US20060043207A1

US20060043207A1 - Apparatus, kit and related methods for administering substances

Info

Publication number: US20060043207A1
Application number: US11/209,716
Authority: US
Inventors: Rasoul Sedaghat Kerdar; Norbert Lamm
Original assignee: Gruenenthal GmbH
Current assignee: Gruenenthal GmbH
Priority date: 2003-02-25
Filing date: 2005-08-24
Publication date: 2006-03-02
Also published as: WO2004075876A1; EP1601342A1; DE10308175A1

Abstract

An apparatus, kit and related methods for orally administering a substance such as a medicine. The apparatus includes a straw with a barrier device movable in a direction of sucking. The apparatus is configured so that movement of the barrier device in a direction against the direction of sucking is limited.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent Application No. PCT/EP2004/001395, filed Feb. 13, 2004, designating the United States of America, and published in German as WO 2004/075876 A1, the entire disclosure of which is incorporated herein by reference. Priority is claimed based on German Patent Application No. 103 08 175.5, filed Feb. 25, 2003.

FIELD OF THE INVENTION

The present invention relates to an apparatus and a kit for orally administering a substance as well as related methods of administration. In particular, the invention relates to an apparatus for the oral administration of active ingredients, vitamins and/or nutrients comprising a drinking straw with a barrier device which is impermeable to an active ingredient, vitamin and/or nutrient formulation, but is permeable to air and a conveying liquid within the drinking straw and is slidable substantially only in the direction of sucking, the sliding surfaces of which barrier device are configured such that motion of the barrier device contrary to the direction of sucking is at least made more difficult, and to a kit made up of the apparatus and a conveying liquid.

BACKGROUND OF THE INVENTION

It is known to administer active ingredients, vitamins and/or nutrients with the assistance of a drinking straw which contains an active ingredient, vitamin and/or nutrient formulation which is conveyable by a liquid. Patients who have difficulty in or an aversion to taking capsules or tablets are provided in this manner with a further apparatus for active ingredients, vitamins or nutrients.
The drinking straws known from the prior art for the oral administration of active ingredients, vitamins and/or nutrients do not, however, offer the option of reliably checking complete consumption of the active ingredient formulation. Due to the large number of medicines to be administered, it is not possible for care staff in hospitals or care homes to provide continuous supervision of the taking of medicines. It is therefore desirable to have a simple way of checking complete intake of a medicine from the drinking straw.

SUMMARY OF THE INVENTION

One object of certain embodiments of present invention is to provide an apparatus and a kit, which permits simple, reliable checking of complete uptake of a medicinal substance.
This object is achieved by an apparatus for the oral administration of substances such as active ingredients, vitamins and/or nutrients comprising a drinking straw, which has two orifices and a barrier device which is at least substantially impermeable to a substance being administered but is permeable to air and a conveying liquid and is slidable in the direction of sucking. In the apparatus, at least part of the sliding surface of the barrier device is configured such that motion of the barrier device contrary to the direction of sucking is at least made more difficult.
In the apparatus, complete withdrawal or intake of the substance being administered, in particular, the active ingredient-, vitamin- and/or nutrient-containing formulation is indicated by a slidable barrier device undergoing a change in its position within the drinking straw in accordance with the intake. The apparatus consequently makes it possible to ascertain from the position of the barrier device the intake, preferably the complete intake, of a medicine. In the event of complete intake of the substance, the barrier device is located at the end of the drinking straw which comprises the orifice facing towards the mouth.
The barrier device is slidable in the direction of sucking and largely not moveable in the contrary direction. The barrier device is suitable for permitting the passage of a conveying liquid and air, but not the active ingredient, vitamin and/or nutrient formulation in the drinking straw. The barrier device is preferably mobile only in the direction of sucking.
The immobilization of the barrier device is ensured by configuring at least part of the sliding surface of the barrier device such that movement contrary to the direction of sucking is at least made more difficult and is preferably completely prevented. In this manner it is possible to indicate the particular withdrawal of the substance by the change in position of the barrier device. The change in position is effected by sucking conveying liquid up through the drinking straw, whereby the barrier device according to the invention and the substance are conveyed.
The configuration of the sliding surface for limiting the directional movement of the barrier device is preferably provided by a regular arrangement with identically shaped movement-limiting structures, such as for example scales, sawteeth or pyrimidal structures.
In a preferred embodiment of the invention, the sliding surfaces of the barrier device substantially reproduce the surface of sharkskin. The person skilled in the art will understand that sharkskin is distinguished by a plurality of pyramidal structures which are preferably flattened or oriented contrary to the desired direction of motion (direction of sucking), whereby particularly good flow characteristics are achieved. In the contrary direction, however, particularly strong resistance to flow or frictional resistance is provided, such that a barrier device configured in this manner is substantially moveable only in the direction of sucking. This surface structure is preferably present over the entire circumference of the barrier device.
In a further preferred embodiment of the invention, the sliding surfaces of the barrier device comprise at least in part a scale structure, preferably similar to fish skin or to the sliding surfaces of cross-country skis. The scales here particularly preferably comprise a straight edge which faces towards the direction of flow and runs substantially perpendicularly to the direction of sucking and an opposing edge which is substantially semicircular in shape. These scales may be arranged both diagonally offset relative to one another and one behind the other. In an especially preferred development of the invention, however, the scales are arranged on the sliding surfaces in such a manner that the substantially semicircular edge of a first scale is arranged over the straight edge, which is perpendicular to the direction of sucking, of a second scale. This structure is preferably present over the entire circumference of the barrier device. The resultant rows of scales are arranged substantially perpendicular to the direction of sucking.
Providing such a structure on the surface of the barrier device creates a checkable apparatus because, without any appreciable reduction in the diameter of the barrier device, sliding of the barrier device is allowed in the direction of sucking while any sliding back on completion of sucking is virtually eliminated.
In a further particularly preferred embodiment of the invention, the sliding surfaces of the barrier device comprise at least in part a regular arrangement of sawteeth, the sloping face of which is directed substantially contrary to the direction of sucking. In the contrary direction, in contrast, the sawteeth preferably do not have a sloping face, but instead a substantially right-angled transition from the sliding surface of the barrier device to the individual sawteeth, especially when at least these sawteeth are made of a relatively rigid material. If the sawteeth are made of a relatively resilient material, such that, due to the corresponding diameter of the barrier device, they assume the above-described configuration on introduction into the drinking straw, the sawteeth need not exhibit a different sloping face.
In a further preferred embodiment of the invention, this configuration of the sliding surfaces extends over the entire circumference of the barrier device. A person skilled in the art will understand that, in the development with sawteeth extending over the entire circumference of the barrier device, rows, preferably arranged over one another and sloping contrary to the direction of sucking, are provided and are arranged substantially perpendicularly to the direction of sucking. Very particularly preferably, the above-stated configurations simply extend over the entire circumference, but only over part of the sliding surfaces of the barrier device. In an especially preferred development of the invention, this surface configuration is embodied in segments of the sliding surface which are preferably distributed uniformly over the circumference of the sliding surfaces.
The material of the sliding surface is preferably the same as that of the remainder of the barrier device. The material preferably exhibits sufficient resilience in order to allow the surface structure to lie flat on sucking while simultaneously allowing the surface structure to spring back up. Plastics, whether synthetic or natural, which may also be foamed, may be considered for this purpose. In this manner, a barrier device is created which is particularly light in weight. Such apparatus according to the invention may also be used by particularly weak patients without requiring a high level of exertion.
The barrier devices with the surface structures according to the invention may be produced by extrusion and/or injection moulding or by surface machining, such as embossing.
The interior of the barrier device may preferably also consist of filter material, particularly preferably of nonwoven material or compressed fibrous material. The barrier device is accordingly comparable to a cigarette filter. A surface structure according to the invention may, for example, be produced by jacketing such a barrier device with a plastics film, preferably a tubular film, which already comprises an appropriately configured surface structure. In one particularly preferred development of the invention, such a barrier device is joined with a structured film according to the invention by means of an adhesive which is safe for use in contact with foodstuffs. This lamination may proceed continuously or discontinuously on the semifinished product or on the singulated product. The surface film preferably comprises the embossing according to the invention.
The barrier device preferably comprises continuous channels such that the conveying liquid can not only flow around but also through the barrier device. This configuration of the barrier device may be selected in accordance with the weight of the barrier device. Care must here be taken to ensure that the orifice of the channels does not permit a particulate formulation of the substance or another form of the substance to pass through.
The dimensions of the barrier device are adapted to the dimension of the drinking straw, wherein, in the case of a round drinking straw, the diameter of the barrier device is adapted, taking account of the surface configuration of the barrier device, to the internal diameter of the drinking straw. The barrier device is otherwise preferably cylindrical, particularly preferably a plug.
According to one embodiment of the invention, the barrier device is mobile between a limit stop at the orifice which is not the mouth orifice, and the sucking orifice (mouth orifice). In a particularly preferred embodiment of the invention, another limit stop is arranged in the immediate vicinity of the mouth orifice. The drinking straw is narrowed by the limit stops, wherein the narrowed portions are designed such that the barrier device is retained thereby, but the formulation particles which may be insoluble in the conveying liquid, are not. In this manner, an apparatus is created in which intake of the formulation may be checked and uptake of the barrier device by patients may reliably be prevented.
The drinking straw may be rigid or flexible, straight or angled and/or preferably reversibly bendable. The drinking straw preferably consists of a synthetic material.
In a preferred embodiment of the invention, the drinking straw comprises two substantially straight legs joined together via a bend and/or bending means. In a particularly preferred development of the invention, the bending means are preferably reversible. In this design of the drinking straw, the barrier device and the formulation are arranged in the leg comprising the mouth orifice between the bending means and the mouth orifice. In this manner, a device is created which is particularly easy to store and simultaneously facilitates intake by recumbent patients.
The drinking straw preferably comprises a transparent outer wall at least in the zone of the orifice facing towards the patient. In a particularly preferred development of the invention, the transparent outer wall here extends over part of the circumference of the drinking straw. In this manner, an apparatus is created which makes it possible to check the position of the barrier device and thus the extent of intake of the formulation.
The internal diameter of the drinking straw should preferably be at least 3 mm, whereby a sufficient quantity of conveying liquid can be sucked through the straw in order to convey the barrier device and the formulation. An internal diameter of 3-20 mm is preferred, with 4-15 mm being particularly preferred and 5-10 mm very particularly preferred.
The drinking straw orifice, in which the active ingredient, vitamin and/or nutrient formulation and the barrier device may be conveyed largely unimpeded, preferably takes the form of a mouthpiece, particularly preferably ribbed, while the other orifice may preferably take the form of a connecting piece to a reservoir of the conveying liquid. The drinking straw is preferably labelled to indicate the mouth part and/or to indicate the direction of sucking for the conveying liquid. Such marking simplifies handling.
In a further preferred development of the invention, at least one of the orifices of the drinking straw comprises a removable closure. In a particularly preferred development of the invention, the closure is a cap or a preferably peelable seal made from a membrane or film.
The active ingredient, vitamin and/or nutrient formulation is preferably solid or pasty at the storage temperature of the system according to the invention, preferably at 25° C. A multiparticulate active ingredient, vitamin and/or nutrient formulation is preferred, wherein the formulation particularly preferably assumes the form of particles, preferably solid particles.
The active ingredients, vitamins and/or nutrients alone or the overall active ingredient, vitamin and/or nutrient formulations may be soluble or insoluble in the conveying liquid.
If the active ingredients, vitamins and/or nutrients or the overall formulations are soluble in the conveying liquid, they are dissolved by the sucked up conveying liquid and administered in dissolved form. If, on the other hand, the active ingredients, vitamins and/or nutrients or the overall formulations are insoluble in the conveying liquid, they are merely conveyed onwards by the sucked up conveying liquid. Multiparticulate formulations are preferably used. The particles should here exhibit dimensions such that they may readily be conveyed out of the drinking straw by sucking up the conveying liquid. Adhesion of the particles to one another or to the walls of the drinking straw should be prevented, which may optionally be achieved by suitable surface treatment of the particles. The particles preferably have a diameter in the range from 100-1500 μm, preferably 150-800 μm. The formulation may also assume tablet form.
Any orally administrable substances may be used as the active ingredients, preferably therapeutic active ingredients, vitamins or nutrients, provided that a suitable formulation is possible for the system according to one embodiment of the invention. The apparatus preferably contains a precisely determined dose of these substances, which are approved or acceptable for administration to humans and animals, preferably to humans. Therapeutic active ingredients are not taken to include nicotines, such as laevo-nicotine, dextro-nicotine, the racemic mixtures and/or pharmaceutical salts thereof.
The active ingredient, vitamin and/or nutrient formulation is arranged, according to one embodiment of the invention, within the drinking straw in the direction of sucking of the conveying liquid between the barrier device and the mouth orifice of the drinking straw.
In one embodiment of the invention, the active ingredient, vitamin and/or nutrient formulation may also be immobilized in the drinking straw and be moveable only by contact with the conveying liquid. To this end, the formulation may be bound to the internal wall of the drinking straw, to the barrier device and/or an optionally present carrier made from a physiologically acceptable material which is soluble in the conveying liquid and/or itself bound adhesively and/or with the assistance of a physiologically acceptable binding material which is soluble in the conveying liquid.
The formulation may preferably be immobilized with the assistance of sugars and/or sugar-like compounds, preferably sucrose, glucose, fructose, mannitol, sorbitol, flucose, maltose, lactose, galactose, trehalose and/or sugar alcohols, of cyclic sugars, preferably cyclodextrins, of proteins, preferably gelatines, gelatine derivatives, gelatine hydroxylates, dextrins, proteins from soya, wheat and/or psyllium seeds, of gums and/or gum-like materials, preferably agar, acacia, guar, xanthan, of starch, preferably starch consisting of amylose with up to 6000 glucose units and amylopectin with 10-60 glucose units, of modified starch, preferably starch with esterified hydroxy groups, hydroxyethyl starch, hydroxypropyl starch and/or distarch phosphates, of pectins, of dextrans, of cellulose derivatives, preferably methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose and/or carboxymethylcellulose, optionally as an alkali metal salt, of alginates, of carrageenans, of amino acids, preferably with 2-12 carbon atoms, particularly preferably glycine, L-alanine, L-aspartic acid, L-glutamic acid, L-hydroxyproline, L-leucine, L-isoleucine and/or L-phenylalanine, of synthetic polymers, preferably polyvinylpyrrolidone, of inorganic salts, preferably sodium phosphate, sodium chloride and/or aluminium silicate, or mixtures.
A carrier used for immobilization preferably consists of a cotton wool-like plug of sugar, preferably sucrose, glucose, fructose, mannitol, sorbitol, flucose, lactose and/or maltose, of a soluble cellulose material, preferably methylcellulose, ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose and/or an alkali metal salt of carboxymethylcellulose, or mixtures thereof.
If the drinking straw comprises a bend or bending means, the barrier device is arranged and is mobile between the bending zone and the mouth orifice of the drinking straw and, before withdrawal of the formulation, is positioned between the bending zone of the drinking straw and the mouth orifice thereof.
In a preferred embodiment of the invention, an additional closing device is arranged within the drinking straw. The closing device preferably serves to prevent a moveable formulation from falling out of the drinking straw before use of the apparatus according to the invention.
The closing device according to the invention is arranged, in the direction of sucking of the conveying liquid, between the active ingredient, vitamin and/or nutrient formulation and the mouth orifice of the drinking straw and preferably consists of a physiologically acceptable material which is soluble in the conveying liquid.
Such a closing device is preferably configured from the same materials, as the above-described immobilization carrier.
The closing device may optionally also serve as a carrier for immobilizing active ingredients, vitamins and/or nutrients.
Alternatively or additionally, the orifice of the drinking straw which faces the active ingredient, vitamin and/or nutrient formulation, may be provided with a closure. The closure is preferably a cap or a plug, which is preferably removed immediately before oral administration.
In a preferred embodiment of the invention, the closure is a closure made from an at least partially removable and/or destructible film attached to the drinking straw orifice, which closure closes at least the drinking straw orifice facing the formulation and is impermeable to the active ingredient, vitamin and/or nutrient formulation before administration.
The film may be compact, porous or mesh-like. The film is preferably peelable, separable, severable, pierceable, is separable and/or severable, particularly preferably only partially, by suction force and/or is soluble in saliva. In order to facilitate separation and/or severing of the film closure, the film may comprise weakening lines, preferably predetermined separating or breaking points, which preferably run radially outwards from the middle of the closure and divide the closure into preferably identically sized segments.
This closing device is preferably configured from materials, which are the same as the above carrier.
In order to protect a film-type closing device, the drinking straw orifice may additionally be provided with a cap.
The second drinking straw orifice may optionally also be provided with the above-described film and/or cap.
The present invention also provides a kit made up of the apparatus according to the invention and a physiologically acceptable conveying liquid which optionally also contains active ingredients, nutrients and/or vitamins. An aqueous liquid is preferably used as the conveying liquid, wherein water, lemonade, fruit juice without fruit pulp, tea or coffee are particularly preferred and should not contain any troublesome solids, such as pieces of fruit pulp.
The invention is explained in greater detail below with reference to two Figures. These Figures are, however, merely exemplary representations of an apparatus produced in accordance with one embodiment of the invention and do not in any way restrict the general concept of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partial view of an apparatus according to the invention,
FIG. 2 shows a magnified partial view of an apparatus according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a partial view of a drinking straw 1, which consists of straight legs 8, 12 connected to one another via the accordion-like bending means 15. The drinking straw 1 has the orifices 6, 9, wherein orifice 6 is intended to be placed in the patient's mouth and the orifice 9 is immersed in the conveying liquid (not shown). A mobile barrier device 3 is arranged in the drinking straw 1 above the bending means 15 of the drinking straw 1. A multiparticulate active ingredient formulation 7 is arranged downstream in the direction of sucking 5 from the barrier device 3. A membrane-like closing device 4 made from a physiologically acceptable material which is soluble in the conveying liquid is arranged in the drinking straw downstream in the direction of sucking 5 from the formulation 7. The barrier device 3 can move in the drinking straw 1 only in the direction of sucking 5 and between the bending means 15 and the limit stop 10. After dissolution of at least part of the closing device 4, the mobile barrier device is moved on sucking the conveying liquid up through the drinking straw 1 together with the formulation 7 towards the orifice 6. The formulation 7 may be conveyed substantially unimpeded with the at least partially dissolved closing device 4 to the orifice 6. Due to the surface configuration of its sliding surface (not shown), the barrier device 3 is held in this position and prevented from moving back. The barrier device 3 is additionally visible from the outside through the viewing window 14 when the formulation has been withdrawn. The person skilled in the art will understand that complete intake, or administration of the formulation may be ascertained when the barrier device 3 rests against the upper limit stop 10.
FIG. 2 shows a magnified representation of a part of the leg 8 with the orifice 6 after the formulation has been sucked up. The orifice 6 is closed by a removable cap 13. Beneath the limit stop 10, which extends around the entire internal circumference of the leg 8, the leg 8 comprises a transparent viewing window 14, which extends over part of the circumference and part of the length of the leg 8 and permits visual verification of the withdrawal of the formulation. The barrier device 3 which is mobile within the drinking straw 1 comprises on its sliding surface 2 two opposing rows of sawteeth, which slope exclusively contrary to the direction of sucking 5.
The foregoing description and examples have been set forth merely to illustrate the invention and are not intended to be limiting. Since modifications of the described embodiments incorporating the spirit and substance of the invention may occur to persons skilled in the art, the invention should be construed broadly to include all variations falling within the scope of the appended claims and equivalents thereof.

LIST OF REFERENCE NUMERALS

1 Drinking straw
2 Sliding surface
3 Barrier device
4 Closing device
5 Direction of sucking
6 Orifice of the drinking straw
7 Formulation
8 Leg of the drinking straw
9 Orifice of the drinking straw
10 Limit stop
12 Leg of the drinking straw
13 Closure
14 Viewing window
15 Bending means

Claims

1. An apparatus for use in orally administering a substance, said apparatus comprising:

a drinking straw having two orifices and a barrier device, said barrier device being substantially impermeable to the substance to be administered, and being permeable to air and a conveying liquid and being movable in a direction of sucking, wherein at least part of an outer surface of the barrier device is configured such that movement of the barrier device contrary to the direction of sucking is substantially prevented.

2. An apparatus according to claim 1, wherein the barrier device is moveable only in the direction of sucking.

3. An apparatus according to claim 1, wherein at least part of the outer surface of the barrier device has a sawtooth arrangement oriented counter to the direction of sucking.

4. An apparatus according to claim 1, wherein at least part of the outer surface of the barrier device has a sharkskin configuration.

5. An apparatus according to claim 1, wherein at least part of the outer surface of the barrier device has a scale configuration.

6. An apparatus according to claim 1, wherein the entire outer surface of the barrier device is configured such that movement of the barrier device contrary to the direction of sucking is substantially prevented.

7. An apparatus according to claim 1, wherein the circumference of the outer surface of the barrier device is configured such that movement of the barrier device contrary to the direction of sucking is substantially prevented.

8. An apparatus according to claim 1, wherein the barrier device is moveable in the drinking straw substantially up to one of the two orifices of the drinking straw.

9. An apparatus according to claim 1, wherein movement of the barrier device is limited to part of a length of the drinking straw.

10. An apparatus according to claim 9, wherein the drinking straw comprises at least one limit stop to limit the movement of the barrier device.

11. An apparatus according to claim 1, wherein the barrier device has a substantially cylindrical shape.

12. An apparatus according to claim 11, wherein the barrier device is a plug.

13. An apparatus according to claim 1, wherein the substance to be administered is arranged between the barrier device and one of the two orifices of the drinking straw.

14. An apparatus according to claim 1, wherein the substance to be administered is a solid.

15. An apparatus according to claim 1, wherein the substance to be administered is insoluble in the conveying liquid.

16. An apparatus according to claim 1, wherein the substance to be administered is multiparticulate.

17. An apparatus according to claim 1, wherein the substance to be administered is tabletted.

18. An apparatus according to claim 1, wherein the substance to be administered is at least partially soluble in the conveying liquid.

19. A kit for administering a substance, said kit comprising:

an apparatus according to claim 1 and a physiologically acceptable conveying liquid.

20. The kit of claim 19, further comprising a substance to be administered.

21. The kit of claim 19, wherein said conveying liquid is an aqueous liquid.

22. A method of administering a substance comprising:

providing a drinking straw having two orifices and a barrier device, said barrier device being substantially impermeable to the substance to be administered, and being permeable to air and a conveying liquid and being movable in a direction of sucking, wherein at least part of an outer surface of the barrier device is configured such that movement of the barrier device contrary to the direction of sucking is substantially prevented;

providing a substance to be administered and a conveying liquid and

administering said substance to be administered.