Classifications

• • 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
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
  • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
• • 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
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
  • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
  • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
• • 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
• • 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
  • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
  • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
• • 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
  • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
  • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
  • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
  • A61M15/0048—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged in a plane, e.g. on diskettes
• • 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
  • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
  • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
  • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
  • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
  • B65D75/34—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents and having several recesses to accommodate a series of articles or quantities of material
• • 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
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/06—Solids
  • A61M2202/062—Desiccants
• • 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
  • A61M2202/00—Special media to be introduced, removed or treated
  • A61M2202/06—Solids
  • A61M2202/064—Powder
• • 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
  • B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
  • B65D2585/56—Containers, packaging elements or packages specially adapted for particular articles or materials for medicinal tablets or pills

Definitions

• the present invention relates to a support structure for a medicament in the form of, for example, a blister pack for a drug or an injection moulded drug dosing element as used in an inhalation device.
• a typical blister pack for a medicament is described in WO 01/45777 and a typical drug dosing element is described in US 5,590,645.
• a support structure which has a lid sealed to a base, having one or more cavities for holding the medicament, is in the region where the lid is sealed to the base.
• the lid and base are often both made from a material having an aluminium layer which makes these elements moisture impermeable. Accordingly, the only region where moisture can penetrate the blister pack is through the lid sealing region which is typically a heat seal. If the base of the blister pack is made from a plastic material then there will also be moisture ingress through the base material to the medicament.
• the injection moulded base will be made from a moisture permeable material whereas the lid will typically have an aluminium layer making it moisture impermeable. In this case, there will also be moisture ingress through both the heat seal between the lid and base and through the base material.
• the problem of moisture ingress has been overcome to a certain degree in prior art inhalation device components by using aluminium containing foil materials for both the lid and base and spacing adjacent cavities by approximately 3mm. With such a construction, moisture within an empty cavity does not then compromise an adjacent cavity which still contains a dose of medicament. The only weakness resides in the heat seal between lid and base.
• a disadvantage with this construction is that there is a limit to the number of doses which can be arranged on the blister pack/dosing element due to the spacing requirement.
• Other prior art solutions include providing a desiccant source which is connected to or placed within a cavity containing the medicament. However, this solution is reactive only, in that moisture is removed after having penetrated a cavity rather than preventing moisture from entering the cavity in the first place.
• an alternative solution has been to use a desiccant box inside an aluminium bag which holds a plurality of medicament doses, e.g., tablets, but this form of moisture protection is destroyed when the bag is opened for the first time so that there is no in- use stability.
• a support structure for a medicament comprising a base with at least one cavity for the medicament and a lid for sealing the medicament within the cavity characterised in that each moisture permeable region of the structure is protected against the ingress of moisture by locating a moisture absorbing sink between that region and the ambient air outside the structure.
• the sink reduces the relative humidity (RH) of the air passing through it to substantially the relative humidity (RH) of the air within the cavity so that there is minimal diffusion of moisture from the sink to the cavity.
• each moisture permeable region comprises an inner moisture permeable barrier located adjacent to the cavity and an outer moisture permeable barrier, the moisture absorbing sink being located between the inner and outer barriers.
• the base and the lid are moisture impermeable and the moisture permeable region of the structure is located where the lid is sealed to the base.
• the moisture absorbing sink between the lid and the base is spaced from the periphery of the cavity thereby forming an inner moisture permeable region and an outer moisture permeable region, the sink breaking the moisture ingress path so that there is minimal diffusion of moisture through the inner moisture permeable region to the cavity.
• the moisture absorbing sink comprises a channel in the base surrounding the cavity which contains dry air.
• each channel is connected to a single desiccant source which dries the air in all the channels.
• the moisture absorbing sink comprises a polymer ring surrounding the cavity and located between the lid and the base.
• the base and the lid have an aluminium layer for moisture impermeability, the lid being heat sealed to the base.
• the lid is moisture impermeable and the base material is moisture permeable, the moisture permeable regions being located where the lid is sealed to the base and within the base material of the cavity walls.
• a first moisture absorbing sink is located between the lid and the base and is spaced from the periphery of the cavity and a second moisture absorbing sink is located within the base material of the cavity walls thereby forming inner moisture permeable barriers and outer moisture permeable barriers, the sink breaking the moisture ingress path so that there is minimal diffusion of moisture through the inner moisture permeable barriers to the cavity.
• the moisture absorbing sink comprises a channel containing dry air surrounding the cavity opening where the lid is sealed to the base and passing through the cavity walls.
• each channel is connected to a single desiccant source which dries the air in all the channels.
• the base is injection moulded and the lid has an aluminium layer for moisture impermeability, the lid being heat sealed to the base.
• the base comprises cooperating stackable elements, each element having a plurality of cavities, the cavities within one of the elements sitting between the cavities within another element when stacked, a moisture absorbing sink being formed by the spacing between the cooperating elements.
• Figure 1 is a graphic representation of the relative humidity gradient across a barrier for a drug with conventional moisture protection
• Figure 2 is a graphic representation of the relative humidity gradient across a barrier arrangement with moisture protection according to the present invention
• Figure 3 is a section through one blister in a blister pack with moisture protection according to a preferred embodiment of the present invention
• Figures 4A, 4B and 4C depict preferred embodiments of blister packs with multiple cavities having moisture protection
• Figure 5 is a plan view of a section of a dosing element for an inhalation device having moisture protection according to a preferred embodiment of the present invention
• Figure 6 is a sectional view in direction X-X through the dosing element in Figure 5
• Figure 7 depicts a further preferred embodiment of a dosing element having moisture protection
• Figure 8 depicts the underside of annular ring 111 b in Figure 7
• Figure 9 is an enlarged view of part of the annular ring in
• FIG. 1 depicts the relative humidity (RH) gradient across a barrier which is moisture permeable.
• the barrier could be, for example, the material from which the base of the support structure is made or the heat seal between the lid and base of the support structure.
• the moisture ingress through the barrier arises because the relative humidity in the ambient air outside the support structure is typically 70% whereas the relative humidity of the air and powdered drug within a cavity is typically 20%.
• the moisture ingress arises both from the ambient air and from neighbouring cavities which have already been emptied.
• the powdered drug is protected only by a single barrier and moisture is continually transported through the barrier by gradient driven diffusion. The transport of moisture continues until the relative humidity inside a cavity reaches the ambient level.
• Moisture protection can only be improved by increasing the barrier thickness or modifying the properties of the barrier material.
• it is proposed to locate a moisture absorbing sink between each moisture permeable region of the support structure and the ambient air. This can be achieved, for example, by breaking the single barrier into an outer barrier and an inner barrier with the sink located between the two barriers.
• Figure 2 depicts a preferred arrangement where the sink effectively breaks the moisture ingress path.
• the relative humidity gradient across the outer barrier is high giving moisture diffusion as in Figure 1.
• any moisture diffusion through the inner barrier will be low.
• Figure 3 depicts a first preferred embodiment of the present invention where the support structure is in the form of a blister pack 1 having a base 2 with at least one cavity 3 holding a medicament and a lid 4 which is sealed to the base 2 by way of heat seals 5 and 6. Between the outer seal 5 and the inner seal 6 is a moisture absorbing sink in the form of a channel 7 which surrounds the cavity 3. The channel 7 could contain dry air to remove moisture in the region of the lid 4.
• the moisture ingress path M for this support structure will only be through the heat seals 5 and 6 as the blister pack base 2 and lid 4 would typically be manufactured from a moisture impermeable material having an aluminium component.
• the moisture ingress path M would result in a relative humidity gradient similar to that depicted in Figure 2.
• the outer barrier would be heat seal 5 and the inner barrier would be heat seal 6.
• the dry air in channel 7 would be dried by way of a desiccant. If the dry air reduces the relative humidity in the channel 7 to approximately 20% then there will only be minimal moisture diffusion through the heat seal 6 to the cavity 3 assuming that the relative humidity within cavity 3 is also approximately 20%.
• Figures 4A, 4B and 4C depict three configurations for a blister pack having a plurality of cavities 3.
• each cavity 3 is surrounded by a dry air channel 7.
• the channels 7 are all connected to a desiccant 8 which ensures that air within the channels is continually dried to the required level.
• the channels and desiccant reservoir would typically be cold formed in the same manufacturing process step as the cavities.
• Figure 4B depicts a further modification using a rectangular channel configuration.
• Figure 4C depicts a preferred configuration when the moisture absorbing sink for each cavity 3 is a moisture absorbing material, e.g., a polymer in the form of a nylon ring 9 . In this case, there is no need for a desiccant and each cavity 3 has a dedicated nylon ring which sits between the base 2 and lid 4 of the support structure.
• the support structure for the medicament is in the form of an annular drug dosing element 101.
• This type of dosing element typically sits within an inhalation device which is able to index the drug cavities 103a, 103b and 103c past a mechanism which ruptures the lid 104 and allows the user to draw the drug from each cavity.
• Figure 5 shows a segment of the annular dosing element 101 containing three adjacent cavities 103a, 103b, 103c. One of the cavities 103a is empty whereas the other two cavities 103b and 103c still contain the powdered drug.
• Figure 6 is a sectional view taken in direction X-X through the dosing element in Figure 5.
• the base 102 of the dosing element 101 would typically be injection moulded and hence would be moisture permeable. With this arrangement, moisture protection is needed both where the lid 104 is heat sealed to the base 102 and within the base material.
• the channels 107 all connect to a desiccant 108 which dries the air in the channels to reduce the relative humidity to that within the cavities.
• the outer heat seal 105 runs around the outer and inner peripheries of the annular dosing disc.
• the channel 107 creates the inner barriers in the form of the inner heat seal 106 and the inner moisture barrier 110 in the base 102.
• FIG. 7 depicts a preferred construction for the dosing element 101 which comprises two cooperating annular rings 111a and 111b which sit one above the other within a containing tray 112. The spacing between the annular rings 111a and 111b forms channels 107. This arrangement allows each cavity to be spaced from an adjacent cavity by as little as 1 mm. In this way, 60 cavities can be arranged on a dosing disc 101 with a diameter of 72mm.
• a desiccant 108 (not shown) to dry the air in the channels 107 between components 111a, 111b and 112 sits on the underside of annular ring 111b (see Figures 8 and 9) in a groove 113.
• a lid 104 would be heat sealed to the arrangement shown in Figure 7.
• the annular ring 111a has a plurality of cavities 114 and the annular ring 111b has a plurality of cavities 115. With this arrangement, it is not necessary to injection mould the annular rings such that there are separate channels as in Figure 5. It is sufficient to injection mould the drug cavities 114 and 115 in the annular rings and sit the annular rings one above the other within the containing tray 112.
• the groove 113 for the desiccant is located on the underside of annular ring 111 b as viewed in Figure 7.
• the spacing between the annular rings 111a and 111b is sufficient for humidity transport. Tooling is considerably simpler and there is no need to form the narrow channels depicted in Figure 5. Spacing between the annular rings can be increased, for example, by increasing the roughness of the walls or applying a lattice pattern to the walls.

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• Engineering & Computer Science (AREA)
• Health & Medical Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Pulmonology (AREA)
• Veterinary Medicine (AREA)
• Mechanical Engineering (AREA)
• Food Science & Technology (AREA)
• Chemical & Material Sciences (AREA)
• Composite Materials (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Packages (AREA)
• Catching Or Destruction (AREA)
• Drying Of Gases (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Publications (1)

Family

ID=32733684

Family Applications (1)

Country Status (15)

Cited By (14)

Families Citing this family (3)

Citations (2)

Family Cites Families (8)

• 2004
  • 2004-06-24 SE SE0401654A patent/SE0401654D0/xx unknown
• 2005
  • 2005-06-21 JP JP2007517445A patent/JP2008503405A/ja active Pending
  • 2005-06-21 WO PCT/GB2005/002440 patent/WO2006000758A1/en active Application Filing
  • 2005-06-21 BR BRPI0512561-8A patent/BRPI0512561A/pt not_active IP Right Cessation
  • 2005-06-21 EP EP05755471A patent/EP1761441A1/en not_active Withdrawn
  • 2005-06-21 MX MXPA06015033A patent/MXPA06015033A/es not_active Application Discontinuation
  • 2005-06-21 KR KR1020067027089A patent/KR20070024635A/ko not_active Application Discontinuation
  • 2005-06-21 AU AU2005256805A patent/AU2005256805A1/en not_active Abandoned
  • 2005-06-21 US US11/571,073 patent/US20080023367A1/en not_active Abandoned
  • 2005-06-21 CA CA002570779A patent/CA2570779A1/en not_active Abandoned
  • 2005-06-21 RU RU2006146876/12A patent/RU2006146876A/ru not_active Application Discontinuation
  • 2005-06-21 CN CNA2005800212358A patent/CN1972850A/zh active Pending
• 2006
  • 2006-11-30 IL IL179746A patent/IL179746A0/en unknown
  • 2006-12-08 ZA ZA200610292A patent/ZA200610292B/xx unknown
• 2007
  • 2007-01-23 NO NO20070426A patent/NO20070426L/no not_active Application Discontinuation

Patent Citations (2)

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