WO2002078774A1 - Systeme permettant de s'assurer de la distribution de medicaments - Google Patents

Systeme permettant de s'assurer de la distribution de medicaments Download PDF

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Publication number
WO2002078774A1
WO2002078774A1 PCT/DK2002/000167 DK0200167W WO02078774A1 WO 2002078774 A1 WO2002078774 A1 WO 2002078774A1 DK 0200167 W DK0200167 W DK 0200167W WO 02078774 A1 WO02078774 A1 WO 02078774A1
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WO
WIPO (PCT)
Prior art keywords
delivery
compliance
modules
delivery module
dose
Prior art date
Application number
PCT/DK2002/000167
Other languages
English (en)
Inventor
Troels Keldmann
Erik Keldmann
Teresa Pallotta
Original Assignee
Direct-Haler A/S
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 Direct-Haler A/S filed Critical Direct-Haler A/S
Publication of WO2002078774A1 publication Critical patent/WO2002078774A1/fr

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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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed 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
    • A61M15/00—Inhalators

Definitions

  • the invention relates to a compliance system for drug delivery comprising at least one compliance device including a number of delivery modules in form of tubular bodies defining an air flow passage, each of said tubular bodies having substantially rectilinear sections and at least one intermediate flexible section and containing a dose of an active particulate substance for nasal or pulmonary delivery arranged in the flow passage, said dose being sealed or closed in relation to the ambient atmosphere by means of closure means which are to be removed by the user prior to use.
  • Such delivery modules for inhalation or insufflation are inter alia described in WO 96/22802 and WO 98/53869.
  • the object of the invention is to show how to design the said compliance device in a more compact manner than hitherto known and at the same time rendering the desired combination therapy possible. Furthermore the said compliance device is designed so as to easily check whether the prescribed doses in fact have been taken by the patient. Another advantage is that it is possible to take the two different formulations separately, which may be of importance for the effect.
  • Another object of the invention is to provide a compliance device comprising compact packed delivery modules.
  • a further object of the invention is to provide an integrated compliance system com- prising a number of compact packed compliance devices.
  • the said delivery modules are formed such that in their unopened state they are complementary in packaging, the closure means of one of the delivery modules being clipable onto the other delivery module such that the joined delivery modules may be packed tightly.
  • the devices are very com- pact, in fact so compact that they may be used in connection with pill dispensing trays comprising seven small compartments for seven days' consumption which for instance are used in nursing homes.
  • the transparent joined delivery modules in transparent packagings it is possible to check whether the dose prescribed by the doctor in fact has been taken.
  • the delivery modules are U-shaped in their unopened state, the U-shaped state being maintained by means of the closure means.
  • each closure means is formed of two closure caps or closure foils interconnected by means of at least one connecting flap.
  • the connecting flap may be arranged such and be of such a length that a tubular body of the second delivery module may be snugly received and retained between the caps, whereby two U-shaped delivery modules may be clipped onto each other such that the U-shape of one delivery module faces opposite to the other delivery module.
  • fig. 1 illustrates a compliance device consisting of a set of delivery modules according to the invention
  • fig. 2 is an end view of one of a closure means for a delivery module
  • fig. 3 is a perspective view of a closure means for a delivery module
  • fig. 4 illustrates another embodiment of a closure means
  • fig. 5 illustrates the compliance device consisting of delivery modules arranged in a transparent packaging
  • fig. 6 illustrates a number of packed compliance devices arranged in a pill dispensing tray for seven days' consumption
  • fig. 7 illustrates an alternative embodiment of the pill dispensing tray shown in Fig. 6,
  • fig. 8 illustrates a compliance device comprising two delivery modules for simultaneous intake of two particulate substances
  • fig. 9 A, 9B and 9C illustrate examples of closure means for the compliance device of fig. 8,
  • fig. 10 illustrates the compliance device of fig. 8 with an additional mouthpiece facilitating the simultaneous intake of two particulate substances
  • fig. 11 illustrates the compliance device of fig. 10 with an associated closure means.
  • the present invention is based on the idea that the two drugs prescribed for a combina- tion therapy are contained in two separate delivery modules.
  • the invention deals with ensuring an optimum use- value of and comfort during combination therapy at the pulmonary and/or nasal delivery.
  • the set of delivery modules shown on the drawing for taking medicine is formed of two substantially U-shaped tubular bodies.
  • Each of the tubular bodies comprises two substantially rectilinear sections 1 and at least one intermediate flexible section 2.
  • a dose of a particulate substance for nasal or pulmonary delivery is further contained in the flexible section 2, said dose being sealed or closed in relation to the ambient atmosphere by means of closure means, which are to be removed by the user prior to use.
  • the said delivery modules are formed such that in their unopened state they are complementary in packaging, the closure means of one of the delivery modules being clipable onto the other delivery module such that the joined delivery modules may be packed in a tight manner.
  • the delivery modules are U-shaped in their unopened state, the U-shaped state being maintained by means of the closure means 4.
  • Each closure means 4 may for instance be formed of two closure caps or closure foils interconnected by means of at least one connecting flap 7 (confer fig. 4).
  • the connecting flap 7 may be formed such that in the mounted state of the closure means 4 the second delivery module may be snugly received and retained between the caps, whereby the two U-shaped delivery modules may be clipped onto each other such that the U-shape of one delivery module faces opposite to the other delivery module.
  • An embodiment of the invention may be a folding action of two delivery modules, each containing a dose of two separate drugs.
  • the folding action allows for a joint packing of two modules, whereby the device comprising said modules becomes compact. Since two different drugs are involved, which have to be taken in the correct order, the delivery modules are differentiated from each other by the design of the caps and their colours such that the user may see and feel a difference between the two "doses".
  • caps and each of the delivery modules are designed such that the two delivery modules may be clipped onto each other and thus only exceed the size of a single delivery module by about 41%.
  • the joined modules are enclosed by a protective packaging 5, which is transparent on one side, whereby the two doses are visible, providing the patient with a sense of security.
  • the other side of the packaging 5 may optionally be supplied with the necessary information (optionally in form of bar codes), such as the day of the week, the dose, content, user instructions, expiry date, etc.
  • Another embodiment of the pulmonary compliance device is a device, in which one module is intended for the upper respiratory passages and the other is intended for the lowerrespiratorypassages. This requires different powder formulations for each target. It is thus a new option for packing two delivery modules together, each having its own powder formulation and thus its own delivery target.
  • the compliance device according to the invention may thus also comprise a nasal delivery module and a pulmonary delivery module.
  • This combination of two delivery modules makes it possible to cover both types of respiratory delivery of the drag. This may be important in relation to future drags used for strengthening the immune response in the respiratory passages. As an example it may be possible to stimulate the immune defense of the cell in the mucous membranes by means of inhalable drugs.
  • nasal compliance device has the same design as the above device, two nasal delivery modules may also be clipped onto each other as described above. Two nasal doses may also be used for a combination therapy in which two different drugs have to be delivered to either nostrils or the same drag has to be delivered to the same nostril.
  • a further embodiment relates to cases where only one dose of a very expensive substance, eg a vaccine, is needed.
  • the other delivery module may be used for training and delivery of a placebo powder.
  • the compliance device may be considered as an "inhalation pill” which allows for an administration system combining the advantages of certain pill-dispensing packing systems with an efficient inhalation therapy.
  • the suggested packaging concept also allows for printing of the inhalation doses for a predetermined dosage schedule, according to which each combined device must be taken at a specific time and the dose concentration is different for each of the packed combined devices.
  • This type of dose "programming" is known from contraceptive pills, where the dose and the timing are vital and where the packaging assists the patient in obtaining compliance.
  • the unit dose dispensing of drags from a pharmacy to the patients is a new way of assisting the patients in taking the correct drug at the correct time. It is intended that pharmacies in the future are able to pack drugs in units such that the drug is packed per time of intake, eg four doses to be taken at noon, and two doses at bedtime, each day for fourteen days.
  • the invention will make such a type of device dispensing possible for inhalation and/or insufflation products. This will also be vital within the hospital services.
  • Fig. 6 illustrates a compliance system comprising a number of packed compliance devices arranged together with any pills in a pill dispensing tray comprising seven small compartments for seven days' consumption.
  • Fig. 7 illustrates an alternative embodiment of the pill dispensing tray shown in fig. 6, in which the packagings containing the tightly packed compliance devices are arranged vertically in a box, which may be closed by means of a lid. In this case it is also easily checked whether the patient has remembered to take the prescribed drug doses.
  • the pill dispensing tray shown in fig. 5 and the box shown in fig. 7 may for instance be packed so as to enable a degree of periodic drag intake, some of the compliance devices for example containing higher drag doses than others.
  • a person may be interested in a simultaneous intake of two or more particulate substances.
  • two delivery modules may be firmly interconnected, each individual delivery module containing separate particulate substances, in special cases, the same particulate substance, if the meaning merely is that the patient should have the double dose.
  • the two interconnected modules, cf fig. 8 are thus closed by means of a common closure means prior to use.
  • Figs. 9A, 9B and 9C illustrate examples of different closure means.
  • the closure means illustrated in fig. 9A is de- signed to delivery modules, in which the one end projects slightly than the other end and essentially corresponds to two closure means of the type illustrated in fig. 3 in one piece.
  • the closure means illustrated in fig. 9B is intended for an embodiment of the said delivery modules, in which the ends flush.
  • the same applies to the closure means illustrated in fig.9C comprising a number of interconnected spherical bodies for inser- tion into and closing of the tubular bodies.
  • a mouthpiece may advantageously be mounted on the two delivery modules as illustrated in fig. 10, in which case, a special closure means is required.
  • Said closure means comprise caps in one piece or the like, closely fitting the joint mouthpiece and the ends of the said delivery modules, respectively, cf fig. 11.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un système permettant de s'assurer de la distribution de médicaments qui comprend un certain nombre de dispositifs d'observation, chacun d'eux étant constitué de deux modules de distribution permettant la prise de médicaments par voie pulmonaire et/ou nasale. Chaque module comprend un corps tubulaire définissant un passage d'écoulement d'air. Ledit corps tubulaire comprend deux sections (1) sensiblement rectilignes et au moins une section intermédiare (2) souple, et contient une dose d'une substance particulaire. Ce corps tubulaire est scellé ou fermé par rapport à l'atmosphère ambiante à l'aide de moyens de fermeture (4) devant être déplacés par un utilisateur avant usage. Les patients entreprenant une thérapie combinée font face à des problèmes quotidiens lorsqu'ils doivent prendre deux ou plusieurs médicaments différents à des moments spécifiques de la journée. Lorsqu'on l'associe à la prise de médicaments, le terme observation signifie que le patient respecte correctement le traitement prescrit par le médecin. Pour tenter de résoudre ce problème, on a développé la prise de médicaments combinés fournis par un dispositif d'inhalation multidose dans lequel le pourcentage de médicaments a été prédéterminé. Selon l'invention, ledit problème a été résolu par utilisation d'un dispositif d'observation composé de deux modules de distribution conçus de sorte qu'à l'état fermé ils sont complémentaires dans l'emballage. Les moyens de fermeture de l'un des dispositifs d'inhalation peuvent être clipsés sur l'autre module de distribution de sorte que les modules reliés peuvent être emballés serrés dans un emballage transparent, et agencés sous forme de plateaux de distribution de médicaments classiques pour une consommation de sept jours. La thérapie combinée désirée permet aux patients de respecter le traitement prescrit par le médecin. Le dispositif de distribution est beaucoup plus compact que les dispositifs connus.
PCT/DK2002/000167 2001-03-28 2002-03-13 Systeme permettant de s'assurer de la distribution de medicaments WO2002078774A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA200100513 2001-03-28
DKPA200100513 2001-03-28

Publications (1)

Publication Number Publication Date
WO2002078774A1 true WO2002078774A1 (fr) 2002-10-10

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007508876A (ja) * 2003-10-21 2007-04-12 ダイレクト−へーラー エイ／エス 吸入器
WO2017136825A1 (fr) * 2016-02-04 2017-08-10 Ip Med, Inc. Dispositif et procédé d'administration de médicament

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3018691A1 (de) * 1980-05-16 1981-11-26 Gerhard 7166 Sulzbach-Laufen Hansen Behaeltnis zur aufnahme einer vorbestimmten menge eines daraus entfernbaren gutes, insbesondere medikamentes
WO1996022802A1 (fr) * 1995-01-23 1996-08-01 Direct-Haler A/S Inhalateur
WO1998053869A1 (fr) * 1997-05-27 1998-12-03 Direct-Haler A/S Inhalateur pour medicaments en poudre
WO1999049922A1 (fr) * 1998-03-31 1999-10-07 Georg Mates Inhalateur unidirectionnel pour l'inhalation de substances actives volatiles

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3018691A1 (de) * 1980-05-16 1981-11-26 Gerhard 7166 Sulzbach-Laufen Hansen Behaeltnis zur aufnahme einer vorbestimmten menge eines daraus entfernbaren gutes, insbesondere medikamentes
WO1996022802A1 (fr) * 1995-01-23 1996-08-01 Direct-Haler A/S Inhalateur
WO1998053869A1 (fr) * 1997-05-27 1998-12-03 Direct-Haler A/S Inhalateur pour medicaments en poudre
WO1999049922A1 (fr) * 1998-03-31 1999-10-07 Georg Mates Inhalateur unidirectionnel pour l'inhalation de substances actives volatiles

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007508876A (ja) * 2003-10-21 2007-04-12 ダイレクト−へーラー エイ／エス 吸入器
JP2011218184A (ja) * 2003-10-21 2011-11-04 Keldmann Healthcare As 吸入器
JP4866242B2 (ja) * 2003-10-21 2012-02-01 ケルドマン ヘルスケア エイ／エス 吸入器
WO2017136825A1 (fr) * 2016-02-04 2017-08-10 Ip Med, Inc. Dispositif et procédé d'administration de médicament
EP3411102A4 (fr) * 2016-02-04 2019-12-25 IP Med, Inc. Dispositif et procédé d'administration de médicament
US11793950B2 (en) 2016-02-04 2023-10-24 Propel-Air Biopharma, Llc Medicament delivery device and method

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