WO2004000080A1 - Administration form for the oral administration of active substances, vitamins, and/or nutrients - Google Patents

Administration form for the oral administration of active substances, vitamins, and/or nutrients Download PDF

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Publication number
WO2004000080A1
WO2004000080A1 PCT/EP2003/006533 EP0306533W WO2004000080A1 WO 2004000080 A1 WO2004000080 A1 WO 2004000080A1 EP 0306533 W EP0306533 W EP 0306533W WO 2004000080 A1 WO2004000080 A1 WO 2004000080A1
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
drinking straw
form according
formulation
vitamin
Prior art date
Application number
PCT/EP2003/006533
Other languages
German (de)
French (fr)
Inventor
Rasoul Sedaghat Kerdar
Original Assignee
Grünenthal 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 Grünenthal GmbH filed Critical Grünenthal GmbH
Priority to AU2003237964A priority Critical patent/AU2003237964A1/en
Priority to DE50308974T priority patent/DE50308974D1/en
Priority to EP03735654A priority patent/EP1517628B1/en
Publication of WO2004000080A1 publication Critical patent/WO2004000080A1/en
Priority to US11/021,643 priority patent/US20050106187A1/en

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Classifications

    • 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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0015—Devices specially adapted for taking medicines
    • A61J7/0038—Straws
    • A—HUMAN NECESSITIES
    • A47—FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47G—HOUSEHOLD OR TABLE EQUIPMENT
    • A47G21/00—Table-ware
    • A47G21/18—Drinking straws or the like
    • A47G21/183—Drinking straws or the like with means for changing the flavour of the liquid

Definitions

  • the invention relates to a dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with a cap with a pierceable bottom made of an optionally laminated aluminum, plastic or cellulose film or with a shockproof, at least partially over a line of weakness embedded, shock-removable plastic base as a closure device, a kit of the dosage form and a transport liquid and a method for producing the dosage form.
  • the drinking straws described in the prior art for the oral administration of active ingredients, vitamins and / or nutrients have stoppers or caps as a closure device for retaining the active ingredient, vitamin and / or nutrient formulation contained in the drinking straw.
  • the plugs or caps must be removed from the straw before using the straw. During the removal of these known closure devices there is a risk of spilling the active ingredient, vitamin and / or nutrient formulation.
  • a dosage form for the oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw which has two openings and a blocking device which is impermeable to an active ingredient, vitamin and / or nutrient formulation but permeable to air and a transport liquid, a locking device which is impermeable to the active ingredient, vitamin and / or nutrient formulation and contains the active substance, vitamin and / or nutrient formulation arranged between the blocking device and the closing device in the drinking straw, characterized in that as the closing device a cap closing the drinking straw opening facing the formulation with a pierceable bottom made of an aluminum foil or an aluminum-plastic Has film laminate, a single or multi-layer plastic film or cellulose film or is equipped with a shockproof, at least partially connected by a line of weakness, buttable removable bottom made of plastic or metal, preferably aluminum.
  • At least one end of the straw can be provided with a removable protective cap, the bottom of which cannot be removed by impact from a shockproof material.
  • the cap used according to the invention can be produced by producing a tube, preferably made of plastic, with the appropriate diameter for covering at least the mouthpiece of the drinking straw and connecting the base from the desired film to it.
  • This film may also have lines of weakness for easier piercing.
  • the cap can also z. B. overall made of the same material, preferably plastic or metal, such as aluminum optionally laminated for reinforcement, the bottom of which at least partially has a line of weakness over the entire outer circumference. This makes it possible to remove the otherwise shockproof floor by impact.
  • the active ingredient, vitamin and / or nutrient formulation is preferably solid or pasty.
  • a multiparticulate active substance, vitamin and / or nutrient formulation is preferred, the particles of the multiparticulate formulation preferably having a diameter of 50-1500 ⁇ m.
  • the active ingredients, vitamins and / or nutrients alone or the active ingredient, vitamin and / or nutrient formulations as a whole can be insoluble or at least partially soluble in the transport liquid.
  • the active ingredients, vitamins or nutrients or their formulations are soluble in the transport liquid, they are dissolved by the transport liquid flowing past and taken away in dissolved form. If, on the other hand, the active substances, vitamins or nutrients or their formulations are insoluble in the transport liquid, they are suspended in the transport liquid flowing past and carried along in suspended form with the transport liquid. Multiparticulate formulations are preferably used for this.
  • the particles should be so small and light that they can be transported by the transport liquid.
  • the adhesion of the particles to each other or to the drinking straw walls should be as low as possible, which can be achieved if necessary by suitable surface treatment of the particles.
  • active ingredients preferably therapeutic active ingredients, vitamins and nutrients, all orally administrable substances can be used in the form of a suitable formulation.
  • the drinking straw preferably contains a precisely defined dose of these substances.
  • the locking device is preferably designed as a plug, the cross section of which is preferably adapted to the cross section of the drinking straw.
  • the loose plug can also have a larger cross section, provided that this plug can be pressed together to a cross section corresponding to the inner cross section of the drinking straw.
  • the locking device can be permanently fixed or movably arranged in the drinking straw.
  • the plug can be permanently fixed in the drinking straw, for example by the plug being fixed by narrowing the drinking straw or by the plug being glued into the drinking straw.
  • the plug is preferably fixed by constriction of the drinking straw.
  • the plug can also be movable between two stops by the transport liquid. The drinking straw is narrowed by the stops, the narrowings being designed in such a way that the plug, but not the formulation particles which are insoluble in the transport liquid, are retained thereby.
  • the plug preferably consists of filter material, particularly preferably of non-woven material or pressed fiber material.
  • a membrane fixed in the drinking straw is also preferred as the blocking device, the cross section of the membrane preferably being adapted to the cross section of the drinking straw and the membrane preferably being glued into the drinking straw.
  • the membrane is preferably made of synthetic material.
  • a blocking device is a grid fixed in the drinking straw, the mesh diameter of which is smaller than the diameter of the smallest formulation particle.
  • the cross section of the grid is preferably matched to the cross section of the drinking straw and the grid is preferably fixed in the drinking straw by constrictions of the drinking straw or glued into the drinking straw.
  • the grid is preferably made of synthetic material.
  • a constriction of the drinking straw which is designed in such a way that even the smallest formulation particles are retained, is also suitable as a blocking device.
  • the blocking device must not reduce the flow of the transport liquid to such an extent that a solid, insoluble active substance, vitamin and / or nutrient formulation can no longer be taken along.
  • the drinking straw can be rigid or flexible, straight, preferably reversibly angled, or angled.
  • the drinking straw is preferably made of a synthetic material. At least the possibly existing area in which the drinking straw can be reversibly bent is preferably made of an elastic, synthetic material or a synthetic material that is plastically deformable at a temperature below its softening point.
  • the area in which the drinking straw can be reversibly angled is preferably designed like an accordion.
  • the inside diameter of the drinking straw should preferably be at least 3 mm so that a sufficient amount of transport liquid can be sucked through the drinking straw to transport the formulation.
  • An inner diameter of 4-15 mm is preferred, very particularly preferably 5-10 mm.
  • the drinking straw preferably has a round, oval, rectangular or square cross section and preferably has a smooth inside.
  • the drinking straw opening facing the formulation is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening facing the locking device is preferably designed as a connection piece to a reservoir of the transport liquid.
  • the drinking straw preferably has a marking to identify the mouth part and / or to indicate the direction of suction of the transport liquid. This marking makes handling easier.
  • At least the part of the drinking straw containing the formulation is transparent and / or colored.
  • a transparent drinking straw the absorption of the active ingredient, vitamin and / or nutrient formulation can be observed, while the use of an opaque colored drinking straw offers the possibility of masking the administration of an active ingredient, vitamin and / or nutrient formulation ,
  • Another object of the invention is also a kit comprising the dosage form according to the invention and a physiologically harmless, optionally active substance, nutrient and / or vitamin-containing transport liquid.
  • An aqueous liquid is preferably suitable as the transport liquid, water, lemonade, fruit juice without pulp, tea or coffee being particularly preferred.
  • Another object of the invention is a method for producing the dosage form, in which the blocking device is inserted into the drinking straw, the formulation is introduced into the drinking straw through the one drinking straw opening, and the drinking straw opening facing the formulation is provided with the closure device.
  • Figures 1a, 1b and 1c show a dosage form according to the invention with a removed cap with a bottom that can be pierced (a), a cap with a bottom that can be pierced (b) and a cap with a bottom that is pierced (c) in a side view.
  • FIGS. 2a, 2b and 2c show a further dosage form according to the invention with a removed cap with a pierceable base (a), a cap with a pierceable base (b) and a cap with a pierced base (c) in a side view.
  • the dosage form shown in Figures 1a, 1b and 1c comprises a drinking straw (1) which has two openings (6, 7) and a plug fixed in the drinking straw as a locking device (2), a cap with a pierceable bottom (5) as Closure device (3) and a formulation (4) located between the blocking device and the closure device in the drinking straw.
  • the drinking straw (1) has a round cross section and is straight.
  • the plug (2) serving as a blocking device consists of filter material and is permeable to air and the transport liquid, but impermeable to the formulation.
  • the plug is cylindrical and has a round cross-section, wherein the diameter of the plug is adapted to the inside diameter of the drinking straw.
  • the plug is permanently fixed in the drinking straw.
  • the formulation (4) is in the form of spherical particles.
  • the cap (3) serving as a closure device is impermeable to the formulation.
  • the inside diameter of the cap (3) is adapted to the outside diameter of the drinking straw (1) so that the cap can be placed on the drinking straw.
  • the bottom (5) of the cap (3) is pierced with the help of the drinking straw (1).
  • the cap (3) with the destroyed base (5) is pulled over the drinking straw.
  • the dosage form shown in FIGS. 2a, 2b and 2c essentially corresponds to the dosage form shown in FIGS. 1a, 1b and 1c.
  • a stopper (2) that can be moved by the transport liquid between two stops (8, 9) is used as a blocking device (2).
  • the diameter of the largest shaping particles is smaller than the inner diameter of the drinking straw at the location of the stop (8), so that the formulation particles can pass this location.

Abstract

The invention relates to an administration form for orally administering active substances, vitamins, and/or nutrients, comprising a drinking straw that is provided with a cap. Said cap comprises a pierceable bottom that is made of an optionally laminated aluminum-plastic film or cellulose film or a shock-proof plastic bottom which is removable by a pushing movement and is at least partly recessed via a weakening line as a sealing device. Also disclosed are a kit comprising said administration form and a conveying liquid, and a method for producing the administration form.

Description

Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder NährstoffenDosage form for oral administration of active ingredients, vitamins and / or nutrients
Die Erfindung betrifft eine Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm mit einer Kappe mit einem durchstoßbaren Boden aus einer ggf. laminierten Aluminium-, Kunststoff- oder Cellulose-Folie oder mit einem stoßfesten, zumindest teilweise über eine Schwächungslinie eingelassenen, durch Stoß entfernbaren Boden aus Kunststoff als Verschlußvorrichtung, ein Kit aus der Darreichungsform und einer Transportflüssigkeit und ein Verfahren zur Herstellung der Darreichungsform.The invention relates to a dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with a cap with a pierceable bottom made of an optionally laminated aluminum, plastic or cellulose film or with a shockproof, at least partially over a line of weakness embedded, shock-removable plastic base as a closure device, a kit of the dosage form and a transport liquid and a method for producing the dosage form.
Die Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen mit Hilfe eines Trinkhalms, der eine durch eine Flüssigkeit transportierbare Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung enthält, ist bekannt. Patienten, die Schwierigkeiten haben oder eine Abneigung empfinden, Kapseln oder Tabletten einzunehmen, wird dadurch eine weitere Darreichungsform von Wirkstoffen, Vitaminen oder Nährstoffen angeboten.The administration of active substances, vitamins and / or nutrients with the aid of a drinking straw which contains an active substance, vitamin and / or nutrient formulation which can be transported through a liquid is known. Patients who have difficulty or feel reluctant to take capsules or tablets are offered a further dosage form of active ingredients, vitamins or nutrients.
Die im Stand der Technik beschriebenen Trinkhalme zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen weisen Stopfen oder Kappen als Verschlußvorrichtung zur Zurückhaltung der sich im Trinkhalm befindenen Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung auf. Die Stopfen oder Kappen müssen vor der Benutzung des Trinkhalms vom Trinkhalm abgenommen werden. Während dem Entfernen dieser bekannten Verschlußvorrichtungen besteht die Gefahr des Verschüttens der Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung.The drinking straws described in the prior art for the oral administration of active ingredients, vitamins and / or nutrients have stoppers or caps as a closure device for retaining the active ingredient, vitamin and / or nutrient formulation contained in the drinking straw. The plugs or caps must be removed from the straw before using the straw. During the removal of these known closure devices there is a risk of spilling the active ingredient, vitamin and / or nutrient formulation.
Es stellte sich daher die Aufgabe, eine Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm mit einer Verschlußvorrichtung zur Verfügung zu stellen, die möglichst einfach herzustellen ist und die Nachteile der im Stand der Technik beschriebenen Darreichungsformen nicht aufweist.It was therefore the object of providing a dosage form for the oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with a closure device which is as simple to manufacture as possible and does not have the disadvantages of the dosage forms described in the prior art.
Die Aufgabe wird erfindungsgemäß durch die Bereitstellung einer Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm, der zwei Öffnungen hat und eine für eine Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung undurchlässige, für Luft und eine Transportflüssigkeit jedoch durchlässige Sperrvorrichtung, eine für die Wirkstoff- Vitamin- und/oder Nährstoff-Formulierung undurchlässige Verschlußvorrichtung und die zwischen Sperrvorrichtung und Verschlußvorrichtung im Trinkhalm angeordnete Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung enthält, dadurch gekennzeichnet, daß als Verschlußvorrichtung eine die der Formulierung zugewandte Trinkhalmöffnung verschließenden Kappe mit einem durchstoßbaren Boden aus einer Aluminium-Folie oder einem Aluminium-Kunststoff-Folienlaminat, einer ein- oder mehrschichtigen Kunststoff-Folie oder Cellulose-Folie aufweist oder mit einem stoßfesten, zumindest teilweise über eine Schwächungslinie verbundene, durch Stoß entfernbaren Boden aus Kunststoff oder Metall, vorzugsweise Aluminium, ausgerüstet ist, gelöst.The object is achieved according to the invention by the provision of a dosage form for the oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw which has two openings and a blocking device which is impermeable to an active ingredient, vitamin and / or nutrient formulation but permeable to air and a transport liquid, a locking device which is impermeable to the active ingredient, vitamin and / or nutrient formulation and contains the active substance, vitamin and / or nutrient formulation arranged between the blocking device and the closing device in the drinking straw, characterized in that as the closing device a cap closing the drinking straw opening facing the formulation with a pierceable bottom made of an aluminum foil or an aluminum-plastic Has film laminate, a single or multi-layer plastic film or cellulose film or is equipped with a shockproof, at least partially connected by a line of weakness, buttable removable bottom made of plastic or metal, preferably aluminum.
Zumindest ein Trinkhalmende kann mit einer abnehmbaren Schutzkappe versehen sein, deren nicht durch Stoß entfernbarer Boden aus einem stoßfesten Material besteht.At least one end of the straw can be provided with a removable protective cap, the bottom of which cannot be removed by impact from a shockproof material.
Die erfindungsgemäß zum Einsatz kommende Kappe kann hergestellt werden, indem ein Rohr, vorzugsweise aus Kunststoff, mit dem entsprechenden Durchmesser zum Umhüllen mindestens des Mundstückes des Trinkhalmes hergestellt wird und der Boden aus der gewünschten Folie damit verbunden wird. Diese Folie kann ggf. auch Schwächungslinien zum leichteren Durchstoßen aufweisen.The cap used according to the invention can be produced by producing a tube, preferably made of plastic, with the appropriate diameter for covering at least the mouthpiece of the drinking straw and connecting the base from the desired film to it. This film may also have lines of weakness for easier piercing.
Die Verschlußkappe kann auch z. B. insgesamt aus demselben Material, vorzugsweise Kunststoff oder Metall, wie Aluminium ggf. zur Verstärkung laminiert, gefertigt sein, deren Boden zumindest teilweise über dem gesamten äußeren Umfang eine Schwächungslinie aufweist. Dadurch gelingt es, den sonst stoßfesten Boden durch Stoß zu entfernen.The cap can also z. B. overall made of the same material, preferably plastic or metal, such as aluminum optionally laminated for reinforcement, the bottom of which at least partially has a line of weakness over the entire outer circumference. This makes it possible to remove the otherwise shockproof floor by impact.
Die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung ist vorzugsweise fest oder pastös. Bevorzugt ist eine multipartikuläre Wirkstoff-, Vitamin- und/oder Nährstoff- Formulierung, wobei die Partikel der multipartikulären Formulierung vorzugsweise einen Durchmesser von 50-1500 μm haben. Die Wirkstoffe, Vitamine und/oder Nährstoffe allein oder die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierungen insgesamt können in der Transportflüssigkeit unlöslich oder zumindest teilweise löslich sein.The active ingredient, vitamin and / or nutrient formulation is preferably solid or pasty. A multiparticulate active substance, vitamin and / or nutrient formulation is preferred, the particles of the multiparticulate formulation preferably having a diameter of 50-1500 μm. The active ingredients, vitamins and / or nutrients alone or the active ingredient, vitamin and / or nutrient formulations as a whole can be insoluble or at least partially soluble in the transport liquid.
Sind die Wirkstoffe, Vitamine oder Nährstoffe oder deren Formulierungen in der Transportflüssigkeit löslich, werden sie durch die vorbeiströmende Transportflüssigkeit gelöst und in gelöster Form mitgenommen. Sind die Wirkstoffe, Vitamine oder Nährstoffe oder deren Formulierungen in der Transportflüssigkeit hingegen unlöslich, werden sie in der vorbeiströmenden Transportflüssigkeit suspendiert und in suspendierter Form mit der Transportflüssigkeit mitgenommen. Vorzugsweise werden dafür multipartikuläre Formulierungen verwendet. Die Partikel sollten so klein und leicht sein, daß sie von der Transportflüssigkeit transportiert werden können. Die Haftung der Partikel aneinander oder an den Trinkhalmwänden sollte möglichst gering sein, was gegebenenfalls durch eine geeignete Oberflächenbehandlung der Partikel erreicht werden kann.If the active ingredients, vitamins or nutrients or their formulations are soluble in the transport liquid, they are dissolved by the transport liquid flowing past and taken away in dissolved form. If, on the other hand, the active substances, vitamins or nutrients or their formulations are insoluble in the transport liquid, they are suspended in the transport liquid flowing past and carried along in suspended form with the transport liquid. Multiparticulate formulations are preferably used for this. The particles should be so small and light that they can be transported by the transport liquid. The adhesion of the particles to each other or to the drinking straw walls should be as low as possible, which can be achieved if necessary by suitable surface treatment of the particles.
Als Wirkstoffe, vorzugsweise therapeutische Wirkstoffe, Vitamine und Nährstoffe können alle oral verabreichbaren Stoffe in Form einer geeigneten Formulierung eingesetzt werden. Der Trinkhalm enthält vorzugsweise eine genau bestimmte Dosis dieser Stoffe.As active ingredients, preferably therapeutic active ingredients, vitamins and nutrients, all orally administrable substances can be used in the form of a suitable formulation. The drinking straw preferably contains a precisely defined dose of these substances.
Die Sperrvorrichtung ist vorzugsweise als ein Pfropfen ausgebildet, dessen Querschnitt vorzugsweise dem Querschnitt des Trinkhalms angepaßt ist. Der lose vorliegende Pfropfen kann aber auch einen größeren Querschnitt aufweisen, sofern dieser Pfropfen auf einen Querschnitt entsprechend dem inneren Querschnitt des Trinkhalms zusammengepresst werden kann.The locking device is preferably designed as a plug, the cross section of which is preferably adapted to the cross section of the drinking straw. However, the loose plug can also have a larger cross section, provided that this plug can be pressed together to a cross section corresponding to the inner cross section of the drinking straw.
Die Sperrvorrichtung kann in dem Trinkhalm permanent fixiert oder bewegbar angeordnet sein. So kann der Pfropfen einerseits im Trinkhalm permanent fixiert sein, indem der Pfropfen beispielsweise durch Verengungen des Trinkhalms fixiert oder indem der Pfropfen in dem Trinkhalm eingeklebt ist. Vorzugsweise ist der Pfropfen durch Verengungen des Trinkhalms fixiert. Der Pfropfen kann andererseits auch durch die Transportflüssigkeit zwischen zwei Anschlägen bewegbar sein. Durch die Anschläge wird der Trinkhalm verengt, wobei die Verengungen so ausgelegt sind, daß der Pfropfen, nicht jedoch die in der Transportflüssigkeit unlöslichen Formulierungspartikel dadurch zurückgehalten werden.The locking device can be permanently fixed or movably arranged in the drinking straw. On the one hand, the plug can be permanently fixed in the drinking straw, for example by the plug being fixed by narrowing the drinking straw or by the plug being glued into the drinking straw. The plug is preferably fixed by constriction of the drinking straw. On the other hand, the plug can also be movable between two stops by the transport liquid. The drinking straw is narrowed by the stops, the narrowings being designed in such a way that the plug, but not the formulation particles which are insoluble in the transport liquid, are retained thereby.
Der Pfropfen besteht vorzugsweise aus Filtermaterial, besonders bevorzugt aus Vliesmaterial oder verpreßtem Fasermaterial.The plug preferably consists of filter material, particularly preferably of non-woven material or pressed fiber material.
Als Sperrvorrichtung bevorzugt ist auch eine im Trinkhalm fixierte Membran, wobei der Querschnitt der Membran vorzugsweise dem Querschnitt des Trinkhalms angepaßt ist und die Membran vorzugsweise in den Trinkhalm eingeklebt ist. Die Membran besteht vorzugsweise aus synthetischem Material.A membrane fixed in the drinking straw is also preferred as the blocking device, the cross section of the membrane preferably being adapted to the cross section of the drinking straw and the membrane preferably being glued into the drinking straw. The membrane is preferably made of synthetic material.
Als Sperrvorrichtung bevorzugt auch ist ein im Trinkhalm fixiertes Gitter, dessen Maschendurchmesser kleiner ist als der Durchmesser des kleinsten Formulierungspartikels. Der Querschnitt des Gitters ist vorzugsweise dem Querschnitt des Trinkhalms angepaßt und das Gitter vorzugsweise durch Verengungen des Trinkhalms im Trinkhalm fixiert oder in den Trinkhalm eingeklebt. Das Gitter besteht vorzugsweise aus synthetischem Material.Also preferred as a blocking device is a grid fixed in the drinking straw, the mesh diameter of which is smaller than the diameter of the smallest formulation particle. The cross section of the grid is preferably matched to the cross section of the drinking straw and the grid is preferably fixed in the drinking straw by constrictions of the drinking straw or glued into the drinking straw. The grid is preferably made of synthetic material.
Ebenfalls als Sperrvorrichtung geeignet ist eine Verengung des Trinkhalms, die so ausgelegt ist, daß auch die kleinsten Formulierungspatikel dadurch zurückgehalten werden.A constriction of the drinking straw, which is designed in such a way that even the smallest formulation particles are retained, is also suitable as a blocking device.
Durch die Sperrvorrichtung darf der Strom der Transportflüssigkeit nicht soweit reduziert werden, daß eine feste, unlösliche Wirkstoff-, Vitamin- und/oder Nährstoff- Formulierung nicht mehr mitgenommen werden kann.The blocking device must not reduce the flow of the transport liquid to such an extent that a solid, insoluble active substance, vitamin and / or nutrient formulation can no longer be taken along.
Der Trinkhalm kann starr oder flexibel, gerade, vorzugsweise reversibel abwinkelbar, oder gewinkelt sein.The drinking straw can be rigid or flexible, straight, preferably reversibly angled, or angled.
Der Trinkhalm besteht vorzugsweise aus einem synthetischen Material. Zumindest der ggf. vorhandene Bereich, in dem der Trinkhalm reversibel abwinkelbar ist, ist vorzugsweise aus einem elastischen, synthetischen Material oder einem bei einer Temperatur unterhalb seines Erweichungspunktes plastisch verformbaren, synthetischen Material aufgebaut. Der Bereich, in dem der Trinkhalm reversibel abwinkelbar ist, ist vorzugsweise ziehharmonika-artig gestaltet.The drinking straw is preferably made of a synthetic material. At least the possibly existing area in which the drinking straw can be reversibly bent is preferably made of an elastic, synthetic material or a synthetic material that is plastically deformable at a temperature below its softening point. The area in which the drinking straw can be reversibly angled is preferably designed like an accordion.
Der Trinkhalminnendurchmesser sollte vorzugsweise mindestens 3 mm betragen, so daß eine ausreichende Transportflüssigkeitsmenge durch den Trinkhalm gesaugt werden kann, um die Formulierung zu transportieren. Bevorzugt ist ein Innendurchmesser von 4-15 mm, ganz besonders bevorzugt von 5-10 mm.The inside diameter of the drinking straw should preferably be at least 3 mm so that a sufficient amount of transport liquid can be sucked through the drinking straw to transport the formulation. An inner diameter of 4-15 mm is preferred, very particularly preferably 5-10 mm.
Der Trinkhalm hat vorzugsweise einen runden, ovalen, rechteckigen oder quadratischen Querschnitt und weist vorzugsweise eine glatte Innenseite auf.The drinking straw preferably has a round, oval, rectangular or square cross section and preferably has a smooth inside.
Die Trinkhalmöffnung, die der Formulierung zugewandt ist, ist vorzugsweise als Mundstück ausgebildet, besonders bevorzugt geriffelt, während die Trinkhalmöffnung, die der Sperrvorrichtung zugewandt ist, vorzugsweise als Verbindungsstück zu einem Reservoir der Transportflüssigkeit ausgebildet ist. Der Trinkhalm weist vorzugsweise eine Markierung zur Kennzeichnung des Mundteils und/oder zur Angabe der Saugrichtung der Transportflüssigkeit auf. Durch diese Kennzeichnung wird die Handhabung erleichtert.The drinking straw opening facing the formulation is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening facing the locking device is preferably designed as a connection piece to a reservoir of the transport liquid. The drinking straw preferably has a marking to identify the mouth part and / or to indicate the direction of suction of the transport liquid. This marking makes handling easier.
Zumindest der die Formulierung enthaltende Teil des Trinkhalms ist transparent und/oder gefärbt. Bei Verwendung eines transparenten Trinkhalms kann die Aufnahme der Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung beobachtet werden, während die Verwendung eines opak gefärbten Trinkhalms die Möglichkeit bietet, die Verabreichung einer Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung zu verdecken.At least the part of the drinking straw containing the formulation is transparent and / or colored. When using a transparent drinking straw, the absorption of the active ingredient, vitamin and / or nutrient formulation can be observed, while the use of an opaque colored drinking straw offers the possibility of masking the administration of an active ingredient, vitamin and / or nutrient formulation ,
Ein weiterer Gegenstand der Erfindung ist auch ein Kit aus der erfindungsgemäßen Darreichungsform und einer physiologisch unbedenklichen, gegebenenfalls Wirkstoff-, nährstoff- und/oder vitaminhaltigen Transportflüssigkeit. Als Transportflüssigkeit eignet sich vorzugsweise eine wäßrige Flüssigkeit, wobei Wasser, Limonade, Fruchtsaft ohne Fruchtfleisch, Tee oder Kaffee besonders bevorzugt sind.Another object of the invention is also a kit comprising the dosage form according to the invention and a physiologically harmless, optionally active substance, nutrient and / or vitamin-containing transport liquid. An aqueous liquid is preferably suitable as the transport liquid, water, lemonade, fruit juice without pulp, tea or coffee being particularly preferred.
Ein weiterer Gegenstand der Erfindung ist ein Verfahren zur Herstellung der Darreichungsform, in dem die Sperrvorrichtung in den Trinkhalm eingeführt, die Formulierung in den Trinkhalm durch die eine Trinkhalmöffnung eingebracht und die der Formulierung zugewandte Trinkhalmöffnung mit der Verschlußvorrichtung versehen wird.Another object of the invention is a method for producing the dosage form, in which the blocking device is inserted into the drinking straw, the formulation is introduced into the drinking straw through the one drinking straw opening, and the drinking straw opening facing the formulation is provided with the closure device.
Die folgenden Figuren zeigen beispielhafte Ausführungsformen der erfindungsgemäßen Darreichungsformen. Dadurch wird der Erfindungsgedanken in keiner Weise eingeschränkt.The following figures show exemplary embodiments of the dosage forms according to the invention. This in no way limits the idea of the invention.
Die Figuren 1a, 1b und 1c zeigen eine erfindungsgemäße Darreichungsform mit einer abgenommenen Kappe mit durchstoßbarem Boden (a), einer aufgesetzten Kappe mit durchstoßbarem Boden (b) und einer Kappe mit durchstoßenem Boden (c) in der Seitenansicht.Figures 1a, 1b and 1c show a dosage form according to the invention with a removed cap with a bottom that can be pierced (a), a cap with a bottom that can be pierced (b) and a cap with a bottom that is pierced (c) in a side view.
Die Figuren 2a, 2b und 2c zeigen eine weitere erfindungsgemäße Darreichungsform mit einer abgenommenen Kappe mit durchstoßbarem Boden (a), einer aufgesetzten Kappe mit durchstoßbarem Boden (b) und einer Kappe mit durchstoßenem Boden (c) in der Seitenansicht.FIGS. 2a, 2b and 2c show a further dosage form according to the invention with a removed cap with a pierceable base (a), a cap with a pierceable base (b) and a cap with a pierced base (c) in a side view.
Die in den Figuren 1a, 1b und 1c gezeigte Darreichungsform umfaßt einen Trinkhalm (1), der zwei Öffnungen (6, 7) hat und einen in dem Trinkhalm fixierten Pfropfen als Sperrvorrichtung (2), eine Kappe mit einem durchstoßbaren Boden (5) als Verschlußvorrichtung (3) und eine sich zwischen Sperrvorrichtung und Verschlußvorrichtung im Trinkhalm befindende Formulierung (4) enthält.The dosage form shown in Figures 1a, 1b and 1c comprises a drinking straw (1) which has two openings (6, 7) and a plug fixed in the drinking straw as a locking device (2), a cap with a pierceable bottom (5) as Closure device (3) and a formulation (4) located between the blocking device and the closure device in the drinking straw.
Der Trinkhalm (1) hat einen runden Querschnitt und ist gerade.The drinking straw (1) has a round cross section and is straight.
Der als Sperrvorrichtung dienende Pfropfen (2) besteht aus Filtermaterial und ist für Luft und die Transportflüssigkeit durchlässig, für die Formulierung jedoch undurchlässig. Der Pfropfen ist zylinderförmig und hat einen runden Querschnitt, wobei der Durchmesser des Pfropfens dem Innendurchmesser des Trinkhalms angepaßt ist. Der Pfropfen ist in den Trinkhalm permanent fixiert.The plug (2) serving as a blocking device consists of filter material and is permeable to air and the transport liquid, but impermeable to the formulation. The plug is cylindrical and has a round cross-section, wherein the diameter of the plug is adapted to the inside diameter of the drinking straw. The plug is permanently fixed in the drinking straw.
Die Formulierung (4) liegt in Form von kugelförmigen Partikeln vor.The formulation (4) is in the form of spherical particles.
Die als Verschlußvorrichtung dienende Kappe (3) ist für die Formulierung undurchlässig. Der Innendurchmesser der Kappe (3) ist dem Außendurchmesser des Trinkhalms (1) angepaßt, so daß die Kappe auf den Trinkhalm gesetzt werden kann. Vor der Benutzung des Trinkhalms (1) wird der Boden (5) der Kappe (3) mit Hilfe des Trinkhalms (1) durchstoßen. Die Kappe (3) mit dem zerstörten Boden (5) wird über den Trinkhalm gezogen.The cap (3) serving as a closure device is impermeable to the formulation. The inside diameter of the cap (3) is adapted to the outside diameter of the drinking straw (1) so that the cap can be placed on the drinking straw. Before using the drinking straw (1), the bottom (5) of the cap (3) is pierced with the help of the drinking straw (1). The cap (3) with the destroyed base (5) is pulled over the drinking straw.
Die in den Figuren 2a, 2b und 2c gezeigte Darreichungsform entspricht im wesentlichen der in den Figuren 1a, 1b und 1c gezeigten Darreichungsform. Anstelle eines fixierten Pfropfens wird jedoch ein durch die Transportflüssigkeit zwischen zwei Anschlägen (8, 9) bewegbarer Pfropfen als Sperrvorrichtung (2) verwendet.The dosage form shown in FIGS. 2a, 2b and 2c essentially corresponds to the dosage form shown in FIGS. 1a, 1b and 1c. Instead of a fixed stopper, however, a stopper (2) that can be moved by the transport liquid between two stops (8, 9) is used as a blocking device (2).
Der Durchmesser der größten Formuüerungspartikel ist kleiner als der Trinkhalminnendurchmesser an der Stelle des Anschlags (8), so daß die Formulierungspartikel diese Stelle passieren können. The diameter of the largest shaping particles is smaller than the inner diameter of the drinking straw at the location of the stop (8), so that the formulation particles can pass this location.

Claims

Patentansprüche claims
1. Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm (1), der zwei Öffnungen (6, 7) hat und eine für eine Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung undurchlässige, für Luft und eine Transportflüssigkeit jedoch durchlässige Sperrvorrichtung (2), eine für die Wirkstoff-, Vitamin- und/oder Nährstoff- Formulierung undurchlässige Verschlußvorrichtung (3) und die sich zwischen Sperrvorrichtung und Verschlußvorrichtung im Trinkhalm befindende Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) enthält, dadurch gekennzeichnet, daß als Verschlußvorrichtung eine die der Formulierung zugewandten Trinkhalmöffnung (6) verschließenden Kappe (3) mit einem durchstoßbaren Boden (5) aus einer Aluminium-Folie oder einem Aluminium- Kunststoff-Folienlaminat, einer ein- oder mehrschichtigen Kunststoff-Folie oder Cellulose-Folie aufweist oder mit einem stoßfesten, zumindest teilweise über eine Schwächungslinie verbundene, durch Stoß entfernbaren Boden (5) aus Kunststoff oder Metall, vorzugsweise Aluminium ausgerüstet ist.1. Dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw (1) which has two openings (6, 7) and one impermeable to an active ingredient, vitamin and / or nutrient formulation, for air and a transport liquid permeable barrier device (2), a closure device (3) impermeable to the active ingredient, vitamin and / or nutrient formulation and the active ingredient, vitamin and / or nutrient formulation located between the barrier device and the closure device in the drinking straw ( 4), characterized in that as a closure device a the straw facing the formulation opening (6) closing cap (3) with a penetrable bottom (5) made of an aluminum foil or an aluminum-plastic foil laminate, a single or multi-layer plastic Film or cellulose film or with a shockproof, at least partially over a weakening Line-connected, removable by impact bottom (5) made of plastic or metal, preferably aluminum.
2. Darreichungsform gemäß Anspruch 1 , dadurch gekennzeichnet, daß zumindest ein Trinkhalmende mit einer abnehmbaren Schutzkappe versehen ist, deren nicht durch Stoß entfernbarer Boden aus einem stoßfesten Material besteht.2. Dosage form according to claim 1, characterized in that at least one drinking straw end is provided with a removable protective cap, the bottom of which cannot be removed by impact, consists of an impact-resistant material.
3. Darreichungsform gemäß Anspruch 1 oder 2, dadurch gekennzeichnet, daß die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) fest ist.3. Dosage form according to claim 1 or 2, characterized in that the active ingredient, vitamin and / or nutrient formulation (4) is solid.
4. Darreichungsform gemäß Ansprüche 1 oder 2, dadurch gekennzeichnet, daß die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) pastös ist.4. Dosage form according to claims 1 or 2, characterized in that the active ingredient, vitamin and / or nutrient formulation (4) is pasty.
5. Darreichungsform gemäß einem der Ansprüche 1-4, dadurch gekennzeichnet, daß die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) multipartikulär vorliegt. 5. Dosage form according to one of claims 1-4, characterized in that the active ingredient, vitamin and / or nutrient formulation (4) is multiparticulate.
6. Darreichungsform gemäß einem der Ansprüche 1-5, dadurch gekennzeichnet, daß die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) in der Transportflüssigkeit unlöslich ist.6. Dosage form according to one of claims 1-5, characterized in that the active ingredient, vitamin and / or nutrient formulation (4) is insoluble in the transport liquid.
7. Darreichungsform gemäß einem der Ansprüche 1-5, dadurch gekennzeichnet, daß die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung (4) in der Transportflüssigkeit zumindest teilweise löslich ist.7. Dosage form according to one of claims 1-5, characterized in that the active ingredient, vitamin and / or nutrient formulation (4) is at least partially soluble in the transport liquid.
8. Darreichungsform gemäß einem der Ansprüche 1-7, dadurch gekennzeichnet, daß die Sperrvorrichtung (2) ein Pfropfen ist.8. Dosage form according to one of claims 1-7, characterized in that the locking device (2) is a plug.
9. Darreichungsform gemäß Anspruch 8, dadurch gekennzeichnet, daß der Pfropfen (2) durch die Transportflüssigkeit zwischen zwei Anschlägen (8, 9) bewegbar ist.9. Dosage form according to claim 8, characterized in that the plug (2) is movable by the transport liquid between two stops (8, 9).
10. Darreichungsform gemäß Anspruch 8, dadurch gekennzeichnet, daß der Pfropfen (2) fixiert ist.10. Dosage form according to claim 8, characterized in that the plug (2) is fixed.
11. Darreichungsform gemäß einem der Ansprüche 1-7, dadurch gekennzeichnet, daß die Sperrvorrichtung (2) eine im Trinkhalm fixierte Membran ist.11. Dosage form according to one of claims 1-7, characterized in that the locking device (2) is a membrane fixed in the drinking straw.
12. Darreichungsform gemäß Anspruch 5, dadurch gekennzeichnet, daß die Sperrvorrichtung (2) ein im Trinkhalm fixiertes Gitter ist, dessen Maschendurchmesser kleiner ist als der kleinste Durchmesser der Formulierungspartikel (4).12. Dosage form according to claim 5, characterized in that the blocking device (2) is a grid fixed in the drinking straw, the mesh diameter of which is smaller than the smallest diameter of the formulation particles (4).
13. Darreichungsform gemäß Anspruch 5, dadurch gekennzeichnet, daß die Sperrvorrichtung (2) aus einer Verengung des Trinkhalms besteht, wodurch der Querschnitt des Trinkhalms enger ist als der kleinste Durchmesser der Formulierungspartikel (4).13. Dosage form according to claim 5, characterized in that the locking device (2) consists of a constriction of the drinking straw, whereby the cross section of the drinking straw is narrower than the smallest diameter of the formulation particles (4).
14. Darreichungsform gemäß einem der Ansprüche 1 -13, dadurch gekennzeichnet, daß der Trinkhalm (1) starr oder flexibel, gerade oder gewinkelt und/oder vorzugsweise reversibel abwinkelbar ist. 14. Dosage form according to one of claims 1-13, characterized in that the drinking straw (1) is rigid or flexible, straight or angled and / or preferably reversibly angled.
15. Kit aus der Darreichungsform gemäß einem der Ansprüche 1-14 und einer physiologisch unbedenklichen, gegebenenfalls Wirkstoff-, nährstoff- und/oder vitaminhaltigen Transportflüssigkeit.15. Kit from the dosage form according to any one of claims 1-14 and a physiologically acceptable, optionally active substance, nutrient and / or vitamin-containing transport liquid.
16. Kit gemäß Anspruch 15, dadurch gekennzeichnet, daß die Transportflüssigkeit eine wäßrige Flüssigkeit ist.16. Kit according to claim 15, characterized in that the transport liquid is an aqueous liquid.
17. Kit gemäß Anspruch 15 oder 16, dadurch gekennzeichnet, daß die Transportflüssigkeit Wasser, Limonade, Fruchtsaft ohne Fruchtfleisch, Tee oder Kaffee ist.17. Kit according to claim 15 or 16, characterized in that the transport liquid is water, lemonade, fruit juice without pulp, tea or coffee.
18. Verfahren zur Herstellung einer Darreichungsform gemäß einem der Ansprüche 1-14, dadurch gekennzeichnet, daß die Sperrvorrichtung (2) in den Trinkhalm (1) eingeführt, die Formulierung (4) durch die eine Trinkhalmöffnung (6) in den Trinkhalm (1) eingebracht und diese Trinkhalmöffnung (6) mit der Verschlußvorrichtung (3) versehen wird.18. A method for producing a dosage form according to any one of claims 1-14, characterized in that the locking device (2) is inserted into the drinking straw (1), the formulation (4) through a drinking straw opening (6) into the drinking straw (1) introduced and this drinking straw opening (6) is provided with the closure device (3).
19. Verfahren zur Herstellung einer Darreichungsform gemäß einem der Ansprüche 1-14, dadurch gekennzeichnet, daß die eine Trinkhalmöffnung (6) mit der Verschlußvorrichtung (3) versehen wird und die Formulierung (4) und die Sperrvorrichtung (2) durch die Trinkhalmöffnung (10) in den Trinkhalm (1) eingeführt werden.19. A method for producing a dosage form according to any one of claims 1-14, characterized in that the one straw opening (6) is provided with the closure device (3) and the formulation (4) and the blocking device (2) through the straw opening (10 ) into the drinking straw (1).
20. Verfahren zur Herstellung einer Darreichungsform gemäß Anspruch 18 oder 19, dadurch gekennzeichnet, daß zumindest ein Trinkhalmende mit einer abnehmbaren Schutzkappe mit einem Boden aus stoßfestem Material versehen wird. 20. A method for producing a dosage form according to claim 18 or 19, characterized in that at least one end of the straw is provided with a removable protective cap with a bottom made of shockproof material.
PCT/EP2003/006533 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients WO2004000080A1 (en)

Priority Applications (4)

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AU2003237964A AU2003237964A1 (en) 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients
DE50308974T DE50308974D1 (en) 2002-06-24 2003-06-20 PHARMACEUTICAL FORM FOR ORAL ADMINISTRATION OF AGENTS, VITAMINS AND / OR NUTRIENTS
EP03735654A EP1517628B1 (en) 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients
US11/021,643 US20050106187A1 (en) 2002-06-24 2004-12-23 Administration form for the oral administration of active substances, vitamins and/or nutrients

Applications Claiming Priority (2)

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DE10228176A DE10228176A1 (en) 2002-06-24 2002-06-24 Dosage form for oral administration of active ingredients, vitamins and / or nutrients
DE10228176.9 2002-06-24

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AT (1) ATE383097T1 (en)
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DE102005004257A1 (en) * 2005-01-28 2006-08-24 Grünenthal GmbH Process for making a drinking straw with controller

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CN111407663A (en) 2019-01-07 2020-07-14 上海汉都医药科技有限公司 Oral administration delivery device

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DE10228176A1 (en) 2004-01-22
ATE383097T1 (en) 2008-01-15
DE50308974D1 (en) 2008-02-21
AU2003237964A1 (en) 2004-01-06
EP1517628A1 (en) 2005-03-30
ES2299708T3 (en) 2008-06-01

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