EP1353854A2 - Couvercle d'inhalateur-doseur contenant un deshydratant - Google Patents

Couvercle d'inhalateur-doseur contenant un deshydratant

Info

Publication number
EP1353854A2
EP1353854A2 EP01939031A EP01939031A EP1353854A2 EP 1353854 A2 EP1353854 A2 EP 1353854A2 EP 01939031 A EP01939031 A EP 01939031A EP 01939031 A EP01939031 A EP 01939031A EP 1353854 A2 EP1353854 A2 EP 1353854A2
Authority
EP
European Patent Office
Prior art keywords
housing
radially oriented
sealant
moisture
metered dose
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Withdrawn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
EP01939031A
Other languages
German (de)
English (en)
Inventor
Craig Steven Herman
Vincent P. Pisculli
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.)
Glaxo Group Ltd
Original Assignee
Glaxo Group Ltd
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 Glaxo Group Ltd filed Critical Glaxo Group Ltd
Publication of EP1353854A2 publication Critical patent/EP1353854A2/fr
Withdrawn legal-status Critical Current

Links

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
    • B65D83/00—Containers or packages with special means for dispensing contents
    • B65D83/14—Containers for dispensing liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant
    • B65D83/40—Closure caps
    • 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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/30—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials for desiccators

Definitions

  • HFC MDI's moisture ingress into HFC MDI's is problematic, particularly for MDI's containing agroscopic drug particles which readily adsorb and/or absord water and form aggregates.
  • One solution to the problem has been to incorporate a dessicant to absorb moisture that in its absence would ingress into the MDI.
  • the manner in which the desiccant is employed can, however, impact to varying degrees several factors.
  • the structures employed for the desiccant can affect the cost of manufacturing. Complex and difficult mechanisms may reduce throughput, decrease efficiencies, and increase material costs.
  • the form of desiccant packaging can also affect the visual and commercial appeal of the MDI. For example, to some vendors and customers, an internal, unseen desiccant may be more appealing than the overrap and loose desiccant pouch disclosed in the above-referenced application.
  • HFC propellant MDI's there is a strong need for effective prevention of moisture ingress in HFC propellant MDI's. It is well established that non-CFC propellants, especially HFC 134a, have much greater water solubility that the CFC propellants traditionally used in MDI's.
  • the maximum water solubility in HFC 134a is about 2200 ppm (and about 1000 ppm in pressurized/stored MDI's) compared to about 130 ppm (and 50-100 ppm in pressurized/stored MDI's) for CFC 1 1 , 12 and 114.
  • the maximum solubility may be further increased where co-solvents such as ethanol are employed in the aerosol formulation.
  • HFC MDI's The mechanism of moisture ingress into HFC MDI's may be found in Williams, G. and Tcherevatchenkoff, A. (1999), "Moisture Transport Into CFC-Free MDI's,” Respiratory Drug Deleivery VI, Hilton Head, SC, USA.
  • moisture ingress is influenced by the elastomeric nature of the valve gaskets as well as the type of HFA formulation and storage conditions emoloyed. It may be appropriate under some circumstances to control moisture ingress into Hr ' C-based MDI's.
  • One example is where hygroscopic drug substance are used, such as albuterol sulfate.
  • the present invention advantageously reduces moisture ingress into MDI's to suitable levels.
  • the present invention employs a desiccant in a manner that is visually appealing and commercially advantageous.
  • the design and structure of the present invention is also advantageously simple, efficient to manufacture, cost effective, smaller and less bulky that other secondary packaging systems.
  • One aspect of the invention is an overcap including an outer housing fitted with a moisture absorber structure having a housing containing a desiccant.
  • the housing of the absorber is preferably constructed from a radially oriented material connected to a moisture permeable material.
  • the radially oriented material is preferably an injection moldable plastic.
  • the moisture permeable material is preferably fiberboard or TYVEKTM available from DuPont.
  • the moisture permeable material is connected to the radially oriented material by crimping over a portion of the radially oriented material.
  • the injection moldable plastic is preferably a polypropylene.
  • the desiccant preferably includes a granular silica gel, preferably 2-10 grams.
  • the housing of the absorber includes at least one radially oriented fin.
  • the radially oriented fin may be a circumferential fin.
  • the absorber may also include a plurality of circumferential fins or a combination of radial and circumferential fins.
  • the outer housing is preferably constructed from an injection moldable plastic, and more preferably a polypropylene.
  • the overcap is connected to a metered dose inhaler by a sealant.
  • the sealant is preferably constructed from an epoxy material, such as DEVCON 2- TON EPOXYTM.
  • the overcap and sealant seals off a valve stem, ferrule, valve housing and neck of the metered dose inhaler.
  • the sealant is preferably a foil label.
  • the foil label may be a structural laminate including an oriented ployamide layer, an aluminum foil layer and a pressure sensitive adhesive.
  • the foil label preferably has a thickness in the range of 9-20 ⁇ m.
  • the sealant may provide a hermetic seal between the metered dose inhaler and the outer housing.
  • the metered dose inhaler may contain a drug such as albuterol sulfate.
  • Fig. 1 is a cross-sectional, cut-away view of the overcap of the present invention in combination with a portion of the metered dose inhaler.
  • Fig. 1 Shown in Fig. 1 is a cross-sectional, cut-away view of an overcap 10 connected to a portion of an MDI 12.
  • the overcap 10 is connected to the MD1 12 by a sealant 14.
  • the portion of the MDI 12 shown in Fig. 1 includes a stem 16, a ferrule 18, a valve housing 20, a neck assembly 22 and a cannister 24.
  • the overcap 10 includes an outer housing 26 fitted with a desiccant container 28 containing a desiccant 30.
  • the desiccant container 28 includes a fitment housing 31 connected to a moisture-permeable overlay 32 to contain the desiccant 30.
  • the fitment 31 is connected to the overlay 32 by a crimp 34 in the fitment 31.
  • the fitment 31 also includes a radial fin 36 for friction fitting the desiccant container 28 within the outer housing 26.
  • the sealant was DEVCON 2-TON EPOXYTM; the injection moldable plastic was polypropylene, the desiccant was 10 g silica gel, and the overlay material was fiberboard.
  • the results are shown in Table 1. The numerical values are the mean moisture content (ppm) of the MDI contents after storage at 40°C and 85% RH.
  • the overcap was compared to a conventional shrink wrap seal and adhesive band seal.
  • the overcap was exceptionally effective at reducing the rate of moisure ingress into the MDI.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Dispersion Chemistry (AREA)
  • Packages (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Closures For Containers (AREA)

Abstract

L'invention concerne un couvercle (10) contenant un déshydratant (30) destiné à être utilisé sur un inhalateur-doseur (12) pour adsorber l'humidité. Ce couvercle permet de réduire avantageusement la quantité et le taux d'humidité qui pénètre dans l'inhalateur-doseur. La réduction de l'entrée d'humidité dans un inhalateur-doseur contenant des particules médicamenteuses agroscopiques permet d'améliorer le fonctionnement de ce dernier.
EP01939031A 2000-05-15 2001-05-15 Couvercle d'inhalateur-doseur contenant un deshydratant Withdrawn EP1353854A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US20425200P 2000-05-15 2000-05-15
US204252P 2000-05-15
PCT/US2001/015551 WO2001087731A2 (fr) 2000-05-15 2001-05-15 Couvercle d'inhalateur-doseur contenant un deshydratant

Publications (1)

Publication Number Publication Date
EP1353854A2 true EP1353854A2 (fr) 2003-10-22

Family

ID=22757204

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01939031A Withdrawn EP1353854A2 (fr) 2000-05-15 2001-05-15 Couvercle d'inhalateur-doseur contenant un deshydratant

Country Status (4)

Country Link
EP (1) EP1353854A2 (fr)
JP (1) JP2004501032A (fr)
AU (1) AU2001264594A1 (fr)
WO (1) WO2001087731A2 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6390291B1 (en) 1998-12-18 2002-05-21 Smithkline Beecham Corporation Method and package for storing a pressurized container containing a drug
US7617932B2 (en) 2003-09-19 2009-11-17 Diabetes Diagnostics, Inc. Medical device package, kit and associated methods
US7516845B2 (en) 2004-03-31 2009-04-14 Inverness Medical Limited Medical device package with deformable projections
DK2400950T3 (da) 2009-02-26 2019-07-29 Glaxo Group Ltd Farmaceutiske formuleringer omfattende 4-{(1 r)-2-[(6-{2-[(2,6-dichlorbenzyl)oxy]ethoxy}hexyl)amino]-1-hydroxyethyl}-2-(hydroxymethyl)phenol
AU2010303040A1 (en) * 2009-09-29 2012-04-19 Glaxo Group Limited Improvements to pressurised metered dose inhalers
GB0921075D0 (en) 2009-12-01 2010-01-13 Glaxo Group Ltd Novel combination of the therapeutic agents
EP2900778B1 (fr) 2012-09-27 2017-05-10 3M Innovative Properties Company Système de distribution

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1962685U (de) * 1962-07-31 1967-06-22 Sanner Kg Friedr Stopfen mit Trocknungseinlage
DE3610345C2 (de) * 1986-03-27 1998-07-09 Rathor Ag Vorrichtung zur Erzeugung von Polyurethan-Montageschaum
DE3715938A1 (de) * 1987-05-13 1988-11-24 Boehringer Mannheim Gmbh Behaelter fuer teststreifen
US5186775A (en) * 1988-10-05 1993-02-16 Cullen John S Method of fabrication of a container for bulk material
HU219899B (hu) * 1995-04-14 2001-09-28 Glaxo Wellcome Inc. Inhalálóberendezés flutikaszon-propionát adagolására mért dózisban
US5749496A (en) * 1996-06-19 1998-05-12 Primary Delivery Systems, Inc. Squeeze and rotate to lift captive cap dispenser

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0187731A3 *

Also Published As

Publication number Publication date
JP2004501032A (ja) 2004-01-15
WO2001087731A3 (fr) 2003-08-28
AU2001264594A1 (en) 2001-11-26
WO2001087731A2 (fr) 2001-11-22

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