Ex vivo modifiable multiple medicament final dosage form

• US 20100068277A1
• Filed: 04/29/2009
• Published: 03/18/2010
• Est. Priority Date: 09/16/2008
• Status: Active Grant

• Current Assignee: Enterprise Science Fund, 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
• Granted Patent: US 8,753,677 B2
• Time in Patent Office: Days
• US Class Current: 424/484
• 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 dosage portion having a medicament and a release element in a first medicament-release state. The medicament has a first bioavailability to the animal. The release element is modifiable ex vivo to a second medicament-release state by an exposure to a stimulus, wherein the medicament has a second bioavailability to the animal. The final dosage form includes another dosage portion having another medicament and another release element in another first medicament-release state. In the another first medicament-release state, the another medicament has another first bioavailability to the animal. The another release element is modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal.

Claims

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

a dosage portion having

a medicament; and

a release element 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 in the first medicament-release state,

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

another dosage portion having

another medicament; and

another release element in another first medicament-release state wherein the another medicament has another first bioavailability to the animal if the final dosage form is administered to the animal in the another first medicament-release state,

the another release element modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal if the final dosage form is administered to the animal in the another second medicament-release state.

2. The final dosage form of claim 1, wherein the first medicament-release state wherein the medicament has a first bioavailability to the animal includes:

a first medicament-release state wherein the medicament is not bioavailable to the animal.

3. The final dosage form of claim 1, wherein the first medicament-release state wherein the medicament has a first bioavailability to the animal includes:

a first medicament-release state wherein the medicament is bioavailable to the animal.

4. The final dosage form of claim 1, wherein the second medicament-release state wherein the medicament has a second bioavailability to the animal includes:

a second medicament-release state wherein the medicament is not bioavailable to the animal.

5. The final dosage form of claim 1, wherein the second medicament-release state wherein the medicament has a second bioavailability to the animal includes:

a second medicament-release state wherein the medicament is bioavailable to the animal.

6. The final dosage form of claim 1, wherein the another first medicament-release state wherein the another medicament has another first bioavailability to the animal includes:

another first medicament-release state wherein the another medicament is not bioavailable to the animal.

7. The final dosage form of claim 1, wherein the another first medicament-release state wherein the another medicament has another first bioavailability to the animal includes:

another first medicament-release state wherein the another medicament is bioavailable to the animal.

8. The final dosage form of claim 1, wherein the another second medicament-release state wherein the another medicament has another second bioavailability to the animal includes:

another second medicament-release state wherein the another medicament is not bioavailable to the animal.

9. The final dosage form of claim 1, wherein the another second medicament-release state wherein the another medicament has another second bioavailability to the animal includes:

another second medicament-release state wherein the another medicament is bioavailable to the animal.

10. The final dosage form of claim 1, wherein the first bioavailability to the animal includes a first bioavailability characteristic and the second bioavailability to the animal includes a second bioavailability characteristic.

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

at least one of a mechanical stimulus, a non-ionizing radiation stimulus, an ionizing radiation stimulus, a chemical stimulus, an acoustic stimulus, an ultrasound stimulus, a radio wave stimulus, a microwave stimulus, a light wave stimulus, or a thermal stimulus.

12. A final dosage form for administering a medicament to an animal, the final dosage form comprises:

a dosage portion having;

a medicament;

a release element 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 in the medicament-holding state,

the release element modifiable ex vivo to a medicament-discharging state by an exposure to a stimulus wherein the medicament is bioavailable to the animal if the final dosage form is administered to the animal in the medicament-discharging state; and

another dosage portion having

another medicament;

another release element in another medicament-holding state wherein the another medicament is substantially not bioavailable to the animal if the final dosage form is administered to the animal in the another medicament-holding state,

the another release element modifiable ex vivo to another medicament-discharge state by an exposure to another stimulus wherein the another medicament is bioavailable to the animal if the final dosage form is administered to the animal in the another medicament-discharge state.

13. The final dosage form of claim 12, further comprising:

an outer layer carrying the dosage portion and the another dosage portion.

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

a dosage portion having

a medicament;

and

a release element 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 in the first medicament-release state,

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

another dosage portion having

another medicament; and

another release element in another first medicament-release state wherein the another medicament has another first bioavailability to the animal if the final dosage form is administered to the animal in the another first medicament-release state,

the another release element modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal if the final dosage form is administered to the animal in the another second medicament-release state;

the method comprising;

transforming the final dosage form into a selected medicament release profile by initiating an ex vivo exposure of the release element or the another release element to a modification stimulus respectfully selected from the stimulus or the another stimulus.

15. The method of claim 14, further comprising:

receiving a signal indicative of a chosen medicament bioavailability of the final dosage form.

16. The method of claim 15, wherein receiving signal indicative of a chosen medicament bioavailability of the final dosage form includes:

receiving a machine-initiated signal indicative indication of a chosen medicament bioavailability of the final dosage form.

17. The method of claim 15, wherein receiving signal indicative of a chosen medicament bioavailability of the final dosage form includes:

receiving a human-initiated signal indicative of a chosen medicament bioavailability of the final dosage form.

18. The method of claim 14, further comprising:

selecting a medicament-release state of the release element or of the another release element in response to the chosen medicament-bioavailability of the final dosage form.

19. The method of claim 18, wherein the selecting a medicament-release state of the release element or of the another release element in response to the selected medicament-bioavailability of the final dosage form includes:

electronically selecting a medicament-release state of the release element or of the another release element in response to the selected medicament-bioavailability of the final dosage form, the selecting a medicament-release state based on an electronically-stored database relating medicament-release state and medicament-bioavailability of the final dosage form, a computer-implemented decision table, a digitally-maintained final dosage form transformation table, or a digital library correlating medicament-release state and medicament-bioavailability of the final dosage form.

20. The method of claim 14, further comprising:

selecting the stimulus for initiation from the stimulus or the another stimulus in response to the selected medicament-release state.

21. The method of claim 20, wherein the selecting the modification stimulus from the stimulus or the another stimulus in response to the selected medicament-release state includes:

electronically selecting the modification stimulus from the stimulus or the another stimulus in response to the selected medicament-release state, the selecting the stimulus based on an electronically-stored database relating stimuli and medicament-release state of the final dosage form, a computer-implemented decision table, a digitally-maintained final dosage form transformation table, or a digital library correlating medicament-release state of the final dosage form and stimuli.

22. The method of claim 14, wherein the transforming the final dosage form into a selected medicament release profile by initiating an ex vivo exposure of the release element or the another release element to a modification stimulus respectfully selected from the stimulus or the another stimulus includes:

transforming the final dosage form into a selected medicament release profile by initiating an ex vivo exposure of the release element and the another release element to the stimulus and the another stimulus.

23. An article of manufacture comprising:

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

a dosage portion having

a medicament; and

a release element 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 in the first medicament-release state,

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

another dosage portion having

another medicament

another release element in another first medicament-release state wherein the another medicament has another first bioavailability to the animal if the final dosage form is administered to the animal in the another first medicament-release state,

the another release element modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal if the final dosage form is administered to the animal in the another second medicament-release state; and

instructions specifying an ex vivo exposure of the release element to the stimulus or an ex vivo exposure of the another release element to the another stimulus which when implemented respectfully transform the release element to the second medicament-release state or the another release element to the another second medicament-release state.

24. An article of manufacture for administering medicament to an animal, the article comprising:

a medicament;

means for medicament release control in a first state wherein the medicament has a first bioavailability to the animal if the article of manufacture is administered to the animal,

the means for medicament release control modifiable ex vivo to a second state by an exposure to a stimulus, wherein the medicament has a second bioavailability to the animal if the article of manufacture is administered to the animal;

another medicament; and

another means for medicament release control in another first state wherein the another medicament has another first bioavailability to the animal if the article of manufacture is administered to the animal,

the another means for medicament release control modifiable ex vivo to another second state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal if the article of manufacture is administered to the animal.