EP4099973A1 - Device for the delivery of a liquid pharmaceutical and/or nutraceutical gelatin speciality to persons having difficulty in swallowing - Google Patents

Device for the delivery of a liquid pharmaceutical and/or nutraceutical gelatin speciality to persons having difficulty in swallowing

Info

Publication number
EP4099973A1
EP4099973A1 EP21706640.6A EP21706640A EP4099973A1 EP 4099973 A1 EP4099973 A1 EP 4099973A1 EP 21706640 A EP21706640 A EP 21706640A EP 4099973 A1 EP4099973 A1 EP 4099973A1
Authority
EP
European Patent Office
Prior art keywords
reservoir
cap
ranron
gelatin
delivery device
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.)
Pending
Application number
EP21706640.6A
Other languages
German (de)
French (fr)
Inventor
Nicolas MICHEAUD
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.)
Paediatis
Original Assignee
Paediatis
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 Paediatis filed Critical Paediatis
Publication of EP4099973A1 publication Critical patent/EP4099973A1/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/067—Flexible ampoules, the contents of which are expelled by squeezing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00—Containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material, by deep-drawing operations performed on sheet material
    • B65D1/09—Ampoules
    • B65D1/095—Ampoules made of flexible material
    • 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
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2203/00—Decoration means, markings, information elements, contents indicators

Definitions

  • the present invention relates to a device for delivering a liquid specialty, of pharmaceutical type and / or of food supplement type, in gelatin produced on a mole capsule type encapsulation machine.
  • the object of this invention is to facilitate the adaptation of drugs intended for adults for the benefit of children by a measured delivery of the contents of said capsules. It may also apply more broadly to people with swallowing difficulties.
  • Liquid forms of drugs can improve palatability and tailor doses to suit the age and weight of the patient.
  • the preparation extemporaneous without pediatric Marketing Authorization generally consists of transforming an adult form such as a tablet, capsule or even injectable into liquid oral preparations.
  • Liquid forms such as syrup and suspension have the disadvantage of not keeping once opened for first use.
  • Using a single dose of mole gelatin (for English softgel) for a single dosage allows you to use only one part of the pack of one medicine without degrading the other.
  • the savings, particularly in the hospital environment, are significant.
  • the use of pipettes can cause false routes if the liquid is sent to the back of the infant's throat. To avoid this risk, it is particularly recommended to exert slow and gradual pressure and to place the end of the syringe or pipette inside the child's cheek to avoid the risk of suffocation, which few parents do.
  • a traditional soft gelatin capsule or the twist-off type is unsuitable for pediatric use.
  • the object can be easily swallowed and may cause suffocation.
  • the present invention aims to remedy all of the drawbacks described above. It therefore aims to provide a device for the distribution of drugs or food supplements or the like, in the form of packaging which best meets the following requirements:
  • the device must remain simple and economical, allowing easy industrial manufacture and integration into a logistics chain.
  • a liquid specialty dispensing device for example of pharmaceutical or food supplement type, comprising a reservoir of molten gelatin and a cap hermetically closing the reservoir.
  • the device further comprises a tab disposed on the opposite side of the cap relative to the reservoir, the tab being filled with mole gelatin.
  • the cap is advantageously tear-off or detachable from the reservoir.
  • the reservoir comprises a portion of substantially cylindrical shape closed on the side of the tongue, and closing on the side of the line of weakness by a portion of substantially conical shape.
  • the delivery device can be molded from the same material, i.e. soft gelatin.
  • gelatin is biodegradable, the device can simply be dissolved in water after use and makes it possible to limit the use of plastic, aluminum or glass, unlike current systems comprising glass vials, pipettes, single-dose PET or sachet.
  • the delivery device can advantageously be molded in one piece.
  • the cap can be filled with mole gelatin.
  • the reservoir may have a line of weakness connecting it to the cap.
  • the line of weakness makes it easier to separate said cap from the rest of the device.
  • the tab may have variable information, for example information on the volume of liquid in the reservoir or the name of the products contained in the reservoir.
  • This tongue will have a cross section equal to or less than the diameter of the reservoir part. This allows during its industrialization to go through the different stages of drying and calibration. The manufactured device can thus rotate on itself during tunnel drying and can pass the calibration step without the transverse dimension of the tab being automatically interpreted as a non-conformity.
  • the method may include a step in which the delivery device is held by a user by means of the tab of said device.
  • the method may include a step of delivering to a child a drug dedicated to adults contained in the reservoir of said device.
  • FIG. 1 is a top view of one embodiment of a liquid specialty delivery device
  • FIG. 1 is a side view of the device shown in Figure 1
  • FIG. 1 is a rear view of the device shown in Figure 1
  • Figure 4 is a front view of the device shown in Figure 1,
  • FIG. 5 is a perspective view of a second embodiment of a liquid specialty delivery device.
  • variants of the invention comprising only a selection of characteristics described, subsequently isolated from the other characteristics described, if this selection of characteristics is sufficient. to confer a technical advantage or to differentiate the invention from the state of the prior art.
  • This selection includes at least one characteristic, preferably functional without structural details, or with only part of the structural details if this part alone is sufficient to confer a technical advantage or to differentiate the invention from the state of the prior art.
  • the necessary dose of active principle is contained in the reservoir of the capsule in its entirety.
  • the soft gelatin capsule is in this case used as a single dose system. It eliminates the need for a syringe or pipette.
  • capsules which have a protuberance forming a cap, to be cut with a scissor-type utensil.
  • the use of scissors is prohibited in hospitals, as opening them could lead to contamination of the product.
  • Unit doses in a similar form can be found in ophthalmology.
  • the practitioner is in contact with the liquid, causing a risk of contamination or a risk for the practitioner;
  • Figure 1 illustrates a liquid specialty delivery device 1 in the form of a mole gelatin capsule.
  • the device 1 comprises a reservoir 2 made of soft gelatin and a cap 3 hermetically closing the reservoir 2.
  • the cap 3 is integrally molded with the rest of the device.
  • the cap 3 is made entirely of gelatin and is preferably solid. It does not contain liquid, so the product is fully housed in the reservoir 2, which guarantees better compliance with the quantity to be ingested.
  • the reservoir 2 is airtight and contains a predetermined quantity of product.
  • the tank 2 has a weakening line 4 connected to the cap 3.
  • the cap 4 and the part of the reservoir 2 showing the line of weakness 4 form an opening system for the reservoir 2, allowing the product to be released without the use of tools.
  • the weakening line 4 is weakened and tends to break. Therefore, the user has access to the product without having been in contact or put an object in contact with said product, thus limiting any risk of contamination.
  • Tab 5 is filled with soft gelatin.
  • the entire device 1 is molded from the same material - which facilitates its manufacture - and in one piece. Thus there is no risk of perforation or leakage subsequent to the molding.
  • the tab 5 allows the practitioner and parents to hold the device during the delivery of the product.
  • the tab 5 offers the possibility of a grip so as not to exert pressure on the reservoir part 2 at the time of opening and thus prevent the exit of the liquid before delivery.
  • the tab 5 may present variable mentions 6, for example the name of the molecule or its code and dosage. It makes it possible to differentiate the products, because the dosage and the name of the product can be noted on it, thus limiting any risk of confusion.
  • the molecule can be chosen from the following group: paractetamol-acetaminophen, ibuprofen, elatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine, acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, sidenazolans, ondametron, ran , prednisone, ivermectin, vitamin D.
  • variable mentions 6 on the tongue 5 may be molded during the filling process. Other means of inscription can be envisaged, such as printing, engraving or adding a label.
  • the tongue 5 makes the device larger and wider in order to prevent any risk of suffocation if a child were to swallow it.
  • the tab 5 holds the device during delivery, allowing a better grip and thus preventing the risk of the child swallowing it.
  • Figure 5 illustrates a liquid specialty delivery device 11 in the form of a mole gelatin capsule.
  • the device 11 comprises a reservoir 12 of soft gelatin and a cap 13 hermetically closing the reservoir 2.
  • the reservoir 12 has a line of weakness 14 connected to the cap 13.
  • a tab 15, also called a tail, is added on the device 11, arranged on the opposite side of the cap 13 with respect to the reservoir 12.
  • the reservoir 12 comprises a portion of substantially cylindrical shape 16 disposed between a hemisphere 17 closing on the side of the tongue 15 and a partial hemisphere 18 closing on the side of the line of weakness 14.
  • the partial hemisphere closes on the side of the line of weakness 14 by a portion preferably of substantially conical shape 19.
  • the portion 19 could be cylindrical or flared.
  • the portion of substantially conical shape 19 can also make it possible to hold and close the reservoir 12, by one hand, while the line of weakness 14 is weakened and tends to break due to the forces exerted, for example by another hand, on the cap 13.
  • the pressure on the conical or flared part will prevent any liquid leakage and ensure that the final dose to be administered remains inside the reservoir.
  • the invention also relates to a device as described above in which the reservoir contains as liquid specialty a pharmaceutical composition comprising a molecule chosen from: paractetamol-acetaminophen, ibuprofen, melatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine , acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, silldenafil, caffeine, midazolam, ranitidine, ondansetron, prednisone, ivermectin, vitamin D.
  • a pharmaceutical composition comprising a molecule chosen from: paractetamol-acetaminophen, ibuprofen, melatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine , acetazolamide, dexamethazone, methotrexate,

Abstract

The invention relates to a device (1) for delivering a liquid speciality of the pharmaceutical or food supplement type, comprising a gelatin mole reservoir (2) and a cap (3) hermetically closing the reservoir, characterized in that it further comprises a tab (5) arranged on the opposite side of the cap with respect to the reservoir, the tab being filled with gelatin mole.

Description

DISPOSITIF DE DELIVRANCE DE SPECIALITE PHARMACEUTICUE ET/OU NUTRACEUTIOUE LIOUIDE EN GELATINE A L’INTENTION DES PERSONNES AYANT DES DIFFICULTES POUR AVALER. SPECIALTY PHARMACEUTICAL AND / OR NUTRACEUTIOUS GELATIN LIOUID DELIVERY SYSTEM FOR PERSONS WITH DIFFICULTIES IN SWALLOWING.
Domaine de l’invention Field of the invention
La présente invention concerne un dispositif de délivrance de spécialité liquide, de type pharmaceutique et/ou de type complément alimentaire, en gélatine fabriqué sur une machine d’encapsulation type capsules moles. À titre d’application particulière, mais non limitative, cette invention a pour objet une adaptation facilitée des médicaments dédiés aux adultes au profit des enfants par une délivrance mesurée du contenu desdites capsules. Elle peut aussi plus largement s’appliquer aux personnes ayant des difficultés à avaler. The present invention relates to a device for delivering a liquid specialty, of pharmaceutical type and / or of food supplement type, in gelatin produced on a mole capsule type encapsulation machine. As a particular, but non-limiting, application, the object of this invention is to facilitate the adaptation of drugs intended for adults for the benefit of children by a measured delivery of the contents of said capsules. It may also apply more broadly to people with swallowing difficulties.
État de la technique antérieure State of the prior art
En Europe, plus de 50 % des médicaments prescrits aux enfants et adolescents ne font pas l’objet d’une évaluation et d’une autorisation d’administration spécifiques à ces classes d’âge. Or, plus de 20 % des Européens en 2010 sont des enfants, représentant plus de 100 millions de personnes. In Europe, more than 50% of drugs prescribed to children and adolescents are not subject to an assessment and authorization for administration specific to these age groups. However, more than 20% of Europeans in 2010 were children, representing more than 100 million people.
La prise orale de médicaments sous forme de comprimés à l’état solide est souvent difficile pour les enfants et pour des personnes âgées, les comprimés ou capsules étant souvent trop gros. De plus, les doses à prescrire ne sont pas uniformes, et les comprimés actuels ne permettent pas une adaptation personnalisée des doses. Taking solid tablets orally is often difficult for children and the elderly, as the tablets or capsules are often too large. In addition, the doses to be prescribed are not uniform, and the current tablets do not allow a personalized adaptation of the doses.
Les formes liquides des médicaments permettent d’améliorer la palatabilité et de personnaliser les doses, en fonction de l’âge et du poids des patients. Liquid forms of drugs can improve palatability and tailor doses to suit the age and weight of the patient.
D’un point de vue industriel, lorsqu’un médicament de type comprimé est mis au point, faire un comprimé simplement plus petit ne convient pas à l’application pédiatrique. L’obtention d’une AMM (Autorisation de Mise sur le Marché) pour une forme liquide pédiatrique nécessite à minima un développement galénique supplémentaire. Ce surcoût tend à freiner le développement des spécialités pédiatriques. From an industry standpoint, when a tablet-type drug is developed, making a tablet simply smaller is not suitable for pediatric application. Obtaining a Marketing Authorization (Marketing Authorization) for a pediatric liquid form requires at least additional galenic development. This additional cost tends to slow down the development of pediatric specialties.
Ainsi, un nombre important de spécialités adultes sont données aux enfants grâce à une préparation extemporanée dite hors AMM. La préparation extemporanée hors AMM pédiatrique consiste généralement à transformer une forme adulte type comprimé, gélule ou même injectable en préparations orales liquides. Thus, a large number of adult specialties are given to children thanks to an extemporaneous preparation known as off-label. The preparation extemporaneous without pediatric Marketing Authorization generally consists of transforming an adult form such as a tablet, capsule or even injectable into liquid oral preparations.
Les formes liquides type sirop et suspension ont le désavantage de ne pas se conserver une fois ouvert pour une première utilisation. L’utilisation d’unidose en gélatine mole (pour l’anglais softgel) pour un dosage unique permet de n’utiliser qu’une partie de la boîte d’un médicament sans dégrader l’autre. Les économies notamment en milieu hospitalier sont importantes. L’utilisation de pipette peut provoquer des fausses routes si le liquide est envoyé au fond de la gorge du nourrisson. Pour éviter ce risque, il est notamment préconisé d’exercer une pression lente et graduelle et de placer l’extrémité de la seringue ou de la pipette à l’intérieur de la joue de l’enfant pour éviter le risque d étouffement, ce que peu de parents font. Liquid forms such as syrup and suspension have the disadvantage of not keeping once opened for first use. Using a single dose of mole gelatin (for English softgel) for a single dosage allows you to use only one part of the pack of one medicine without degrading the other. The savings, particularly in the hospital environment, are significant. The use of pipettes can cause false routes if the liquid is sent to the back of the infant's throat. To avoid this risk, it is particularly recommended to exert slow and gradual pressure and to place the end of the syringe or pipette inside the child's cheek to avoid the risk of suffocation, which few parents do.
Diverses propositions ont été déjà faites, pour la réalisation de préparations pour enfants, elle consiste jusqu’alors à faciliter les préparations extemporanées. À titre d’exemples, on peut citer les documents brevets FR 1233412, FR 1486502, FR 1508658, FR 2190094, FR 2238644, FR 2427960 et FR 2628075. Various proposals have already been made, for the production of preparations for children, it has so far consisted in facilitating extemporaneous preparations. As examples, mention may be made of patent documents FR 1233412, FR 1486502, FR 1508658, FR 2190094, FR 2238644, FR 2427960 and FR 2628075.
Dans les préparations extemporanées traditionnelles, il existe un risque de contamination pour les produits stériles, risque de perte d’une partie des composants, risque d’erreur sur la quantité administrée. D’une façon générale, on rencontre des difficultés de mise en œuvre ou d’exploitation de la méthode à suivre pour réaliser correctement le mélange. Par ailleurs, le mélange obtenu présente une stabilité n’excédant jamais plusieurs jours. In traditional extemporaneous preparations, there is a risk of contamination for sterile products, risk of loss of part of the components, risk of error in the quantity administered. In general, there are difficulties in implementing or operating the method to follow to properly mix. Furthermore, the mixture obtained exhibits a stability never exceeding several days.
Une capsule en gélatine molle traditionnelle ou du type dévissable (pour l’anglais twist-off) est inadaptée à l’usage pédiatrique. L’objet peut être facilement avalé et peut causer un étouffement. A traditional soft gelatin capsule or the twist-off type is unsuitable for pediatric use. The object can be easily swallowed and may cause suffocation.
La présente invention vise à remédier à l’ensemble des inconvénients précédemment exposés. Elle a donc pour objectif de fournir un dispositif pour la distribution de médicaments ou de compléments alimentaires ou analogues, sous la forme d’un conditionnement qui satisfasse au mieux les exigences suivantes : The present invention aims to remedy all of the drawbacks described above. It therefore aims to provide a device for the distribution of drugs or food supplements or the like, in the form of packaging which best meets the following requirements:
• aucun mélange extemporané ; • no extemporaneous mixing;
• prélèvement sécurisé de la dose, et précision du dosage ; • limitation du développement galénique ; • safe withdrawal of the dose, and precision of the dosage; • limitation of galenic development;
• limitation de l’emballage. • limitation of packaging.
• limitation du débit de liquide et de risque de fausse route ou d’étouffement.• limitation of liquid flow and risk of aspiration or suffocation.
Le dispositif doit rester simple et économique, permettant sa fabrication industrielle aisée et son intégration à une chaîne logistique. The device must remain simple and economical, allowing easy industrial manufacture and integration into a logistics chain.
Exposé de l’invention Disclosure of the invention
Selon un premier aspect de l’invention, il est proposé un dispositif de délivrance de spécialité liquide, par exemple de type pharmaceutique ou complément alimentaire, comportant un réservoir en gélatine mole et un capuchon fermant hermétiquement le réservoir. Selon le premier aspect de l’invention, le dispositif comporte en outre une languette disposée du côté opposé du capuchon par rapport au réservoir, la languette étant remplie de gélatine mole. Le capuchon est avantageusement arrachable ou détachable du réservoir. According to a first aspect of the invention, there is provided a liquid specialty dispensing device, for example of pharmaceutical or food supplement type, comprising a reservoir of molten gelatin and a cap hermetically closing the reservoir. According to the first aspect of the invention, the device further comprises a tab disposed on the opposite side of the cap relative to the reservoir, the tab being filled with mole gelatin. The cap is advantageously tear-off or detachable from the reservoir.
Selon un mode de réalisation préféré, le réservoir comporte une partie de forme sensiblement cylindrique fermée du côté de la languette, et se refermant du côté de la ligne d’affaiblissement par une partie de forme sensiblement conique. According to a preferred embodiment, the reservoir comprises a portion of substantially cylindrical shape closed on the side of the tongue, and closing on the side of the line of weakness by a portion of substantially conical shape.
Avantageusement, le dispositif de délivrance peut être moulé à partir du même matériau, c’est-à-dire en gélatine molle. Advantageously, the delivery device can be molded from the same material, i.e. soft gelatin.
La gélatine étant biodégradable, le dispositif peut se dissoudre simplement dans l’eau après utilisation et permet de limiter l’utilisation de plastique, aluminium ou verre contrairement aux systèmes actuels comprenant flacon verre, pipettes, unidoses en PET ou sachet. Since gelatin is biodegradable, the device can simply be dissolved in water after use and makes it possible to limit the use of plastic, aluminum or glass, unlike current systems comprising glass vials, pipettes, single-dose PET or sachet.
Le dispositif de délivrance peut être avantageusement moulé d’un seul tenant. The delivery device can advantageously be molded in one piece.
De préférence, le capuchon peut être rempli de gélatine mole. Preferably, the cap can be filled with mole gelatin.
Avantageusement, le réservoir peut présenter une ligne d’affaiblissement le reliant au capuchon. La ligne d’affaiblissement permet de faciliter la séparation dudit capuchon du reste du dispositif. Advantageously, the reservoir may have a line of weakness connecting it to the cap. The line of weakness makes it easier to separate said cap from the rest of the device.
La languette peut présenter des mentions variables, par exemple une information de volume de liquide dans le réservoir ou le nom de produits contenus dans le réservoir. Cette languette aura une section transversale égale ou inférieure au diamètre de la partie réservoir. Cela permet lors de son industrialisation de passer les différentes étapes de séchage et de calibrage. Le dispositif fabriqué peut ainsi tourner sur elle-même lors du séchage en tunnel et peut passer l’étape de calibrage sans que la dimension transversale de la languette ne soit automatiquement interprétée comme une non-conformité. The tab may have variable information, for example information on the volume of liquid in the reservoir or the name of the products contained in the reservoir. This tongue will have a cross section equal to or less than the diameter of the reservoir part. This allows during its industrialization to go through the different stages of drying and calibration. The manufactured device can thus rotate on itself during tunnel drying and can pass the calibration step without the transverse dimension of the tab being automatically interpreted as a non-conformity.
Selon un deuxième aspect de l’invention, il est proposé un procédé de délivrance d’une spécialité liquide au moyen d’un dispositif de délivrance selon le premier aspect de l’invention, ou l’un ou plusieurs de ses perfectionnements. According to a second aspect of the invention, there is provided a method of delivering a liquid specialty by means of a delivery device according to the first aspect of the invention, or one or more of its improvements.
Le procédé peut comporter une étape dans laquelle le dispositif de délivrance est maintenu par un utilisateur au moyen de la languette dudit dispositif. Selon une possibilité, le procédé peut comporter une étape de délivrance à un enfant d’un médicament dédié aux adultes contenu dans le réservoir dudit dispositif. The method may include a step in which the delivery device is held by a user by means of the tab of said device. According to one possibility, the method may include a step of delivering to a child a drug dedicated to adults contained in the reservoir of said device.
Description des figures Description of figures
D’autres avantages et particularités de l’invention apparaîtront à la lecture de la description détaillée de mises en œuvre et de modes de réalisation nullement limitatifs, au regard de dessins annexés sur lesquels : Other advantages and features of the invention will become apparent on reading the detailed description of implementations and embodiments which are in no way limiting, with regard to the accompanying drawings in which:
- Figure 1 est une vue de dessus d’un mode de réalisation d’un dispositif de délivrance de spécialité liquide, - Figure 1 is a top view of one embodiment of a liquid specialty delivery device,
- Figure 2 est une vue latérale du dispositif représenté sur Figure 1 ,- Figure 2 is a side view of the device shown in Figure 1,
- Figure 3 est une vue arrière du dispositif représenté sur Figure 1 ,- Figure 3 is a rear view of the device shown in Figure 1,
- Figure 4 est une vue de face du dispositif représenté sur Figure 1 ,- Figure 4 is a front view of the device shown in Figure 1,
- Figure 5 est une vue en perspective d’un deuxième mode de réalisation d’un dispositif de délivrance de spécialité liquide. - Figure 5 is a perspective view of a second embodiment of a liquid specialty delivery device.
Description générale de l’invention General description of the invention
Les modes de réalisation décrits ci-après n’étant nullement limitatifs, on pourra notamment considérer des variantes de l’invention ne comprenant qu’une sélection de caractéristiques décrites, par la suite isolées des autres caractéristiques décrites, si cette sélection de caractéristiques est suffisante pour conférer un avantage technique ou pour différencier l’invention par rapport à l’état de la technique antérieure. Cette sélection comprend au moins une caractéristique, de préférence fonctionnelle sans détails structurels, ou avec seulement une partie des détails structurels si cette partie uniquement est suffisante pour conférer un avantage technique ou pour différencier l’invention par rapport à l’état de la technique antérieure. Since the embodiments described below are in no way limiting, it is in particular possible to consider variants of the invention comprising only a selection of characteristics described, subsequently isolated from the other characteristics described, if this selection of characteristics is sufficient. to confer a technical advantage or to differentiate the invention from the state of the prior art. This selection includes at least one characteristic, preferably functional without structural details, or with only part of the structural details if this part alone is sufficient to confer a technical advantage or to differentiate the invention from the state of the prior art.
Dans la suite de la description, des éléments présentant une structure identique ou des fonctions analogues seront désignés par de mêmes références. In the remainder of the description, elements having an identical structure or similar functions will be designated by the same references.
Selon la présente invention, la dose nécessaire de principe actif est contenue dans le réservoir de la capsule en intégralité. La capsule en gélatine molle est dans ce cas utilisée comme un système uni dose. Elle dispense de l’utilisation de seringue ou pipette. According to the present invention, the necessary dose of active principle is contained in the reservoir of the capsule in its entirety. The soft gelatin capsule is in this case used as a single dose system. It eliminates the need for a syringe or pipette.
Il existe des capsules qui possède une excroissance formant capuchon, à couper avec un ustensile de type ciseaux. L’utilisation de ciseaux est proscrite à l’hôpital, car l’ouverture pourrait engendrer une contamination du produit. There are capsules which have a protuberance forming a cap, to be cut with a scissor-type utensil. The use of scissors is prohibited in hospitals, as opening them could lead to contamination of the product.
Des unidoses sous une forme similaire peuvent être trouvées en ophtalmologie. Unit doses in a similar form can be found in ophthalmology.
Il existe par ailleurs des capsules à dévissage, généralement utilisées en cosmétique. L’ouverture est une étape critique. En effet, l’ouverture de la capsule nécessite de maintenir à la fois le corps de la capsule et le système d’ouverture. Ce faisant, le praticien exerce une pression sur la partie contenant le produit, qui sort ainsi immédiatement. Ce qui présente au moins trois inconvénients : There are also unscrewing capsules, generally used in cosmetics. Opening up is a critical step. Indeed, opening the capsule requires maintaining both the body of the capsule and the opening system. In doing so, the practitioner exerts pressure on the part containing the product, which thus comes out immediately. This has at least three drawbacks:
- le praticien est en contact avec le liquide, causant un risque de contamination ou un risque pour le praticien ; - the practitioner is in contact with the liquid, causing a risk of contamination or a risk for the practitioner;
- un volume de produit est perdu, non seulement par pression du praticien sur le réservoir qui fait s’écouler du liquide, mais également par le capuchon qui contient aussi du liquide, qui est nécessairement perdu ; - a volume of product is lost, not only by pressure from the practitioner on the reservoir which makes liquid drain, but also by the cap which also contains liquid, which is necessarily lost;
- le volume de produit perdu entraîne une inexactitude de la dose effectivement ingérée par le patient. - the volume of product lost leads to an inaccuracy of the dose actually ingested by the patient.
Figure 1 illustre un dispositif 1 de délivrance de spécialité liquide se présentant comme une capsule en gélatine mole. Figure 1 illustrates a liquid specialty delivery device 1 in the form of a mole gelatin capsule.
Le dispositif 1 comporte un réservoir 2 en gélatine molle et un capuchon 3 fermant hermétiquement le réservoir 2. The device 1 comprises a reservoir 2 made of soft gelatin and a cap 3 hermetically closing the reservoir 2.
Le capuchon 3 est moulé d’un seul tenant avec le reste du dispositif. Le capuchon 3 est constitué uniquement de gélatine et est de préférence plein. Il ne contient pas de liquide, de sorte que le produit est intégralement logé dans le réservoir 2, ce qui garantit une meilleure observance de la quantité à faire ingérer. The cap 3 is integrally molded with the rest of the device. The cap 3 is made entirely of gelatin and is preferably solid. It does not contain liquid, so the product is fully housed in the reservoir 2, which guarantees better compliance with the quantity to be ingested.
Le réservoir 2 est hermétique et contient une quantité de produit prédéterminée. The reservoir 2 is airtight and contains a predetermined quantity of product.
Le réservoir 2 présente une ligne d’affaiblissement 4 reliée au capuchon 3.The tank 2 has a weakening line 4 connected to the cap 3.
Le capuchon 4 et la partie du réservoir 2 présentant la ligne d’affaiblissement 4 forment un système d’ouverture du réservoir 2, permettant de libérer le produit sans l’utilisation d’outils. Lorsque le capuchon est tourné ou tiré par l’utilisateur, la ligne d’affaiblissement 4 est fragilisée et tend à se rompre. De ce fait, l’utilisateur a accès au produit sans avoir été en contact ou mis un objet en contact avec ledit produit, limitant ainsi tout risque de contamination. The cap 4 and the part of the reservoir 2 showing the line of weakness 4 form an opening system for the reservoir 2, allowing the product to be released without the use of tools. When the cap is turned or pulled by the user, the weakening line 4 is weakened and tends to break. Therefore, the user has access to the product without having been in contact or put an object in contact with said product, thus limiting any risk of contamination.
Une languette 5, aussi appelée queue, est ajoutée sur le dispositif 1 , disposée du côté opposé du capuchon 3 par rapport au réservoir 2. A tab 5, also called a tail, is added to the device 1, arranged on the opposite side of the cap 3 with respect to the reservoir 2.
La languette 5 est remplie de gélatine molle. Tab 5 is filled with soft gelatin.
L’ensemble du dispositif 1 est moulé dans un même matériau — ce qui facilite sa fabrication — et d’un seul tenant. Ainsi il n’existe aucun risque de perforation ou de fuite ultérieur au moulage. The entire device 1 is molded from the same material - which facilitates its manufacture - and in one piece. Thus there is no risk of perforation or leakage subsequent to the molding.
La languette 5 permet au praticien et aux parents de tenir le dispositif lors de la délivrance du produit. The tab 5 allows the practitioner and parents to hold the device during the delivery of the product.
La languette 5 offre la possibilité d’une prise en main afin de ne pas exercer de pression sur la partie réservoir 2 au moment de l’ouverture et ainsi de prévenir de la sortie du liquide avant délivrance. The tab 5 offers the possibility of a grip so as not to exert pressure on the reservoir part 2 at the time of opening and thus prevent the exit of the liquid before delivery.
La languette 5 pourra présenter des mentions variables 6, par exemple le nom de la molécule ou son code et dosage. Elle permet de différencier les produits, car le dosage et le nom du produit peuvent être notés dessus, limitant ainsi tout risque de confusion. The tab 5 may present variable mentions 6, for example the name of the molecule or its code and dosage. It makes it possible to differentiate the products, because the dosage and the name of the product can be noted on it, thus limiting any risk of confusion.
La molécule peut être choisie parmi le groupe suivant : paractétamol- acétaminophen, ibuprofen, ùélatonine, loratadine, vitamines, vitamine K, loperamide, nephopam, morphine, acetazolamide,dexamethazone, methotrexate, aprepitan, spironolactone, sidenafil, caféine, midazolam, ranitidine, ondansetron, prednisone, ivermectine, vitamine D. The molecule can be chosen from the following group: paractetamol-acetaminophen, ibuprofen, elatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine, acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, sidenazolans, ondametron, ran , prednisone, ivermectin, vitamin D.
Les mentions variables 6 sur la languette 5 pourront être moulées lors du procédé de remplissage. D’autres moyens d’inscription peuvent être envisagés comme l’impression, le gravage ou l’ajout d’une étiquette. La languette 5 permet de rendre le dispositif plus grand et large afin de prévenir tout risque d’étouffement, si un enfant venait à l’avaler. The variable mentions 6 on the tongue 5 may be molded during the filling process. Other means of inscription can be envisaged, such as printing, engraving or adding a label. The tongue 5 makes the device larger and wider in order to prevent any risk of suffocation if a child were to swallow it.
La languette 5 permet de tenir le dispositif lors de la délivrance, permettant une meilleure prise et ainsi prévenant le risque pour l’enfant de l’avaler. The tab 5 holds the device during delivery, allowing a better grip and thus preventing the risk of the child swallowing it.
Figure 5 illustre un dispositif 11 de délivrance de spécialité liquide se présentant comme une capsule en gélatine mole. Figure 5 illustrates a liquid specialty delivery device 11 in the form of a mole gelatin capsule.
Comme précédemment, le dispositif 11 comporte un réservoir 12 en gélatine molle et un capuchon 13 fermant hermétiquement le réservoir 2. Le réservoir 12 présente une ligne d’affaiblissement 14 reliée au capuchon 13. Une languette 15, aussi appelée queue, est ajoutée sur le dispositif 11, disposée du côté opposé du capuchon 13 par rapport au réservoir 12. As before, the device 11 comprises a reservoir 12 of soft gelatin and a cap 13 hermetically closing the reservoir 2. The reservoir 12 has a line of weakness 14 connected to the cap 13. A tab 15, also called a tail, is added on the device 11, arranged on the opposite side of the cap 13 with respect to the reservoir 12.
Le réservoir 12 comporte une partie de forme sensiblement cylindrique 16 disposée entre une demi-sphère 17 se refermant du côté de la languette 15 et une demi-sphère partielle 18 se referment du côté de la ligne d’affaiblissement 14. The reservoir 12 comprises a portion of substantially cylindrical shape 16 disposed between a hemisphere 17 closing on the side of the tongue 15 and a partial hemisphere 18 closing on the side of the line of weakness 14.
La demi-sphère partielle se referme du côté de la ligne d’affaiblissement 14 par une partie de préférence de forme sensiblement conique 19. La partie 19 pourrait être cylindrique ou évasée. La partie de forme sensiblement conique 19 peut aussi permettre de tenir et fermer le réservoir 12, par une main, alors que la ligne d’affaiblissement 14 est fragilisée et tend à se rompre du fait des forces exercées, par exemple par une autre main, sur le capuchon 13. La pression opérée sur la partie conique ou évasée préviendra toute fuite de liquide et garantira que la dose finale à administrer reste à l’intérieur du réservoir. The partial hemisphere closes on the side of the line of weakness 14 by a portion preferably of substantially conical shape 19. The portion 19 could be cylindrical or flared. The portion of substantially conical shape 19 can also make it possible to hold and close the reservoir 12, by one hand, while the line of weakness 14 is weakened and tends to break due to the forces exerted, for example by another hand, on the cap 13. The pressure on the conical or flared part will prevent any liquid leakage and ensure that the final dose to be administered remains inside the reservoir.
L’invention concerne aussi un dispositif tel que décrit précédemment dans lequel le réservoir contient en tant que spécialité liquide une composition pharmaceutique comprenant une molécule choisie parmi : paractétamol- acétaminophen, ibuprofène, mélatonine, loratadine, vitamines, vitamine K, loperamide, nephopam, morphine, acétazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, silldénafil, caféine, midazolam, ranitidine, ondansetron, prednisone, ivermectine, vitamine D. The invention also relates to a device as described above in which the reservoir contains as liquid specialty a pharmaceutical composition comprising a molecule chosen from: paractetamol-acetaminophen, ibuprofen, melatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine , acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, silldenafil, caffeine, midazolam, ranitidine, ondansetron, prednisone, ivermectin, vitamin D.
Bien sûr, l’invention n’est pas limitée aux exemples qui viennent d’être décrits et de nombreux aménagements peuvent être apportés à ces exemples sans sortir du cadre de l’invention. De plus, les différentes caractéristiques, formes, variantes et modes de réalisation de l’invention peuvent être associés les uns avec les autres selon diverses combinaisons dans la mesure où ils ne sont pas incompatibles ou exclusifs les uns des autres. Of course, the invention is not limited to the examples which have just been described and numerous modifications can be made to these examples without departing from the scope of the invention. In addition, the different characteristics, shapes, variants and embodiments of the invention can be combined with each other. with others in various combinations as long as they are not mutually exclusive or mutually exclusive.

Claims

Revendications Claims
1. Dispositif (1 ; 11) de délivrance de spécialité liquide de type pharmaceutique ou complément alimentaire comportant un réservoir (2 ; 12) en gélatine mole et un capuchon (3, 13) fermant hermétiquement le réservoir, comportant en outre une languette (5, 15) disposée du côté opposé du capuchon par rapport au réservoir, la languette étant remplie de gélatine mole, caractérisé en ce que la languette présente une section transversale inférieure ou égale à la section transversale du réservoir. 1. Device (1; 11) for dispensing a liquid specialty of pharmaceutical type or food supplement comprising a reservoir (2; 12) made of molten gelatin and a cap (3, 13) hermetically closing the reservoir, further comprising a tab (5 , 15) disposed on the opposite side of the cap relative to the reservoir, the tongue being filled with molten gelatin, characterized in that the tongue has a cross section less than or equal to the cross section of the reservoir.
2. Dispositif de délivrance selon la revendication précédente, dans lequel le réservoir (12) comporte une partie de forme sensiblement cylindrique (16) fermée du côté de la languette (15), et se refermant du côté de la ligne d’affaiblissement (14) par une partie de forme sensiblement conique (17). 2. Delivery device according to the preceding claim, wherein the reservoir (12) comprises a portion of substantially cylindrical shape (16) closed on the side of the tongue (15), and closing on the side of the line of weakness (14). ) by a portion of substantially conical shape (17).
3. Dispositif de délivrance selon l’une des deux revendications précédentes, dans lequel l’ensemble est moulé à partir du même matériau. 3. A delivery device according to one of the two preceding claims, wherein the assembly is molded from the same material.
4. Dispositif de délivrance selon la revendication précédente, dont l’ensemble est moulé d’un seul tenant. 4. A delivery device according to the preceding claim, the whole of which is molded in one piece.
5. Dispositif de délivrance selon l’une quelconque des revendications précédentes, dans lequel le capuchon (3) est rempli de gélatine mole. 5. A delivery device according to any preceding claim, wherein the cap (3) is filled with mole gelatin.
6. Dispositif selon l’une quelconque des revendications précédentes, dans lequel le réservoir présente une ligne d’affaiblissement (4) reliant le réservoir (2) au capuchon (3). 6. Device according to any one of the preceding claims, wherein the reservoir has a line of weakness (4) connecting the reservoir (2) to the cap (3).
7. Dispositif selon l’une quelconque des revendications précédentes, dans lequel la languette (5) présente des mentions variables (6). 7. Device according to any one of the preceding claims, wherein the tab (5) has variable markings (6).
8. Dispositif selon l’une des revendications précédentes, dans lequel le réservoir contient en tant que spécialité liquide une composition pharmaceutique comprenant une molécule choisie parmi : paractétamol- acétaminophen, ibuprofene, mélatonine, loratadine, vitamines, vitamine K, loperamide, nephopam, morphine, acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, sidenafil, caféine, midazolam, ranitidine, ondansetron, prednisone, ivermectine, vitamine D. 8. Device according to one of the preceding claims, wherein the reservoir contains a composition as liquid specialty. pharmaceutical comprising a molecule chosen from: paractetamol-acetaminophen, ibuprofen, melatonin, loratadine, vitamins, vitamin K, loperamide, nephopam, morphine, acetazolamide, dexamethazone, methotrexate, aprepitan, spironolactone, sidenafil, caffeine, midaznisolamide, ranron, ranron, ranron, ranron, ranron, ranron, ranron ivermectin, vitamin D.
9. Procédé de délivrance d’une spécialité liquide au moyen d’un dispositif de délivrance selon l’une quelconque des revendications précédentes, dans lequel le dispositif de délivrance est maintenu par un utilisateur au moyen de la languette dudit dispositif. 9. A method of delivering a liquid specialty by means of a delivery device according to any preceding claim, wherein the delivery device is held by a user by means of the tab of said device.
EP21706640.6A 2020-02-04 2021-01-28 Device for the delivery of a liquid pharmaceutical and/or nutraceutical gelatin speciality to persons having difficulty in swallowing Pending EP4099973A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR2001099A FR3106748A1 (en) 2020-02-04 2020-02-04 PROVISION OF PHARMACEUTICAL AND / OR NUTRACEUTICAL SPECIALTY LIQUID GELATIN FOR PERSONS WITH DIFFICULTIES IN SWALLOWING.
PCT/FR2021/050151 WO2021156557A1 (en) 2020-02-04 2021-01-28 Device for the delivery of a liquid pharmaceutical and/or nutraceutical gelatin speciality to persons having difficulty in swallowing

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US (1) US20230076203A1 (en)
EP (1) EP4099973A1 (en)
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Publication number Priority date Publication date Assignee Title
FR1486502A (en) 1967-10-16
US2957501A (en) 1958-08-25 1960-10-25 Burroughs Wellcome Co Device for dispensing muscle relaxant drugs
DE1296606B (en) 1966-01-20 1969-06-04 Ver Draht & Kabelwerke Ag Device for bringing together and mixing two substances
DE7200242U (en) * 1972-01-05 1975-07-03 Karlsruhe Augsburg Iweka Aseptic packaging
FR2190094A5 (en) 1972-06-19 1974-01-25 Roussel Uclaf
FR2238644A1 (en) 1973-07-27 1975-02-21 Bigotte Georges Connection device between two containers - has piercing point forced through stopper by screwing in other container
FR2427960A1 (en) 1978-06-06 1980-01-04 Dehais Claude Polypropylene adaptor for linking two bottles - with an integral diaphragm for sterile protection
JPH0531058Y2 (en) * 1986-12-29 1993-08-10
FR2628075B1 (en) 1988-03-02 1990-08-17 Merck Sharp & Dohme PACKAGING AND DISPENSING ASSEMBLY FOR SEPARATING TWO COMPONENTS SEPARATELY, AND MAKING THEIR EXTEMPORANEOUS MIXTURE ON THE FIRST USE, AND METHOD FOR MANUFACTURING SUCH AN ASSEMBLY
US5063057A (en) * 1990-09-26 1991-11-05 Elizabeth Arden Co., Division Of Conopco, Inc. Cosmetic capsules

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