Medicament delivery and packaging

• US 6,418,926 B1
• Filed: 10/04/1999
• Issued: 07/16/2002
• Est. Priority Date: 12/18/1996
• Status: Expired due to Term

• Current Assignee: CustomArray, Inc. (Genscript Biotech Corp.)
• Original Assignee: CustomArray, Inc. (Genscript Biotech Corp.)
• Inventors: Chawla, Brindra Paul Singh
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/319,754
• Time in Patent Office: 1,016 Days
• Field of Search: 128/203.12, 128/203.15, 128/203.21, 128/204.13, 128/204.14
• US Class Current: 128/203.12
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61M 11/003 by passing the aerosol trough sieves or filters
• CPC Class Codes: A61M 15/0008 rotating by airflow
• 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 15/0033 Details of the piercing or cutting means
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows

Abstract

A system for the administration of a powdered medicament by inhalation comprises a container (21) containing a unit dose of medicament in powder form, and a device (10) having a chamber (16) adapted to receive the container (21). The device (10) has air inlets (19, 20) by which air may be drawn into the chamber (16) and a mouthpiece (14) by which air and entrained medicament may be drawn out of the chamber (16). The chamber (16) is substantially circular or annular in form and, in use, the container (21) follows an orbital path within the chamber (16), medicament being dispensed from the container (21) through at least one opening in the container (21). Also described are novel forms of packaging for powdered medicaments which are particularly suitable for use in the system.

Claims

1. A system for the administration of a powdered medicament by inhalation, the system comprising a container containing a unit dose of medicament in powder form, the container having at least one dispensing aperture and being cylindrical or substantially cylindrical in shape, the diameter of the container being greater than its depth and the container being formed from first and second cooperating components, and a device having a chamber adapted to receive said container, the device further comprising air inlet means by which air may be drawn into the chamber and a mouthpiece by which air and entrained medicament may be drawn out of the chamber, wherein the chamber is substantially circular or annular in form and, in use, the container follows an orbital path within the chamber.

2. A system as claimed in claim 1, wherein the air inlet means are arranged such that air enters the chamber substantially tangentially so as to facilitate orbital motion of the container within the chamber.

3. A system as claimed in claim 1, wherein a part of a wall of the chamber into which the air inlet means open is continuous and unbroken.

4. A system as claimed in claim 3, wherein the air inlet means open into a peripheral wall of the chamber, which peripheral wall has a height, but said air inlet means have a depth which is less than said height so that at least part of said peripheral wall forms an uninterrupted annular surface.

5. A system as claimed in claim 1, wherein the chamber is provided with a formation which serves to constrain the movement of the container to the orbital path.

6. A system as claimed in claim 5, wherein said formation is a protrusion in the centre of the chamber.

7. A system as claimed in claim 1, wherein air passes out of the chamber to the mouthpiece through a mesh or grid formed in part of a wall of the chamber.

8. A system as claimed in claim 7, wherein the mesh or grid is formed in a base of the chamber and a radially outer part of the base is solid.

9. A system as claimed in claim 1, wherein the mouthpiece is formed at the open end of a passageway or conduit which connects the chamber to the mouthpiece and the passageway or conduit is disposed substantially orthogonally to an axis of rotation of the container in the chamber.

10. A system as claimed in any preceding claim, wherein the device is configured for repeated use, and means are provided for introducing a container into the chamber and removing the container after use.

11. A system as claimed in claim 1, which is for single dose use and is supplied with a container of medicament incorporated into the device in such a way that the dispensing aperture is sealed, the container being released from the device, and the dispensing aperture thereby opened, by the patient immediately before use.

12. A system as claimed in claim 1, wherein said first cooperating component is of generally cylindrical construction and has an open end, said second cooperating component fitting closely within or about the open end of the first cooperating component.

13. A system as claimed in claim 1, wherein the container is provided with a plurality of dispensing apertures.

14. A system as claimed in claim 1, wherein the container is of a material which is substantially impermeable to moisture.

15. A system as claimed in claim 1, wherein the container is formed at least in part from metal sheet.

16. A system as claimed in claim 15, wherein the metal sheet is aluminium sheet.

17. A system as claimed in any preceding claim, wherein the motion of the container, in use, is epicyclic.

18. A method for the administration of a powdered medicament by inhalation, which method comprises:

a) providing a container containing a unit dose of said powdered medicament, the container having at least one dispensing aperture and being cylindrical or substantially cylindrical in shape, the diameter of the container being greater than its depth and the container being formed from first and second cooperating components,

b) providing a device having a chamber adapted to receive said container, the device further comprising air inlet means by which air may be drawn into the chamber and a mouthpiece by which air may be drawn out of the chamber, the chamber being substantially circular or annular in form, and

c) generating an airstream within the chamber by drawing air from the chamber via the mouthpiece so as to cause the container to follow an orbital path within the chamber, powdered medicament thereby being dispensed from within the container via said at least one dispensing aperture, entrained in said airstream and withdrawn from the chamber.

19. A method as claimed in claim 18, wherein the motion of the container is epicyclic.

20. A device for the administration of a powdered medicament to a patient by inhalation, which device has a chamber adapted to receive a container containing a unit dose of medicament in powder form, the container having a dispensing aperture, air inlet means by which air may be drawn into the chamber and a mouthpiece by which air and entrained medicament may be drawn out of the chamber, wherein the chamber is substantially circular or annular in form and is provided with one or more formations effective to constrain, in use, the container to an orbital path within the chamber, said one or more formations comprising a spigot or the like in the centre of said chamber, and wherein the device is for single dose use and is supplied with the container of medicament incorporated into the device in such a way that the dispensing aperture is sealed, the container being released into the chamber, and the dispensing aperture thereby opened, by the patient immediately before use.

21. A device as claimed in claim 20, wherein the air inlet means are arranged such that air enters the chamber substantially tangentially so as to facilitate orbital motion of the container within the chamber.

22. A device as claimed in claim 20, wherein a part of a wall of the chamber into which the air inlet means open is continuous and unbroken.

23. A device as claimed in claim 22, wherein the air inlet means open into a peripheral wall of the chamber, but have a depth which is less than a height of said peripheral wall so that at least part of said peripheral wall forms an uninterrupted annular surface.

24. A device as claimed in claim 20, wherein said spigot or the like is a protrusion in the centre of a base of the chamber.

25. A device as claimed in claim 20, wherein air passes out of the chamber to the mouthpiece through a mesh or grid formed in part of a wall of the chamber.

26. A device as claimed in claim 25, wherein the mesh or grid is formed in a base of the chamber and a radially outer part of the base is solid.

27. A device as claimed in claim 20, wherein the mouthpiece is formed at an open end of a passageway or conduit which connects the chamber to the mouthpiece and the passageway or conduit is disposed substantially orthogonally to an axis of rotation of the container in the chamber.

28. A cylindrical or substantially cylindrical container having at least one dispensing aperture, the diameter of the container being greater than its depth, the container being of a material which is substantially impermeable to moisture, the container being formed from first and second cooperating components, wherein said first cooperating component is of generally cylindrical construction and has an open end, said second cooperating component fitting closely within or about the open end of the first cooperating component, and the container having contents consisting essentially of a single unit dose of a powdered inhalation medicament.

29. A container as claimed in claim 28, wherein the container is formed at least in part from metal sheet.

30. A container as claimed in claim 29, wherein the metal sheet is aluminium sheet.

31. A medicament package containing at least one unit dose of a non-pressurised, dry powdered inhalation medicament, said medicament package comprising a container which contains a unit dose of non-pressurised, dry powdered inhalation medicament and has at least one dispensing aperture, the container being of a material which is substantially impermeable to moisture, and a sealing means arranged to close the at least one dispensing aperture, wherein the sealing means comprises a planar support having an opening or recess within which the container is received such that the planar support overlies and closes the at least one dispensing aperture.

32. A package as claimed in claim 31, wherein the planar support comprises a sheet of plastics material, the sheet having an opening within which the container is received, the circumference of said opening being constituted by a ring of elastomeric material, said ring bearing upon said container so as to close said at least one dispensing aperture.

33. A cylindrical or substantially cylindrical container, the diameter of the container being greater than its depth, the container being formed from first and second cooperating components, wherein said first cooperating component is of generally cylindrical construction and has an open end, said second cooperating component fitting closely within or about the open end of the first cooperating component, and the container having contents consisting essentially of a single unit dose of a powdered inhalation medicament.

34. A container as claimed in claim 33, wherein the container is provided with at least one dispensing aperture.

35. A container as claimed in claim 34, wherein the dispensing aperture is closed by a removable sealing means.

36. A system for the administration of a powdered medicament by inhalation, the system comprising a container containing a unit dose of medicament in powder form, the container having at least one dispensing aperture and the container being formed from first and second cooperating components, and a device having a chamber adapted to receive said container, the device further comprising air inlet means by which air may be drawn into the chamber and a mouthpiece by which air and entrained medicament may be drawn out of the chamber, wherein the chamber is substantially circular or annular in form and, in use, the container follows an orbital path within the chamber, and wherein the air inlet means open into a peripheral wall of the chamber, which peripheral wall has a height, but said air inlet means have a depth which is less than said height so that at least part of said peripheral wall forms an uninterrupted annular surface.

37. A system as claimed in claim 36, wherein the air inlet means are arranged such that air enters the chamber substantially tangentially so as to facilitate orbital motion of the container within the chamber.

38. A system as claimed in claim 36, wherein the chamber is provided with a formation which serves to constrain the movement of the container in its orbital path.

39. A system as claimed in claim 38, wherein said formation is a protrusion in the centre of the chamber.

40. A system as claimed in claim 36, wherein air passes out of the chamber to the mouthpiece through a mesh or grid formed in part of a wall of the chamber.

41. A system as claimed in claim 40, wherein the mesh or grid is formed in a base of the chamber and a radially outer part of the base is solid.

42. A system as claimed in claim 36, wherein the mouthpiece is formed at the open end of a passageway or conduit which connects the chamber to the mouthpiece and the passageway or conduit is disposed substantially orthogonally to an axis of rotation of the container in the chamber.

43. A system as claimed in claim 36, wherein the device is configured for repeated use, and means are provided for introducing a container into the chamber and removing the container after use.

44. A system as claimed in claim 36, which is for single dose use and is supplied with a container of medicament incorporated into the device in such a way that the dispensing aperture is sealed, the container being released from the device, and the dispensing aperture thereby opened, by the patient immediately before use.

45. A system as claimed in claim 36, wherein the container is cylindrical or substantially cylindrical.

46. A system as claimed in claim 45, wherein the diameter of the container is greater than its depth.

47. A system as claimed in claim 36, wherein said first cooperating component is of generally cylindrical construction and has an open end, said second cooperating component fitting closely within or about the open end of the first cooperating component.

48. A system as claimed in any claim 36, wherein the container is provided with a plurality of dispensing apertures.

49. A system as claimed in any claim 36, wherein the container is of a material which is substantially impermeable to moisture.

50. A system as claimed in claim 36, wherein the container is formed at least in part from metal sheet.

51. A system as claimed in claim 50, wherein the metal sheet is aluminium sheet.

52. A system as claimed in claim 36, wherein the motion of the container, in use, is epicyclic.