Modifying a medicament availability state of a final dosage form

• US 20100068254A1
• Filed: 02/05/2009
• 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: The Invention Science Fund I, L.L.C. (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:
  US12/322,874
• Publication Number:
  US 20100068254A1
• Time in Patent Office: Days
• US Class Current: 424/450
• CPC Class Codes: A61K 41/00 Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
• 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 9/127 Liposomes

Abstract

Provided embodiments include a final dosage form, an article of manufacture, and method. A method of modifying a medicament availability state of a final dosage form is provided. The method includes initiating an exposure of a particle or polymeric material of the final dosage form to a stimulus. The initiated stimulus is selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state.

Claims

1. An article of manufacture comprising:

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

the medicament; and

a particle or polymeric material carrying the medicament in a medicament-retention state wherein the medicament is substantially not bioavailable to the animal after administration of the final dosage form and modifiable ex vivo to a medicament-release state by an exposure to a stimulus wherein the medicament is substantially bioavailable to the animal after administration of the final dosage form; and

an instruction for the exposure of the particle or polymeric material ex vivo to a human-initiated stimulus sufficient to transform the particle or polymeric material to allow a discharge of at least a portion of the therapeutically effective amount of the medicament from the particle or polymeric carrier.

2. The article of manufacture of claim 1, wherein the instruction includes a pointer to another instruction.

3. The article of manufacture of claim 1, further comprising:

a label associated with the at least one final dosage form and providing the instruction.

4. The article of manufacture of claim 1, further comprising:

an insert into a package containing the at least one final dosage form and providing the instruction.

5. The article of manufacture of claim 1, further comprising:

a transport medium suitable for administering the particle or polymeric material carrying the medicament to the animal.

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

an indicator substance configured to indicate an exposure of the particle or polymeric material to the stimulus.

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

at least one molecule of the medicament; and

a particle or polymeric carrier bound with the at least one molecule of the medicament, configured in a first medicament-bioavailability state, and modifiable ex vivo to a second medicament-bioavailability state by an exposure to a stimulus.

8. The final dosage form of claim 7, wherein the particle or polymeric carrier bound with the at least one molecule of the medicament comprises:

a pharmaceutically-acceptable inert particle or polymeric carrier bound with the at least one molecule of the medicament.

9. The final dosage form of claim 7, wherein the particle or polymeric carrier bound with the at least one molecule of the medicament comprises:

a particle or polymeric carrier operable to at least one of engage, retain, or entrap the medicament.

10. The final dosage form of claim 7, wherein the particle or polymeric carrier bound with the at least one molecule of the medicament comprises:

a particle or polymeric carrier conjugated with the medicament.

11. The final dosage form of claim 7, wherein the particle or polymeric carrier bound with the at least one molecule of the medicament comprises:

a particle or polymeric carrier molecularly bound to the medicament.

12. The final dosage form of claim 7, wherein the first medicament-bioavailability state retards medicament release in vivo and the second medicament-bioavailability state allows medicament release in vivo.

13. The final dosage form of claim 7, wherein the first medicament-bioavailability state allows medicament release in vivo and the second medicament-bioavailability state retards medicament release in vivo.

14. The final dosage form of claim 7, wherein the particle or polymeric carrier includes a liposome carrier bound with the at least one molecule of the medicament and having an intact particle size resulting in an insignificant uptake in the gastrointestinal tract of the animal.

15. The final dosage form of claim 14, wherein the liposome carrier bound with the at least one molecule of the medicament and having an intact particle size resulting in an insignificant uptake in the gastrointestinal tract of the animal includes:

a liposome carrier bound with the at least one molecule of the medicament and having an intact particle size of at least approximately one micron.

16. The final dosage form of claim 14, wherein the liposome carrier bound with the at least one molecule of the medicament and having an intact particle size resulting in an insignificant uptake in the gastrointestinal tract of the animal includes:

a liposome carrier bound with the at least one molecule of the medicament and having an intact particle size of at least approximately three microns.

17. The final dosage form of claim 14, wherein the liposome carrier bound with the at least one molecule of the medicament and having an intact particle size resulting in an insignificant uptake in the gastrointestinal tract of the animal includes:

a liposome carrier bound with the at least one molecule of the medicament and having an intact particle size of at least approximately four microns.

18. The final dosage form of claim 7, further comprising:

a transport medium suitable for delivering the particle or polymeric carrier holding the at least one molecule of the medicament to the animal.

19. The final dosage form of claim 7, further comprising:

an indicator substance configured to indicate an exposure of the particle or polymeric carrier holding the at least one molecule of the medicament to the stimulus.

20. A method of modifying a medicament availability state of a final dosage form, wherein the final dosage form includes

the medicament;

and

a particle or polymeric material carrying the medicament in a medicament-retention state wherein the medicament is substantially not bioavailable if the final dosage form is administered to the animal, and transformable to the medicament-release state by the ex vivo exposure of the particle or polymeric material to a stimulus wherein the medicament is substantially bioavailable if the final dosage form is administered to the animal; and

the method comprising;

initiating an ex vivo exposure of the particle or polymeric material of the final dosage form to a stimulus, the initiated stimulus selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state.

21. The method of claim 20, 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.

22. The method of claim 20, wherein the final dosage form further comprises:

an indicator element configured to indicate an exposure of the particle or polymeric material to the stimulus.

23. The method of claim 20, wherein the initiated stimulus comprises:

the initiated stimulus having a parameter selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state.

24. The method of claim 20, wherein the initiated stimulus comprises:

the initiated stimulus having at least one of a stimulation characteristic or a spatial characteristic selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state.

25. The method of claim 20, wherein the ex vivo exposure of the particle or polymeric material of the final dosage form to a stimulus, the initiated stimulus selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state comprises:

initiating a first ex vivo exposure of the particle or polymeric material of the final dosage form to a stimulus, the first initiated stimulus selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state;

receiving an indication of the first 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

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

26. The method of claim 20, wherein the ex vivo exposure of the particle or polymeric material of the final dosage form to a stimulus, the initiated stimulus selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release state comprises:

initiating an ex vivo exposure of the particle or polymeric material of the final dosage form to a stimulus, the initiated stimulus selected to transform the particle or polymeric material from a medicament-retention state to a medicament-release 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.

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

means for releasably engaging at least one molecule of the medicament;

means for controlling an availability of the releasably engaged at least one molecule of medicament, wherein the releasably engaged at least one molecule of medicament is initially substantially not bioavailable if the final dosage form is administered to the animal, and wherein the availability of the releasably engaged medicament is modifiable ex vivo by an exposure to a stimulus to be substantially bioavailable if the final dosage form is administered to the animal;

means for protecting the means for entrapping at least one molecule of the medicament from an ex vivo environment of the final dosage form; and

the medicament.

28. The final dosage form of claim 27, wherein the means for controlling an availability of the entrapped at least one molecule of medicament comprises:

means for controlling an availability of the entrapped at least one molecule of medicament and having a premodification characteristic resulting in an insignificant uptake in the gastrointestinal tract of the animal.

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

means for indicating an exposure to the stimulus by the means for controlling an availability of the entrapped at least one molecule of medicament.

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

means for containing the medicament within the final dosage form before the final dosage form is administered to the animal.

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

means for carrying the final dosage form into the animal.