EP3565622A1 - Sucette équipée d'un dispositif d'inhalation - Google Patents

Sucette équipée d'un dispositif d'inhalation

Info

Publication number
EP3565622A1
EP3565622A1 EP17828939.3A EP17828939A EP3565622A1 EP 3565622 A1 EP3565622 A1 EP 3565622A1 EP 17828939 A EP17828939 A EP 17828939A EP 3565622 A1 EP3565622 A1 EP 3565622A1
Authority
EP
European Patent Office
Prior art keywords
pacifier
cartridge
nipple
typically
atomizer
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.)
Withdrawn
Application number
EP17828939.3A
Other languages
German (de)
English (en)
Inventor
Florian Matl
Christoph Kocher
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP3565622A1 publication Critical patent/EP3565622A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61J7/0053—Syringes, pipettes or oral dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0085—Inhalators using ultrasonics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/10—Expectorants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/12—Mucolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A61P23/02—Local anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02—Local antiseptics

Definitions

  • TECHNICAL FIELD The present disclosure relates to nipples and pacifiers for use in the treatment of ailments, typically in the upper respiratory tract of infants and young children, and generally for the targeted, local administration of active ingredients to infants and toddlers.
  • Embodiments further relate to the dosage forms comprising the appropriately provided active ingredients, and in particular their physical nature.
  • a nipple for a pacifier, and a pacifier, according to the claims.
  • a nipple comprising a rubbery material is provided for a pacifier.
  • the nipple comprises a central cavity for receiving a first active substance, and at least a part of its outer surface (wall, body wall) a plurality of passages connecting the cavity with an external space around the pacifier, so that the passages in the use state of the pacifier the cavity with the mouth of a child (infant or infant) Small child).
  • a pacifier is proposed which comprises a nipple according to the first aspect, and a sheet-like shield on which the nipple is attached.
  • a pacifier comprises a nipple, optionally according to the first aspect, and a flat shield to which the nipple is attached, and a replaceable cartridge having an active substance, with at least one opening through which the active substance can be dispensed.
  • a holding element serves to receive the cartridge, wherein the holding element is attached to the suction side facing away from the shield and is designed so that the at least one opening of the cartridge in the use of the pacifier exposed to the nose of the child (infant or small child) out is aligned so that the drug can be delivered in the direction of the nose.
  • a pacifier which comprises an active substance-loadable nipple, optionally according to the first aspect, and a dosage form which can be eroded by means of liquid.
  • the drug form is provided in the form of a suitable for sucking dosage form, and comprises a first active ingredient.
  • the dosage form is configured to be introduced into the nipple as a refillable element and further preferably is a composition for use in the treatment of diseases of infants and infants, particularly for the topical treatment of mammalian upper airway disorders - lingen and small children.
  • the use of a dosage form in a pacifier according to the present invention is proposed.
  • the dosage form is used as a refillable element.
  • a dosage form for use in the treatment of diseases of infants and infants comprises at least one active substance.
  • the drug form is erodible with the aid of liquid, and is in a suitable for sucking, solid, single-dose dosage form.
  • a pacifier for generating an aerosol.
  • the pacifier comprises a nipple and a nebulizer unit configured to nebulize a liquid, preferably an aqueous liquid.
  • a cartridge for loading a pacifier with active ingredient is proposed.
  • the cartridge includes a cartridge wall enclosing a cavity and at least one opening in the cartridge wall connecting the cavity to an exterior space around the cartridge.
  • the cartridge is adapted to be releasably connected to a pacifier, the cartridge opening after connecting the cartridge to the pacifier being oriented to close to the nostrils of the baby during use of the pacifier is located and aligned to this.
  • Fig. 1 shows schematically a perspective view of a nipple according to embodiments, for a pacifier according to embodiments, as well as an enlarged detail of one of the passages in the nipple;
  • Fig. 2 shows the teat of Figure 1 in a front view.
  • Fig. 3 shows in a rear view of the sucker of Fig. 1 and Fig. 2;
  • FIG. 4 shows a perspective view of a pacifier according to embodiments
  • Fig. 5 shows in perspective an exploded view of a pacifier according to further embodiments
  • FIG. 6 shows another perspective view of the exploded view of FIG.
  • Fig. 7 shows an interchangeable cartridge for or from a pacifier according to
  • Fig. 8 shows a pacifier with a nebulizer unit according to embodiments
  • FIG. 9 shows an exploded view of the pacifier of FIG. 8.
  • a pacifier is a pacifier designed to satisfy the suckling needs of infants (especially infants and toddlers).
  • embodiments relate to suckers / mouthpieces for pacifiers, or pacifiers for toddlers (especially for infants and toddlers), with which in a novel way one or more active ingredients in / on the mouth, and / or throat, and / or nasal cavity can be applied.
  • a sucker made of a rubber-like, elastic material is provided, which has a central cavity.
  • a wall (outer surface, body wall) of the nipple which simultaneously represents the wall or enclosure of the central cavity.
  • the passages provide a fluidic connection between the central cavity and the exterior around the pacifier.
  • an active ingredient for example in the form of a fruit gum, in the central cavity is present, this comes through the passages with the saliva of the child in touch.
  • the saliva dissolves the active ingredient successively.
  • the drug comes into contact with the mouth of the child through the return of the drug-enriched saliva. It is absorbed or swallowed via the oral mucosa.
  • the instinctive, dynamic suction movement promotes the above process or salivation in both directions - in and out.
  • the passages are arranged in a targeted manner or in a focal point in certain regions of the nipple, for example in the area close to the palate, and / or a region facing the tongue, and / or the region close to the nasal cavity, it can be ensured that the active substance is focused in the region concerned and operates there.
  • the cavity is thus configured to receive a first active substance.
  • the cavity is further configured so that liquid can only pass through the passages into the cavity.
  • the passages are conical, that is to say their outer opening has a significantly larger diameter than the inner opening facing the central cavity with the active substance. This allows for a given number and surface density (number of passages per unit area) of the passages to increase the contact surface with the oral mucosa. Depending on the active ingredient, its water solubility and the This may be useful in order to achieve the desired dose in an acceptable period of time.
  • the conically shaped passages are particularly useful in solid forms of the drug, as they also prevent about fragments of the drug or drug body (dosage form), such as a tablet, undesirably get out of the cavity of the teat into the mouth of the child.
  • the sucker In order to introduce the active ingredient in the central cavity, the sucker has a kind of valve.
  • This can be provided in the form of a passage passage, for example as a slot (preferably as a cross-slot), in a - remote from the mouth of the child during use - back wall of the teat.
  • a passage passage for example as a slot (preferably as a cross-slot)
  • This reduces the risk that the drug form, or fragments of it, will not accidentally get into the child's mouth, which in extreme cases may lead to an unwanted swallowing with following respiratory disturbance.
  • an opening for drug loading in a - during use the mouth of the child facing - area of the teat unwanted ingestion of at least fragments of the dosage form due to incorrect use of the dosage form and depending on the fragility of the dosage form is quite possible.
  • a drug coating applied to the outer suction wall is even less suitable for the reasons given above because larger pieces of the coating detach themselves from the wall of the teat as a result of the suction movement and thus penetrate into the Can reach the child's mouth.
  • the above-mentioned passage passage is designed as a purely structural modification of the (wall) material of the nipple. This facilitates the manufacture of the nipple, makes it less expensive, since no additional material has to be processed, and further prevents the occurrence of possible breakages (as might be the case with the use of a slider or a flap made of a different material).
  • nipple back wall 45 the fact that the nipple is detachable from the shield results in a synergistic effect: the remnants of saliva dissolving form are only at the nipple (in the cavity 15 and at the outer surface of the mouth) on no other pacifier component.
  • This "dirty" nipple can be removed from the rest of the pacifier and cleaned (boil and sterilized if necessary) .
  • the rest of the pacifier can be used with another nipple independently of the "dirty" nipple.
  • the passage passage allows to introduce an active substance body, such as a fruit gum, in the teat or its central cavity.
  • the passage passage prevents the escape of liquid, ie saliva or active ingredient or a mixture of both, from the nipple or through the shield in the rear part of the pacifier.
  • the nipple so the mouthpiece of the pacifier is typically connected in use with a shield (releasably).
  • the sucker can thus be separable from the shield so that it can be cleaned individually, e.g. by decoction. It can also be replaced as a single part.
  • a nose attached to the nipple prevents the nipple from rotating relative to the shield (tongue and groove principle).
  • the sign should also prevent the swallowing of the mouth part.
  • the shield may according to embodiments have any known in the prior art forms.
  • the shield may have a butterfly-like shape.
  • the shield may have at least two through holes, which is beneficial for ventilation.
  • the nipple may be made of latex and / or silicone and / or a rubber-like material.
  • the mouthpiece of the nipple may have any shape.
  • the mouthpiece may have a round cherry shape, or the anteriorly beveled, oral cavity-adapted palate shape.
  • the pacifier is equipped with a holder or a holding element for a replaceable cartridge.
  • the retaining element is mounted on the opposite side of the sucker of the shield.
  • the cartridge is designed to receive a (preferably) liquid (second) active substance.
  • the cartridge On one side, the cartridge has at least one opening, which is aligned after insertion of the cartridge in the holding element so that it is located near the nostrils of the child and is aligned therewith. If a cover or a closure is removed, the second active ingredient evaporates at room temperature through the at least one opening and is discharged in the direction of the nose. In this way, volatile compounds, such as an essential oil for the relief of cold symptoms can be administered.
  • the cartridge can be held in place by means of a cap which is placed on the retaining element.
  • the cap may also be releasably connectable to the retaining element by means of a locking mechanism which requires a combination of at least two simultaneous or sequential movements.
  • the cap can be releasably connected to the holding element by means of a push-turn closure.
  • the cap can be fastened to the holding element by means of a rotatably detachable bayonet closure, which can not be opened by small children. This is a parental control against accidental loosening / opening and prevents injury from loose parts or their ingestion.
  • the suckers according to embodiments are similar in shape and design to commercial pacifier suckers.
  • the nipples may have an axial extent of from about 1.5 to about 3.5 cm, typically from about 2.5 to 3.2 cm (measured from the nipple tip to the shield).
  • the nipple has a transverse axis, which is perpendicular to the longitudinal or axial axis of the nipple, and in the use state of the pacifier parallel to a connecting line of the mouth angle of the wearer of the pacifier.
  • the teat at its widest point which is usually in use in the mouth, may have a width of 1.5 cm to about 2.8 cm, typically 1.18 to 2.3 cm.
  • An applying child thus sees little or no difference to his usual pacifier.
  • the controlled, relatively slow (sustained release) delivery of both the first active substance 17 through the teat and the second active ingredient via the cartridge makes possible a prolonged (prolonged and / or retarded) release of active ingredient, e.g. over several minutes / hours.
  • no waking up of the child is usually necessary to perform a pacifier exchange, because an active ingredient is consumed.
  • Fig. 1 shows a nipple 10 according to embodiments for a pacifier 1.
  • the nipple comprises a rubbery material, such as silicone, rubber, latex, or similar materials.
  • the nipple has a central cavity 15 for receiving a first active substance 17.
  • it has a plurality of passages 30. These represent a fluid connection of the cavity 15 with an outer space 35 around the nipple.
  • the passages 30 connect the cavity 15 with the mouth of a child (especially a baby or very small child).
  • the teat In order to load the teat 10 with a first active substance 17, the teat has a passage passage 50 on a surface 45 (wall) which does not come into contact with the palate, tongue and lips of the child in use.
  • the teat may have a passage passage 50 on a surface 45 (wall 45) located outside of the mouth when in use.
  • the teat 10 may also have a passage passage 50 on, for example, a surface 45 in use within the mouth, the surface 45 not being in contact with the palate, tongue and lips when in use.
  • the surface 45 thus represents a kind of inner wall of the nipple and is preferably constructed of the same material as the rest of the nipple.
  • the surface 45 is (in both alternatives mentioned above) liquid-tight in the normal state and can be opened temporarily by mechanical pressure from the outside, for example by a manually pressed tablet with the first active substance 17.
  • the first active ingredient 17 is typically carried out generally as part of a solid dosage form, for example a lozenge.
  • the drug form with the first active substance 17 is thereby introduced manually through the passage passage 50 into the cavity 15.
  • the passage passage 50 is made as a purely structural modification of the rubber-like material of the nipple 10. This may be about a slot as sketched in FIG. 1 (and in particular a cross slot).
  • the slot (or cross slot) can be designed with partially overlapping walls, which increases the tightness.
  • Passage passage 50 typically has a length (extension) of 0.5 cm to 1.5 cm, more typically from 0.7 cm to 1.2 cm. As a result, a solid dosage form can be conveniently and easily brought into the central cavity.
  • Fig. 2 is a front view of the teat of Fig. 1 is shown, with passages 30 at an upper and lower side of the mouthpiece 60 of the teat 10.
  • Fig. 3 shows a passage passage 50 which in a surface 45 of (preferred round) end piece 55 is provided. The end piece 55 serves for attachment to a shield 20.
  • the portion of the teat 10 that is at least partially in use in the use state is the mouthpiece 60.
  • the troughs 30 can only be used in certain areas of the mouthpiece 60, or in particular 3 may be provided reinforced in certain areas of the mouthpiece 60. In this case, a distinction is made between an upper region 61, which rests on the palate in use, and a lower region 62, which rests mainly on the tongue in use.
  • a passage 30 belongs to the upper area 61 when the normal vector 63 of the outer area 25 at the position of the passage 30 has a component in the direction from the lower region 62 (tongue-near) to the upper region 61 (palate-near).
  • a passage 30 belongs to the lower portion 62 when the normal vector 63 of the outer surface 25 at the position of the passage 30 has a component in the direction from the upper portion 61 (near the palate) to the lower portion 62 (near the tongue).
  • An example of such a normal vector 63 for a passage 30 in the upper area 61 is shown in FIG.
  • a passage 30 in the typical operating mode is palate-facing or in contact therewith, by definition it belongs to the upper one By region 61, if a passage 30 is tongue-facing in typical usage mode, it is defined as belonging to the lower region 62.
  • Passages 30 at the throat-side end and tip of the nipple 10 may be conveniently assigned according to the above geometric definition because in use they have neither contact with the palate nor the tongue or are not clearly assigned to it.
  • the central cavity 15 of the nipple 10 is thus defined as the one space which is limited by a) the inside (ie the side facing away from the palate or tongue) of the wall of the mouthpiece 60 and b) the inside (ie the in). If the drug form is introduced with the first active substance 17 through the passage passage 50 into the cavity 15, the drug form within the central cavity is freely movable, that is, that the drug form not the entire Room of the central cavity 15 occupies. This promotes the play instinct of the child, stimulates the production of saliva and thereby intensifies the liquid removal from the mouth and throat, which is, for example, beneficial for colds.
  • the nipple 10 may be a total of three to one hundred and fifty (3 to 150), typically four to one hundred (4 to 100), typically ten to eighty (10 to 80), more typically twenty to sixty (20 to 60) ports 30 have.
  • the present nipple is not suitable for liquid dosage forms, as they are delivered too quickly in the mouth and throat, which in extreme cases can lead to an unwanted ingestion with the following breath disorder.
  • a teat with only one or two passages basically not suitable for solid dosage forms (eg lozenges or similar).
  • the release of active ingredient through only one or two openings is not effective in the local treatment of oral and pharyngeal diseases.
  • the apertures 30 may typically be provided both in the upper region 61 (i.e. palatal facing in typical use mode) and in the lower region 62 (ie tongue-facing in typical usage mode).
  • the upper region 61 and the lower region 62 may also have different numbers of passages 30, depending on the active ingredient used and the indication.
  • passages both in the upper and in the lower region allows a defined drug release of the first active ingredient 17 from the drug form, as well as an evenly distributed throughout the mouth and throat area drug delivery, and thus an optimized effect of the first drug 17 at the site of action.
  • passages in the upper and lower portions of the nipple allow saliva to flow from opposite nipple sides into the central lumen and, due to the suction motion of the child, can completely nourish the dosage form. This regularly leads to a defined dissolution of the drug form, and thus to a defined drug release of the first drug 17 from its drug form.
  • the reflux of the active ingredient-enriched saliva can also take place over both regions 61 and 62, which leads to the abovementioned uniformly distributed active ingredient delivery throughout the mouth and throat area.
  • an erodible dosage form such as, for example, a throat tablet or a fruit gum
  • the reflux of the drug-enriched saliva is carried over both areas 61 and 62, thus ensuring a uniformly distributed drug delivery throughout the mouth and throat area.
  • the passages 30 are typically arranged at a generally uniform distance from each other.
  • the apertures 30 may typically have a generally circular cross-section.
  • the passages 30 typically have a uniform cross-sectional size, that is, all the passages have the same cross-section.
  • different cross-sectional sizes may also be used, which are selected, for example, depending on their position on the outer surface 25.
  • the passages 30 may in principle have any desired shape. For example, they may be cylindrical, conical, cuboidal, cube-shaped, or combinations thereof (as a non-limiting enumeration).
  • the passages may have a uniform shape, but alternatively, different shapes may be used.
  • At least a portion of the passages 30 may be cylindrically shaped.
  • all the passages 30 may be cylindrically shaped. This simplifies the production of the nipple and thereby reduces the production costs.
  • at least a portion of the passages 30 may be conically shaped.
  • all the passages 30 may be conically shaped, or only a portion of the passages 30 may be conical and the remainder of the passages 30 may be cylindrically shaped.
  • Cone-shaped passages 30 mean that the inner opening 31 of the conically shaped passages 30 located proximal to the cavity 15 of the teat 10 has a diameter d 1 which is smaller than the diameter d 2 of the distal direction to the cavity 15 of the teat 10 (ie outside).
  • the inner opening 31 of the conical passages 30 in this case has an at least 30 percent smaller diameter dl than diameter d2 of the outside opening 32, more typically at least 50 percent smaller diameter.
  • the diameter d2 is typically 0.1 mm to 1 mm, more typically 0.2 mm to 0.8 mm, more typically 0.3 mm to 0.6 mm.
  • the conical shaped Passages allow to increase the contact surface with the oral mucosa.
  • the conically shaped passages prevent - despite the large contact area with the oral mucus - too large fragments of the drug form, such as a tablet, undesirably get out of the cavity of the nipple into the child's mouth, resulting in an unwanted swallowing in extreme cases with the following breath disorder.
  • This is particularly useful for those solid dosage forms that form particularly hard and pointed fragments during erosion, so that even very small fragments of them can become a danger to the child.
  • cylindrically shaped passages have a cross-sectional diameter of from 0.1 mm to 1 mm, more typically from 0.2 mm to 0.8 mm, more typically from 0.3 mm to 0.6 mm.
  • the passages 30 may be arranged in a variety of patterns.
  • the passages 30, without prejudice to their provision both in the upper region 61 and in the lower region 62, may appear reinforced in some parts of the outer surface 25, while in other parts of the outer surface there are no passages 30.
  • the teat 10 in the part which bears against the so-called. Lip bow of the child no passages 30. This prevents the active ingredient from being delivered to the lips of the sucking child, which, depending on the active substance, could lead to irritation, but at least loss of active substance to areas of the mouth which should not be treated at all.
  • the teat 10 has, for example, a plurality of passages 30 at the throat-side end and the tip of the teat 10, respectively. That is, the passages 30 are located only at the throat-side end and tip of the nipple 10, respectively, while the remainder of the nipple has none, or alternatively, fewer passages 30. In the latter case, therefore, a larger number of passages 30 are provided per outer surface unit of the teat 10 at the throat-side end or at the tip of the teat 10 than in the remaining part of the teat 10. This leads to an increased release of active ingredient in the rear part of the oral cavity , ie in the transition from the hard palate to the soft palate or in the throat.
  • the teat 10 can only be located in that part of the teat 10 which rests on the so-called dental arch. a plurality of passages 30.
  • appropriate active ingredients such as the local anesthetic lidocaine
  • the first active substance 17 can be dispensed in a targeted and concentrated manner at the desired site of action.
  • apertures 30 of generally circular cross-section having smaller diameters eg, 0.1 mm
  • less saliva per unit time enters the central cavity of the nipple 10, resulting in slower dissolution of the (solid) dosage form and thus delayed release of the drug first active ingredient 17 leads from its drug form.
  • the reflux of the drug-enriched saliva is slowed down by such "narrower" passages, which in turn results in delayed drug delivery to the site of action.
  • the interplay of the aforementioned parameters allows for tailor-made treatment of upper respiratory tract disorders in infants (preferred of infants and young children), depending on the active substance, dosage form, indication, etc.
  • the nipple may typically include an end piece 55 for attachment to a shield, as well as a mouthpiece 60.
  • the mouthpiece typically represents that part of the teat which is designed for the mouth of the child, which is therefore completely enclosed in the use state of the teat by the mouth (including the lips).
  • the mouthpiece may typically include a nipple neck and a nipple body.
  • the nipple body is that part of the mouthpiece which, in use, is essentially surrounded by the oral cavity and the dental arch of the child.
  • the nipple neck is that part of the mouthpiece which, in use, is substantially enclosed by the child's lips.
  • the nipple neck thus represents the connection between end piece 55 and nipple body.
  • the nipple in this particular embodiment, the surface (rear wall) 45 (as shown in FIGS. 1 and 3 and described above) in the end piece 55, but in the nipple neck.
  • the active substance 17 can be introduced as a constituent of a solid dosage form into the cavity 15, in particular as a refillable element structural modification of the rubber-like material of the teat 10 is performed.
  • the passages are typically provided only in the region of the nipple body.
  • the active ingredient only reaches the oral mucosa (palate and tongue) but not the lips.
  • the end piece (which is preferably a round end piece) in the use state of the nipple is typically connected to a shield, preferably releasably detachable.
  • the nipple can thus be separated from the shield, so that it can be cleaned individually, for example by boiling. Also, it can be replaced as a single item.
  • the nipple 10 may be combined with a shield 20 as shown in FIG. 4. On the flat plate 20, which may have openings for better ventilation of the skin, the sucker 10 is attached.
  • Pacifier with cartridge / cartridge Pacifier with cartridge / cartridge
  • a pacifier (preferably the above pacifier 1 of FIG. 4) is provided, which is provided with an exchangeable cartridge 70.
  • an exchangeable cartridge 70 This is shown schematically as an exploded view in Fig. 5, wherein the cartridge 70 has two openings 71 as an example here.
  • the cartridge 70 comprises a second active substance 18 which can be dispensed via at least one opening 71.
  • the cartridge is held or provided in a holding element 75, which is attached to the side facing away from the teat 10 of the shield 20.
  • the holding member 75 is designed so that the opening (s) 71 of the cartridge 70 in the use state of the pacifier 1 is exposed to the nose of the toddler (infant).
  • the holding element can have a recess on a part of its circumference, as shown in FIG.
  • the cartridge 70 has in embodiments to be removed before use, a closure 72 of the openings 71, which may be designed as a tear-off film (non-limiting), or as a cap as shown in Fig. 5 schematically.
  • a closure 72 of the openings 71 which may be designed as a tear-off film (non-limiting), or as a cap as shown in Fig. 5 schematically.
  • Other possible closure forms are known to those skilled in the art and are considered to be within the scope of the disclosure.
  • the opening (s) 71 of the cartridge 70 may be configured so that no liquid can escape from the cartridge (ie, escape in liquid form).
  • the pacifier 1 comprises a preferably cap-shaped end 80. This is designed to cooperate with the support member 75 so that the cartridge 70 is stably held therebetween.
  • the termination 80 may create a fixation mechanism on the cartridge 70.
  • the termination 80 is typically designed to engage with the support member 75.
  • the closure 80 can be detachably connectable to the holding element 75 by a bayonet closure 85.
  • the bayonet lock 85 is typically lockable and releasable by rotation through an angle of several degrees, such as about 5 degrees to 30 degrees.
  • a spring 90 and a pressure ring 95 may be provided in the cap-shaped end 80. These generate a compressive force that inhibits twisting of the termination 80. This also reduces the risk of unintentional release.
  • the closure is not operable by infants and babies and thus represents a child safety.
  • a pacifier may be equipped with a conventional nipple, that is, without passages 30, with the cartridge 70 and the retention system.
  • the nipple of FIG. 1 and the cartridge or their retention system are combined.
  • a solid dosage form is typically provided which comprises a first active substance 17.
  • the dosage form is typically provided in a lozenge-like dosage form.
  • the second agent 18 is for use in the cartridge 70 (see also Fig. 7). He is chosen to achieve a soothing effect for cold symptoms of the nose by evaporation. Typical would be here about essential oils.
  • follicles Nalla sativa
  • chamomile oil matricaria chamomilla
  • pine needle oil picea abies
  • angelica angelica archangelica
  • eucalyptus oil oleum eucalypti
  • a commercially available oil mixture for infants and toddlers is Babix®, a blend of pine needle and eucalyptus oil.
  • the fiction, contemporary cartridge 70 may be refillable, or typically designed as a replaceable disposable cartridge.
  • the cartridge 70 is designed as a replaceable disposable cartridge. This is because:
  • the use of essential oils in infants and toddlers is not without controversy. Thus, not every essential oil is suitable for every age and every child.
  • the use of 1.8 cineole eg in eucalyptus oil
  • this ingredient dissolves the viscous mucous membrane of the respiratory tract, but can not reliably cough up infants under the age of 6 months.
  • due to a hyperemia the sensitive bronchial mucosa of infants, which can lead to a life-threatening respiratory distress, depending on the "sensitivity" of the infant.
  • the clothing of the child is dirty, or it requires an additional carrier medium for the oil, for example. A Wattebauschs. After opening the bottle, the oil has only a limited shelf life. The child's clothing and pacifier components in contact with the oil must be cleaned in one additional step.
  • the change of the cartridge 70 can, for example, be made by the bayonet lock 85, even if the pacifier 1 is in the mouth of the child.
  • a twist lock with safety stopper is an alternate push-and-turn closure and is considered to be part of the disclosure.
  • Other types of closure of the cartridge 70 are also possible and are considered to be within the scope of the disclosure.
  • the bayonet lock is a parental lock, as it is in principle not possible for infants and toddlers to perform the relatively complicated pressure and rotational movement. This also applies, mutatis mutandis, to screw caps with safety stoppers.
  • a simple screw cap between the cap-shaped end 80 and the holding element 75 would pose a risk.
  • a cartridge is provided.
  • the cartridge is typically configured to load a pacifier with drug.
  • the cartridge includes: a cartridge wall enclosing a cavity and at least one opening in the cartridge wall which typically connects the cavity to an exterior space around the cartridge.
  • the cartridge is typically configured to be releasably connected to a pacifier.
  • the opening of the cartridge, after connecting the cartridge to the pacifier, is typically oriented so that, in use, the pacifier is in proximity to and aligned with the child's nostrils.
  • the cavity of the cartridge may contain a composition, which is typically a semi-solid or liquid composition.
  • the composition may contain at least one lipophilic, typically volatile mixture.
  • the mixture of substances may be an essential oil.
  • the cartridge When maximally filled with the composition, the cartridge has a weight of from 1 g to 7 g, preferably from 2 g to 6 g, particularly preferably from 2.5 g to 5 g.
  • the oily liquid may comprise at least one therapeutic agent which may be delivered via the at least one orifice and, in the use state of the pacifier, via the nose into the respiratory tract of the infant
  • the essential oil may typically be selected from the group consisting from blackcurrant oil (Nigella sativa), chamomile oil (Matricaria chamomilla), pine needle oil (Picea abies), angelica (Angelica archangelica), eucalyptus oil (Oleum eucalypti) and combinations thereof.
  • the at least one opening of the cartridge is typically designed in such a way that no liquid can escape from the cartridge.
  • the cartridge may comprise a removable closure which closes the at least one opening in a liquid-tight (in particular hermetic) manner.
  • the cartridge according to the invention has a maximum spatial extent, which is characterized in that the cartridge can be completely enclosed by an imaginary hollow sphere with a radius of 1.5 cm. Typically, there is no point of contact and / or intersection between the sphere surface and the cartridge. Cartridges exceeding the impending spatial extent are perceived by the child to be sterically disturbing and "pacifier-alien.” Moreover, such oversized cartridges interfere with the child's vision, and affect the weight of the baby. those pacifiers (see above).
  • the cavity of the cartridge typically has a volume of 0.5 ml to 3 ml, preferably 1 ml to 2 ml.
  • the cartridge wall contains plastic or aluminum.
  • the plastic is selected from PE, PET, PVC, PS, PP, PA and / or PC, preferably PE and / or PET.
  • the cartridge wall may be made of plastic, preferably made of PE and / or PET, or of aluminum, or may consist of the aforementioned materials.
  • embodiments pertain to the use of a pacifier for delivering upper respiratory tract (typically mouth, throat and nose) to infants and toddlers (children aged 0 to 2 years).
  • embodiments relate to a pacifier for use in the treatment of upper respiratory tract (typically the mouth, throat and nose) disorders of infants and infants (children aged 0 to 2 years).
  • the pacifier according to the invention makes it possible to deliver active substances both to the nose and to the mouth / throat. This can be done simultaneously or sequentially as needed.
  • embodiments relate to a liquid form (particularly saliva) erodible (i.e., dissolvable) dosage form typically configured for a pacifier comprising a drug-loadable nipple.
  • the pharmaceutical form is provided in the form of a dosage form suitable for sucking (for example in the form of a lozenge), and comprises a first active substance 17.
  • the dosage form is designed such that it can be introduced into the teat as a refillable element. That is, the dosage form has the dimensions and properties required to be inserted into the nipple of the pacifier.
  • the required dimensions and properties of the drug form depend essentially on the particular configuration of the nipple, and in particular of the respective mechanism for introducing the pharmaceutical form.
  • the passage passage 50 sets the course as to whether or not a dosage form can be introduced into the nipple 10.
  • the dosage form is also typically a composition for use in the treatment of diseases of infants and infants, and more particularly for topical (local) treatment of upper respiratory tract disorders in infants and infants.
  • the dosage form is a solid dosage form such as a lozenge, chewable tablet, sublingual tablet, buccal tablet, dragee, capsule, candy, fruit gum, gum candy, jellybean, marshmallow candy, gum drop and combination thereof.
  • the dosage form is not in the form of homeopathic globules or as a coating on the teat wall.
  • embodiments of the present invention also relate to a drug form (drug composition) in a suitable for sucking dosage form, typically for use in the treatment of diseases of infants and infants, in particular for the topical (local) treatment of upper respiratory tract disorders of infants and infants.
  • the dosage form is typically a solid (preferably single dose) solid dosage form (typically liquid, especially saliva), especially for prolonged oral cavity residence time for use in the treatment of infants and infants.
  • the dosage form according to the invention is a dosage form which can be dissolved by sucking (with the aid of saliva).
  • the drug is therefore intended for the treatment of children in the 1st and 2nd year of life (ie for the treatment of children up to and including 2 years).
  • time in the oral cavity is meant the time required to completely dissolve the dosage form in the oral cavity, typically by sucking with the aid of saliva Typically, the time to fully dissolve the dosage form according to the invention in the oral cavity is about 1 to about 30 minutes, more typically about 2 to about 25 minutes, even more typically about 5 to about 15 minutes
  • the residence time in the oral cavity can be determined based on corresponding dissolution tests described in pharmacopoeias.
  • the dosage form according to the invention is intended for use in the treatment of diseases of infants and young children.
  • the dosage form according to the invention is a dosage form suitable for the topical treatment of diseases of the upper respiratory tract.
  • Upper respiratory tract disorders are typically cough, catarrh, mucosal irritation in the upper airways, and / or inflammatory diseases of the oropharynx, i. Oral and pharyngeal inflammation, such as sore throat, throat scratching, hoarseness, dry throat and / or gingivitis. These diseases often occur as a concomitant of cold and flu infections, but also as independent diseases.
  • Non-limiting examples of such inflammatory diseases of the cervical area are throat inflammation, especially angina, laryngitis, pharyngitis, and tonsillitis. Such diseases of the throat / throat are often accompanied by dysphagia. Also inflammations in the area of the oral cavity, such as Stomatitis, gingivitis, oral mucosal lesions, inflammation caused by teething and the like, have a very unpleasant symptoms for children and are included in the invention.
  • the dosage form has a weight of from 200 mg to 1000 mg, preferably from 300 mg to 700 mg.
  • the dosage form according to the invention typically contains a first active substance 17.
  • the first active substance 17 is typically selected from the group consisting of local antibiotics, local anesthetics, antiseptics, expectorants, anticariogenic agents, mucous drugs or their extracts, tanning agent drugs or their extracts, and combinations thereof. Further possible drug classes for the drug are antitussives, An exemplary topical antibiotic is tyrotricin, preferably used in combination with lactoferrin and lysozyme.
  • Non-limiting examples of local anesthetics are benzocaine or lidocaine.
  • Non-limiting examples of local antiseptics are octenidine, chlorhexidine, triclosan, dequalinium chloride, cetylpyridinium chloride, hexamidine diisethionate, amylmetacresol, 2,4-dichlorobenzyl alcohol, benzalkonium chloride.
  • Expectorants are medicines that liquefy the mucus in diseases with tough mucus formation, promote the removal of the mucus or facilitate expectoration.
  • Non-limiting examples of expectorants are bromhexine and its metabolites ambroxol, acetlycysteine carbocysteine, and / or guaifenesin.
  • Non-limiting examples of phlegm drugs are ribwort plantain (Plantago lanceolata L), Icelandic moss (Liehen islandicus), marshmallow (Althaea officinal L.), mallow (Malva sylvestris L. and M. neglecta TRUE), boxhorn clover (Trigonella foenum-graecum L.) .), Salep and quince (Cydonia oblonga MILL.) And their combinations, preferably plantain (Plantago lanceolata L.).
  • Non-limiting examples of tanning agent drugs are pelargonium, blackberry (Rubus fruetiosus), oak (Quercus rubor and / or Quercus petraea), goose fingerwort (Potentilla anserina), cloves (Szygium aromaticum), blueberry (Vaccinium myrtillus), myrrh (Commiphora molmol ), Ratanhia (Krameria triandra), Sage (Salvia triloba), Blackthorn (Prunus spinosa), Deadnettle (Lamium album), Bloodroot (Potentilla erecta), Strawberry (Fragaria vesca), Hymenoptera (Agrimonla eupatoria), Lady's mantle (Alchemilla xanthochlora ), Rose (Rosa gallica), Meadow button (Sanguisorba officinalis) and their combinations.
  • the ingredients of drug drugs such as ivy, peppermint, thyme, primrose,
  • the concentration of the first active substance 17 in the dosage form according to the invention can vary within wide ranges, depending on the active ingredient and the age of the child.
  • the dosage form according to the invention contains the first active ingredient 17 in a therapeutically effective amount, in particular from 0.05 to 30% by weight, typically 0.1 to 20% by weight, more typically 0.2 to 10% by weight. more typically 0.5 to 5% by weight, based on the total weight of the dosage form. Nevertheless, depending on the application, it may be advantageous or necessary to deviate from the aforementioned quantities.
  • the dosage form according to the invention typically comprises a matrix.
  • the active substance is typically embedded in the matrix in the dosage form according to the invention.
  • the matrix is a solid, in particular when sucking and / or saliva dissolvable matrix.
  • the matrix is in the dosage form according to the invention typically in amounts of 70 to 99.05 wt .-%, more typically 80 to 99.9 wt .-%, still typistically 90 to 99.8 wt .-%, more typically 95 to 99.9 Wt .-%, based on the total weight of the dosage form.
  • the matrix comprises a hydrocolloid, especially those selected from the group consisting of starch, cellulose, pectins, gum arabic, galactomannans, carubin, agar, carrageenan, alginates, gelatin, caseinates, xanthan , Dextrans, scleroglucan, and combinations thereof.
  • the dosage form according to the invention has elastic and / or plastic properties.
  • the dosage form generally has elastic properties when they change their shape under the action of force and can return to the original form when the acting force ceases.
  • the dosage form has plastic properties if it is irreversibly deformed when force is applied after exceeding a yield point and this shape is retained after exposure.
  • the dosage form may exhibit nonlinear elastic behavior, in particular rubber elasticity.
  • the dosage form has a Shore A hardness of from 1 to 30, more typically from 2 to 25, more typically from 5 to 15.
  • Shore hardness A is typically determined according to DIN ISO 7619-1 standard. Since the active substance has no significant influence on the Shore hardness A, it can also be said that the matrix has a Shore A hardness of 1 to 30, more typically from 2 to 25, more typically from 5 to 15. If the Shore hardness A is too small, the cohesion of the dosage form is not guaranteed and causes the dosage form to lose its shape instantaneously under pressure (chewing movements) and to dissolve too rapidly (as with pure gelatine, for example).
  • the drug form according to the invention is optimally suitable for use in a drug-loadable nipple of a pacifier.
  • the drug form according to the invention can optimally compensate for the pressure caused by the sucking and chewing movement of the child without it having a disturbing effect on the child.
  • This is particularly advantageous, for example in comparison to conventional lozenges (such as Dolo-Dobendan® throat tablets) and neck pastilles with a higher Shore A hardness (such as "Ipalat®) mild", which are rigid and therefore disturbing foreign bodies during the suction movement
  • Such "harder” dosage forms are not or only very poorly accepted by babies.
  • the pharmaceutical form of the invention differs from commercially available tablets for babies, such as, for example, vitamin D3 tablets, etc., which are intended to dissolve within a few seconds on contact with liquid. But it also differs from conventional fruit gums, etc. in that it is tailor-made for infants and toddlers.
  • the drug forms according to the invention on the age-appropriate drug dose for the respective indication and can be used by the parents stress-free and without extensive research regarding dosage / application, etc.
  • the dosage forms according to the invention represent a heretofore unknown form of administration in that they are tailor-made for children up to 2 years.
  • the dosage form may further include, in addition to the active ingredient in the appropriate dosage depending on the type of dosage form conventional excipients (fillers, sequestering agents, etc.). These are widely known to the person skilled in pharmaceutical technology and can be used in a suitable manner. For example, in a fruit gum in addition to active ingredient and hydrocolloid sweeteners, acids, fruit and vegetable extracts, flavors, water, plasticizers, and sequestering agents may be included. For example, sugars, glucose syrup, fructose and sugar alcohols are used as sweeteners. Typically, the dosage form has no disintegrant.
  • the dosage form according to the invention can be used in particular as a refillable element, in a drug-loadable nipple of a pacifier.
  • the pacifier may be a pacifier according to the present invention, or any other drug-loadable pacifier, that is, each pacifier is configured to temporarily integrate a (solid) dosage form such that it in use of the pacifier an active substance to the oral cavity of the child.
  • the dosage form according to the invention can be provided in a variety of child-friendly forms, for example as animal figures, and can furthermore be packed as a single dose.
  • Exemplary embodiments of the medicament form according to the invention Exemplary embodiment 1:
  • the exemplary embodiment 1 relates to a dosage form according to the invention in the form of fruit gums with the active compounds 2,4-diclorobenzyl alcohol and amylmetacresol, and their preparation.
  • the starting materials glucose syrup, sugar, modified starch and pectin are boiled with the addition of water. Then citric acid and, if necessary, flavors and coloring fruit and vegetable extracts are added and mixed. Thereafter, the hot mass is cooled to about 60 ° C and the antiseptic active ingredients 2,4-diclorobenzyl alcohol and amylmetacresol homogeneously stirred therein. The still warm mass is poured into powder-filled and embossed molds. The fruit gum mass solidifies by cooling, whereby the dosage form according to the invention arises.
  • the solidified Fruchtgummilikilikilikilikilikin be formed and dried in an air-conditioned room at a drying temperature between 45 and 55 ° C over a drying period of 36 to 96 hours. Then the fruit gums are freed from adhering powder thickness, surrounded with a thin film of a release agent and packed in single doses.
  • Embodiment 2 refers to a dosage form according to the invention in the form of gum drops with the active ingredient "ivy dry extract” (5-7.5: 1), extracting agent: ethanol 30% (m / m) (35 mg per 5 ml), and their preparation.
  • active ingredient "ivy dry extract”
  • extracting agent ethanol 30% (m / m) (35 mg per 5 ml)
  • the starting materials fruit juice and gelatin are combined and allowed to stand for about 5-10 minutes. Lemon juice and sugar are added.
  • the mixture is heated under moderate heat (about 40 ° C) for about 10 min. stirred.
  • the ivy dry extract is added with uniform stirring.
  • the still warm mass is poured into powder-filled and embossed molds.
  • the Gummidropmasse solidifies by cooling, wherein the dosage form according to the invention is formed.
  • the solidified rubber drops are molded and dried in an air-conditioned room at a drying temperature between 45 and 55 ° C over a drying period of 36 to 96 hours. Subsequently, the rubber drops are freed from adhering powder thickness, surrounded with a thin film of a release agent and packaged in single doses.
  • Embodiment 3 relates to a dosage form according to the invention in the form of gumdrops (gelatin-free) with the active ingredient ambroxol hydrochloride, and their preparation.
  • the agar-agar powder and the starch are mixed in the fruit juice, and then honey, aniseed fennel extract, sugar and salt are added thereto.
  • the mixture is heated under moderate heat (about 40 ° C) for about 10 min. stirred and then boiled briefly with stirring until a viscous mass has resulted. Thereafter, the hot mass is cooled to about 60 ° C, and lemon juice and ambroxol hydrochloride stirred homogeneously therein.
  • the still warm mass is poured into powder-filled and embossed molds.
  • the gum candy solidifies by cooling to form the dosage form according to the invention.
  • the solidified gumdrops are shaped and dried in an air-conditioned room at a drying temperature of between 45 and 55 ° C over a drying time of 36 to 96 hours. Then the gumdrops are freed from adhering powder, surrounded with a thin film of a release agent and packed in single doses.
  • Embodiment 4 In Example 4, the Shore A hardness of inventive dosage forms AI (fruit gum according to Embodiment 1), A2 (Gummidrop according to Embodiment 2) and A3 (gum base according to Embodiment 3), and the Shore A hardness of a commercial
  • a compliance test was carried out with comparable dosage forms of the dosage forms AI-A3 and Ipalat® mild (according to DIN ISO 7619-1 standard (5 tests per dosage form). The size of "Ipalat® mild” was adapted accordingly) in a pacifier according to the invention in 5 children at the age of about 1, 5 years carried out.
  • X Sucker is spat out after a short time (a few seconds) and no longer accepted. Dosage form can not be used. Pacifier with atomizer
  • Fig. 8 shows a pacifier 1 according to further embodiments, which is designed to generate an aerosol.
  • the pacifier 1 comprises a nipple 10, which may be designed according to the prior art, or according to other embodiments described herein, such as those described with reference to Figures 1 to 5.
  • the pacifier 1 has an atomizer unit 100 configured to atomize a liquid 18b.
  • the liquid 18b may typically comprise an aqueous or low viscosity oily liquid.
  • the liquid 18b may comprise an aqueous liquid, typically an aqueous solution.
  • a therapeutic agent can be dissolved, which can be delivered via the nose in the respiratory tract of the infant.
  • NaCl sodium chloride
  • therapeutic agents dissolved in the fluid 18b include agents from the group of bronchodilators (for example formoterol) and steroids (for example glucocorticoids, such as budesonide).
  • the atomizer unit 100 typically has at least one opening 105, which is aligned in the use state of the pacifier 1 so that an aerosol generated in the nebulizer unit can be delivered in the direction of the nose of the infant.
  • the atomizing unit 100 may be secured via a holding member 75 to a flat plate 20 of the pacifier 1, on which the nipple 10 is attached.
  • the atomizing unit 100 or the holding element 75 is attached to the side facing away from the teat 10 of the shield 20.
  • the atomizer unit 100 is located between the holding element 75 and a preferably cap-shaped closure 80. This is designed to engage with the holding element 75, so that the destruction unit 100 is held between the holding element 75 and the closure 80.
  • the seal 80 typically has a recess through which the aerosol can exit from the opening 105 of the atomizer unit 100.
  • the termination 80 may be releasably connectable to the retention member 75 by a closure mechanism 85 which requires a combination of at least two simultaneous or sequential movements.
  • a spring 90 and a pressure ring 95 are preferably provided in the cap-shaped end 80 (not shown, see approximately FIG. 5).
  • FIG. 9 shows in an exploded view a non-limiting example of the construction of an atomizer unit 100 according to embodiments.
  • the atomizer unit 100 typically comprises a piezo atomizer 110.
  • the liquid 18b to be atomized is typically stored in a cartridge 125 or, in principle, in a container.
  • the atomizer unit 100 is configured such that the cartridge 125 can be changed quickly, easily, or in a few simple steps, for example Consumption of the liquid 18b, or to switch to another liquid 18b, for example, with another solvent or another dissolved active ingredient.
  • An electronic control unit 115 is operatively coupled to the piezo atomizer 110. It draws energy from a power source 120, such as a battery or a battery, which, as shown in Fig. 9, structurally combined with the control electronics 115.
  • a power source 120 such as a battery or a battery, which, as shown in Fig. 9, structurally combined with the control electronics 115.
  • a wick unit 140 which ensures the transport of the liquid 18b from the cartridge 125 to the piezo atomizer 110.
  • a wick made of natural or synthetic material may be provided, for example, which via the capillary action and / or by gravity directs the liquid 18b out of the cartridge 125 to the membrane of the piezo atomizer 110.
  • the piezo-side end of the wick touches a surface of the membrane of the piezo atomizer.
  • the liquid 18b is thus transported past the membrane of the piezo atomizer, where it is atomized by the high frequency movement of the membrane.
  • Typical frequencies for operation of the piezoelectric atomizer are several tens of kHz to several hundreds of kHz, for example, from 30 kHz to 400 kHz, more typically from 50 kHz to 300 kHz.
  • an adjuster such as a potentiometer (not shown) may be provided which acts on the drive electronics 115.
  • an on / off switch for the activation and deactivation of the piezo atomizer 110 or the atomization unit 100 is also provided.
  • the piezo atomizer 110 is activated by means of an integrated pressure switch when mounting the closure 80 or deactivated after removal.
  • the elements of the atomizing unit 100 described above are each designed as separate assemblies. They are fastened to a base body 130 and together with it form the atomizer unit 100. Each form its own assembly: the control electronics 115, including the power source 120; the piezo atomizer 110; the wick unit 140; and the cartridge 125 for the liquid 18b.
  • the assemblies can be designed as follows in order to achieve a simple assembly or disassembly of the atomizer unit 100.
  • the wick unit 140 is configured to be attached to the body 130. Thereafter, the cartridge 125 is pushed into a recess in the drive electronics 115.
  • the control electronics 115 is placed on the body and can be screwed.
  • the wick unit is fixed between control electronics 115 and the main body 130.
  • the piezo atomizer 110 is typically plugged into the control electronics 115 and / or screwed.
  • the control of the nebulizer unit 100 may be implemented, as described, via a switch or button integrated therein, or by remote control.
  • a remote control can be designed as a per se known radio remote control with a hand control unit or wireless control by an information technology device.
  • this can be a mobile device such as a smartphone or a tablet.
  • the remote control can be performed approximately (non-limiting) via the wireless standards WLAN or Bluetooth.
  • the control electronics in the atomizer unit 100 typically include an integrated circuit with an antenna, which allows the control by means of WLAN or Bluetooth.
  • the operation can be done via a browser interface, or typically via its own application software for the respective operating system. In the case of smartphones or tablet computers, this can be, in particular, a mobile application (app) which is usually downloadable or made available there from an Internet-based App Store.
  • the connection between the information technology device and the atomizer unit 100 may be designed as a direct connection in the ad hoc mode.
  • both devices are part of a common WLAN (wireless network) with a common WLAN access point, typically a WLAN router.
  • a plurality of pacifiers with atomizer unit 100 can also be operated jointly in a WLAN, and be jointly controlled by one (or more) information technology device. In this way, in a nursery or in a clinical setting, for example, a plurality of pacifiers according to embodiments may be applied and commonly controlled by an operator, either with a mobile device or via a stationary PC connected to the WLAN.
  • an interval nebulization may be adjustable, e.g. a fixed duration of nebulization, followed by a break with a duration also defined after which the nebulization begins again. Also, a fixed duration may be programmable by remote control so that the nebulizer - e.g. at night - after a period of time completely off.
  • a cartridge which can typically be used in a pacifier with atomizer.
  • the cartridge is typically configured to load the pacifier with drug.
  • the cartridge comprises: a cartridge wall enclosing a cavity and at least one opening in the cartridge wall which, after loading the pacifier, typically forms a fluidic connection with the pacifier.
  • the cartridge is typically configured to be releasably connected to the pacifier.
  • the cartridge may further comprise an aqueous liquid.
  • the aqueous liquid is an aqueous solution.
  • the cartridge When maximally filled with the aqueous liquid, the cartridge has a weight of from 1 g to 7 g, preferably from 2 g to 6 g, particularly preferably from 2.5 g to 5 g.
  • the aqueous fluid may comprise at least one therapeutic agent which may be delivered via the nose into the respiratory tract of the infant by nebulizing the fluid in the use state of the pacifier
  • the therapeutic agent typically contains at least one of NaCl, bronchodilators , and steroids.
  • the cartridge may comprise a removable closure which seals the at least one opening in a liquid-tight manner.
  • the cartridge of the invention has a maximum spatial extent, which is characterized in that the cartridge can be completely enclosed by an imaginary hollow sphere with a radius of 1, 5 cm. Typically, there is no point of contact and / or intersection between the sphere surface and the cartridge.
  • Cartridges that exceed the impending spatial reach are perceived by the child to be sterically disturbing and "pacifier-alien.”
  • oversized cartridges interfere with the child's vision and affect the weight of the loaded pacifier (see above) typically has a volume of from 0.5 ml to 3 ml, preferably from 1 ml to 2 ml
  • the cartridge wall contains plastic or aluminum, of which the plastic is selected from PE, PET, PVC, PS, PP, PA and / or PC , preferably PE and / or PET
  • the cartridge wall may be made of plastic, preferably of PE and / or PET, or of aluminum, or may consist of the aforementioned materials.
  • a nipple for a pacifier comprising a rubbery material, the nipple having a central cavity for receiving a first active substance, and the nipple in at least part of it Outside surface having a plurality of passages connecting the cavity with an outside space around the pacifier, so that the Passages in the state of use of the pacifier connect the cavity with the mouth of a child.
  • nipple according to any one of the preceding aspects, wherein the nipple comprises a (particularly round) end piece for detachable attachment to a shield and a mouthpiece, and wherein the passageway is typically a slot in a surface of the round End piece is executed.
  • Sucker according to one of the preceding aspects, having an axial extent of about 2.5 to about 3.2 cm (measured from the nipple tip to the shield).
  • the nipple has a transverse axis which is perpendicular to the longitudinal or axial axis of the nipple, and in the state of use of the pacifier parallel to a connecting line of the mouth of the wearer of the pacifier, and wherein the teat has a width of 1.5 cm to about 2.8 cm in the direction of the transverse axis at its widest point, which is usually in use in the mouth during use.
  • a nipple according to any one of the preceding aspects comprising three to one hundred and fifty (3 to 150), typically four to one hundred (4 to 100) ports.
  • a nipple for a pacifier comprising a tail for attachment to a shield, and a mouthpiece
  • the mouthpiece comprises an upper portion, which in use mainly (substantially) rests on the palate of the child, and comprises a lower portion which in use mainly (substantially) rests on the tongue of the child
  • the mouthpiece has a plurality of passages in at least part of its wall, the passages being positioned substantially in the upper region and the lower region, wherein a passage belongs to the upper region when the normal vector of the outer surface at the position of the passage has a component in the direction from the lower region (tongue near) to the upper region (near the palate), and wherein a passage belongs to the lower region when the normal vector of the outer surface at the position of the passageway is a component toward the upper region (near the palate) to the lower part (tongue-near).
  • a sucker configured for a pacifier comprising: a body having a cross-sectional shape extending along a longitudinal axis of the nipple, the body having a rubbery body wall, and the body comprising a mouthpiece and an endpiece, the rubbery body wall of the mouthpiece forms a central cavity for receiving a first active substance, and the rubbery body wall of the endpiece is designed such that it can be connected to a shield, wherein the rubbery body wall of the mouthpiece has a plurality of passages, which surrounds the cavity with an outer space connect the pacifier so that the passages in the use state of the pacifier connect the cavity with the mouth of a child, and wherein the body wall of the mouthpiece and / or the end piece in an in use state with the palate, tongue and lips of the child not coming into contact surface ( Wall) has a passage passage which d erart is designed so that it is liquid-tight in the normal state, and can be introduced by the first active ingredient as part of a solid dosage form in the
  • Pacifier comprising:
  • a sucker comprising a rubbery material
  • the nipple has a central cavity for receiving a drug, and in at least a part of its outer surface having a plurality of passages connecting the cavity with an outside space around the pacifier, so that the passages in the use state of the pacifier, the cavity with the mouth of a Child connect, wherein the teat in a state of use outside the mouth and facing away from the mouth of the child rear wall of the teat has a valve in the form of a passage passage which is designed such that it is liquid-tight in the normal state, and through which the active ingredient introduced as part of a solid dosage form in the cavity, in particular as a refillable element can, and wherein the passage passage is designed as a purely structural modification of the rubber-like material of the nipple,
  • pacifier comprising:
  • a sucker comprising a rubbery material
  • the nipple has a central cavity for receiving a drug, and in at least a part of its outer surface having a plurality of passages connecting the cavity with an outside space around the pacifier, so that the passages in the use state of the pacifier, the cavity with the mouth of a Child, wherein the nipple in the use state of the pacifier in a non-palatal, tongue and lips surface (wall) having a valve in the form of a passage passage which is designed so that it is liquid-tight in the normal state, and by the Active ingredient can be introduced into the cavity as a constituent of a solid dosage form, in particular as a refillable element, and wherein the passage passage is typically designed as a purely structural modification of the rubber-like material of the teat,
  • Pacifier comprising:
  • a sucker comprising a rubbery material, the sucker having a central cavity for receiving a first active agent, and the sucker having in at least a part of its outer surface a plurality of passages connecting the cavity to an outside space around the soother Passages in the state of use of the pacifier connect the cavity with the mouth of a child,
  • the sucker comprises an end piece for attachment to a shield, as well as a mouthpiece,
  • the mouthpiece comprising a nipple neck and a nipple body, the nipple neck being the connection between the end piece and nipple body,
  • the nipple neck comprises an inner partition which has a valve in the form of a passage passage which is designed so that it is liquid-tight in the normal state, and through which the active ingredient can be introduced as part of a solid dosage form in the cavity, in particular as a refillable element
  • the average Passage is typically designed as a purely structural modification of the rubber-like material of the nipple, and wherein the passages are typically provided only in the region of the nipple body, and optionally
  • Pacifier with Replaceable Cartridge [001 15] 16. Pacifier comprising:
  • An exchangeable cartridge having an active substance, with at least one opening through which the active ingredient can be discharged;
  • the holding element is attached to the side facing away from the sucker of the shield and is designed so that the at least one opening of the cartridge is exposed in the use state of the pacifier exposed to the nose of the child, so that the active ingredient can be delivered in the direction of the nose ,
  • a pacifier according to aspect 16 further comprising a, preferably cap-shaped, conclusion that is designed to engage with the holding element, so that the cartridge between the holding element and completion is supported.
  • a pacifier according to aspect 17 wherein the closure is releasably connectable to the retaining element by a locking mechanism which requires a combination of at least two simultaneous or sequential movements.
  • a pacifier for producing an aerosol comprising:
  • an atomizer unit configured to atomize a liquid.
  • the atomizer unit comprises a piezoelectric atomizer.
  • the nebulizer unit further comprises:
  • a drive electronics which is operatively coupled to the piezoelectric atomizer
  • wick unit configured to transport the liquid from the cartridge to the piezo atomizer.
  • a pacifier according to aspect 29 further comprising a preferably cap-shaped termination configured to engage with the retaining member so that the nebulizer unit is supported between the retaining member and the termination.
  • the closure with the retaining element by a closure mechanism which requires a combination of at least two simultaneous or successive movements, is releasably connectable, and preferably in the cap-shaped end of a spring and a pressure ring are provided.
  • a pacifier according to any one of the preceding aspects 23-31 wherein the nipple has a central cavity for receiving a first active substance, and in at least a part of its outer surface has a plurality of passages which surround the cavity with an outer space around the pacifier connect so that the passages in the use state of the pacifier connect the cavity with the mouth of a child, and the teat optionally has a passage passage in a state in use outside of the mouth, which is designed such that it is liquid-tight in the normal state, and by which the first active ingredient can be introduced into the cavity as a constituent of a solid dosage form, in particular as a refillable element, and wherein the passage passage is preferably designed as a purely structural modification of the rubber-like material of the teat.
  • nebulizer unit in a pacifier for generating an aerosol by nebulizing a liquid, preferably an aqueous liquid.
  • a method of producing an aerosol comprising:
  • drug form for use in the treatment of diseases of infants and young children, comprising at least one active ingredient, wherein the dosage form is erodible by means of liquid and is present in a suitable for sucking, solid, single-dose dosage form.
  • dosage form according to any one of the preceding aspects 35-37 wherein the concentration of the active ingredient of 0.05 to 30 wt .-%, typically 0.1 to 20 wt .-%, more typically 0.2 to 10 wt %, more typically 0.5 to 5% by weight, based on the total weight of the dosage form.
  • concentration of the active ingredient of 0.05 to 30 wt .-%, typically 0.1 to 20 wt .-%, more typically 0.2 to 10 wt %, more typically 0.5 to 5% by weight, based on the total weight of the dosage form.
  • the matrix comprises a hydrocolloid selected from the group consisting of starch, cellulose, pectins, gum arabic, galactomannans, carubin, agar, carrageenan, alginates, gelatin, caseinates, xanthan gum , Dextrans, scleroglucan, and combinations thereof.
  • the active substance is selected from the group consisting of local antibiotics, local anesthetics, antiseptics, expectorants, anticariogenic agents, mucous drugs or their extracts, tannin drugs or their extracts, and combinations thereof.
  • composition according to one of the preceding aspects 35-44 wherein the pharmaceutical form has a Shore A hardness, determined in accordance with DIN ISO 7619-1 standard, from 1 to 30, more typically from 2 to 25, still type-safe 5 to 15.
  • a drug-loadable pacifier which is typically a pacifier according to the present invention
  • a sucker which is typically a sucker according to the present invention.
  • a cartridge which is typically a cartridge according to the present invention.
  • Aspect V Cartridge
  • a cartridge for loading a pacifier with active agent comprising: a cartridge wall enclosing a cavity, and at least one opening in the cartridge wall connecting the cavity to an exterior space around the cartridge, wherein the cartridge is configured in that it can be detachably connected to a pacifier, the opening of the cartridge, after connecting the cartridge to the pacifier, being oriented so as to be close to and aligned with the nostrils of the child when the pacifier is in use , 50.
  • the cavity contains a composition, wherein the composition is typically a semi-solid or liquid composition.
  • the substance mixture is an essential oil.
  • Cartridge according to one of the preceding aspects 50-52 wherein the cartridge, when filled to the maximum with the composition, has a weight of from 1 g to 7 g, preferably from 2 g to 6 g, particularly preferably from 2.5 g to 5 g.
  • a cartridge according to aspect 52 wherein the essential oil is selected from the group consisting of tincture oil (Nigella sativa), chamomile oil (matricaria chamomilla), pine needle oil (picea abies), angelica (angelica archangelica) eucalyptus oil (oleum eucalypti) and combinations thereof.
  • the essential oil is selected from the group consisting of tincture oil (Nigella sativa), chamomile oil (matricaria chamomilla), pine needle oil (picea abies), angelica (angelica archangelica) eucalyptus oil (oleum eucalypti) and combinations thereof.
  • Cartridge according to one of the preceding aspects 50-55 wherein the at least one opening of the cartridge is designed so that the composition can not escape from the cartridge in a liquid state.
  • Cartridge according to one of the preceding aspects 49-56 further comprising a detachable closure which seals the at least one openings liquid-tight (in particular hermetically).
  • Cartridge according to one of the preceding aspects 49-59 wherein the cartridge wall plastic (typically selected from PE, PET, PVC, PS, PP, PA and / or PC) or aluminum.
  • the cartridge wall plastic typically selected from PE, PET, PVC, PS, PP, PA and / or PC
  • Cartridge according to the preceding aspect 60 wherein the cartridge wall made of plastic, preferably made of PE and / or PET, or of aluminum is constructed.
  • a drug-loadable pacifier which is typically a pacifier according to the present invention
  • a sucker which is typically a sucker according to the present invention.
  • a dosage form which is typically a dosage form according to the present invention.

Abstract

L'invention concerne une sucette (1) destinée à produire un aérosol, comprenant, une tétine (10); et une unité de pulvérisation (100) conçue pour pulvériser un liquide (18b).
EP17828939.3A 2017-01-03 2017-12-29 Sucette équipée d'un dispositif d'inhalation Withdrawn EP3565622A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017100042.9A DE102017100042B4 (de) 2017-01-03 2017-01-03 Wirkstoffbeladbares Saugstück, Schnuller und Verwendung einer Arzneiform in einem Schnuller
PCT/EP2017/084851 WO2018127464A1 (fr) 2017-01-03 2017-12-29 Sucette équipée d'un dispositif d'inhalation

Publications (1)

Publication Number Publication Date
EP3565622A1 true EP3565622A1 (fr) 2019-11-13

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EP17828939.3A Withdrawn EP3565622A1 (fr) 2017-01-03 2017-12-29 Sucette équipée d'un dispositif d'inhalation

Country Status (3)

Country Link
EP (1) EP3565622A1 (fr)
DE (3) DE102017100042B4 (fr)
WO (1) WO2018127464A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109464284B (zh) * 2018-11-29 2022-08-26 陕西省人民医院 多重保护式住院婴儿专用辅助安抚装置
SE544941C2 (en) * 2020-06-15 2023-02-07 Vivolab Ab Pacifier comprising an aerosolization device

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1790504U (de) 1958-03-27 1959-06-18 Kurt Dr Med Sokol Medikamententraeger zum verabreichen von auf die mund- und rachenschleimhaut von saeuglingen und kleinstkindern einwirkenden medikamenten.
AU561009B2 (en) * 1982-01-12 1987-04-30 Magel Nicolene De Greef Anaesthetic induction device
US5395392A (en) 1989-10-02 1995-03-07 Suhonen; Jouko Device for the oral administration of an active substance for prevention of tooth decay in infants
CH684160A5 (de) 1991-09-13 1994-07-29 Nicole Maurer Schnuller zur oralen Verabreichung von Medikamenten.
EP0681824A1 (fr) 1994-05-11 1995-11-15 Wima Kunststoff Produkte Gmbh Sucette médicale pour administrer des médicaments
US5904140A (en) * 1997-06-24 1999-05-18 Mcgoogan; Elizabeth M. Medical pacifier
DE10239037A1 (de) * 2002-08-26 2004-03-11 Rüschen, Heinrich, FRCA Gummisauger (Schnuller) zur Verabreichung von medizinischen Gasen oder vernebelten Medikamenten an Kleinkinder und Babys
US20090062855A1 (en) * 2007-08-29 2009-03-05 Lemery Tammy L Baby nebulizer
DE202008005693U1 (de) 2008-04-24 2008-08-21 Weigert, Sabine Saugobjekt zur Einnahme von Wirk- und/oder Geschmacksstoffen
US9452274B2 (en) * 2011-01-20 2016-09-27 Pneumoflex Systems, Llc Metered dose atomizer
WO2014140774A1 (fr) * 2013-03-15 2014-09-18 Trudell Medical International Dispositif d'administration et kit, et procédé d'utilisation

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WO2018127464A1 (fr) 2018-07-12
DE102017100042A1 (de) 2018-07-05
DE202017006932U1 (de) 2018-11-19
DE102017100042B4 (de) 2019-02-21
DE202017006926U1 (de) 2018-11-12

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