Ex vivo activatable final dosage form

• US 20100068153A1
• Filed: 02/05/2009
• Published: 03/18/2010
• Est. Priority Date: 09/16/2008
• Status: Abandoned Application

• Current Assignee: Deep Science LLC (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:
  US12/322,878
• Publication Number:
  US 20100068153A1
• Time in Patent Office: Days
• US Class Current: 424/10.100
• CPC Class Codes: A61K 41/0028 Disruption, e.g. by heat or ultrasounds, sonophysical or sonochemical activation, e.g. thermosensitive or heat-sensitive liposomes, disruption of calculi with a medicinal preparation and ultrasounds
• 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 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209

Abstract

Provided embodiments include a final dosage form, an article of manufacture, and method. A final dosage form for administering a medicament to an animal is provided. The final dosage form includes an outer layer, the medicament, and a release element. The release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus. In an embodiment, the final dosage form includes a chamber substantially within the outer layer and carrying the medicament. In an embodiment, the final dosage form includes an indicator element configured to indicate an exposure of the release element to the stimulus.

Claims

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

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus; and

the medicament.

2. The final dosage form of claim 1, further comprising:

an outer layer.

3. The final dosage form of claim 1, further comprising:

a site carrying the medicament.

4. The final dosage form of claim 1, wherein the site carrying the medicament comprises:

a chamber carrying the medicament.

5. The final dosage form of claim 1, wherein the site carrying the medicament comprises:

a region carrying the medicament.

6. The final dosage form of claim 1, wherein the site carrying the medicament comprises:

a binding site releasably carrying the medicament.

7. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state wherein the medicament is substantially not bioavailable to the animal if the final dosage form is administered to the animal, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus wherein the medicament is substantially bioavailable to the animal if the final dosage form is administered to the animal.

8. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state wherein the medicament is insubstantially bioavailable if the final dosage form is administered to the animal, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus wherein the medicament is substantially bioavailable if the final dosage form is administered to the animal.

9. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state wherein the medicament is substantially bio-unavailable if the final dosage form is administered to the animal, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus wherein the medicament is substantially bioavailable if the final dosage form is administered to the animal.

10. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state wherein the medicament has a substantially insignificant effect on the animal if the final dosage form is administered to the animal, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus wherein the medicament has a substantially significant effect on the animal if the final dosage form is administered to the animal.

11. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-withholding state and modifiable ex vivo to a medicament-supplying state by an exposure to a stimulus.

12. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state and field-modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus.

13. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state and modifiable ex vivo post-manufacture to a medicament-discharge state by an exposure to a stimulus.

14. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element forming an imperforate barrier in a medicament-holding state and modifiable ex vivo by an exposure to a stimulus to form a perforate barrier in a medicament-discharge state.

15. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus, the stimulus including at least one of light, radio, or electromagnetic waves.

16. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus, the stimulus including at least one of a thermal, acoustic or ultrasound stimulus.

17. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus, the release element including at least one of a gel, gel matrix, hydrogel, or a dendrimer.

18. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a particle configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus.

19. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a polymer substance configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus.

20. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a non-shape-memory material configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus.

21. The final dosage form of claim 1, wherein the release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus comprises:

a release element disposed at least partially within an outer layer, configured in a medicament-holding state, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus, whereby the medicament is substantially available for an in vivo release into the animal if the final dosage form is administered to the animal while the release element is configured in the medicament-discharge state.

22. The final dosage form of claim 1, further comprising:

an indicator element configured to indicate an exposure of the release element to the stimulus.

23. A final dosage form for administering a medicament to an animal, the final dosage form comprising:

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus; and

a site carrying the medicament.

24. The final dosage form of claim 23, wherein the site carrying the medicament comprises:

a chamber carrying the medicament.

25. The final dosage form of claim 23, wherein the site carrying the medicament comprises:

a region carrying the medicament.

26. The final dosage form of claim 23, wherein the site carrying the medicament comprises:

a binding site releasably carrying the medicament.

27. The final dosage form of claim 23, further comprising:

a containment element retaining the medicament within the final dosage form until the final dosage form is administered to the animal.

28. The final dosage form of claim 27, wherein the containment element retaining the medicament within the final dosage form until the final dosage form is administered to the animal comprises:

a carrier, excipient, or admixture retaining the medicament within the final dosage form until the final dosage form is administered to the animal.

29. The final dosage form of claim 27, wherein the containment element retaining the medicament within the final dosage form until the final dosage form is administered to the animal comprises:

a particle or polymeric substance retaining the medicament within the final dosage form until the final dosage form is administered to the animal.

30. The final dosage form of claim 23, further comprising:

an outer layer surrounding the release element.

31. The final dosage form of claim 23, further comprising:

an indicator element configured to indicate an exposure of the release element to the stimulus.

32. An article comprising:

at least one final dosage form for administering a therapeutically effective amount of a medicament to an animal, the final dosage form comprising;

a release element configured in a medicament-holding state and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus;

a site carrying the medicament; and

instructions specifying the ex vivo exposure of the release element to a stimulus sufficient to modify the release element to the medicament-discharge state.

33. The article of claim 32, further comprising:

an outer layer surrounding the release element.

34. A method of modifying a medicament availability characteristic of a final dosage form for administering a medicament to an animal, wherein the final dosage form includes

a release element configured in the medicament-holding state wherein a medicament is substantially not bioavailable to the animal and modifiable ex vivo to a medicament-discharge state by the exposure to a stimulus wherein the medicament is substantially bioavailable to the animal;

and

a site carrying the medicament; and

the method comprising;

initiating a ex vivo exposure of the release element of the final dosage form to a stimulus, the initiated stimulus selected to transform the release element from a medicament-holding state to a medicament-discharge state.

35. The method of claim 34, wherein the final dosage form further comprises:

a containment element retaining the medicament within the final dosage form until the final dosage form is introduced into the animal.

36. The method of claim 34, wherein the final dosage form further comprises:

an indicator element configured to indicate an exposure of the release element to the stimulus.

37. The method of claim 34, wherein the initiated stimulus comprises:

an initiated stimulus having a parameter selected to transform the release element from a medicament-holding state to a medicament-discharge state.

38. The method of claim 34, wherein the initiated stimulus comprises:

an initiated stimulus having at least one of a stimulation characteristic or a spatial characteristic selected to transform the release element from a medicament-holding state to a medicament-discharge state.

39. The method of claim 34, wherein the initiating an ex vivo exposure of the release element of the final dosage form to a stimulus comprises:

initiating a first ex vivo exposure of the release element of the final dosage form to a stimulus, the first initiated stimulus selected to transform the release element from a medicament-holding state to a medicament-discharge state;

receiving an indication of the first ex vivo exposure of the release element of the final dosage form to the first initiated stimulus, the indication generated in response to an indicator element of the final dosage form configured to indicate an exposure of the release element to the stimulus; and

initiating a second ex vivo exposure of the release element of the final dosage form to the stimulus, the second initiated ex vivo exposure stimulus selected to further transform the release element from the medicament-holding state to the medicament-discharge state.

40. The method of claim 34, wherein the initiating an ex vivo exposure of the release element of the final dosage form to a stimulus comprises:

initiating an ex vivo exposure of the release element of the final dosage form to a stimulus, the stimulus selected to transform the release element from a medicament-holding state to a medicament-discharge state;

receiving an indication of the ex vivo exposure of the release element of the final dosage form to the stimulus, the indication generated in response to an indicator element of the final dosage form configured to indicate an exposure of the release element to the stimulus; and

terminating the ex vivo exposure of the release element of the final dosage form to the stimulus in response to the received indication of the ex vivo exposure of the release element of the final dosage form to the stimulus.

41. A final dosage form for administering a medicament to an animal, the final dosage form comprising:

means for protecting the final dosage form from an ex vivo environment;

means for releasing the medicament, configured in a medicament-holding state, and modifiable ex vivo to a medicament-discharge state by an exposure to a stimulus; and

the medicament.

42. The final dosage form of claim 41, further comprising:

means for carrying the medicament.

43. The final dosage form of claim 41, further comprising:

means for indicating an exposure of the means for releasing the medicament to the stimulus.

44. The final dosage form of claim 41, further comprising:

means for containing the medicament within the final dosage form until the final dosage form is introduced into the animal.