or other fluent material is not important
    • B05C9/08—Apparatus or plant for applying liquid or other fluent material to surfaces by means not covered by any preceding group, or in which the means of applying the liquid or other fluent material is not important for applying liquid or other fluent material and performing an auxiliary operation
    • B05C9/14—Apparatus or plant for applying liquid or other fluent material to surfaces by means not covered by any preceding group, or in which the means of applying the liquid or other fluent material is not important for applying liquid or other fluent material and performing an auxiliary operation the auxiliary operation involving heating or cooling
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B13/00—Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
    • F26B13/10—Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B13/00—Machines and apparatus for drying fabrics, fibres, yarns, or other materials in long lengths, with progressive movement
    • F26B13/10—Arrangements for feeding, heating or supporting materials; Controlling movement, tension or position of materials
    • F26B13/101—Supporting materials without tension, e.g. on or between foraminous belts
    • F26B13/104—Supporting materials without tension, e.g. on or between foraminous belts supported by fluid jets only; Fluid blowing arrangements for flotation dryers, e.g. coanda nozzles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05C1/00—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating
    • B05C1/04—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length
    • B05C1/08—Apparatus in which liquid or other fluent material is applied to the surface of the work by contact with a member carrying the liquid or other fluent material, e.g. a porous member loaded with a liquid to be applied as a coating for applying liquid or other fluent material to work of indefinite length using a roller or other rotating member which contacts the work along a generating line

Definitions

  • the invention relates to a device for coating a carrier film with a pharmaceutical agent according to the preamble of claim 1.
  • a device for coating a carrier film with a pharmaceutical agent according to the preamble of claim 1.
  • Such a device is used in particular for the production of transdermally acting plasters and comprises an unwinding station for the carrier film, an application station for applying liquid or pasty pharmaceutical agent the carrier film, a dryer station for drying the applied active substance on the carrier film and a winding station for the coated carrier film.
  • Transdermal patches are flexible pharmaceutical active ingredients of various sizes that are applied to the undamaged skin to bring one or more active ingredients into contact with the skin surface, where after a certain exposure time they can overcome the skin barrier and enter the patient's bloodstream.
  • Transdermally acting plasters usually consist of an outer film " which a preparation carries with the active substances.
  • This outer film does not allow any active substances to pass through and is normally also waterproof and can either have the dimensions of the preparation surface or can be larger and outside the preparation surface with one Until the transdermal patch is used, the active substance is usually covered by a second film, which is removed from the patch to apply it.
  • pharmaceutical active ingredients that have to be taken in constant doses over a long period of time, such as hormone preparations for contraception, can be used as an alternative to regular taking of pill-shaped medication particularly conveniently via transdermal patches, which can remain in place for several days become.
  • Transdermal patches are used with great benefits, especially in rural areas of countries whose industrialization is not yet very advanced, as well as in cultural circles that are unfamiliar with the regular oral intake of medicines.
  • Such plasters are produced using a device of the type mentioned at the outset.
  • a carrier film wound on a spool is unwound in a unwinding station and in line in a subsequent application station is wetted with a liquid or pasty pharmaceutical mixture of active ingredient and adhesive or other carriers ,
  • the order must be dosed very precisely in tolerances that must be strictly observed.
  • the mixture applied to the carrier film which is usually applied as a low-viscosity liquid, must be dried.
  • the dryer station between the application station and the winding station is used for this purpose.
  • the carrier film coated with the dried mixture is then wound onto a spool in the winding station.
  • a cover film is applied to the coating of the carrier film, so that the pharmaceutical active substance-adhesive mixture comes to lie sandwiched between two films.
  • the wound coated carrier film with cover film can then be processed further into individual transdermal patches, in that the coil is usually separated into several narrow partial coils and small pieces - the transdermal patches - are cut off or punched out from the tapes wound on the partial coils.
  • the carrier film usually consists of a material to which the active ingredient hardly adheres, since the carrier peeling film for applying the transdermal patch is peeled off and the (compared to the carrier film thinner and more flexible) cover film takes over the supporting function when applying the patch.
  • This cover film which becomes a "carrier film" when the plaster is used, therefore usually consists of a material to which the active pharmaceutical ingredient adheres well.
  • a device of the type mentioned is intended for the mass production of plasters, in particular transdermally acting; Accordingly, efforts are being made to be able to achieve the highest possible production speeds.
  • the dryer station is the problem here: While unwinding the carrier film, applying the cover film and winding the coated film can take place almost as quickly as required, and also applying low-viscosity liquid active ingredient at high throughput speeds of the carrier film of about 3 m / min can be controlled with high accuracy, the drying process of the 300 ⁇ m thick layers can hardly be accelerated.
  • An increase in the production speed must therefore always be accompanied by an extension of the dryer section before the coated carrier film is wound up, in order to ensure a certain minimum residence time of the carrier film with the freshly applied liquid active substance in the dryer station.
  • Drying station in a device of the type mentioned narrow limits.
  • a given clean room size ultimately limits the production speed of a device of the present type and thus its productivity to a predetermined value by the maximum possible dryer section.
  • the object of the present invention is to improve a device of the type mentioned at the outset in such a way that its production speed can be increased without increasing the required base area for the device or at least avoiding the need for a given clean room to increase the production speed need to enlarge.
  • a device for coating a carrier film with a pharmaceutical active ingredient is designed according to the invention in such a way that it consists of an application module and at least one dryer module arranged next to it.
  • the order module contains the unwinding station, the order station and the take-up station, while the dryer module or several dryer modules arranged in line form the dryer station.
  • the carrier film with the active substance applied thereon is preferably passed through the drying station in such a way that the carrier film is deflected in or behind the dryer module which is the most distant from the application module and each dryer module passes in two opposite directions.
  • the design in balcony design of the application module and the dryer modules means that only their front sides have to be operated under clean room conditions, while the rear drive and fan devices do not necessarily have to be in the clean room itself.
  • the return of the carrier film guided through the dryer module into the application module for winding it up is most advantageously carried out by deflecting the carrier film halfway through the dryer section, after which it runs through the dryer modules again in reverse order in order to finally arrive in the order module and be wound up there to become. How our- Indirectly illuminated, this halves the space required for the dryer station.
  • the modular structure has further advantages: For example, the production speed and thus the production capacity of the device can be increased by retrofitting additional dryer modules. Furthermore, the individual modules can be transported separately, which enables a high degree of prefabrication of the device with easy transportability and thereby minimizes the assembly and installation work on site.
  • the application module according to the invention can expediently be provided in front of the winding station with a device for applying a cover film to the coated carrier film, so that a simple punching process is then sufficient to obtain the finished transdermal patches.
  • a device for applying a cover film to the coated carrier film so that a simple punching process is then sufficient to obtain the finished transdermal patches.
  • the active pharmaceutical ingredient is mixed with an adhesive, so that the active substance passes through the skin into the bloodstream of the user under all conditions of use.
  • the dryer modules can each contain a first and a second, individually controllable dryer zone, the carrier film with the applied active ingredient first passing through the first dryer zone for drying the applied liquid or pasty active ingredient and then (in the opposite direction) through the second dryer zone for removing residual solvents ,
  • the carrier film expediently passes through the first dryer zone of the dryer module in such a way that the liquid or pasty active substance is on top of the carrier film and, consequently, the second Dryer zone passes "upside down" after the deflection.
  • the second dryer zone does not have to be run horizontally here, but a zigzag-like web guide is also conceivable in order to increase the dryer path again.
  • the application station can contain a knife caster or a slot caster as an application device, and thus a technique known per se.
  • the knife foundry technology has been perfected for the production of magnetic tapes for the recording of sound and images, where, as with the present application of active pharmaceutical ingredients, compliance with narrow tolerances, the purity and the uniformity of the layer application are important.
  • the application module can additionally be provided with a longitudinal separating device for separating the coated carrier film into two or more sheets, from which sheets the transdermal patches can then be punched out or cut off.
  • a warmed air stream or other gas stream is expedient, in particular using inert gases.
  • blowing on a relatively thick layer of liquid very quickly leads to skin formation on the surface of the layer, which hinders further drying of this layer, since the solvent can no longer escape from the layer, especially on the " underside " Therefore, it is particularly preferred in the context of the present invention if the dryer modules are provided with warm air nozzles, which blow the passed through carrier film with warm air or a heated other gas or gas mixture from below or pasty active ingredient is thereby avoided and the heat is introduced from below, through the carrier film, into the layer to be dried.
  • the warm air nozzles preferably form a floating dryer, known per se, through which the carrier film is carried out on a warm air cushion.
  • a horizontal screen with suction openings in the dryer modules above the carrier film and to produce an essentially horizontal air or gas stream above this horizontal screen so that the air or the gas mixture above the carrier film and the active substance layer is sucked up through the suction openings due to the Bernoulli effect.
  • the partial pressure of the solvents above the layer to be dried is advantageously kept low, while at the same time the risk of skin formation on the layer to be dried is avoided. So it is a matter of a gentle suction of the atmospheric environment of the active substance layer to be dried.
  • This effect can be improved further in that the evaporation space formed between the carrier film and the horizontal diaphragm is divided into individual zones by wall elements.
  • Figure 1 is a schematic representation of the functionally important parts of a device according to the invention
  • Figure 2 is a schematic side view of an embodiment of a device according to the invention
  • FIG. 3 shows a schematic illustration of an upper dryer zone of the exemplary embodiment from FIG. 2.
  • a carrier film 2 is unwound from a spool in an unwinding station 1 and is guided in line in an application station 3 around a precision roller.
  • an active ingredient 5 is applied to the top surface of the carrier film 2, after which it is guided into the dryer station 6.
  • the carrier film 2 is deflected so that it passes through the dryer station 6 twice before a cover film 7 is placed on the dried active substance 5 in a laminating station 8 and connected to the carrier film * 2.
  • the web edges 10 are separated, which are passed into a waste container 11, while the carrier film 2 with the dried active substance 5 and the covering film 7 lying thereon is wound onto a spool in a winding station 12.
  • FIG. 2 shows, the device shown schematically in FIG. 1 is divided according to the invention into two dryer modules 13, 13 ' and one application module 14.
  • the application module 14 contains the unwinding station 1, the application station 3 with its knife caster 4 and the winding station 12.
  • the carrier film 2 leaves the application module 14 after the application station 3 is provided with the liquid active substance 5 and is successively replaced by the two dryer modules 13, 13 '. , which form the dryer station 6, passed.
  • a deflection module 15 Arranged behind the second dryer module 13 ' is a deflection module 15, where the carrier film 2 with the already dried-on active substance 5 is deflected downward and the dryer modules 13 ' , 13 are passed back in the reverse order to the application module 14, where they are finally in the winding station 12 is wound on a spool.
  • the two dryer modules 13, 13 ' have separately controllable first dryer zones 16, 16 ' and second dryer zones 17, 17 ' , the first dryer zones in the present case being arranged at the top and serving to dry the liquid active substance 5.
  • the second dryer zones 17, 17 ' remove residual solvents from the active substance 5.
  • the application module 14 also contains the motor drives for the unwinding station 1, the order station 3 and the rewinding station 12 and all other units.
  • it also contains a container 18 for the active ingredient 5 or an active ingredient-adhesive mixture, which is conveyed to the knife caster 4 via a pump 19 without contact with the surroundings.
  • FIG. 2 shows an embodiment with only two dryer modules 13, 13 ' . By adding further dryer modules, the dryer section can be extended almost arbitrarily in order to increase the production speed of the entire device. Additional dryer modules can also be retrofitted.
  • FIG. 3 finally shows the schematic structure of a first dryer zone 16 of a dryer module 13.
  • a horizontal diaphragm 23 with suction openings 24 is arranged above the carrier film 2 and the active ingredient 5 thereon, above which a Fan 25 produces a constant air flow 26. Because of the Bernoulli effect, the evaporation space formed between the carrier film 2 and the horizontal diaphragm 23 is sucked off through the suction openings 24, so that the partial pressure of the solvent remains small and the expulsion of the solvent from the active substance 5 continues.
  • wall elements 27 are also arranged at regular intervals, which subdivide the evaporation space between the carrier film 2 and the horizontal diaphragm 23.

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  • Engineering & Computer Science (AREA)
  • Textile Engineering (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne un dispositif pour revêtir un film de support (2) avec un principe actif pharmaceutique (5), en particulier pour réaliser des pansements à action transdermique, le dispositif comprenant une station de déroulement (1) pour le film de support (2), une station d'application (3) pour appliquer le principe actif pharmaceutique (5) liquide ou pâteux sur le film de support (2), une station de séchage (6) pour sécher le principe actif (5) appliqué sur le film de support (2), et une station d'enroulement (12) pour le film de support revêtu (2). Le dispositif est composé d'un module d'application (14) et d'au moins un module de séchage (13) disposé à côté de celui-ci, le module d'application (14) contenant la station de déroulement (1), la station d'application (3) et la station d'enroulement (12), alors qu'un module de séchage (13) ou plusieurs modules de séchage (13, 13') disposés en ligne, constitue(nt) la station de séchage (6).
PCT/EP2004/004585 2004-04-30 2004-04-30 Dispositif pour revetir un film de support avec un principe actif pharmaceutique WO2005116552A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE202004020631U DE202004020631U1 (de) 2004-04-30 2004-04-30 Vorrichtung zum Beschichten einer Trägerfolie mit einem pharmazeutischen Wirkstoff
DE112004002828.0T DE112004002828B4 (de) 2004-04-30 2004-04-30 Vorrichtung zum Beschichten einer Trägerfolie mit einem pharmazeutischen Wirkstoff
PCT/EP2004/004585 WO2005116552A1 (fr) 2004-04-30 2004-04-30 Dispositif pour revetir un film de support avec un principe actif pharmaceutique

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2004/004585 WO2005116552A1 (fr) 2004-04-30 2004-04-30 Dispositif pour revetir un film de support avec un principe actif pharmaceutique

Publications (1)

Publication Number Publication Date
WO2005116552A1 true WO2005116552A1 (fr) 2005-12-08

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PCT/EP2004/004585 WO2005116552A1 (fr) 2004-04-30 2004-04-30 Dispositif pour revetir un film de support avec un principe actif pharmaceutique

Country Status (2)

Country Link
DE (1) DE112004002828B4 (fr)
WO (1) WO2005116552A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2626144A1 (fr) * 2012-02-07 2013-08-14 Nederlandse Organisatie voor toegepast -natuurwetenschappelijk onderzoek TNO Système de fabrication rouleau à rouleau avec une zone de déposition à salle blanche et une zone de traitement séparée
DE102015115444A1 (de) 2015-09-14 2017-03-16 Optimags Dr. Zimmermann Gmbh Verfahrenstechnische Anlage, Verfahren zum Überwachen und Einrichten derselben sowie tragbarer Computer zur Verwendung im Verfahren

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10058531B1 (en) 2017-06-01 2018-08-28 Spartak LLC Dosage delivery film

Citations (11)

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Publication number Priority date Publication date Assignee Title
FR823052A (fr) * 1936-06-20 1938-01-13 Bandage perfectionné et son procédé de fabrication
GB691182A (en) * 1950-02-04 1953-05-06 Herts Pharmaceuticals Ltd New or improved method and process for applying a coating to a web or strip of material
US3559301A (en) * 1968-07-29 1971-02-02 Egan Machinery Co Air flotation system for conveying web materials
US4556441A (en) * 1983-01-24 1985-12-03 Faasse Jr Adrian L Pharmaceutical packaging method
EP0300815A2 (fr) * 1987-07-24 1989-01-25 Ethicon, Inc. Pansement élastique épousant les contours par les plaies
US4911155A (en) * 1987-02-17 1990-03-27 Molinier S.A. Manufacturing process for a cohesive compression bandage, the means of implementation and the bandage obtained
US5293699A (en) * 1991-08-21 1994-03-15 Hoechst Aktiengesellschaft Process and apparatus for guiding a coated material strip
US5447566A (en) * 1993-12-27 1995-09-05 Autographic Business Forms, Inc. Paper coating and drying machine
US5622707A (en) * 1991-12-18 1997-04-22 M.U.R.S.T. (Italian Ministry For Universities And Scientific And Technological Research) Composite membranes for the guided regeneration of tissues
EP0997697A2 (fr) * 1998-10-28 2000-05-03 VITS-Maschinenbau GmbH Dispositif pour sécher et refroidir des bandes de papier fraíchement imprimées
EP1221325A2 (fr) * 2001-01-09 2002-07-10 Johnson & Johnson Limited Composition topique contenant de la centella et du ginseng pour le traitement de blessures sans formation de cicatrices

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US3924022A (en) * 1974-02-22 1975-12-02 Gen Electric Method of applying an organic coating onto an inorganic coated steel sheet for a magnetic laminate application
DE20304641U1 (de) * 2003-03-21 2003-05-22 Josef Schiele Ohg Beschichtungsvorrichtung

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR823052A (fr) * 1936-06-20 1938-01-13 Bandage perfectionné et son procédé de fabrication
GB691182A (en) * 1950-02-04 1953-05-06 Herts Pharmaceuticals Ltd New or improved method and process for applying a coating to a web or strip of material
US3559301A (en) * 1968-07-29 1971-02-02 Egan Machinery Co Air flotation system for conveying web materials
US4556441A (en) * 1983-01-24 1985-12-03 Faasse Jr Adrian L Pharmaceutical packaging method
US4911155A (en) * 1987-02-17 1990-03-27 Molinier S.A. Manufacturing process for a cohesive compression bandage, the means of implementation and the bandage obtained
EP0300815A2 (fr) * 1987-07-24 1989-01-25 Ethicon, Inc. Pansement élastique épousant les contours par les plaies
US5293699A (en) * 1991-08-21 1994-03-15 Hoechst Aktiengesellschaft Process and apparatus for guiding a coated material strip
US5622707A (en) * 1991-12-18 1997-04-22 M.U.R.S.T. (Italian Ministry For Universities And Scientific And Technological Research) Composite membranes for the guided regeneration of tissues
US5447566A (en) * 1993-12-27 1995-09-05 Autographic Business Forms, Inc. Paper coating and drying machine
EP0997697A2 (fr) * 1998-10-28 2000-05-03 VITS-Maschinenbau GmbH Dispositif pour sécher et refroidir des bandes de papier fraíchement imprimées
EP1221325A2 (fr) * 2001-01-09 2002-07-10 Johnson & Johnson Limited Composition topique contenant de la centella et du ginseng pour le traitement de blessures sans formation de cicatrices

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2626144A1 (fr) * 2012-02-07 2013-08-14 Nederlandse Organisatie voor toegepast -natuurwetenschappelijk onderzoek TNO Système de fabrication rouleau à rouleau avec une zone de déposition à salle blanche et une zone de traitement séparée
WO2013119110A1 (fr) 2012-02-07 2013-08-15 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Installation de fabrication et procédé de fabrication
CN104203433A (zh) * 2012-02-07 2014-12-10 荷兰应用自然科学研究组织Tno 生产设备和生产方法
CN104203433B (zh) * 2012-02-07 2016-06-29 荷兰应用自然科学研究组织Tno 生产设备和生产方法
US9610602B2 (en) 2012-02-07 2017-04-04 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Manufacturing facility and method of manufacturing
DE102015115444A1 (de) 2015-09-14 2017-03-16 Optimags Dr. Zimmermann Gmbh Verfahrenstechnische Anlage, Verfahren zum Überwachen und Einrichten derselben sowie tragbarer Computer zur Verwendung im Verfahren

Also Published As

Publication number Publication date
DE112004002828A5 (de) 2007-07-26
DE112004002828B4 (de) 2015-10-08

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