Modifiable dosage form

• US 20100068233A1
• Filed: 09/16/2008
• Published: 03/18/2010
• Est. Priority Date: 09/16/2008
• Status: Abandoned Application

• Current Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Original Assignee: Searete LLC (Intellectual Ventures LLC)
• Inventors: Ishikawa, Muriel Y., Boyden, Edward S., Wood, Lowell L. JR., Rivet, Dennis J., Hyde, Roderick A., Sweeney, Elizabeth A., Wood, Victoria Y.H., Bangera, Mahalaxmi Gita
• Application Number:
  US12/284,013
• Publication Number:
  US 20100068233A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/28 Dragees; Coated pills or tablets , e.g. with film or compression coating A61K9/2072 takes precedence, e.g. partially coated tablets A61K9/2072, coated multilayer tablets A61K9/2086, tablets with drug-coated core A61K9/209

Abstract

Provided embodiments include a final dosage form, an article of manufacture, and method. A final dosage form for delivering a medicament to an animal is provided. The final dosage form includes an outer layer. The final dosage form also includes a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus. The final dosage form further includes a chamber at least substantially within the outer layer and configured to carry the medicament. The final dosage form includes the medicament. The final dosage form may include an indicator element configured to indicate an exposure of the release element to the stimulus.

Claims

1. A final dosage form for delivering a medicament to an animal, the final dosage form comprising:

an outer layer;

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus;

a chamber at least substantially within the outer layer and configured to carry the medicament; and

the medicament.

2. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer of at least one of a tablet, capsule, particle, or solid dosage form.

3. The final dosage form of claim 1, wherein the outer layer includes:

an outer peripheral layer.

4. The final dosage form of claim 1, wherein the outer layer is configured for administration to the animal by at least one of an oral, enteral, inhalation, or implant route.

5. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer configured to release the medicament in an in vivo environment of the animal.

6. The final dosage form of claim 1, wherein the outer layer includes:

an erodible outer layer.

7. The final dosage form of claim 6, wherein the erodible outer layer includes:

an erodible outer layer that is at least one of soluble, permeable, or disintegrable within the animal.

8. The final dosage form of claim 6, wherein the erodible outer layer includes:

an erodible outer layer having at least a portion that is at least one of soluble, permeable, or disintegrable in response to an acidic environment within the animal.

9. The final dosage form of claim 6, wherein the erodible outer layer includes:

an erodible outer layer having at least a portion that is at least one of soluble, permeable, or disintegrable in response to a basic environment within the animal.

10. The final dosage form of claim 1, wherein the outer layer includes:

an outer portion of a molecule.

11. The final dosage form of claim 1, wherein the outer layer includes:

an outer portion of a particle.

12. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer configured to allow an in vivo discharge of at least a portion of the medicament from the chamber after an exposure of the release element to the stimulus.

13. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer configured in cooperation with the release element to allow an in vivo discharge of at least a portion of the medicament from the chamber after an exposure of the release element to the stimulus.

14. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer that includes at least a portion of the release element.

15. The final dosage form of claim 1, wherein the outer layer includes:

an outer layer configured to contain the medicament until the final dosage form is administered into the animal.

16. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element disposed at least partially within the outer layer and configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus.

17. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and reconfigurable to a second medicament-release state upon an ex vivo exposure to a stimulus.

18. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and changeable to a second medicament-release state upon an ex vivo exposure to a stimulus.

19. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a non-ionizing radiation.

20. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to an electromagnetic radiation.

21. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to at least one of a light radiation, terahertz radiation, microwave radiation, and radio wave radiation.

22. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a magnetic stimulus.

23. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to an electric field stimulus.

24. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to an energetic stimulus.

25. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a chemical stimulus.

26. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a mechanical stimulus.

27. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus, the release element including at least one of a mechanically activatable structure, heat activatable structure, or pressure activatable structure.

28. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to at least one of an activation stimulus, or an actuation stimulus.

29. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a de-activation stimulus.

30. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to at least one of at least one of a thermal, acoustic, and ultrasound stimulus.

31. The final dosage form of claim 1, wherein the first medicament-release state is configured to retard medicament release in vivo and the second medicament-release state is configured to allow medicament release in vivo.

32. The final dosage form of claim 1, wherein the first medicament-release state is configured to allow medicament release in vivo and the second medicament-release state is configured to retard medicament release in vivo.

33. The final dosage form of claim 1, wherein the release element includes at least one of polymeric micelle, nanoparticles, cyclodextrin, gel, gel matrix, hydrogel, or cellulose.

34. The final dosage form of claim 1, wherein the release element includes at least one of a poly(vinyl alcohol), gel, gel matrix, hydrogel, or azopolymer membrane.

35. The final dosage form of claim 1, wherein the release element includes at least one of a foil, gold foil, a liposome, wax, or dielectric/wax composite.

36. The final dosage form of claim 1, wherein the release element includes at least one of polyanhidrides, polyglycolides, polyactides, poly(vinyl acetate), poly(glycolic acid), poly (ethylene), poly(lactic acid), or chitosan.

37. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element enclosing the chamber, configured in a first medicament-release state, and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus.

38. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element encapsulating the chamber, configured in a first medicament-release state, and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus.

39. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element encapsulating the medicament in cooperation with the chamber, configured in a first medicament-release state, and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus.

40. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element obstructing an aperture of the chamber, configured in a first medicament-release state, and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus.

41. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

at least two particles each respectively forming a chamber carrying a respective instance of the medicament, the at least two particles configured in a first medicament-release state, and modifiable to a second medicament-release state upon an ex vivo exposure of the at least two particles to a stimulus.

42. The final dosage form of claim 1, wherein the release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus includes:

a release element configured in a first medicament-release state and modifiable to a second medicament-release state upon an ex vivo exposure to a stimulus, and configured to contain the medicament at least until the final dosage form is administered into the animal.

43. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament further includes:

a singular chamber structure at least substantially within the outer layer and configured to carry the medicament.

44. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament further includes:

a chamber at least substantially within the outer layer and configured to carry the medicament, the chamber including at least one of an aggregation of cells formed by interstitial cavities, at least two smaller chambers, interstices of a molecular structure, or amorphous cavities.

45. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a chamber disposed within the outer layer and configured to carry the medicament.

46. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a chamber at least substantially within the outer layer and configured to carry the medicament until released by the release element.

47. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

at least one chamber at least substantially within the outer layer and configured to carry the medicament.

48. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

at least two chambers configured to carry respective instances of the medicament.

49. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a first chamber configured to carry a first medicament and a second chamber configured to carry a second medicament.

50. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a chamber configured to confine the medicament in cooperation with the release element.

51. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

least one chamber configured to confine the medicament in a structural cooperation with the release element.

52. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a chamber configured to carry the medicament, and configured to release at least a portion of the medicament from the outer layer upon at least one of a bursting, puncture, permeation, dissolution, and disintegration of the release element.

53. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a first chamber configured to carry a first constituent of the medicament and a second chamber configured to carry a second constituent of the medicament.

54. The final dosage form of claim 1, wherein the chamber at least substantially within the outer layer and configured to carry the medicament includes:

a first chamber configured to carry a first reactant of the medicament and a second chamber configured to carry a second reactant of the medicament.