WO2010094749A1 - Procédé et dispositif destiné à sécher ou conditionner des matériaux d'emballage, afin de fabriquer des emballages de médicaments - Google Patents

Procédé et dispositif destiné à sécher ou conditionner des matériaux d'emballage, afin de fabriquer des emballages de médicaments Download PDF

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Publication number
WO2010094749A1
WO2010094749A1 PCT/EP2010/052074 EP2010052074W WO2010094749A1 WO 2010094749 A1 WO2010094749 A1 WO 2010094749A1 EP 2010052074 W EP2010052074 W EP 2010052074W WO 2010094749 A1 WO2010094749 A1 WO 2010094749A1
Authority
WO
WIPO (PCT)
Prior art keywords
dried
film web
film
protection
drying
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.)
Ceased
Application number
PCT/EP2010/052074
Other languages
German (de)
English (en)
Inventor
Eduard Balthes
Johannes Geser
Christoph Kreher
Nadine LEHNÉ
Burkhard Peter Metzger
Michael Walz
Oliver Wendland
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.)
Boehringer Ingelheim International GmbH
Original Assignee
Boehringer Ingelheim International 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 Boehringer Ingelheim International GmbH filed Critical Boehringer Ingelheim International GmbH
Publication of WO2010094749A1 publication Critical patent/WO2010094749A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B13/00—Conditioning or physical treatment of the material to be shaped
    • B29B13/06—Conditioning or physical treatment of the material to be shaped by drying
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29B—PREPARATION OR PRETREATMENT OF THE MATERIAL TO BE SHAPED; MAKING GRANULES OR PREFORMS; RECOVERY OF PLASTICS OR OTHER CONSTITUENTS OF WASTE MATERIAL CONTAINING PLASTICS
    • B29B13/00—Conditioning or physical treatment of the material to be shaped
    • B29B13/02—Conditioning or physical treatment of the material to be shaped by heating
    • B29B13/023—Half-products, e.g. films, plates
    • 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
    • F26B21/00—Arrangements for supplying or controlling air or other gases for drying solid materials or objects
    • F26B21/30—Controlling, e.g. regulating, parameters of gas supply
    • F26B21/33—Humidity
    • 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
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers

Definitions

  • the present invention describes a process for drying packaging material, in particular film, which is used for the production of packaging, in particular blister packs, for the storage of pharmaceutical formulations.
  • packaging material in particular film
  • the storage time of moisture-sensitive pharmaceutical formulations can be significantly extended.
  • the film to be dried is removed from moisture, solvent residues or traces of other volatile product-damaging substances (so-called volatile substances) (for example ethanol, ethyl acetate, methyl ketone, isopropanol, acetone, formaldehyde, acetaldehyde) within a protection.
  • volatile substances for example ethanol, ethyl acetate, methyl ketone, isopropanol, acetone, formaldehyde, acetaldehyde
  • drying or conditioning of packaging materials with the combination of high-frequency electromagnetic radiation and ultrasound is applicable for the removal of all other polar volatile substances from packaging materials.
  • the drying or conditioning of ultrasonic packaging materials alone is applicable to the removal of all (i.e., polar and impolar) volatile substances from packaging.
  • films especially those made of polymeric materials, have a tendency to accumulate surface water (i.e., adsorption) in the volume (i.e., absorption) from the ambient air. This property causes the surface of the films is always coated with a thin film of water, or the film contains a certain amount of water
  • blister packs In this case, two film layers are laminated so that between them closed cavities arise. These cavities host the pharmaceutical formulations to be packaged.
  • blister packs are used in particular in the pharmaceutical industry, where Complex formulations are often packaged as tablets, capsules, granules, powders, inhalants, liquid formulations and solutions in blister packs.
  • moisture or volatile substances One of the determining factors in the stability or decomposition of active pharmaceutical ingredients is moisture or volatile substances.
  • a reduction and control of moisture in packaging of pharmaceutical products is necessary. It is particularly efficient, the entry of moisture or other volatile substances into a package due to the water content of the packaging itself as fast as possible and reduce as much. In order to prevent re-uptake of water, it seems most convenient to dry packaging immediately prior to its processing (e.g., blistering). For this purpose, the drying method proposed here is used.
  • a sorbent which binds the moisture, especially water vapor, from the air inside the blister pack and so for a low Moisture inside the blister pack ensures.
  • Suitable absorbents are i.a. Silica gels, drying or moisture or water adsorbing clays, aluminosilicates such as zeolites or bentonites, molecular sieves, activated carbon, alkaline earth oxides, calcium sulfate or mixtures thereof proposed.
  • Such sorbent-containing films require an additional process step for the incorporation of the sorbents in the production of the films. Furthermore, change by the sorbent, the mechanical properties of the films.
  • the object of the present invention is to provide a process for producing a blister pack for pharmaceutical formulations which avoids the disadvantages of the prior art.
  • This procedure contains the steps i) introducing a film web into a protection in which a relative humidity of at most 30% at 25 ° C, preferably 20% at 25 0 C, preferably 10% at 25 ° C, preferably 5% at 25 ° C and more preferably 0 , 5% at 25 ° C, ii) removal of moisture from the film web, iii) delivery of the dried film web to a receiving device.
  • the present invention describes a device for drying film webs, in which the method described above can be carried out.
  • “Blister packaging” in the context of the present invention refers to packaging in which the product to be packaged, in particular pharmaceutical formulations, is arranged in cavities (so-called cavities) between two films which are connected to one another around the product to be packaged may be made by any suitable technique, such as gluing, pressure or hot-sealing, ultrasonic welding, induction sealing, etc.
  • the term “blistering” is hereafter referred to as the process of packaging pharmaceutical formulations in blister packs. In defoliation, the pharmaceutical formulation is placed between two sheets, which are then bonded together around the pharmaceutical formulation.
  • packing material describes materials which are suitable for packaging medicaments or pharmaceutical formulations, in particular films.
  • Film or “film web” in the context of the present invention are made of polymeric material (eg polyvinyl chloride).
  • a "closed cavity” is a cavity that is completely sealed off from the environment, so that the atmosphere in the cavity has no direct possibility of exchanging gas or other particles with the atmosphere located outside the cavity.
  • “Pharmaceutical formulation” in the context of the present application refers to all common forms of administration of medicaments, including pure active substances and mixtures thereof with pharmaceutical excipients, carriers and / or with other active ingredients, including tablets, capsules, granules, powders, inhalable powders, liquid formulations and solutions.
  • the aforementioned devices for removing moisture from the film web can act according to various principles: First, they can heat the film webs, examples being thermal heating elements, infrared radiators, microwave emitters and electromagnetic induction devices On the other hand, these devices can also emit moisture from the material of the film web by emission of high-frequency radiation (HF) . In addition, these devices can also detect the emission of ultrasonic water he deploy from the material of the film web.
  • HF high-frequency radiation
  • materials for the protection in the case of purely thermal treatment of the foil stainless steel are considered.
  • materials for treatment with electromagnetic radiation materials are suitable, which also provide a sufficient shielding of electromagnetic radiation.
  • the type of materials depends on the frequency range of the HF
  • the air-flow rate should be selected so that the desired low level of humidity is stationary in the airspace of the protection, in which case the protection must be flooded with conditioned air to transport the moisture (or volatile vapors) out of the protection not be tight.
  • the method claimed herein for drying a film web comprises the following steps: i) introducing a film web into a protection in which a relative humidity of at most 30% at 25 ° C, preferably 20% at 25 ° C, preferably 10% at 25 ° C, preferably 5% at 25 ° C and more preferably 0.5% at 25 0 C, ii) almost complete removal ("drying") or partial removal ("conditioning") of moisture from the film web, iii) delivery the dried film web to a recording device.
  • the film web which is introduced into the protection and dried therein, either predominantly smooth or already have depressions, which may be advantageous in the subsequent subsequent blistering process.
  • Removal of moisture from the film web within the barrier may be accomplished by any suitable device. These devices are preferably arranged inside the protection.
  • a first group of suitable devices are those which remove moisture from the film web by heating it. Examples of these are thermal heating elements, infrared radiators, microwave radiators or devices for electromagnetic induction.
  • the temperature of the film web achieved during the heating depends on the composition of the film and must not reach the softening, melting or decomposition temperature.
  • the film web eg PVC, PP, PE, PA, PET, PVDC, PCTFE, COC, POM, Aclar TM, Aclon TM, but also film composites and sealing films
  • the temperature should be based on the materials to be dried, eg 50 0 C is suitable for PVC, HDPE and PP, and 8O 0 C for PET.
  • the maximum temperature depends on the softening temperature of the film material or the thermally least stable component of a composite.
  • the film web is heated in such a manner for a time interval of about a few seconds - 1 minute (with sealing foils) or to about 5 - 10 minutes (for floor films and film composites).
  • a second group of suitable devices are those which remove moisture from the film web by emitting RF radiation thereon.
  • the frequency range or the energy depends on the binding or accumulation state of the water on the molecules or in the free volume of the film material.
  • the frequency and energy range can be between 300MHz (about 1, 2 ⁇ eV) and the infrared, ie 120THz (500meV).
  • the HF eg by a magnetron, klystron, maser, transmitter for mobile radio, microwave, television or else be generated by a laser.
  • the decisive factor for the speed and efficiency, eg of film drying is the triggering work which has to be applied in order to trigger the water molecules from their respective bonding state in the material.
  • Thermal drying encounters limits at this point because the applied thermal energy is in the range of about 0.025eV, while some of the above-mentioned bonding states have energies greater than 0, IeV. This makes the thermal drying process tedious. In addition, the entire material is heated. Increasing the efficiency by increasing the temperature is very limited, since temperatures are reached quickly at which the material to be dried is damaged. High-frequency electromagnetic radiation (HF) offers decisive advantages here. HF is absorbed in the material only by polar molecules. This makes it possible to selectively introduce energy into polarities of polymers - exactly where water is preferentially attached or bound. This leads to a triggering of the water from the polymer network, thus increasing the mobility, ie the diffusion of the water and increases the speed and efficiency of the drying process.
  • HF high-frequency electromagnetic radiation
  • HF therefore has the advantage of selectively heating the material to be dried - exactly where the energy needed to trigger and mobilize the water or the volatile substance is needed. Furthermore, the energy input automatically decreases with the reduction of the water content in the material, which contributes to its conservation.
  • the frequency is set to the resonance frequency which corresponds to the triggering work of the largest amount of water in the material (eg in the range of THz in Van der Waals bonds).
  • the corresponding Resonance frequencies are given by the structure of the water molecule itself: the resonance frequencies of 58.9THz, 121.4THz and 122.4THz of the water molecule can be used in all cases (ie independent of the binding state of the water) for an efficient energy transfer from the radiation to the water molecule water molecule.
  • the resonance frequencies are material-dependent and also highly dependent on the binding or incorporation state of the water in the material (preferably 300MHz to 900THz, more preferably ITHz to 900 THz).
  • a third group of suitable devices are those which remove moisture from the film web by emitting ultrasound (i.e., sound in the frequency range between 2OkHz and IGHz with powers up to the kW range) thereon.
  • ultrasound i.e., sound in the frequency range between 2OkHz and IGHz with powers up to the kW range
  • Ultrasound can currently be relatively easily e.g. by piezo modules (or as previously by magnetostrictive transducers) are generated.
  • the drying rate is indeed maximized by internal mobilization of the water, but limited by the fact that the water must first escape from the surface of the material (desorption) to the material itself
  • Desorption of a water molecule is, among other things, the number k D of experiments per unit time that the molecule undertakes to leave the surface of the material.
  • the ultrasonic frequency can be adapted to the material properties so the
  • the water vapor may e.g. be quickly removed from the surface of the material by a dry air blower to maintain a high moisture gradient at the interface of the material.
  • HF drying in combination with ultrasound offers the possibility of coordinating the two methods to optimize the drying speed. Furthermore, the material to be dried is spared.
  • RF and ultrasonic generators are compact and therefore easy to integrate into a production plant. Due to said compactness, it is also possible to integrate several drying modules in the production plant.
  • the Aufhahmevoroplasty according to the present invention is used to store the dried film or their forwarding to a further processing apparatus.
  • An exemplary embodiment is a roll on which the dried film web is wound up to store it in a dried state. This role is preferably located within the protection. In an alternative variant, the role is surrounded by its own protection, so that it can be stored independently, without the dried film web is exposed to atmospheric moisture.
  • a second possible embodiment of the receiving device is a device which forwards the dried film web to a further processing apparatus.
  • An exemplary variant of this embodiment is a system of rollers comprising the dried film web of a further processing apparatus feeds. This can be arranged inside or outside the protection.
  • An example of a further processing apparatus is a packaging machine which packages pharmaceutical formulations in blister packs with the aid of the dried film webs.
  • the present invention describes a method of packaging pharmaceutical formulations comprising the steps of i) applying a pharmaceutical formulation to a first dried one
  • the first and / or the second dried film web were dried by the method described above.
  • the combination of the two dried film webs can be done by any suitable technique, such as gluing, printing or hot-sealing, ultrasonic welding, induction sealing mentioned as examples.
  • an apparatus for drying film webs contains a Verschutzung, which encloses an interior, wherein the protection is provided with an inlet device for film webs and with a receiving device for dried film webs.
  • the protection can have in its interior at least one tensioning element and / or a deflection roller with which or over which the film web to be dried is guided.
  • This, for example, spring-loaded, clamping element is in a preferred embodiment, a deflection roller, preferably a plurality of deflection rollers that guide the film web to be dried within the security.
  • the receiving device is used to store the dried film or its forwarding to a further processing apparatus.
  • An exemplary embodiment is a roll on which the dried film web is wound is to keep them in a dry state. This role is preferably located within the protection. In an alternative variant, the role of its own protection is surrounded, so that it can be stored independently, without the dried film web is exposed to the humidity.
  • a second possible embodiment of the Aufhahmevoriques is a device that passes the dried film web to a further processing apparatus.
  • An exemplary variant of this embodiment is a system of rollers which feeds the dried film web to a further processing apparatus. This can be arranged inside or outside the protection.
  • An example of a further processing apparatus is a Ve ⁇ ackungsmaschine that packs pharmaceutical formulations in blister packs using the dried film webs.
  • a further aspect of the present invention is based on the observation that a film web dried as described above is also suitable as a desiccant (in the sense of a water absorber) for a pharmaceutical formulation to be dried. It is thus possible with the aid of the film webs dried as described above to package pharmaceutical formulations and to dry them at the same time. In this case, due to the hygroscopic properties of the dried film web, further desiccants may possibly be dispensed with.
  • a film composite consisting of Al (45 microns) / PP (60 .mu.m) (base film) is reconditioned within 200min / dried.
  • the associated sealing foil consisting of Al (20 ⁇ m) / heat sealing lacquer (5 ⁇ m) is reconditioned within 3 minutes. The reconditioning times are independent of the initial and target moisture content.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • General Engineering & Computer Science (AREA)
  • Textile Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Drying Of Solid Materials (AREA)

Abstract

La présente invention concerne un procédé de séchage de film utilisé pour la fabrication d'emballages, en particulier d'emballages de type blister, pour la conservation de formulations pharmaceutiques. En utilisant un film séché, la durée de stockage des formulations pharmaceutiques sensibles à l'humidité peut être nettement prolongée. Selon l'invention, l'humidité ou d'autres substances volatiles sont retirées du film à sécher à l'intérieur d'un capotage. Le film ainsi séché est ensuite soit transformé directement, soit stocké au sec.
PCT/EP2010/052074 2009-02-20 2010-02-18 Procédé et dispositif destiné à sécher ou conditionner des matériaux d'emballage, afin de fabriquer des emballages de médicaments Ceased WO2010094749A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP09153359 2009-02-20
EP09153359.6 2009-02-20

Publications (1)

Publication Number Publication Date
WO2010094749A1 true WO2010094749A1 (fr) 2010-08-26

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/052074 Ceased WO2010094749A1 (fr) 2009-02-20 2010-02-18 Procédé et dispositif destiné à sécher ou conditionner des matériaux d'emballage, afin de fabriquer des emballages de médicaments

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WO (1) WO2010094749A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994007761A1 (fr) * 1992-09-30 1994-04-14 R.P. Scherer Corporation Emballage pellicule a bords creneles et utilisation de ces creneaux
DE10058253A1 (de) * 2000-09-18 2002-04-04 Lohmann Therapie Syst Lts Vorrichtung und Verfahren zur gleichmäßigen Trocknung von bahnförmigen, durch Beschichtung hergestellten Produkten
US20030009879A1 (en) * 2000-03-17 2003-01-16 Allan Draisey Capsules
US20050037055A1 (en) * 2002-04-11 2005-02-17 Monosolrx Llc. Polyethylene oxide-based films and drug delivery systems made therefrom
DE102005022862A1 (de) 2005-05-18 2006-12-14 Airsec S.A.S Kapseln für Inhalatoren
US20080241393A1 (en) * 2007-03-29 2008-10-02 Fujifilm Corporation Method for making positive photosensitive planographic printing plate

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994007761A1 (fr) * 1992-09-30 1994-04-14 R.P. Scherer Corporation Emballage pellicule a bords creneles et utilisation de ces creneaux
US20030009879A1 (en) * 2000-03-17 2003-01-16 Allan Draisey Capsules
DE10058253A1 (de) * 2000-09-18 2002-04-04 Lohmann Therapie Syst Lts Vorrichtung und Verfahren zur gleichmäßigen Trocknung von bahnförmigen, durch Beschichtung hergestellten Produkten
US20050037055A1 (en) * 2002-04-11 2005-02-17 Monosolrx Llc. Polyethylene oxide-based films and drug delivery systems made therefrom
DE102005022862A1 (de) 2005-05-18 2006-12-14 Airsec S.A.S Kapseln für Inhalatoren
US20080241393A1 (en) * 2007-03-29 2008-10-02 Fujifilm Corporation Method for making positive photosensitive planographic printing plate

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