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EP1490010B1 - Administration form for oral administration of active ingredients, vitamins and/or nutrients - Google Patents

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

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Publication number
EP1490010B1
EP1490010B1 EP03717238A EP03717238A EP1490010B1 EP 1490010 B1 EP1490010 B1 EP 1490010B1 EP 03717238 A EP03717238 A EP 03717238A EP 03717238 A EP03717238 A EP 03717238A EP 1490010 B1 EP1490010 B1 EP 1490010B1
Authority
EP
European Patent Office
Prior art keywords
drinking straw
formulation
administration according
bent
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
Application number
EP03717238A
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German (de)
French (fr)
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EP1490010A1 (en
Inventor
Rasoul Sedaghat Kerdar
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Gruenenthal GmbH
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Gruenenthal GmbH
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Publication date
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Publication of EP1490010A1 publication Critical patent/EP1490010A1/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 reversibly bendable between the formulation and a drinking straw opening part of the drinking straw as a closure device, whereby in an angled position leakage of the formulation from the drinking straw is prevented according to the
  • the preamble of claim 1 a kit of the dosage form and a transport liquid according to the preamble of claim 19 and a method for producing the dosage form according to the preamble of claim 22.
  • EP 0383503, US 5718681, US 4792333 and US6210713 disclose the administration of active ingredients, vitamins and / or nutrients by means of a drinking straw containing a liquid, active substance, vitamin and / or nutrient formulation transportable by a liquid. Patients who have difficulty or a disinclination to take capsules or tablets, this is another form of active ingredients, vitamins or nutrients offered.
  • 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 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 containing an impermeable to an active ingredient, vitamin and / or nutrient formulation, for air and a transport liquid permeable barrier device and one for the active ingredient, vitamin and / or nutrient formulation impermeable closure device, wherein a contained in the drinking straw active ingredient, vitamin and / or nutrient formulation is arranged between locking device and closure device, characterized in that the closure device from a reversible angled between the formulation and the formulation freely accessible for drinking straw opening part of the Drinking straw is, whereby leakage of the formulation is prevented from the drinking straw, solved.
  • This drinking straw opening is the opening from which the formulation is removed by means of the transport liquid, d. H. the opening on the side facing away from the locking device.
  • the bendable part of the drinking straw can be reversibly fixed in the angled position by means of a ring, a clamp, a collar or a tube.
  • 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. If the active ingredients, vitamins or nutrients or their formulations in the transport liquid, however, are insoluble, they are in the passing liquid transport suspended and taken in suspended form with the transport liquid. 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.
  • 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 a plug whose cross section is preferably adapted to the cross section of the drinking straw.
  • the plug may be fixed on the one hand in the drinking straw, wherein the plug is preferably fixed by constrictions of the drinking straw or glued into the drinking straw.
  • the plug can also be movable 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 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 is 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 particles 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 is flexible, at least in the area in which it is reversibly bendable.
  • the drinking straw is preferably made of a synthetic material. At least the region in which the straw is reversibly bendable, is preferably constructed of an elastic, synthetic material or a synthetic material plastically deformable at a temperature below its softening point.
  • the area in which the drinking straw is reversibly angled, is preferably designed accordion-like.
  • the drinking straw inner 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 is freely accessible for the formulation, is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening, which faces the blocking device, preferably as Connecting piece is formed to a reservoir of the transport 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 active substance, nutrient and / or vitamin-containing transport liquid.
  • the 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 introduced the locking device in the drinking straw, introduced the formulation through the a drinking straw opening in the drinking straw and the straw between the formulation and the freely accessible for the formulation drinking straw opening, d. H. the formulation facing drinking straw is angled.
  • Another object of the invention is a method for producing the dosage form, in which the drinking straw is angled and the formulation and the locking device are successively introduced through the accessible drinking straw opening in the drinking straw.
  • the dosage form shown in FIG. 1 comprises a drinking straw (1) which has two openings (6, 9) and a stopper fixed in the drinking straw as a blocking device (2), a reversibly bendable part as a closure device (3) and a between blocking device and Closure device contained in the drinking straw formulation (4).
  • the drinking straw (1) has a round cross-section and is straight.
  • the plug (2) 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 inner diameter of the drinking straw. The plug is glued into the drinking straw.
  • Formulation (4) is in the form of spherical particles.
  • the area (10) in which the drinking straw (1) is reversibly bendable, is accordion-like design.
  • the dosage form shown in FIG. 2 substantially corresponds to the dosage form shown in FIG. However, instead of a fixed plug, a between two stops (7, 8) movable plug used as a locking 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 (7) so that the formulation particles can pass through this site.
  • the dosage form shown in FIGS. 3 a to 3 d comprises a drinking straw (1) with a reversibly bendable part (3).
  • the angled position can be reversibly fixed by means of a tube (5) open on both sides.
  • the drinking straw (1) is introduced in an angled position into the tube (5).
  • the tube (5) is moved so far that the reversibly angled part (3) of the drinking straw (1) is exposed and the reversible bendable part (3) of the drinking straw (1) can be adjusted as desired.
  • the inner diameter of the tube (5) is matched to the space requirement of the drinking straw (1) in an angled position.
  • the length of the tube (5) is smaller than the length of the drinking straw (1) in an angled position.

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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)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Table Equipment (AREA)

Abstract

The invention relates to an administration form for oral administration of active ingredients, vitamins and/or nutrients, comprising a straw with a sealing device in the form of a straw part which can be bent in a reversible manner between the formulation and the opening of the straw providing free access to said formulation. When said part is bent, the formulation is prevented from exiting from said straw. The invention also relates to a kit consisting of the administration form and a transport liquid, and to a method for the production of said administration form.

Description

Die Erfindung betrifft eine Darreichungsform zur oralen Verabreichung von Wirkstoffen, Vitaminen und/oder Nährstoffen umfassend einen Trinkhalm mit einem zwischen der Formulierung und einer Trinkhalmöffnung reversibel abwinkelbaren Teil des Trinkhalms als Verschlussvorrichtung, wodurch in abgewinkelter Stellung ein Austreten der Formulierung aus dem Trinkhalm verhindert wird gemäß dem Oberbegriff des Anspruchs 1, ein Kit aus der Darreichungsform und einer Transportflüssigkeit gemäß dem Oberbegriff des Anspruchs 19 und ein Verfahren zur Herstellung der Darreichungsform gemäß dem Oberbegriff des Anspruchs 22.The invention relates to a dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with a reversibly bendable between the formulation and a drinking straw opening part of the drinking straw as a closure device, whereby in an angled position leakage of the formulation from the drinking straw is prevented according to the The preamble of claim 1, a kit of the dosage form and a transport liquid according to the preamble of claim 19 and a method for producing the dosage form according to the preamble of claim 22.

Aus EP 0383503, US 5718681, US 4792333 und US6210713 ist 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, bekannt. Patienten, die Schwierigkeiten haben oder eine Abneigung empfinden, Kapseln oder Tabletten einzunehmen, wird dadurch eine weitere Darreichungsform von Wirkstoffen, Vitaminen oder Nährstoffen angeboten.EP 0383503, US 5718681, US 4792333 and US6210713 disclose the administration of active ingredients, vitamins and / or nutrients by means of a drinking straw containing a liquid, active substance, vitamin and / or nutrient formulation transportable by a liquid. 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 entfernt 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 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.

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 an object to provide a dosage form for oral administration of active ingredients, vitamins and / or nutrients comprising a drinking straw with a closure device to provide the simplest to manufacture 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 der eine für eine Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung undurchlässige, für Luft und eine Transportflüssigkeit jedoch durchlässige Sperrvorrichtung enthält und eine für die Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung undurchlässige Verschlussvorrichtung aufweist, wobei eine im Trinkhalm befindliche Wirkstoff-, Vitamin- und/oder Nährstoff-Formulierung zwischen Sperrvorrichtung und Verschlussvorrichtung angeordnet ist, dadurch gekennzeichnet, dass die Verschlussvorrichtung aus einem zwischen der Formulierung und der für die Formulierung ungehindert zugänglichen Trinkhalmöffnung reversibel abgewinkelte Teil des Trinkhalms besteht, wodurch ein Austreten der Formulierung aus dem Trinkhalm verhindert wird, 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 containing an impermeable to an active ingredient, vitamin and / or nutrient formulation, for air and a transport liquid permeable barrier device and one for the active ingredient, vitamin and / or nutrient formulation impermeable closure device, wherein a contained in the drinking straw active ingredient, vitamin and / or nutrient formulation is arranged between locking device and closure device, characterized in that the closure device from a reversible angled between the formulation and the formulation freely accessible for drinking straw opening part of the Drinking straw is, whereby leakage of the formulation is prevented from the drinking straw, solved.

Diese Trinkhalmöffnung ist die Öffnung, aus der die Formulierung mit Hilfe der Transportflüssigkeit entnommen wird, d. h. die Öffnung auf der von der Sperrvorrichtung abgewandten Seite.This drinking straw opening is the opening from which the formulation is removed by means of the transport liquid, d. H. the opening on the side facing away from the locking device.

Der abwinkelbare Teil des Trinkhalms kann mit Hilfe eines Ringes, einer Schelle, einer Manschette oder eines Rohres in der abgewinkelten Stellung reversibel fixiert werden.The bendable part of the drinking straw can be reversibly fixed in the angled position by means of a ring, a clamp, a collar or a tube.

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. If the active ingredients, vitamins or nutrients or their formulations in the transport liquid, however, are insoluble, they are in the passing liquid transport suspended and taken in suspended form with the transport liquid. 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 ein Pfropfen, dessen Querschnitt vorzugsweise dem Querschnitt des Trinkhalms angepaßt ist.The locking device is preferably a plug whose cross section is preferably adapted to the cross section of the drinking straw.

Der Pfropfen kann einerseits im Trinkhalm fixiert sein, wobei der Pfropfen vorzugsweise durch Verengungen des Trinkhalms fixiert oder in den Trinkhalm eingeklebt ist.The plug may be fixed on the one hand in the drinking straw, wherein the plug is preferably fixed by constrictions of the drinking straw or glued into the drinking straw.

Der Pfropfen kann andererseits auch 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 movable 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 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 is 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 Formulierungspartikel 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 particles 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.Due to 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 ist zumindest in dem Bereich, in dem er reversibel abwinkelbar ist, flexibel.The drinking straw is flexible, at least in the area in which it is reversibly bendable.

Der Trinkhalm besteht vorzugsweise aus einem synthetischen Material. Zumindest der 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 region in which the straw is reversibly bendable, is preferably constructed of an elastic, synthetic material or a synthetic material plastically deformable at a temperature below its softening point. 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 inner 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 für die Formulierung ungehindert zugänglich 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 is freely accessible for the formulation, is preferably designed as a mouthpiece, particularly preferably corrugated, while the drinking straw opening, which faces the blocking device, preferably as Connecting piece is formed to a reservoir of the transport 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 wirkstoff-, 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 active substance, 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 the 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 durch die eine Trinkhalmöffnung in den Trinkhalm eingebracht und der Trinkhalm zwischen der Formulierung und der für die Formulierung ungehindert zugänglichen Trinkhalmöffnung, d. h. der Formulierung zugewandten Trinkhalmöffnung abgewinkelt wird.Another object of the invention is a method for producing the dosage form in which introduced the locking device in the drinking straw, introduced the formulation through the a drinking straw opening in the drinking straw and the straw between the formulation and the freely accessible for the formulation drinking straw opening, d. H. the formulation facing drinking straw is angled.

Ein weiterer Gegenstand der Erfindung ist ein Verfahren zur Herstellung der Darreichungsform, in dem der Trinkhalm abgewinkelt wird und die Formulierung und die Sperrvorrichtung nacheinander durch die zugängliche Trinkhalmöffnung in den Trinkhalm eingeführt werden.Another object of the invention is a method for producing the dosage form, in which the drinking straw is angled and the formulation and the locking device are successively introduced through the accessible drinking straw opening in the drinking straw.

Bevorzugt ist ein Verfahren zur Herstellung der erfindungsgemäßen Darreichungsform, in dem der abwinkelbare Teil des Trinkhalms mit Hilfe eines Ringes, einer Schelle, einer Manschette oder eines Rohres in der abgewinkelten Stellung reversibel fixiert wird.Preference is given to a method for producing the dosage form according to the invention, in which the bendable part of the drinking straw with the aid of a Ringes, a clamp, a cuff or a pipe is reversibly fixed in the angled position.

Die folgenden Figuren zeigen beispielhafte Ausführungsformen der erfindungsgemäßen Darreichungsformen. Dadurch wird der Erfindungsgedanken in keiner Weise eingeschränkt.

  • Figur 1 zeigt eine erfindungsgemäße Darreichungsform in der Seitenansicht.
  • Figur 2 zeigt eine weitere erfindungsgemäße Darreichungsform in der Seitenansicht. Die Figuren 3a bis 3d zeigen eine erfindungsgemäße Darreichungsform mit einem beidseitig offenen Rohr zur reversiblen Fixierung des reversibel abwinkelbaren Teils des Trinkhalms vor, während und nach der Benutzung.
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.
  • FIG. 1 shows a side view of a dosage form according to the invention.
  • FIG. 2 shows a further dosage form according to the invention in a side view. Figures 3a to 3d show a dosage form according to the invention with a tube open on both sides for reversible fixation of the reversible bendable part of the drinking straw before, during and after use.

Die in Figur 1 gezeigte Darreichungsform umfasst einen Trinkhalm (1), der zwei Öffnungen (6, 9) hat und einen in dem Trinkhalm fixierten Pfropfen als Sperrvorrichtung (2), einen reversibel abwinkelbaren Teil als Verschlussvorrichtung (3) und eine sich zwischen Sperrvorrichtung und Verschlussvorrichtung im Trinkhalm befindende Formulierung (4) enthält.The dosage form shown in FIG. 1 comprises a drinking straw (1) which has two openings (6, 9) and a stopper fixed in the drinking straw as a blocking device (2), a reversibly bendable part as a closure device (3) and a between blocking device and Closure device contained 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 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 eingeklebt.The plug (2) 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 inner diameter of the drinking straw. The plug is glued into the drinking straw.

Die Formulierung (4) liegt in Form von kugelförmigen Partikeln vor.Formulation (4) is in the form of spherical particles.

Der Bereich (10), in dem der Trinkhalm (1) reversibel abwinkelbar ist, ist ziehharmonika-artig gestaltet.The area (10) in which the drinking straw (1) is reversibly bendable, is accordion-like design.

Die in Figur 2 gezeigte Darreichungsform entspricht im wesentlichen der in Figur 1 gezeigten Darreichungsform. Anstelle eines fixierten Pfropfens wird jedoch ein zwischen zwei Anschlägen (7, 8) bewegbarer Pfropfen als Sperrvorrichtung (2) verwendet.The dosage form shown in FIG. 2 substantially corresponds to the dosage form shown in FIG. However, instead of a fixed plug, a between two stops (7, 8) movable plug used as a locking device (2).

Der Durchmesser der größten Formulierungspartikel ist kleiner als der Trinkhalminnendurchmesser an der Stelle des Anschlags (7), 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 (7) so that the formulation particles can pass through this site.

Die in den Figuren 3a bis 3d gezeigte Darreichungsform umfasst einen Trinkhalm (1) mit einem reversibel abwinkelbaren Teil (3). Die abgewinkelte Stellung kann mit Hilfe eines beidseitig offenen Rohres (5) reversibel fixiert werden. Dazu wird der Trinkhalm (1) in abgewinkelter Stellung in das Rohr (5) eingeführt. Vor der Benutzung wird das Rohr (5) soweit verschoben, dass der reversibel abgewinkelte Teil (3) des Trinkhalms (1) frei liegt und der reversibel abwinkelbare Teil (3) des Trinkhalms (1) beliebig verstellt werden kann.The dosage form shown in FIGS. 3 a to 3 d comprises a drinking straw (1) with a reversibly bendable part (3). The angled position can be reversibly fixed by means of a tube (5) open on both sides. For this purpose, the drinking straw (1) is introduced in an angled position into the tube (5). Before use, the tube (5) is moved so far that the reversibly angled part (3) of the drinking straw (1) is exposed and the reversible bendable part (3) of the drinking straw (1) can be adjusted as desired.

Der Innendurchmesser des Rohres (5) ist auf den Raumanspruch des Trinkhalms (1) in abgewinkelter Stellung abgestimmt. Die Länge des Rohres (5) ist kleiner als die Länge des Trinkhalms (1) in abgewinkelter Stellung.The inner diameter of the tube (5) is matched to the space requirement of the drinking straw (1) in an angled position. The length of the tube (5) is smaller than the length of the drinking straw (1) in an angled position.

Claims (24)

  1. Form of administration for oral administration of active ingredients, vitamins and/or nutrients, comprising a drinking straw (1) which has two openings (6, 9) and which contains a blocking device (2) which is impermeable for an active ingredient, vitamin and/or nutrient formulation but is permeable to air and a conveying liquid, and comprises a closure device (3) impermeable for the active ingredient, vitamin and/or nutrient formulation, said active ingredient, vitamin and/or nutrient formulation (4) being arranged between the blocking device and the closure device in the drinking straw, characterised in that the closure device (3) comprises a part (3) of the drinking straw which is reversibly bent between the formulation (4) and the drinking straw opening (6) freely accessible for the formulation, so that exiting of the formulation from the drinking straw is prevented.
  2. Form of administration according to claim 1, characterised in that the bent part (3) of the straw (1) can be reversibly fixed in the bent position with the aid of a ring, a clip, a sleeve or a tube (5).
  3. Form of administration according to claim 1 or claim 2, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is solid.
  4. Form of administration according to either claim 1 or claim 2, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is highly viscous.
  5. Form of administration according to any one of claims 1 to 4, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is multi-particulate.
  6. Form of administration according to any one of claims 1 to 5, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is insoluble in the conveying liquid.
  7. Form of administration according to any one of claim 1 to 5, characterised in that the active ingredient, vitamin and/or nutrient formulation (4) is at least partially soluble in the conveying liquid.
  8. Form of administration according to any one of claims 1 to 7, characterised in that the blocking device (2) is a stopper.
  9. Form of administration according to claim 8, characterised in that the stopper (2) can be moved between two stops (7, 8).
  10. Form of administration according to claim 8, characterised in that the stopper (2) is fixed.
  11. Form of administration according any one of claims 1 to 7, characterised in that the blocking device (2) is a membrane fixed in the drinking straw.
  12. Form of administration according to claim 5, characterised in that the blocking device (2) is a grid fixed in the drinking straw, of which the mesh diameter is less than the smallest diameter of the formulation particles (4).
  13. Form of administration according to claim 5, characterised in that the blocking device (2) consists of a constriction of the drinking straw, so the cross-section of the drinking straw is narrower than the smallest diameter of the formulation particles (4).
  14. Form of administration according to any one of claims 1 to 13, characterised in that at least the region (10) in which the drinking straw (1) is reversibly bent is flexible.
  15. Form of administration according to any one claims 1 to 14, characterised in that the drinking straw (1) consists of a synthetic material.
  16. Form of administration according to claim 15, characterised in that at least the region (10) in which the drinking straw (1) is reversibly bent is constructed from a resilient, synthetic material.
  17. Form of administration according to claim 15, characterised in that at least the region (10) in which the drinking straw (1) is reversibly bent is constructed from a synthetic material plastically deformable at a temperature below its softening point.
  18. Form of administration according to either claim 16 or claim 17, characterised in that at least the region (10) in which the drinking straw (1) is reversibly bent is configured in the manner of a concertina.
  19. Kit consisting of the form of administration according to any one claims 1 to 18 and a physiologically safe conveying liquid optionally containing active ingredients, nutrients and/or vitamins.
  20. Kit according to claim 19, characterised in that the conveying liquid is an aqueous liquid.
  21. Kit according to claim 19 or claim 20, characterised in that the conveying liquid is water, lemonade, fruit juice without fruit pulp, tea or coffee.
  22. Method for producing a form of administration according to any one of claims 1 to 18, characterised in that the blocking device (2) is introduced in to the drinking straw (1), the formulation (4) is introduced through one drinking straw opening (6) into the drinking straw (1) and the drinking straw (1) is bent between the formulation (4) and the drinking straw opening (6).
  23. Method for producing a form of administration according to any one of claims 1 to 18, characterised in that the drinking straw (1) is bent and the formulation (4) and the blocking device (2) are introduced one after the other through the drinking straw opening (9) into the drinking straw.
  24. Method for producing a form of administration according to either claim 22 or 23, characterised in that the part (3) of the drinking straw which is bent is reversibly fixed in the bent position with the aid of a ring, a clip, a sleeve or a tube (5).
EP03717238A 2002-03-27 2003-03-26 Administration form for oral administration of active ingredients, vitamins and/or nutrients Expired - Lifetime EP1490010B1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE10213773 2002-03-27
DE10213773 2002-03-27
DE10228175 2002-06-24
DE10228175A DE10228175A1 (en) 2002-03-27 2002-06-24 Dosage form for oral administration of active ingredients, vitamins and / or nutrients
PCT/EP2003/003133 WO2003079957A1 (en) 2002-03-27 2003-03-26 Administration form for oral administration of active ingredients, vitamins and/or nutrients

Publications (2)

Publication Number Publication Date
EP1490010A1 EP1490010A1 (en) 2004-12-29
EP1490010B1 true EP1490010B1 (en) 2007-04-25

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP03717238A Expired - Lifetime EP1490010B1 (en) 2002-03-27 2003-03-26 Administration form for oral administration of active ingredients, vitamins and/or nutrients

Country Status (7)

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US (1) US20050109858A1 (en)
EP (1) EP1490010B1 (en)
AT (1) ATE360410T1 (en)
AU (1) AU2003221524A1 (en)
DE (2) DE10228175A1 (en)
ES (1) ES2286422T3 (en)
WO (1) WO2003079957A1 (en)

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Also Published As

Publication number Publication date
ATE360410T1 (en) 2007-05-15
EP1490010A1 (en) 2004-12-29
AU2003221524A1 (en) 2003-10-08
US20050109858A1 (en) 2005-05-26
DE50307131D1 (en) 2007-06-06
ES2286422T3 (en) 2007-12-01
DE10228175A1 (en) 2003-10-09
WO2003079957A1 (en) 2003-10-02

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