Apparatus for the nasal or oral delivery of a medicament

• US 20050028813A1
• Filed: 10/03/2002
• Published: 02/10/2005
• Est. Priority Date: 10/05/2001
• Status: Active Grant

• Current Assignee: Alchemy Pharmatech Limited
• Original Assignee: Alchemy Healthcare Limited (Alchemy Pharmatech Limited)
• Inventors: Harrison, Ian
• Granted Patent: US 7,163,013 B2
• Time in Patent Office: Days
• US Class Current: 128/200.220
• 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 15/0031 by bursting or breaking the package, i.e. without cutting or piercing
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/071 hand operated

Abstract

An apparatus (1) for the nasal or oral delivery of a medicament, comprises: (a) a sealed flexible container (3) containing the medicament and a gaseous propellant for the medicament; and (b) a delivery device (5), comprising: (i) a main body part (5a) which, at least in use, holds the sealed flexible container (3); and (ii) a compressive part (5b) which, when actuated in use, causes the sealed flexible container (3) to be ruptured and the propellant to expel the medicament from the container, thereby delivering the medicament.

Claims

1. An apparatus for the nasal or oral delivery of a medicament to a patient, comprising:

(a) a sealed flexible container including the medicament and a gaseous propellant for the medicament; and

(b) a delivery device, including;

(i) a main body part which, at least in use, holds the sealed flexible container; and

(ii) a compressive part which, when actuated in use, compresses the sealed flexible container, thereby pressurizing the gaseous propellant within the container, which pressurization of the gaseous propellant causes the sealed flexible container to be ruptured and the propellant to expel the medicament from the apparatus, thereby delivering the medicament to the patient.

2. The apparatus according to claim 1, wherein the sealed flexible container is formed from one of a metal foil and a polymeric sheet material.

3. The apparatus according to claim 1, wherein the sealed flexible container is molded and comprises one or more parts.

4. The apparatus according to claim 1, wherein the sealed flexible container comprises a frangible portion adapted to rupture when the compressive part of the delivery device is actuated in use.

5. The apparatus according to claim 1, wherein the propellant included in the sealed flexible container comprises one or more of air, oxygen, nitrogen, argon, and substantially any non-CFC propellant suitable for human inhalation.

6. The apparatus according to claim 1, wherein the medicament is in one or more of a powder form, a liquid form, a vapor form, and a gaseous form.

27. The apparatus according to claim 2, wherein the sealed flexible container comprises a laminated structure formed from a metal foil laminated to a polymeric sheet material.

28. The apparatus according to claim 1, wherein each of the compressive part and the main body part include an interlockable member, such that when the compressive part is activated, the compressive part interlocks with the main body part.

29. The apparatus according to claim 28, wherein the interlockable members are arranged to undergo a two-stage interlocking action including a first stage and a second stage, wherein the first stage includes closure of the delivery device to hold the sealed flexible container, and wherein the second stage occurs open activation of the compressive part.

30. The apparatus according to claim 1, wherein the compressive part comprises a part which is movable with respect to the main body part so as to compress the sealed flexible container, and activation of the compressive part includes such movement.

31. The apparatus according to claim 1, wherein activation of the compressive part is arranged to be carried out by manual depression of the compressive part with respect to the main body part.

32. The apparatus according to claim 1, wherein the compressive part is one of hinged and rotatably mounted with respect to the main body part.

33. The apparatus according to claim 32, wherein the compressive part is hinged to the main body part by a flexible web.

34. The apparatus according to claim 1, wherein the main body part comprises a nozzle for delivering the medicament.

35. The apparatus according to claim 34, wherein the main body part comprises a protrusion, disposed adjacent to the nozzle, to assist in rupturing the flexible container.

36. The apparatus according to claim 34, further comprising atomizing means, disposed in or adjacent to the nozzle, to atomize a liquid medicament.

37. The apparatus according to claim 1, further comprising a visible indicator for indicating when the apparatus has been activated.

38. The apparatus according to claim 37, wherein the visible indicator comprises a colored portion disposed on one of the compressive part and the main body part.

7. A delivery device for the nasal or oral delivery of a medicament, comprising:

(i) a main body part arranged to hold, in use, a sealed flexible container containing a medicament and a gaseous propellant for the medicament; and

(ii) a compressive part arranged to cause, when actuated in use, a sealed flexible container held by the main body part to be ruptured and the propellant to expel the medicament from the container, thereby delivering the medicament, wherein each of the compressive part and the main body part include interlockable members by which the compressive part may interlock with the main body part, wherein the interlockable members are arranged to undergo a two-stage interlocking action including a first stage and a second stage, wherein the first stage includes closure of the delivery device to hold the sealed flexible container, and wherein the second stage occurs open activation of the compressive part.

8. The device according to claim 7, wherein the compressive part comprises a part which is movable with respect to the main body part so as to compress the sealed flexible container, and actuation of the compressive part comprises such movement.

9. The or device according to claim 7, wherein actuation of the compressive part is arranged to be carried out by manual depression of the compressive part with respect to the main body part.

10. The device according to claim 7, wherein the compressive part is one of hinged and rotatably mounted with respect to the main body part.

11. The apparatus or device according to claim 10, wherein the compressive part is hinged to the main body part by a flexible web.

12. The device according to claim 7, in which the main body part comprises a nozzle by which the medicament is delivered, in use.

13. The device according to claim 12, wherein the main body part comprises a protrusion, adjacent to the nozzle, to assist the rupture of the flexible container.

14. The device according to claim 12, further comprising atomizing means, disposed in or adjacent to the nozzle, to atomize a liquid medicament.

16. The device according to claim 7, wherein the interlocking of the interlockable members prevents re-actuation of the compressive part.

17. The device according to claim 7, wherein, when the compressive part has been actuated, the compressive part interlocks with the main body part such that further depression of the compressive part is substantially prevented.

19. The device according to claim 7, further comprising a visible indicator for indicating when the device has been actuated, which is visible only once the apparatus has been actuated.

20. The device according to claim 19, wherein the visible indicator comprises a colored portion disposed on one of the compressive part and the main body part.

21. The device according to claim 7, wherein the delivery device is formed from a polymer material.

22. The device according to claim 21, in which the delivery device is molded as a single integral part.

23. The device according to claim 7, wherein the gaseous propellant contained in the sealed flexible container is in a pressurized state prior to actuation of the compressive part.

24. The device according to claim 7, wherein the gaseous propellant is pressurized only upon actuation of the compressive part.

15. (cancelled)

18. (cancelled)

25. (cancelled)

26. (cancelled)