Medicament storage and delivery devices

• US 20050205083A1
• Filed: 04/27/2005
• Published: 09/22/2005
• Est. Priority Date: 03/07/2002
• Status: Abandoned Application

• Current Assignee: PharmaKodex Ltd. (Orexo AB)
• Original Assignee: Vectura Limited (Vectura Group Ltd.)
• Inventors: Bowman, Nicholas John, Brook Simpson, David Badley, Wright, Matthew, Tobyn, Michael, Staniforth, John Nicholas, Howard, Gary Stephen
• Application Number:
  US11/115,826
• Publication Number:
  US 20050205083A1
• Time in Patent Office: Days
• US Class Current: 128/200.140
• 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, wherein the medicament is in the form of a solid wherein the solid comprises drug particles of a size such that pulmonary deposition of an effective dose of said drug is avoided in a human 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.

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.

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.

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.

78. The device of claim 1, wherein the solid comprises drug particles having a mean diameter of greater than about 50 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.

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, wherein the medicament is in the form of a solid, wherein the solid comprises drug particles of a size such that pulmonary deposition of an effective dose of said drug is avoided in a human 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.

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.

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.

79. The device of claim 2, wherein the solid comprises drug particles having a mean diameter of greater than about 50 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.

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, wherein the medicament is in the form of a solid wherein the solid comprises drug particles of a size such that pulmonary deposition of an effective dose of said drug is avoided in a human patient.

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.

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.

80. The device of claim 3, wherein the solid comprises drug particles having a mean diameter of greater than about 50 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.

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, wherein the medicament is in the form of a solid, wherein the solid comprises drug particles of a size such that pulmonary deposition of an effective dose of said drug is avoided in a human 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.

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.

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.

81. The device of claim 4, wherein the solid comprises drug particles having a mean diameter of greater than about 50 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.

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, wherein the medicament is in the form of a solid, wherein the solid comprises drug particles of a size such that pulmonary deposition of an effective dose of said drug is avoided in a human patient.

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.

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.

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.

82. The device of claim 5, wherein the solid comprises drug particles having a mean diameter of greater than about 50 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.

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72. A method of delivering a unit dose of a medicament to an oral cavity of a patient for gastrointestinal, esophageal, or oral cavity administration, 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 for gastrointestinal, esophageal, or oral cavity absorption or action via the mouthpiece.