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EP1517628B1 - 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
EP1517628B1
EP1517628B1 EP03735654A EP03735654A EP1517628B1 EP 1517628 B1 EP1517628 B1 EP 1517628B1 EP 03735654 A EP03735654 A EP 03735654A EP 03735654 A EP03735654 A EP 03735654A EP 1517628 B1 EP1517628 B1 EP 1517628B1
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EP
European Patent Office
Prior art keywords
drinking straw
dosage form
form according
formulation
vitamin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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EP03735654A
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German (de)
French (fr)
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EP1517628A1 (en
Inventor
Rasoul Sedaghat Kerdar
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Gruenenthal GmbH
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Gruenenthal GmbH
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Publication of EP1517628A1 publication Critical patent/EP1517628A1/en
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    • 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 shock-resistant, embedded via a line of weakness, removable by shock plastic or metal bottom as closure device, a kit of the dosage form and a transport liquid and a method for producing the dosage form.
  • the drinking straws for oral administration of active ingredients, vitamins and / or nutrients described in the prior art have stoppers or caps as closure device for restraining the active ingredient, vitamin and / or nutrient formulation present in the drinking straw.
  • the plugs or caps must be removed from the drinking straw before using the drinking straw. During the removal of these known closure devices there is a risk of spillage of the active ingredient, vitamin and / or nutrient formulation.
  • a dosage form for oral administration of drugs, vitamins and / or nutrients comprising a drinking straw having two openings and a barrier device permeable to an active ingredient, vitamin and / or nutrient formulation but permeable to air and a transport liquid, a closure device impermeable to the active substance, vitamin and / or nutrient formulation and the between the locking device and closure device arranged in the drinking straw containing active ingredient, vitamin and / or nutrient formulation, characterized in that the closing device is a closing the formulation facing drinking straw opening cap, the total of the same material, plastic or metal, preferably aluminum , Is manufactured and their otherwise shock-resistant floor over the entire outer circumference has a line of weakness and is thus removed by shock, solved.
  • the cap is generally made of the same material, plastic or metal, such as aluminum, optionally laminated for reinforcement, the bottom of which has a line of weakness over its entire outer circumference. This makes it possible to remove the otherwise impact-resistant soil by impact.
  • the active ingredient, vitamin and / or nutrient formulation is preferably solid or pasty. Preference is given to a multiparticulate active ingredient, vitamin and / or nutrient formulation, wherein the particles of the multiparticulate formulation preferably have 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 may 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 fluid flowing past and taken in dissolved form.
  • the active ingredients, vitamins or nutrients or their formulations are insoluble in the transport fluid, they are suspended in the transport fluid flowing past and taken in suspended form with the transport fluid.
  • multiparticulate formulations are used for this purpose.
  • 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 optionally be achieved by a suitable surface treatment of the particles.
  • active ingredients preferably therapeutic agents, vitamins and nutrients, all orally administrable substances can be used in the form of a suitable formulation.
  • the drinking straw preferably contains a precisely determined dose of these substances.
  • the locking device is preferably designed as a plug whose cross section is preferably adapted to the cross section of the drinking straw.
  • the loosely present plug can also have a larger cross section, provided that this plug can be compressed to a cross section corresponding to the inner cross section of the drinking straw.
  • the locking device may be permanently fixed or movably mounted in the drinking straw.
  • the plug can be permanently fixed on the one hand in the drinking straw by the plug, for example, fixed by constrictions of the drinking straw or by the plug is glued into the drinking straw.
  • the plug is fixed by constrictions of the drinking straw.
  • the plug can also be moved by the transport liquid between two stops.
  • the constrictions are designed so that the plug, but not the transport liquid insoluble in the formulation particles are retained by it.
  • the plug preferably consists of filter material, more preferably of nonwoven material or pressed fiber material.
  • a blocking device is a membrane fixed in the drinking straw, wherein the cross section of the membrane is preferably adapted to the cross section of the drinking straw and the membrane is preferably glued into the drinking straw.
  • the membrane is preferably made of synthetic material.
  • a blocking device is a grid fixed in the drinking straw whose mesh diameter is smaller than the diameter of the smallest formulation particle.
  • the cross section of the grid is preferably adapted to the cross section of the drinking straw and the grid preferably fixed by constrictions of the drinking straw in the drinking straw or glued into the drinking straw.
  • the grid is preferably made of synthetic material.
  • a blocking device is a constriction of the drinking straw, which is designed so that even the smallest formulation paticles are retained by it.
  • the flow of the transport liquid must not be reduced so much that a solid, insoluble active ingredient, vitamin and / or nutrient formulation can no longer be taken.
  • the drinking straw may 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 is reversibly angled, is preferably composed of an elastic, synthetic material or a plastically deformable at a temperature below its softening point, synthetic material. The area in which the drinking straw is reversibly angled, is preferably designed accordion-like.
  • the drinking straw inside diameter should preferably be at least 3 mm, so that a sufficient amount of transport liquid can be sucked through the drinking straw in order to transport the formulation.
  • Preferred is an inner diameter of 4-15 mm, most preferably 5-10 mm.
  • the drinking straw preferably has a round, oval, rectangular or square cross-section and preferably has a smooth inner side.
  • the drinking straw opening which faces the formulation, is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening, which faces the blocking device, is preferably designed as a connecting piece to a reservoir of the transporting liquid.
  • the drinking straw preferably has a marking for identifying the mouth part and / or for specifying the suction direction of the transport liquid. This marking facilitates handling.
  • At least the portion of the drinking straw containing the formulation is transparent and / or colored.
  • the uptake of the active ingredient, vitamin and / or nutrient formulation can be observed while the use of an opaque colored drinking straw offers the opportunity to obscure the administration of a drug, vitamin and / or nutrient formulation ,
  • Another object of the invention is also a kit of the dosage form according to the invention and a physiologically acceptable, optionally varkstoff-, nutrient and / or vitamin-containing transport liquid.
  • transport liquid is preferably an aqueous liquid
  • water, lemonade, fruit juice without pulp, tea or coffee are particularly preferred.
  • Another object of the invention is a method for producing the dosage form, in which the locking device introduced into the drinking straw, introduced the formulation in the drinking straw through a drinking straw and the formulation facing the drinking straw opening is provided with the closure device.
  • Figures 1a, 1 b and 1c show a dosage form according to the invention with a removable cap with pierceable bottom (a), an attached cap with pierceable bottom (b) and a cap pierced bottom (c) in side view.
  • Figures 2a, 2b and 2c show a further dosage form according to the invention with a removed cap with pierceable bottom (a), an attached cap with pierceable bottom (b) and a cap pierced bottom (c) in side view.
  • the dosage form shown in Figures 1 a, 1 b and 1 c comprises a drinking straw (1) having two openings (6, 7) and a fixed in the drinking straw plug as a locking device (2), a cap with a pierceable bottom ( 5) as a closure device (3) and located between locking device and closure device in the drinking straw formulation (4).
  • the drinking straw (1) has a round cross-section and is straight.
  • the serving as a locking device plug (2) consists of filter material and is permeable to air and the transport liquid, for the formulation, however, impermeable.
  • the plug is cylindrical and has a round cross section, wherein the diameter of the plug is adapted to the inner diameter of the drinking straw.
  • the plug is permanently fixed in the drinking straw.
  • Formulation (4) is in the form of spherical particles.
  • the serving as a closure device cap (3) is impermeable to the formulation.
  • the inner diameter of the cap (3) is adapted to the outer 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 by means of the drinking straw (1).
  • the cap (3) with the destroyed bottom (5) is pulled over the drinking straw.
  • the dosage form shown in FIGS. 2 a, 2 b and 2 c essentially corresponds to the administration form shown in FIGS. 1 a, 1 b and 1 c.
  • a plug which can be moved by the transport liquid between two stops (8, 9) is used as the blocking device (2).
  • the diameter of the largest formulation 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 through this site.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

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

Die Erfindung betrifft eine Darreichungsform zur oralen Verabreichung von . Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm mit einer Kappe mit einem stoßfesten, über eine Schwächungslinie eingelassenen, durch Stoß entfernbaren Boden aus Kunststoff oder Metall 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 shock-resistant, embedded via a line of weakness, removable by shock plastic or metal bottom as 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 ingredients, vitamins and / or nutrients by means of a drinking straw containing a fluid-transportable active ingredient, vitamin and / or nutrient formulation is known. Patients who have difficulty or a disinclination to take capsules or tablets, this is another form of active ingredients, vitamins or nutrients offered.

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 for oral administration of active ingredients, vitamins and / or nutrients described in the prior art have stoppers or caps as closure device for restraining the active ingredient, vitamin and / or nutrient formulation present in the drinking straw. The plugs or caps must be removed from the drinking straw before using the drinking straw. During the removal of these known closure devices there is a risk of spillage of the active ingredient, vitamin and / or nutrient formulation.

Sofern in dem US-Patent US-A-6,096,003 mehrteilige Verschlusskappen als Verschlussvorrichtung offenbart sind, besteht aufgrund ihrer Konstruktion die Gefahr, dass sich Teile mit der Wirkstoff-Formulierung bei der Einnahme durch den Patienten mischen, was unter allen Umständen zu vermeiden ist.If in the U.S. Patent US-A-6,096,003 is disclosed as a closure device, there is the risk that mix parts with the drug formulation when taken by the patient, which is to be avoided under all circumstances.

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 task of a dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with provide a closure device is available, which is as simple to produce 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 vorliegt, die insgesamt aus demselben Material, Kunststoff oder Metall, vorzugsweise Aluminium, gefertigt ist und deren sonst stoßfester Boden über den gesamten äußeren Umfang eine Schwächungslinie aufweist und dadurch durch Stoß entfernbar ist, gelöst.The object is achieved by providing a dosage form for oral administration of drugs, vitamins and / or nutrients comprising a drinking straw having two openings and a barrier device permeable to an active ingredient, vitamin and / or nutrient formulation but permeable to air and a transport liquid, a closure device impermeable to the active substance, vitamin and / or nutrient formulation and the between the locking device and closure device arranged in the drinking straw containing active ingredient, vitamin and / or nutrient formulation, characterized in that the closing device is a closing the formulation facing drinking straw opening cap, the total of the same material, plastic or metal, preferably aluminum , Is manufactured and their otherwise shock-resistant floor over the entire outer circumference has a line of weakness and is thus removed by shock, solved.

Die Verschlußkappe ist insgesamt aus demselben Material, Kunststoff oder Metall, wie Aluminium ggf. zur Verstärkung laminiert, gefertigt, deren Boden über dem gesamten äußeren Umfang eine Schwächungslinie aufweist. Dadurch gelingt es, den sonst stoßfesten Boden durch Stoß zu entfernen.The cap is generally made of the same material, plastic or metal, such as aluminum, optionally laminated for reinforcement, the bottom of which has a line of weakness over its entire outer circumference. This makes it possible to remove the otherwise impact-resistant soil 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.The active ingredient, vitamin and / or nutrient formulation is preferably solid or pasty. Preference is given to a multiparticulate active ingredient, vitamin and / or nutrient formulation, wherein the particles of the multiparticulate formulation preferably have a diameter of 50-1500 μm.

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 ingredients, vitamins and / or nutrients alone or the active ingredient, vitamin and / or nutrient formulations as a whole may 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 fluid flowing past and taken in dissolved form. On the other hand, if the active ingredients, vitamins or nutrients or their formulations are insoluble in the transport fluid, they are suspended in the transport fluid flowing past and taken in suspended form with the transport fluid. Preferably, multiparticulate formulations are used for this purpose. 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 optionally be achieved by a 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 agents, vitamins and nutrients, all orally administrable substances can be used in the form of a suitable formulation. The drinking straw preferably contains a precisely determined 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 whose cross section is preferably adapted to the cross section of the drinking straw. However, the loosely present plug can also have a larger cross section, provided that this plug can be compressed 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.The locking device may be permanently fixed or movably mounted in the drinking straw. Thus, the plug can be permanently fixed on the one hand in the drinking straw by the plug, for example, fixed by constrictions of the drinking straw or by the plug is glued into the drinking straw. Preferably, the plug is fixed by constrictions of the drinking straw.

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.On the other hand, the plug can also be moved by the transport liquid between two stops. By the stops of the straw is narrowed, the constrictions are designed so that the plug, but not the transport liquid insoluble in the formulation particles are retained by it.

Der Pfropfen besteht vorzugsweise aus Filtermaterial, besonders bevorzugt aus Vliesmaterial oder verpreßtem Fasermaterial.The plug preferably consists of filter material, more preferably of nonwoven 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.Also preferred as a blocking device is a membrane fixed in the drinking straw, wherein the cross section of the membrane is preferably adapted to the cross section of the drinking straw and the membrane is preferably 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 whose mesh diameter is smaller than the diameter of the smallest formulation particle. The cross section of the grid is preferably adapted to the cross section of the drinking straw and the grid preferably fixed by constrictions of the drinking straw in 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.Also suitable as a blocking device is a constriction of the drinking straw, which is designed so that even the smallest formulation paticles are retained by it.

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.By the blocking device, the flow of the transport liquid must not be reduced so much that a solid, insoluble active ingredient, vitamin and / or nutrient formulation can no longer be taken.

Der Trinkhalm kann starr oder flexibel, gerade, vorzugsweise reversibel abwinkelbar, oder gewinkelt sein.The drinking straw may 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 is reversibly angled, is preferably composed of an elastic, synthetic material or a plastically deformable at a temperature below its softening point, synthetic material. The area in which the drinking straw is reversibly angled, is preferably designed accordion-like.

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 drinking straw inside diameter should preferably be at least 3 mm, so that a sufficient amount of transport liquid can be sucked through the drinking straw in order to transport the formulation. Preferred is an inner diameter of 4-15 mm, most 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 inner side.

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, which faces the formulation, is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening, which faces the blocking device, is preferably designed as a connecting piece to a reservoir of the transporting liquid. The drinking straw preferably has a marking for identifying the mouth part and / or for specifying the suction direction of the transport liquid. This marking facilitates handling.

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 portion of the drinking straw containing the formulation is transparent and / or colored. When using a transparent drinking straw, the uptake of the active ingredient, vitamin and / or nutrient formulation can be observed while the use of an opaque colored drinking straw offers the opportunity to obscure the administration of a drug, vitamin and / or nutrient formulation ,

Ein weiterer Gegenstand der Erfindung ist auch ein Kit aus der erfindungsgemäßen Darreichungsform und einer physiologisch unbedenklichen, gegebenenfalls varkstoff-, nährstoff und/oder vitaminhaltigen Transportflüssigkeit.Another object of the invention is also a kit of the dosage form according to the invention and a physiologically acceptable, optionally varkstoff-, nutrient and / or vitamin-containing transport liquid.

Als Transportflüssigkeit eignet sich vorzugsweise eine wäßrige Flüssigkeit, wobei Wasser, Limonade, Fruchtsaft ohne Fruchtfleisch, Tee oder Kaffee besonders bevorzugt sind.As transport liquid is preferably an aqueous liquid, water, lemonade, fruit juice without pulp, tea or coffee are 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 locking device introduced into the drinking straw, introduced the formulation in the drinking straw through a drinking straw and the formulation facing the drinking straw opening 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. As a result, the idea of the invention is in no way limited.

Die Figuren 1a, 1 b 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.
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.Figures 1a, 1 b and 1c show a dosage form according to the invention with a removable cap with pierceable bottom (a), an attached cap with pierceable bottom (b) and a cap pierced bottom (c) in side view.
Figures 2a, 2b and 2c show a further dosage form according to the invention with a removed cap with pierceable bottom (a), an attached cap with pierceable bottom (b) and a cap pierced bottom (c) in side view.

Die In den Figuren 1 a, 1 b und 1 c 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 1 a, 1 b and 1 c comprises a drinking straw (1) having two openings (6, 7) and a fixed in the drinking straw plug as a locking device (2), a cap with a pierceable bottom ( 5) as a closure device (3) and located between locking device and closure device in the drinking straw formulation (4).

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 serving as a locking device plug (2) consists of filter material and is permeable to air and the transport liquid, for the formulation, however, impermeable. The plug is cylindrical and has a round cross section, wherein the diameter of the plug is adapted to the inner diameter of the drinking straw. The plug is permanently fixed in the drinking straw.

Die Formulierung (4) liegt in Form von kugelförmigen Partikeln vor.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 serving as a closure device cap (3) is impermeable to the formulation. The inner diameter of the cap (3) is adapted to the outer 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 by means of the drinking straw (1). The cap (3) with the destroyed bottom (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. 2 a, 2 b and 2 c essentially corresponds to the administration form shown in FIGS. 1 a, 1 b and 1 c. Instead of a fixed plug, however, a plug which can be moved by the transport liquid between two stops (8, 9) is used as the blocking device (2).

Der Durchmesser der größten Formulierungspartikel ist kleiner als der Trinkhalminnendurchmesser an der Stelle des Anschlags (8), so daß die Formulierungspartikel diese Stelle passieren können.The diameter of the largest formulation 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 through this site.

Claims (18)

  1. A dosage form for the oral administration of active ingredients, vitamins and/or nutrients comprising a drinking straw (1), which has two orifices (6, 7) and contains a barrier device (2) which is impermeable to an active ingredient, vitamin and/or nutrient formulation, but is permeable to air and a conveying liquid, a closing device (3) which is impermeable to the active ingredient, vitamin and/or nutrient formulation, and the active ingredient, vitamin and/or nutrient formulation (4) arranged in the drinking straw between the barrier device and the closing device, characterised in that a cap (3) which closes the drinking straw orifice (6) facing the formulation is present as the closing device, which cap (3) is overall produced from the same material, plastics or metal, preferably aluminium, and the otherwise impact-resistant bottom of which comprises a weakening line around the entire outer periphery and may consequently be removed by impact.
  2. A dosage form according to claim 1, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is solid.
  3. A dosage form according to claim 1 or claim 2, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is pasty.
  4. A dosage form according to any one of claims 1-3, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is in multiparticulate form.
  5. A dosage form according to any one of claims 1-4, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is insoluble in the conveying liquid.
  6. A dosage form according to any one of claims 1-4, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is at least partially soluble in the conveying liquid.
  7. A dosage form according to any one of claims 1-6, characterised in that the barrier device (2) is a plug.
  8. A dosage form according to claim 7, characterised in that the plug (2) is movable by the conveying liquid between two limit stops (8, 9).
  9. A dosage form according to claim 7, characterised in that the plug (2) is fixed.
  10. A dosage form according to any one of claims 1-8, characterised in that the barrier device (2) is a membrane fixed in the drinking straw.
  11. A dosage form according to claim 4, characterised in that the barrier device (2) is a mesh fixed in the drinking straw, the mesh diameter of which is smaller than the smallest diameter of the formulation particles (4).
  12. A dosage form according to claim 4, characterised in that the barrier device (2) consists of a narrowing of the drinking straw, wherein the cross-section of the drinking straw is narrower than the smallest diameter of the formulation particles (4).
  13. A dosage form according to any one of claims 1-12, characterised in that the drinking straw (1) is rigid or flexible, straight or angled and/or preferably reversibly bendable.
  14. A kit comprising the dosage form according to any one of claims 1-13 and a physiologically unproblematic conveying liquid which optionally contains active ingredients, nutrients and/or vitamins.
  15. A kit according to claim 14, characterised in that the conveying liquid is an aqueous liquid.
  16. A kit according to claim 14 or claim 15, characterised in that the conveying liquid is water, lemonade, fruit juice without fruit pulp, tea or coffee.
  17. A process for the production of a dosage form according to any one of claims 1-13, characterised in that the barrier device (2) is inserted into the drinking straw (1), the formulation (4) is introduced into the drinking straw (1) through one drinking straw orifice (6) and this drinking straw orifice (6) is provided with the closing device (3).
  18. A process for the production of a dosage form according to any one of claims 1-13, characterised in that one drinking straw orifice (6) is provided with the closing device (3) and the formulation (4) and the barrier device (2) are introduced into the drinking straw (1) through the other drinking straw orifice (7).
EP03735654A 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients Expired - Lifetime EP1517628B1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10228176A DE10228176A1 (en) 2002-06-24 2002-06-24 Dosage form for oral administration of active ingredients, vitamins and / or nutrients
DE10228176 2002-06-24
PCT/EP2003/006533 WO2004000080A1 (en) 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients

Publications (2)

Publication Number Publication Date
EP1517628A1 EP1517628A1 (en) 2005-03-30
EP1517628B1 true EP1517628B1 (en) 2008-01-09

Family

ID=29761359

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03735654A Expired - Lifetime EP1517628B1 (en) 2002-06-24 2003-06-20 Administration form for the oral administration of active substances, vitamins, and/or nutrients

Country Status (6)

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EP (1) EP1517628B1 (en)
AT (1) ATE383097T1 (en)
AU (1) AU2003237964A1 (en)
DE (2) DE10228176A1 (en)
ES (1) ES2299708T3 (en)
WO (1) WO2004000080A1 (en)

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US12186272B2 (en) 2019-01-07 2025-01-07 Shanghai Wd Pharmaceutical Co., Ltd Oral drug delivery device

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DE102005004257A1 (en) * 2005-01-28 2006-08-24 Grünenthal GmbH Process for making a drinking straw with controller
DE102005004256A1 (en) * 2005-01-28 2006-08-10 Grünenthal GmbH Drinking straw with a stiffener

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US3824322A (en) * 1971-12-20 1974-07-16 J Fiorella Flavored stirrer for alcoholic beverages
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Publication number Priority date Publication date Assignee Title
US12186272B2 (en) 2019-01-07 2025-01-07 Shanghai Wd Pharmaceutical Co., Ltd Oral drug delivery device

Also Published As

Publication number Publication date
EP1517628A1 (en) 2005-03-30
DE10228176A1 (en) 2004-01-22
AU2003237964A1 (en) 2004-01-06
ES2299708T3 (en) 2008-06-01
ATE383097T1 (en) 2008-01-15
WO2004000080A1 (en) 2003-12-31
DE50308974D1 (en) 2008-02-21

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