Ex vivo modifiable multiple medicament final dosage form

• US 8,753,677 B2
• Filed: 04/29/2009
• Issued: 06/17/2014
• Est. Priority Date: 09/16/2008
• Status: Expired due to Fees

• Current Assignee: Enterprise Science Fund, LLC (Intellectual Ventures LLC)
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Bangera, Mahalaxmi Gita, Boyden, Edward S., Hyde, Roderick A., Ishikawa, Muriel Y., Rivet, Dennis J., Sweeney, Elizabeth A., Wood, Lowell L. Jr., Wood, Victoria Y. H.
• Primary Examiner(s): TRAN, SUSAN T
• Application Number:
  US12/387,325
• Publication Number:
  US 20100068277A1
• Time in Patent Office: 1,875 Days
• US Class Current: 424/451
• 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,

wherein, when the release element is exposed ex vivo to a particular stimulus, an alteration occurs in a structure of the release element switching the release element from the first medicament-release state to a second medicament-release state wherein the medicament has a second bioavailability to the animal;

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,

wherein, when the release element is exposed ex vivo to another particular stimulus, an alteration occurs in a structure of the another release element switching the release element from the another first medicament-release state to another second medicament-release state wherein the medicament has another second bioavailability to the animal;

a capsule structure including an outer layer and enclosing the dosage portion and the another dosage portion;

an electronically detectable indicator element including a material that polymerizes responsive to the particular stimulus to thereby indicate exposure to the particular stimulus, the responsive polymerization inducing a change in a conductive property of the electronically detectable indicator element, the electronically detectable indicator element at least partially embedded in the outer layer of the capsule structure; and

another electronically detectable indicator element including a material that polymerizes responsive to the another particular stimulus to thereby indicate exposure to the another particular stimulus, the responsive polymerization inducing a change in a conductive property of the another electronically detectable indicator element, the another electronically detectable indicator element at least partially embedded in the outer layer of the capsule structure.

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 particular stimulus includes:

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

14. The final dosage form of claim 1, wherein the final dosage form has completed a manufacturing or production process and is suitable for direct administration to the animal.

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,

wherein, when the release element is exposed ex vivo to a particular stimulus, an alteration occurs in a structure of the release element switching the release element from the medicament-holding state to a medicament-discharging state wherein the medicament is substantially bioavailable to the animal; and

wherein the particular stimulus includes at least one of a particular non-ionizing radiation stimulus, a particular ionizing radiation stimulus, a particular chemical stimulus, a particular acoustic stimulus, a particular ultrasound stimulus, a particular radio wave stimulus, a particular microwave stimulus, or a particular light wave stimulus;

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,

wherein, when the another release element is exposed ex vivo to another particular stimulus, an alteration occurs in a structure of the another release element switching the another release element from the another medicament-holding state to another medicament-discharging state wherein the medicament is substantially bioavailable to the animal; and

wherein the another particular stimulus includes at least one of a particular non-ionizing radiation stimulus, a particular ionizing radiation stimulus, a particular chemical stimulus, a particular acoustic stimulus, a particular ultrasound stimulus, a particular radio wave stimulus, a particular microwave stimulus, or a particular light wave stimulus;

a capsule structure including an outer layer and enclosing the dosage portion and the another dosage portion; and

a plurality of electronically detectable indicator elements different than the release element and the another release element and exhibiting a physical property that changes responsive to exposure to the particular stimulus or the another particular stimulus to thereby indicate exposure to the particular stimulus or the another particular stimulus, the plurality of electronically detectable indicator elements at least partially embedded in the outer layer of the capsule structure.

15. The final dosage form of claim 12, wherein the final dosage form is a tablet, a capsule, a suppository, or a structure carryable or transportable by a liquid or other fluid carrier, has completed a manufacturing or production process, and is suitable for direct administration to the animal.

13. 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;

a release element in a first medicament-release state wherein the medicament has a first bioavailability to the animal,

wherein, when the release element is exposed ex vivo to a particular stimulus, an alteration occurs in a structure of the release element switching the release element from the first medicament-release state to a second medicament-release state wherein the medicament has a second bioavailability to the animal;

wherein the particular stimulus includes at least a particular ultrasound stimulus;

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, wherein, when the release element is exposed ex vivo to another particular stimulus, an alteration occurs in a structure of the another release element switching the release element from the another first medicament-release state to another second medicament-release state wherein the medicament has another second bioavailability to the animal;

a capsule structure including an outer layer enclosing the dosage portion and the another dosage portion;

an electronically detectable indicator element including a material that polymerizes in response to exposure to the particular stimulus, the polymerization inducing a change in a conductivity property of the electronically detectable indicator element, the electronically detectable indicator element at least partially embedded in the outer layer of the capsule structure;

another electronically detectable indicator element including a material that polymerizes in response to exposure to the another particular stimulus, the polymerization inducing a change in a conductivity property of the another electronically detectable indicator element, the another electronically detectable indicator element at least partially embedded in the outer layer of the capsule structure; and

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

16. The final dosage form of claim 13, wherein the final dosage form is a tablet, a capsule, a suppository, or a structure carryable or transportable by a liquid or other fluid carrier, has completed a manufacturing or production process, and is suitable for direct administration to the animal.