Ex vivo-modifiable multiple-release state final dosage form

• US 20100068266A1
• Filed: 04/29/2009
• 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: Wood, Victoria Y.H., Ishikawa, Muriel Y., Boyden, Edward S., Wood, Lowell L. JR., Rivet, Dennis J., Hyde, Roderick A., Sweeney, Elizabeth A., Bangera, Mahalaxmi Gita
• Application Number:
  US12/387,326
• Publication Number:
  US 20100068266A1
• Time in Patent Office: Days
• US Class Current: 424/457
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: A61K 9/51 Nanocapsules; Nanoparticles; nanotubes A61K9/0092; polymeric micelles A61K9/1075; polymersomes A61K9/1273; pure drug nanoparticles A61K9/14; drug nanoparticles with adsorbed surface modifiers A61K9/141; conjugates, e.g. between drug and non-active nanoparticles, A61K47/50; preparations for in vivo diagnosis A61K49/00; with radioactive substances A61K51/00
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

Described embodiments include a final dosage form for administering a medicament to an animal, an article of manufacture, and method. A described final dosage form includes a medicament. The final dosage form also includes a release-control substance carrying the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal. The release-control substance is modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal. The release-control substance is modifiable ex vivo by an exposure to second stimulus to carry the medicament in a third medicament-release state wherein the medicament has a third bioavailability to the animal if the final dosage form is administered to the animal.

Claims

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

a medicament; and

a release-control substance carrying the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal,

the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal, and

the release-control substance modifiable ex vivo by an exposure to second stimulus to carry the medicament in a third medicament-release state wherein the medicament has a third bioavailability to the animal if the final dosage form is administered to the animal.

2. The final dosage form of claim 1, wherein the first bioavailability to the animal includes the medicament being substantially not bioavailable to the animal.

3. The final dosage form of claim 1, wherein the first bioavailability to the animal includes the medicament being substantially bioavailable to the animal.

4. The final dosage form of claim 3, wherein the second bioavailability to the animal includes the medicament being substantially bioavailable to the animal, wherein the second bioavailability to the animal is substantially different from the first bioavailability to the animal.

5. The final dosage form of claim 1, wherein the second bioavailability to the animal includes the medicament being substantially not bioavailable to the animal.

6. The final dosage form of claim 1, wherein the second bioavailability to the animal includes the medicament being substantially bioavailable to the animal.

7. The final dosage form of claim 1, wherein the third bioavailability to the animal includes the medicament being substantially not bioavailable to the animal.

8. The final dosage form of claim 1, wherein the third bioavailability to the animal includes the medicament being substantially bioavailable to the animal.

9. The final dosage form of claim 1, wherein the third bioavailability to the animal includes the medicament being substantially bioavailable to the animal, wherein the third bioavailability to the animal is substantially different than the second bioavailability to the animal.

10. The final dosage form of claim 1, wherein the third bioavailability to the animal includes the medicament being substantially bioavailable to the animal, wherein the third bioavailability is substantially different from both the first bioavailability and the second bioavailability.

11. The final dosage form of claim 1, wherein the first bioavailability includes a first bioavailability characteristic, the second bioavailability includes a second bioavailability characteristic, and the third bioavailability includes a third bioavailability characteristic.

12. The final dosage form of claim 1, wherein the release-control substance includes a biocompatible substance.

13. The final dosage form of claim 1, wherein the release-control substance includes a release-control substance having a modifiable medicament release characteristic.

14. The final dosage form of claim 1, wherein the release-control substance includes a release-control substance carrying the medicament in an initial medicament-retention state.

15. The final dosage form of claim 1, wherein the release-control substance includes a particle.

16. The final dosage form of claim 1, wherein the release-control substance includes a polymeric material.

17. The final dosage form of claim 1, wherein the release-control substance includes a small molecule.

18. The final dosage form of claim 1, wherein the release-control substance includes a capsule structure.

19. The final dosage form of claim 1, wherein the second stimulus includes a substantially different category of stimulus than the first stimulus.

20. The final dosage form of claim 1, wherein the second stimulus has at least a substantially different intensity than the first stimulus.

21. The final dosage form of claim 1, wherein the second stimulus includes a substantially different duration than the first stimulus.

22. The final dosage form of claim 1, wherein the second stimulus includes a substantially different waveform than the first stimulus.

23. The final dosage form of claim 1, wherein the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a second medicament-release state includes:

a release-control substance modifiable ex vivo by an exposure of a first portion of the release-control substance to a first stimulus to carry the medicament in a second medicament-release state; and

the release-control substance modifiable ex vivo by an exposure to second stimulus to carry the medicament in a third medicament-release state includes;

a release-control substance modifiable ex vivo by an exposure of a second portion of the release-control substance to second stimulus to carry the medicament in a third medicament-release state.

24. The final dosage form of claim 23, wherein the second portion of the release-control substance is substantially the same as the first portion of the release-control substance.

25. The final dosage form of claim 23, wherein the second portion of the release-control substance is substantially different from the first portion of the release-control substance.

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

a transport medium configured to facilitate administering the medicament and the release-control substance to the animal.

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

an indicator substance configured to indicate an exposure of at least a portion of the release-control substance to at least one of the first stimulus or the second stimulus.

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

an in vivo degradable containment element configured to retain the release-control substance until the final dosage form is administered to the animal.

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

the medicament; and

a release-control substance carrying the medicament in a medicament-retention state wherein the medicament is substantially not bioavailable to the animal if the final dosage form is administered to the animal,

the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal, and

the release-control substance modifiable ex vivo by an exposure to a second stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal.

30. The final dosage form of claim 29, wherein the first bioavailability includes a first bioavailability characteristic and the second bioavailability includes a second bioavailability characteristic.

31. The final dosage form of claim 29, wherein the release-control substance modifiable ex vivo by an exposure to a first stimulus includes:

a release-control substance modifiable prior to administration to the animal by an exposure to a first stimulus.

32. An article of manufacture comprising:

a final dosage form for administering a medicament to an animal, the final dosage form comprising;

the medicament; and

a release-control substance carrying the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal,

the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal, and

the release-control substance modifiable ex vivo by an exposure to a second stimulus to carry the medicament in a third medicament-release state wherein the medicament has a third bioavailability to the animal if the final dosage form is administered to the animal; and

instructions specifying an ex vivo exposure of the release-control substance to the first stimulus or the second stimulus to achieve a selected second medicament release state or a selected third medicament-release state.

33. The article of manufacture of claim 32, wherein the instructions specifying an ex vivo exposure of the release-control substance to the first stimulus or the second stimulus to achieve a selected second medicament release state or a selected third medicament-release state include:

instructions specifying an ex vivo exposure of the release-control substance to a selected first stimulus or a selected second stimulus, such that when implemented transform the release-control substance to the selected second medicament-release state or the selected third medicament-release state.

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

a medicament, and

a release-control substance carrying the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal,

the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal, and

the release-control substance modifiable ex vivo by an exposure to a second stimulus to carry the medicament in a third medicament-release state wherein the medicament has a third bioavailability to the animal if the final dosage form is administered to the animal;

the method comprising;

transforming the medicament release state of the release-control substance to the second medicament-release state or the third medicament-release state by initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus.

35. The method of claim 34, wherein the transforming the medicament release state of the release-control substance to the second medicament-release state or the third medicament-release state by initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus includes:

modifying the medicament release state of the release-control substance to the second medicament-release state or the third medicament-release state by initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus.

36. The method of claim 34, wherein the transforming the medicament release state of the release-control substance by initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus includes:

transforming the medicament release state of the release-control substance to the second medicament-release state or the third medicament-release state by initiating an ex vivo exposure of the release-control substance to a stimulus selected respectively from the first stimulus or the second stimulus.

37. The method of claim 34, wherein the initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus includes:

initiating an ex vivo exposure of the release-control substance respectively to a modification stimulus selected from the first stimulus or the second stimulus, the selected modification stimulus having a parameter operative to transform the release-control substance carrying the medicament from the first medicament-release state to the second medicament-release state or to the third medicament-release state.

38. The method of claim 34, wherein the initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus includes:

initiating an ex vivo exposure of the release-control substance to a modification stimulus selected from the first stimulus or the second stimulus, the selected modification stimulus operative to transform the release-control substance carrying the medicament from the first medicament-release state to the second medicament-release state or from the first medicament-release state to the third medicament-release state.

39. The method of claim 34, wherein the initiating an ex vivo exposure of the release-control substance respectively to the first stimulus or the second stimulus includes:

initiating an ex vivo exposure of the release-control substance respectively to a modification stimulus selected from the first stimulus or the second stimulus, the selected modification stimulus having at least one of a stimulation characteristic or a spatial characteristic operable to transform the release-control substance carrying the medicament from the first medicament-release state to the second medicament-release state or to the third medicament-release state.

40. The method of claim 34, further comprising:

selecting a medicament-release state from the second medicament-release state and the third medicament-release state in response to a chosen medicament bioavailability of the final dosage form.

41. The method of claim 40, further comprising:

selecting a modification stimulus from the first stimulus and the second stimulus in response to the selected medicament-release state.

46. The vehicle of claim 40, further comprising:

means for protecting the means for releasably encompassing the medicament against an ex vivo environment.

47. The vehicle of claim 40, further comprising:

means for indicating an exposure of the means for releasably encompassing the medicament to the first stimulus or the second stimulus.

42. A method of modifying medicament bioavailability of a final dosage form for administering a medicament to an animal, wherein the final dosage form includes

the medicament, and

a release-control substance carrying the medicament in a medicament-retention state wherein the medicament is substantially not bioavailable to the animal if the final dosage form is administered to the animal,

the release-control substance modifiable ex vivo by an exposure to a first stimulus to carry the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the final dosage form is administered to the animal, and

the release-control substance modifiable ex vivo by an exposure to a second stimulus to carry the medicament in a second medicament-release state wherein the medicament has a second bioavailability to the animal if the final dosage form is administered to the animal;

the method comprising;

transforming the medicament release state of the release-control substance by initiating an ex vivo exposure of the release-control substance to a selected modification stimulus.

43. The method of claim 42, further comprising:

automatically selecting a medicament-release state from the first medicament-release state and the second medicament-release state based on a specified medicament bioavailability of the final dosage form.

44. The method of claim 43, further comprising:

automatically selecting a modification stimulus from the first stimulus and the second stimulus in response to the selected medicament-release state

45. A vehicle for administering a medicament to an animal, the vehicle comprising:

means for releasably encompassing the medicament in a first medicament-release state wherein the medicament has a first bioavailability to the animal if the vehicle is administered to the animal,

the means for releasably encompassing the medicament in a first medicament-release state being modifiable to a second medicament-release state upon an ex vivo exposure to a first stimulus, the medicament in the second medicament-release state having a second bioavailability to the animal if the vehicle is administered to the animal, and

the means for releasably encompassing the medicament in a first medicament-release state being modifiable to a third medicament-release state upon an ex vivo exposure to a second stimulus, the medicament in the third medicament-release state having a third bioavailability to the animal if the vehicle is administered to the animal; and

the medicament.