Medicament dispenser

• US 20050268909A1
• Filed: 07/23/2003
• Published: 12/08/2005
• Est. Priority Date: 07/25/2002
• Status: Abandoned Application

• Current Assignee: Glaxo Group Limited (GSK plc)
• Original Assignee: Glaxo Group Limited (GSK plc)
• Inventors: Bonney, Stanley George, Davies, Michael Birsha
• Application Number:
  US10/523,121
• Publication Number:
  US 20050268909A1
• Time in Patent Office: Days
• US Class Current: 128/203.150
• CPC Class Codes: A61M 11/005 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 11/06 of the injector type
• CPC Class Codes: A61M 15/0003 with means for dispensing more than one drug
• CPC Class Codes: A61M 15/0026 Hinged caps
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0043 Non-destructive separation of the package, e.g. peeling
• CPC Class Codes: A61M 15/0045 using multiple prepacked dosages on a same carrier, e.g. blisters
• CPC Class Codes: A61M 15/0048 the dosages being arranged in a plane, e.g. on diskettes
• CPC Class Codes: A61M 15/0051 the dosages being arranged on a tape, e.g. strips
• CPC Class Codes: A61M 15/0055 the used dosages being coiled
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 15/0096 Hindering inhalation before activation of the dispenser
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/3546 : Range
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/80 : voice-operated command
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2206/16 : Rotating swirling helical flow, e.g. by tangential inflows

Abstract

A medicament dispenser device for use in the delivery of a multi-component combination medicament product. The device comprises a first medicament container containing plural co-formulation compatible medicament components; first release means for releasing the contents of the first medicament container for delivery thereof; at least one further medicament container, each containing at least one co-formulation incompatible medicament component; and at least one further release means for releasing the contents of each at least one further medicament container for delivery thereof. The at least one co-formulation incompatible medicament component is kept separate from the plural co-formulation compatible components until the point of release thereof for delivery in combination.

Claims

1. A medicament dispenser device for use in the delivery of a multi-component combination medicament product, the device comprising

a first medicament container containing plural co-formulation compatible medicament components;

first release means for releasing the contents of the first medicament container for delivery thereof;

at least one further medicament container, each containing at least one co-formulation incompatible medicament component; and

at least one further release means for releasing the contents of each at least one further medicament container for delivery thereof,

wherein the at least one co-formulation incompatible medicament component is kept separate from the plural co-formulation compatible components until the point of release thereof for delivery in combination.

2. A medicament dispenser device according to claim 1, wherein the dispenser device comprises a first medicament container containing two co-formulation compatible medicament components and one further medicament container containing one co-formulation incompatible medicament component.

3. A medicament dispenser device according to claim 1, wherein the dispenser device comprises a first medicament container containing two co-formulation compatible medicament components and one further medicament container containing two co-formulation incompatible medicament components.

4. A medicament dispenser device according to claim 1, wherein the dispenser device comprises a first medicament container containing two co-formulation compatible medicament components a second medicament container containing one co-formulation incompatible medicament component and a third medicament container containing one co-formulation incompatible medicament component.

5. A medicament dispenser device according to claim 1, wherein the first medicament container and the at least one further medicament container are suitable for use with a medicament dispenser selected from the group consisting of a reservoir dry powder inhaler (RDPI), a multi-dose dry powder inhaler (MDPI), a unit dose dry powder inhaler (UDPI), a metered dose inhaler (MDI) and a liquid spray inhaler (LSI).

6. A medicament dispenser device according to claim 1, wherein the first and at least one further medicament container are of a similar type.

7. A medicament dispenser device according to claim 1, wherein the first and at least one further medicament container are of a different type.

8. A medicament dispenser device according to claim 1, wherein the first release means and the at least one further release means are coupled together

9. A medicament dispenser device according to claim 1, wherein the device further comprises a mixing chamber including a first inlet for receiving the released contents of the first medicament container;

a second inlet for receiving the released contents of the at least one further medicament container; and

an outlet for delivery of combination medicament product therefrom.

10. A medicament dispenser device according to claim 1, wherein the plural co-formulation compatible medicament components and the at least one co-formulation incompatible medicament component are selected from the group consisting of anti-inflammatory agents, anticholinergic agents, other β

₂-adrenoreceptor agonists, anti-infective agents and antihistamines.

11. A medicament dispenser device according to claim 10, wherein said anti-inflammatory agents are selected from the group consisting of corticosteroids and NSAIDs.

12. A medicament dispenser device according to claim 11, wherein said corticosteroids are selected from the group consisting of methyl prednisolone, prednisolone, dexamethasone, fluticasone propionate, 6α

,9α

-difluoro-17α

-[(2-furanylcarbonyl)oxy]-11β

-hydroxy-16α

-methyl-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester, 6α

,9α

-difluoro-11β

-hydroxy-16α

-methyl-3-oxo-17α

-propionyloxy-androsta-1,4-diene-17β

-carbothioic acid S-(2-oxo-tetrahydro-furan-3S-yl) ester, beclomethasone esters, budesonide, flunisolide, mometasone esters, triamcinolone acetonide, rofleponide, ciclesonide, butixocort propionate, RPR-106541 and ST-126.

13. A medicament dispenser device according to claim 12, wherein said corticosteroids are selected from the group consisting of fluticasone propionate, 6α

,9α

-difluoro-11β

-hydroxy-16α

-methyl-17α

-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester and 6α

,9α

-difluoro-17α

-[(2-furanylcarbonyl)oxy]-11β

-hydroxy-16α

-methyl-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester.

14. A medicament dispenser device according to claim 11, wherein said NSAIDs are selected from the group consisting of sodium cromoglycate, nedocromil sodium, phosphodiesterase (PDE) inhibitors, leukotriene antagonists, inhibitors of leukotriene synthesis, iNOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists, adenosine receptor agonists or antagonists, cytokine antagonists and inhibitors of cytokine synthesis.

15. A medicament dispenser device according to claim 14, wherein said phosphodiesterase (PDE) inhibitors are selected from the group consisting of theophylline, PDE4 inhibitors and mixed PDE3/PDE4 inhibitors.

16. A medicament dispenser device according to claim 10, wherein said other β

₂-adrenoreceptor agonists are selected from the group consisting of salmeterol, salbutamol, formoterol, fenoterol, terbutaline and any salts or solvates thereof.

17. A medicament dispenser device according to claim 10, wherein said anticholinergic agents are selected from the group consisting of M₁, M₂, M₁/M₂ and M₃ receptor antagonists.

18. A medicament dispenser device according to claim 17, wherein said anticholinergic agents are selected from the group consisting of ipratropium, oxitropium, tiotropium and any salts or solvates thereof.

19. A medicament dispenser device according to claim 1, wherein the plural co-formulation compatible medicament components comprise a β

₂-adrenoreceptor agonist and a corticosteroid; and

the at least one further co-formulation incompatible medicament component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

20. A medicament dispenser device according to claim 19, wherein the β

₂-adrenoreceptor agonists is selected from the group consisting of salbutamol, salmeterol, formoterol and any salts and solvates thereof, and the corticosteroid is selected from the group consisting of beclomethasone ester, a fluticasone ester, budesonide and any salts of solvates thereof.

21. A medicament dispenser device according to claim 20, wherein the plural co-formulation compatible medicament components comprise fluticasone propionate and salmeterol xinafoate;

and the co-formulation incompatible component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

22. A medicament dispenser device according to claim 20, wherein the plural co-formulation compatible medicament components comprise budesonide and formoterol fumarate;

and the co-formulation incompatible component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

23. A medicament pack for use with the medicament dispenser device according to claim 1, the pack comprising

a first medicament container containing plural co-formulation compatible medicament components;

and

at least one further medicament container, each at least one further medicament container containing at least one co-formulation incompatible medicament component; and

wherein the at least one co-formulation incompatible medicament component is kept separate from the plural co-formulation compatible components.

24. A medicament pack according to claim 23, wherein the plural co-formulation compatible medicament components and the at least one co-formulation incompatible medicament component are selected from the group consisting of anti-inflammatory agents, anticholinergic agents, other β

₂-adrenoreceptor agonists, anti-infective agents and antihistamines.

25. A medicament pack according to claim 24, wherein said anti-inflammatory agents are selected from the group consisting of corticosteroids and NSAIDs.

26. A medicament pack according to claim 25, wherein said corticosteroids are selected from the group consisting of methyl prednisolone, prednisolone, dexamethasone, fluticasone propionate, 6α

,9α

-difluoro-17α

-[(2-furanylcarbonyl)oxy]-11β

-hydroxy-16α

-methyl-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester, 6α

,9α

-difluoro-11β

-hydroxy-16α

-methyl-3-oxo-17α

-propionyloxy-androsta-1,4-diene-17β

-carbothioic acid S-(2-oxo-tetrahydro-furan-3S-yl) ester, beclomethasone esters, budesonide, flunisolide, mometasone esters, triamcinolone acetonide, rofleponide, ciclesonide, butixocort propionate, RPR-106541 and ST-126.

27. A medicament pack according to claim 26, wherein said corticosteroids are selected from the group consisting of fluticasone propionate, 6α

,9α

-difluoro-11β

-hydroxy-16α

-methyl-17α

-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester and 6α

,9α

-difluoro-17α

-[(2-furanylcarbonyl)oxy]-11-hydroxy-16α

-methyl-3-oxo-androsta-1,4-diene-17β

-carbothioic acid S-fluoromethyl ester.

28. A medicament pack according to claim 25, wherein said NSAIDs are selected from the group consisting of sodium cromoglycate, nedocromil sodium, phosphodiesterase (PDE) inhibitors, leukotriene antagonists, inhibitors of leukotriene synthesis, iNOS inhibitors, tryptase and elastase inhibitors, beta-2 integrin antagonists, adenosine receptor agonists or antagonists, cytokine antagonists and inhibitors of cytokine synthesis.

29. A medicament pack according to claim 28, wherein said phosphodiesterase (PDE) inhibitors are selected from the group consisting of theophylline, PDE4 inhibitors and mixed PDE3/PDE4 inhibitors.

30. A medicament pack according to claim 24, wherein said other β

₂-adrenoreceptor agonists are selected from the group consisting of salmeterol, salbutamol, formoterol, fenoterol, terbutaline and any salts or solvates thereof.

31. A medicament pack according to claim 24, wherein said anticholinergic agents are selected from the group consisting of M₁, M₂, M₁/M₂ and M₃ receptor antagonists.

32. A medicament pack according to claim 31, wherein said anticholinergic agents are selected from the group consisting of ipratropium, oxitropium, tiotropium and any salts or solvates thereof.

33. A medicament pack according to claim 23, wherein the plural co-formulation compatible medicament components comprise a β

₂-adrenoreceptor agonist and a corticosteroid; and

the at least one further co-formulation incompatible medicament component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

34. A medicament dispenser device according to claim 33, wherein the β

₂-adrenoreceptor agonist is selected from the group consisting of salbutamol, salmeterol, formoterol and any salts and solvates thereof; and

the corticosteroid is selected from the group consisting of beclomethasone ester, a fluticasone ester, budesonide and any salts of solvates thereof.

35. A medicament dispenser device according to claim 34, wherein the plural co-formulation compatible medicament components comprise fluticasone propionate and salmeterol xinafoate;

and the co-formulation incompatible component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

36. A medicament dispenser device according to claim 34, wherein the plural co-formulation compatible medicament components comprise budesonide and formoterol fumarate;

and the co-formulation incompatible component is selected from the group consisting of a PDE-4 inhibitor, an anti-cholinergic, and any mixtures thereof.

37. Refill medicament pack in kit of parts form for use with the medicament dispenser device according to claim 1, the refill pack comprising

as a first part of said kit, a first medicament container containing plural co-formulation compatible medicament components;

and

as a further part of the kit, at least one further medicament container, each at least one further medicament container containing at least one co-formulation incompatible medicament component; and

wherein the at least one co-formulation incompatible medicament component is kept separate from the plural co-formulation compatible components.