Medicament storage and delivery devices

• US 20030172924A1
• Filed: 03/07/2003
• Published: 09/18/2003
• Est. Priority Date: 03/07/2002
• Status: Active Grant

• Current Assignee: PharmaKodex Ltd. (Orexo AB)
• Original Assignee: Vectura Drug Delivery (Philip Morris Limited)
• Inventors: Wright, Matthew, Tobyn, Michael, Staniforth, John Nicholas, Howard, Gary Stephen, Simpson, David Bradley Brook, Bowman, Nicolas John
• Granted Patent: US 6,941,948 B2
• Time in Patent Office: Days
• US Class Current: 128/200.14
• CPC Class Codes: A61J 1/03 for pills or tablets containers for pills or tablets with special dispensing means therefor B65D83/04
• CPC Class Codes: A61J 3/005 Coating of tablets or the like coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006
• CPC Class Codes: A61J 7/0061 Swallow helping devices, e.g. tongue shields
• CPC Class Codes: A61J 7/0076 Medicament distribution means with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/341 not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/4402 only substituted in position 2, e.g. pheniramine, bisacodyl
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61K 31/661 Phosphorus acids or esters thereof not having P—C bonds, e.g. fosfosal, dichlorvos, malathion or mevinphos
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/1617 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/5047 Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings
• CPC Class Codes: A61K 9/5078 with drug-free core

Abstract

A multiple dose delivery device for delivering a medicament into an oral cavity of a patient is provided. The device includes a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip. The device further includes a sachet advance mechanism and a mouthpiece. Upon actuation by a user, the sachet advance mechanism, which is engaged with the sachet pack, separates the first strip from the second strip to release one of the plurality of the unit doses from the sachet pack. The mouthpiece includes an opening, and each released unit dose passes through the opening.

Claims

1. A delivery device, comprising:

a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip;

a first member;

a second member;

an actuator, the actuator pulling the first strip against the first member and the second strip against the second member to release a unit dose of the medicament from the a sachet pack; and

a mouthpiece positioned relative to the sachet pack, the first member, and the second member, to deliver the unit dose of the medicament to an oral cavity of a patient.

17. The device of claim 1, wherein the first member is a first roller and the second member is a second roller, and wherein the first roller is spaced apart forward from the second roller.

18. The device of claim 1, wherein the actuator includes

an actuator input;

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the first strip passing though the second nip; and

a drive coupled to the actuator input, the first pair of index rollers and the second pair of index rollers;

and wherein upon actuation of the actuator input by a patient, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull the a portion of the first and second strips through the first and second nips, respectively.

19. The device of claim 18, wherein the drive comprises a gear, the gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the gear being coupled to the actuator input such that actuation of the actuator input causes a predetermined rotation of the gear.

26. The device of claim 1, wherein the actuator includes an actuator input coupled to a carriage, wherein the carriage is coupled to the first and second strips, and wherein actuation of the actuator input causes a movement of the carriage away from the first and second members.

27. The device of claim 1, wherein the actuator includes an actuator input coupled to a carriage, wherein the carriage is coupled to the first and second strips wherein actuation of the actuator input causes a movement of the carriage from a first position to a second position and then to the first position, the first position being closer to the first and second members than the second position.

28. The device of claim 27, wherein the carriage includes a first draw roller and a second draw roller, the first and second draw rollers being rotationally fixed when the carriage moves from the first position to the second position, the first draw roller rotating to wrap the first strip thereabout when the carriage moves from the second position to the first position, the second draw roller rotating to wrap the second strip thereabout when the carriage moves from the second position to the first position.

40. The device of claim 1, wherein the actuator includes

a stored energy component;

a stored energy initiator coupled to the stored energy component, wherein the stored energy initiator, upon actuation, stores energy in the stored energy component;

an actuation trigger which, upon actuation, releases the energy from the stored energy component; and

a draw component coupled to the stored energy component, the draw component pulling the first strip against the first member and the second strip against the second member when the energy is released from the stored energy component.

41. The device of claim 40, wherein the draw component comprises

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the second strip passing though the second nip; and

a drive coupled to the stored energy component, the first pair of index rollers and the second pair of index rollers;

and wherein upon release of the energy from the stored energy component, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull a portion of the first and second strips through the first and second nips, respectively.

42. The device of claim 41,

wherein the drive comprises a first gear, the first gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the first gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear,

wherein the stored energy component includes a second gear and a torsion element, the second gear engaged with the first gear, the torsion element coupled between the stored energy initiator and the second gear.

52. The device of claim 1, wherein the medicament is in the form of a solid.

53. The device of claim 1, wherein the solid comprises drug particles having a mean diameter of greater than 10 μ

m to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

54. The device of claim 1, wherein the medicament is in the form of a liquid.

55. The device of claim 1, wherein the medicament is in the form of a semi-solid.

73. The device of claim 1, wherein the unit dose includes a non-compressed free flowing plurality of particles comprising an active agent and a water-soluble excipient, said particles having a mean diameter of greater than about 10 μ

m to about 1 mm, and said formulation dissolving or dispersing in a patient'"'"'s mouth within 1 minute after administration without the coadministration of a fluid.

74. The device of claim 1, wherein the unit dose delivered is substantially independent of the orientation of the device.

75. The device of claim 1,

wherein the first strip separates from the second strip at a separation point;

wherein the device includes a window located adjacent a path of the first strip, downstream of the separation point; and

wherein an interior surface of the first strip includes sequential dose numbering, such that a number corresponding to a next dose to be delivered is on the interior surface and visible to a user of the device through the window.

76. The device of claim 1, wherein the device includes a housing, and wherein the actuation input is a lever which actuated by a user squeezing the lever towards the housing.

77. The device of claim 74, wherein the wherein the first strip separates from the second strip at a separation point, and wherein the separation point is directly above an opening in the mouthpiece.

2. A delivery device, comprising:

a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip;

a first roller spaced apart forward from a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

an actuator, the actuator, upon actuation by a patient, pulling the first strip around the first roller and pulling the second strip around the second roller to release a unit dose of the medicament from the sachet pack;

a mouthpiece positioned relative to the sachet pack, the first roller, and the second roller, to deliver the unit dose of the medicament to an oral cavity of the patient.

11. The device of claim 2, wherein the mouthpiece surrounds the first and second rollers, the mouthpiece having a top surface, a bottom surface, and a pair of lateral surfaces, the bottom surface having an opening formed therein, the released medicament passing through the opening.

12. The device of claim 11, wherein the opening has a forward edge, a rear edge, and a pair of lateral edges, and wherein the forward edge contacts the first strip and the rear edge contacts the second strip.

13. The device of claim 12, wherein the first strip separates from the second strip at a separation point, and wherein the separation point is approximately midway between the forward and rear edges.

20. The device of claim 2, wherein the actuator includes

an actuator input;

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the first strip passing though the second nip; and

a drive coupled to the actuator input, the first pair of index rollers and the second pair of index rollers;

and wherein upon actuation of the actuator input by a patient, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull the a portion of the first and second strips through the first and second nips, respectively.

21. The device of claim 20, wherein the drive comprises a gear, the gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear.

29. The device of claim 2, wherein the actuator includes an actuator input coupled to a carriage, wherein the carnage is coupled to the first and second strips, and wherein actuation of the actuator input causes a movement of the carriage away from the first and second rollers.

30. The device of claim 2, wherein the actuator includes an actuator input coupled to a carnage, wherein the carriage is coupled to the first and second strips wherein actuation of the actuator input causes a movement of the carriage from a first position to a second position and then to the first position, the first position being closer to the first and second rollers than the second position.

31. The device of claim 30, wherein the carriage includes a first draw roller and a second draw roller, the first and second draw rollers being rotationally fixed when the carriage moves from the first position to the second position, the first draw roller rotating to wrap the first strip thereabout when the carriage moves from the second position to the first position, the second draw roller rotating to wrap the second strip thereabout when the carriage moves from the second position to the first position.

43. The device of claim 2, wherein the actuator includes

a stored energy component;

a stored energy initiator coupled to the stored energy component, wherein the stored energy initiator, upon actuation, stores energy in the stored energy component;

an actuation trigger which, upon actuation, releases the energy from the stored energy component; and

a draw component coupled to the stored energy component, the draw component pulling the first strip against the first member and the second strip against the second member when the energy is released from the stored energy component.

44. The device of claim 43, wherein the draw component comprises

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the second strip passing though the second nip; and

a drive coupled to the stored energy component, the first pair of index rollers and the second pair of index rollers;

and wherein upon release of the energy from the stored energy component, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull a portion of the first and second strips through the first and second nips, respectively.

45. The device of claim 44,

wherein the drive comprises a first gear, the first gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the first gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear,

wherein the stored energy component includes a second gear and a torsion element, the second gear engaged with the first gear, the torsion element coupled between the stored energy initiator and the second gear.

56. The device of claim 2, wherein the medicament is in the form of a solid.

57. The device of claim 2, wherein the solid comprises drug particles having a mean diameter of greater than 10 μ

m to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

58. The device of claim 2, wherein the medicament is in the form of a liquid.

59. The device of claim 2, wherein the medicament is in the form of a semi-solid.

3. A multiple dose delivery device for delivering a medicament into an oral cavity of a patient, comprising:

a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip;

a sachet advance mechanism engaged with the sachet pack, the sachet advance mechanism, upon user actuation, separating the first strip from the second strip to release one of the plurality of the unit doses from the sachet pack;

a mouthpiece having an opening, each released unit dose passing through the opening.

14. The device of claim 3, wherein the mouthpiece has a top surface, a bottom surface, and a pair of lateral surfaces, the bottom surface having an opening formed therein, the released medicament passing through the opening.

15. The device of claim 14, wherein the opening has a forward edge, a rear edge, and a pair of lateral edges, and wherein the forward edge contacts the first strip and the rear edge contacts the second strip.

16. The device of claim 15, wherein the first strip separates from the second strip at a separation point, and wherein the separation point is approximately midway between the forward and rear edges.

36. The device of claim 3, wherein the sachet advance mechanism includes

a first roller spaced apart forward from a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

an actuator, the actuator, upon actuation by a patient, pulling the first strip around the first roller and pulling the second strip around the second roller to release a unit dose of the medicament from the sachet pack.

37. The device of claim 3, wherein the sachet advance mechanism includes

a first member;

a second member; and

an actuator, the actuator pulling the first strip against the first member and the second strip against the second member to release a unit dose of the medicament from the a sachet pack.

38. The device of claim 3, wherein the sachet advance mechanism includes,

a first roller spaced apart forward from a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

and

an actuator that, upon actuation by a patient, causes a predetermined rotation of the first and second rollers, the predetermined rotation being selected such that repeated actuation of the actuator will cause successive ones of the plurality of the unit doses to be released from the sachet pack.

39. The device of claim 3, wherein the sachet advance mechanism includes

a first roller spaced apart forward from and above a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

and

an actuator, the actuator, upon actuation by a patient, pulling the first strip around the first roller and pulling the second strip around the second roller to release a unit dose of the medicament from the sachet pack.

60. The device of claim 3, wherein the medicament is in the form of a solid.

61. The device of claim 3, wherein the solid comprises drug particles having a mean diameter of greater than 10 μ

m to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

62. The device of claim 3, wherein the medicament is in the form of a liquid.

63. The device of claim 3, wherein the medicament is in the form of a semi-solid.

4. A delivery. device, comprising:

a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip;

a first roller spaced apart forward from a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

an actuator that, upon actuation by a patient, causes a predetermined rotation of the first and second rollers, the predetermined rotation being selected such that repeated actuation of the actuator will cause successive ones of the plurality of the unit doses to be released from the sachet pack;

a mouthpiece positioned relative to the sachet pack, the first roller, and the second roller, to deliver the unit dose of the medicament to an oral cavity of the patient.

8. The device of claim 4, wherein the mouthpiece surrounds the first and second rollers, the mouthpiece having a top surface, a bottom surface, and a pair of lateral surfaces, the bottom surface having an opening formed therein, the released medicament passing through the opening.

9. The device of claim 8, wherein the opening has a forward edge, a rear edge, and a pair of lateral edges, and wherein the forward edge contacts the first strip and the rear edge contacts the second strip.

10. The device of claim 9, wherein the first strip separates from the second strip at a separation point, and wherein the separation point is approximately midway between the forward and rear edges.

24. The device of claim 4, wherein the actuator includes

an actuator input;

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the first strip passing though the second nip; and

a drive coupled to the actuator input, the first pair of index rollers and the second pair of index rollers;

and wherein upon actuation of the actuator input by a patient, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull the a portion of the first and second strips through the first and second nips, respectively.

25. The device of claim 24, wherein the drive comprises a gear, the gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the gear being coupled to the actuator input such each actuation of the actuator input causes rotation of the gear in an amount sufficient to cause the predetermined rotation of the first and second rollers.

32. The device of claim 4, wherein the actuator includes an actuator input coupled to a carriage, wherein the carriage is coupled to the first and second strips wherein actuation of the actuator input causes a movement of the carriage from a first position to a second position and then to the first position, the first position being closer to the first and second rollers than the second position.

33. The device of claim 32, wherein the carriage includes a first draw roller and a second draw roller, the first and second draw rollers being rotationally fixed when the carriage moves from the first position to the second position, the first draw roller rotating to wrap the first strip thereabout when the carriage moves from the second position to the first position, the second draw roller rotating to wrap the second strip thereabout when the carriage moves from the second position to the first position.

46. The device of claim 4, wherein the actuator includes

a stored energy component, and

a stored energy initiator coupled to the stored energy component, wherein the stored energy initiator, upon actuation, stores energy in the stored energy component;

an actuation trigger which, upon actuation, releases the energy from the stored energy component; and

a draw component coupled to the stored energy component, the draw component pulling the first strip against the first member and the second strip against the second member when the energy is released from the stored energy component.

47. The device of claim 46, wherein the draw component comprises

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the second strip passing though the second nip; and

a drive coupled to the stored energy component, the first pair of index rollers and the second pair of index rollers;

and wherein upon release of the energy from the stored energy component, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull a portion of the first and second strips through the first and second nips, respectively.

48. The device of claim 47,

wherein the drive comprises a first gear, the first gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the first gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear;

wherein the stored energy component includes a second gear and a torsion element, the second gear engaged with the first gear, the torsion element coupled between the stored energy initiator and the second gear.

64. The device of claim 4, wherein the medicament is in the form of a solid.

65. The device of claim 4, wherein the solid comprises drug particles having a mean diameter of greater than 10 μ

m to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

66. The device of claim 4, wherein the medicament is in the form of a liquid.

67. The device of claim 4, wherein the medicament is in the form of a semi-solid.

5. A delivery device, comprising:

a sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip;

a first roller spaced apart forward from and above a second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller;

an actuator, the actuator, upon actuation by a patient, pulling the first strip around the first roller and pulling the second strip around the. second roller to release a unit dose of the medicament from the sachet pack;

a mouthpiece surrounding the first and second rollers, the mouthpiece having a top surface, a bottom surface, and a pair of lateral surfaces, the bottom surface having an opening formed therein, the released medicament passing through the opening.

6. The device of claim 5, wherein the opening has a forward edge, a rear edge, and a pair of lateral edges, and wherein the forward edge contacts the first strip and the rear edge contacts the second strip.

7. The device of claim 6, wherein the first strip separates from the second strip at a separation point, and wherein the separation point is approximately midway between the forward and rear edges.

22. The device of claim 5, wherein the actuator includes

an actuator input;

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the first strip passing though the second nip; and

a drive coupled to the actuator input, the first pair of index rollers and the, second pair of index rollers;

and wherein upon actuation of the actuator input by a patient, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull the a portion of the first and second strips through the first and second nips, respectively.

23. The device of claim 22, wherein the drive comprises a gear, the gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear.

34. The device of claim 5, wherein the actuator includes an actuator input coupled to a carnage, wherein the carriage is coupled to the first and second strips wherein actuation of the actuator input causes a movement of the carriage from a first position to a second position and then to the first position, the first position being closer to the first and second rollers than the second position.

35. The device of claim 34, wherein the carriage includes a first draw roller and a second draw roller, the first and second draw rollers being rotationally fixed when the carriage moves from the first position to the second position, the first draw roller rotating to wrap the first strip thereabout when the carriage moves from the second position to the first position, the second draw roller rotating to wrap the second strip thereabout when the carriage moves from the second position to the first position.

49. The device of claim 5, wherein the actuator includes

a stored energy component, and

a stored energy initiator coupled to the stored energy component, wherein the stored energy initiator, upon actuation, stores energy in the stored energy component;

an actuation trigger which, upon actuation, releases the energy from the stored energy component; and

a draw component coupled to the stored energy component, the draw component pulling the first strip against the first member and the second strip against the second member when the energy is released from the stored energy component.

50. The device of claim 49, wherein the draw component comprises

a first pair of index rollers defining a first nip therebetween, the first strip passing through the first nip;

a second pair of index rollers defining a second nip therebetween, the second strip passing though the second nip; and

a drive coupled to the stored energy component, the first pair of index rollers and the second pair of index rollers;

and wherein upon release of the energy from the stored energy component, the drive causes rotation of the first and second pairs of index rollers, which in turn, pull a portion of the first and second strips through the first and second nips, respectively.

51. The device of claim 50,

wherein the drive comprises a first gear, the first gear engaging one of the first pair of index rollers and one of the second pair of index rollers, the first gear being coupled to the actuator input such each actuation of the actuator input causes a predetermined rotation of the gear;

wherein the stored energy component includes a second gear and a torsion element, the second gear engaged with the first gear, the torsion element coupled between the stored energy initiator and the second gear.

68. The device of claim 5, wherein the medicament is in the form of a solid.

69. The device of claim 5, wherein the solid comprises drug particles having a mean diameter of greater than 10 μ

m to about 1 mm such that an effective dose of said drug cannot be delivered into the lower lung of a human patient.

70. The device of claim 5, wherein the medicament is in the form of a liquid.

71. The device of claim 5, wherein the medicament is in the form of a semi-solid.

72. A method of delivering a unit dose of a medicament to a patient, comprising:

providing a device having a sachet pack, an actuator, a first roller, a second roller, and mouthpiece, the sachet pack including a plurality of unit doses of a medicament enclosed between a first strip and a second strip, the first roller spaced apart forward from the second roller, the first strip being wrapped around the first roller, the second strip being wrapped around the second roller; and

upon actuation of the actuator by a patient, rotating the first and second rollers such that one of the plurality of the unit doses is released from the sachet pack and delivered to an oral cavity of the patient via the mouthpiece.