Pharmaceutical dosages delivery system

• US 8,597,186 B2
• Filed: 01/05/2010
• Issued: 12/03/2013
• Est. Priority Date: 01/06/2009
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Moon, Gregory, Au-Yeung, Kityee, Duck, Robert, Holen, Maria Casillas
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US12/673,150
• Publication Number:
  US 20110306852A1
• Time in Patent Office: 1,428 Days
• Field of Search: 604/19, 600/302
• US Class Current: 600/302
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Pharmaceutical delivery systems for delivering dosages according to the present invention include a carrier component and a cap configured to seal an internal volume of the carrier component, wherein the cap includes a device that produces a unique current signature. Dosages prepared to be delivered according to embodiments of the invention find use in a variety of different applications, including clinical trials.

Claims

1. A pharmaceutical delivery system for tracking delivery parameters, the system comprising:

a carrier housing having a closed end and an open end, wherein the carrier housing defines a cavity;

a pharmaceutical agent positioned within the cavity of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes a sealing portion that is in physical communication with the open end of the carrier housing to seal the cavity containing the pharmaceutical agent; and

a device associated with the system, wherein the device produces an identifiable current signature for communicating information, wherein the device is secured to a top portion of the cap such that the device is able to come into contact with the surrounding environment as the carrier housing comes into contact with the surrounding environment.

2. The system of claim 1, wherein the sealing portion defines at least one channel that allows the cap to be pressure fitted into the open end of the carrier housing.

3. The system of claim 1, wherein the sealing portion is secured to the open end of the carrier housing an adhesive.

4. The system of claim 1, wherein the device comprises:

a frame;

a conductance control module secured within the frame for producing the identifiable current signature representing the information;

a first material secured to the frame and electrically coupled to the conductance control module; and

a second material secured to the frame and electrically coupled to the conductance control module,

wherein the first material and the second material are separated by a non-conducting material and selected to produce a voltage potential when in contact with a conducting fluid.

5. A pharmaceutical carrier comprising:

a housing that defines a cavity, wherein the housing includes an open end and a closed end;

an apparatus positioned within the cavity of the housing for altering the buoyancy of the carrier;

a cap comprising a top end and a bottom end, wherein the bottom end defines at least one channel for fitting the cap into the open end of the housing to seal the content of the cavity; and

a current control device secured to the cap and for producing a unique current signature, wherein the current control device comprises;

a conductance control module secured within a frame for producing an identifiable current signature; and

a partial power source comprising a first material and a second material insulated from one another and each of the first material and the second material electrically coupled to the conductance control module, wherein the first material and the second material are secured to the frame.

6. The carrier of claim 5, wherein the partial power source of the current control device produces a voltage potential when the first material and the second material are electrically coupled through a conducting fluid in contact therewith and the voltage potential is used to activate the conductance control module to produce the identifiable current signature.

7. The carrier of claim 6, wherein the current control device is secured to the top end of the cap such that the current control device comes into contact with the conducting fluid at about the same time that the housing comes into contact with the conducting fluid and, hence, the current control device is activated upon contact with the conducting fluid.

8. The carrier of claim 6, wherein the current control device is secured to the top end of the cap and wherein the carrier further comprises an over-cap positioned over the top end of the cap, such that the over-cap prevents contact of the conducting fluid with the current control device until the over-cap dissolves, which causes a delay between the time of introduction of the carrier to the environment and activation of the conductance control module and thereby delaying generation of the identifiable current signature.

9. The carrier of claim 6, wherein the current control device is secured to the bottom end of the cap such that the current control device comes into contact with the surrounding environment after the cap is separated from the housing thereby delaying the current control device from producing the identifiable current signature.

10. The carrier of claim 5, wherein the cap includes a tapered portion at the bottom end and the housing includes a tapered portion at the open end such that the tapered portions are male-female mated and glued together thereby causing the cap to be secured into the open end of the housing to seal the cavity.

11. The carrier of claim 5, wherein the cap is mechanically fitted to the open end of the housing to seal the cavity of the housing.

12. The carrier of claim 5 further comprising a pharmaceutical agent positioned within the cavity of the housing.

13. The carrier of claim 5, wherein the apparatus has a composition that imparts to the device a density that is greater than stomach fluid.

14. An ingestible carrier for providing information associated with the ingestion of a pharmaceutical product, the carrier comprising:

a dissolvable casing that defines a cavity, wherein the casing includes an open end and a closed end and the pharmaceutical product is positionable within the cavity defined by the casing;

a cap comprising a top end and a bottom end that includes a securing portion, wherein the securing portion defines a plurality of channels that allow for insertion of the cap into the open end of the casing; and

a current signature-production device associated with the carrier for producing a current signature that represents the information associated with the ingestion of the pharmaceutical product, wherein the device comprises;

a frame;

a conductance control module secured to the frame for producing the current signature representing the information; and

a partial power source comprising a first material and a second material each electrically coupled to the conductance control module, wherein the first material and the second material are secured to the frame and separated by a non-conducting material and wherein the partial power source produces a voltage potential when the first material and the second material are electrically coupled through a conducting fluid in contact therewith and the voltage potential activates the conductance control module and hence the device.

15. The carrier of claim 14, wherein the device is secured to the top end of the cap such that the device contacts the conducting fluid at about the same time that the casing contacts the conducting fluid.

16. The carrier of claim 14, wherein the device is positioned on the top end of the cap and wherein the carrier further comprises an over-cap positioned around the cap and secured to the cap, such that the over-cap causes a delay in activation of the device by delaying contact between the device and the conducting fluid and, hence, a delay in production of the current signature.

17. The carrier of claim 14, wherein the device is secured to a bottom of the securing end such that the device comes into contact with the conducting fluid after the casing is dissolved to the point where the cap is released thereby causing a delay in producing the current signature.

18. The carrier of claim 14, wherein the device is placed within the cavity defined by the casing.

19. The carrier of claim 14, wherein the carrier further comprises a filler composition positioned within the cavity defined by the casing to prevent movement of the pharmaceutical product and the device within the cavity defined by the casing.

20. The carrier of claim 14, further comprising a buoyancy altering apparatus positioned within the cavity defined by the casing.

21. The carrier of claim 14, wherein the securing portion is glued into the open end of the casing.

22. The carrier of claim 14, wherein the securing portion is mechanically secured the open end of the casing.

23. The carrier of claim 14, wherein the securing portion is pressure fitted to the open end of the casing.

24. A pharmaceutical delivery system for tracking delivery parameters, the system comprising:

a carrier housing having a closed end and an open end, wherein the carrier housing defines a cavity;

a pharmaceutical agent positioned within the cavity of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes a sealing portion that is in physical communication with the open end of the carrier housing to seal the cavity containing the pharmaceutical agent; and

a device associated with the system, wherein the device produces an identifiable current signature for communicating information, wherein the sealing portion defines at least one channel that allows the cap to be pressure fitted into the open end of the carrier housing.

25. A pharmaceutical delivery system for tracking delivery parameters, the system comprising:

a carrier housing having a closed end and an open end, wherein the carrier housing defines a cavity;

a pharmaceutical agent positioned within the cavity of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes a sealing portion that is in physical communication with the open end of the carrier housing to seal the cavity containing the pharmaceutical agent; and

a device associated with the system, wherein the device produces an identifiable current signature for communicating information, wherein the sealing portion is secured to the open end of the carrier housing an adhesive.

26. A pharmaceutical delivery system for tracking delivery parameters, the system comprising:

a carrier housing having a closed end and an open end, wherein the carrier housing defines a cavity;

a pharmaceutical agent positioned within the cavity of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes a sealing portion that is in physical communication with the open end of the carrier housing to seal the cavity containing the pharmaceutical agent; and

a device associated with the system, wherein the device produces an identifiable current signature for communicating information, wherein the device comprises;

a frame;

a conductance control module secured within the frame for producing the identifiable current signature representing the information;

a first material secured to the frame and electrically coupled to the conductance control module; and

a second material secured to the frame and electrically coupled to the conductance control module,

wherein the first material and the second material are separated by a non-conducting material and selected to produce a voltage potential when in contact with a conducting fluid.