Oral delivery of discrete units

• US 6,210,713 B1
• Filed: 02/25/2000
• Issued: 04/03/2001
• Est. Priority Date: 07/21/1995
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Rosen, Howard B., Roth, Nathan, Wong, Patrick S.-L., Gardner, Phyllis I.
• Primary Examiner(s): Spear, James M.
• Application Number:
  US09/513,074
• Time in Patent Office: 403 Days
• Field of Search: 424/473, 424/439, 424/451, 424/464, 424/489, 604/85, 604/57, 604/58
• US Class Current: 424/473
• CPC Class Codes: A47G 21/183 with means for changing the flavour of the liquid
• CPC Class Codes: A61J 7/0038 Straws
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes

Abstract

The present invention is an oral active agent delivery system and method for delivering discrete units of an active agent formulation to a patient. An active agent formulation chamber containing the active agent formulation and having a fluid passing active agent formulation retainer is placed at a first end into a fluid and at a second end into a patient'"'"'s mouth. The active agent is delivered when the patient sips on the second end of the chamber.

Claims

1. An oral active agent delivery system for delivering to a patient active agent in admixture with a fluid, comprising:

a tubular active agent formulation chamber having a first end configured for fluid communication with the fluid and a second end configured for oral application of suction by the patient, wherein said first end is crimped to form a restriction in a cross-sectional area of said first end of said active agent formulation chamber;

a one-way valve disposed in said active agent formulation chamber, wherein said one-way valve prevents passage of active agent out of said first end and allows passage of fluid through said active agent formulation chamber, and

a removable tab, wherein said removable tab prevents release of active agent from said second end of said active agent formulation chamber prior to use by the patient.

3. The oral active agent delivery system of claim 1, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber.

4. The oral active agent delivery system of claim 3, wherein said quantity of discrete units is disposed between said second end and said one-way valve.

5. The oral active agent delivery system of claim 1, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber, wherein each of said discrete units has a diameter greater than said restriction.

6. The oral active agent delivery system of claim 5, wherein said quantity of discrete units is disposed between said second end and said one-way valve.

7. The oral active agent delivery system of claim 1, wherein said one-way valve is transportable toward said second end upon application of suction by the patient.

8. The oral active agent delivery system of claim 3, wherein said quantity of discrete units comprises oral dosage forms that comprise an osmotic layer and an active agent layer.

9. The oral active agent delivery system of claim 5, wherein said quantity of discrete units comprises oral dosage forms that comprise an osmotic layer and an active agent layer.

10. The oral active agent delivery system of claim 1, further comprising:

an end cap concentrically surrounding said first end of said active a gent formulation chamber.

11. The oral active agent delivery system of claim 1, further comprising:

an end cap concentrically surrounding said second end of said active agent formulation chamber.

12. The oral active agent delivery system of claim 1, wherein said one-way valve allows fluid to pass from said first end toward said second end.

2. An oral active agent delivery system for delivering to a patient active agent in admixture with a fluid, comprising:

a tubular active agent formulation chamber having a first end configured for fluid communication with the fluid and a second end configured for oral application of suction by the patient; and

a one-way valve disposed in said active agent formulation chamber, wherein said one-way valve is transportable toward said second end upon application of suction by the patient and allows passage of fluid through said active agent formulation chamber.

14. The oral active agent delivery system of claim 2, further comprising:

an end cap concentrically surrounding said second end of said active agent formulation chamber.

39. The oral active agent delivery system of claim 2, wherein said one-way valve allows fluid to pass from said first end toward said second end.

40. The oral active agent delivery system of claim 2, wherein said one-way valve comprises a porous plug.

41. The oral active agent delivery system of claim 2, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber.

13. An oral active agent delivery system for delivering to a patient active agent in admixture with a fluid, comprising:

a tubular active agent formulation chamber having a first end configured for fluid communication with the fluid and a second end configured for oral application of suction by the patient, wherein said first end is crimped to form a restriction in a cross-sectional area of said first end of said active agent formulation chamber;

a one-way valve disposed in said active agent formulation chamber, wherein said one-way valve prevents passage of active agent out of said first end and allows passage of fluid through said active agent formulation chamber; and

a removable seal, wherein said removable seal prevents release of active agent from said second end of said active agent formulation chamber prior to use by the patient.

15. The oral active agent delivery system of claim 13, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber.

16. The oral active agent delivery system of claim 15, wherein said quantity of discrete units is disposed between said second end and said one-way valve.

17. The oral active agent delivery system of claim 13, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber, wherein each of said discrete units have a diameter greater than said restriction.

18. The oral active agent delivery system of claim 17, wherein said quantity of discrete units is disposed between said second end and said one-way valve.

19. The oral active agent delivery system of claim 13, wherein said one-way valve is transportable toward said second end upon application of suction by the patient.

20. The oral active agent delivery system of claim 15, wherein said quantity of discrete units comprises oral dosage forms that comprise an osmotic layer and an active agent layer.

21. The oral active agent delivery system of claim 17, wherein said quantity of discrete units comprises oral dosage forms that comprise an osmotic layer and an active agent layer.

22. The oral active agent delivery system of claim 13, further comprising:

an end cap concentrically surrounding said first end of said active agent formulation chamber.

23. The oral active agent delivery system of claim 13, further comprising:

an end cap concentrically surrounding said second end of said active agent formulation chamber.

24. The oral active agent delivery system of claim 13, wherein said one-way valve allows fluid to pass from said first end toward said second end.

25. An oral active agent delivery system for delivering to a patient active agent in admixture with a fluid, comprising:

a tubular active agent formulation chamber having a first end configured for fluid communication with the fluid and a second end configured for oral application of suction by the patient;

a one-way valve disposed in said active agent formulation chamber, wherein said one-way valve allows passage of fluid through said active agent formulation chamber; and

a fluid passing active agent formulation retainer disposed in said active agent formulation chamber, wherein said fluid passing active agent formulation retainer prevents passage of active agent out of said active agent formulation chamber and allows passage of fluid through said active agent formulation chamber.

26. The oral active agent delivery system of claim 25, wherein said fluid passing active agent formulation retainer is transportable toward said second end upon application of suction by the patient.

27. The oral active agent delivery system of claim 25, wherein said fluid passing active agent formulation retainer comprises a porous plug.

28. The oral active agent delivery system of claim 27, wherein said porous plug is transportable toward said second end upon application of suction by the patient.

29. The oral active agent delivery system of claim 26, wherein a position of said fluid passing active agent formulation retainer is an indication of the extent of active agent delivery.

30. The oral active agent delivery system of claim 28, wherein a position of said porous plug is an indication of the extent of active agent delivery.

31. The oral active agent delivery system of claim 25, further comprising:

a removable tab, wherein said removable tab prevents release of active agent from said second end of said active agent formulation chamber prior to use by the patient.

32. The oral active agent delivery system of claim 25, further comprising:

a removable seal, wherein said removable seal prevents release of active agent from said second end of said active agent formulation chamber prior to use by the patient.

33. The oral active agent delivery system of claim 25, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber.

34. The oral active agent delivery system of claim 33, wherein said quantity of discrete units is disposed between said second end and said fluid passing active agent formulation retainer.

35. The oral active agent delivery system of claim 27, further comprising:

a quantity of discrete units that comprise the active agent disposed in said active agent formulation chamber.

36. The oral active agent delivery system of claim 35, wherein said quantity of discrete units is disposed between said second end and said porous plug.

37. The oral active agent delivery of system of claim 25, further comprising:

an end cap concentrically surrounding said first end of said active agent formulation chamber.

38. The oral active agent delivery system of claim 25, further comprising:

an end cap concentrically surrounding said second end of said active agent formulation chamber.

42. An oral active agent delivery system for delivering to a patient active agent in admixture with a fluid, comprising:

a tubular active agent formulation chamber having a first end configured for fluid communication with the fluid and a second end configured for oral application of suction by the patient; and

a one-way valve disposed in said active agent formulation chamber, wherein said one-way valve comprises a porous plug and allows passage of fluid through said active agent formulation chamber.