DESIGN OF SWALLOWABLE MULTI-NOZZLE DOSING DEVICE FOR RELEASING MEDICINES IN THE GASTROINTESTINAL TRACT

• US 20100049120A1
• Filed: 10/17/2007
• Published: 02/25/2010
• Est. Priority Date: 10/31/2006
• Status: Active Grant

• Current Assignee: Biora Therapeutics Incorporated
• Original Assignee: Koninklijke Philips Electronics N.V. (Koninklijke Philips N.V.)
• Inventors: Schram, Ivar, Shimizu, Jeff, Dijksman, Johan Frederik, Pierik, Anke, Rensen, Judith Margreet, Zou, Hans
• Granted Patent: US 8,597,279 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A capsule and methodology for dispensing a medicament in the gastrointestinal tract of a mammal is disclosed, the gastrointestinal tract having tissue sites of interest. The capsule may include a medicament reservoir; medicament dispensing means such as a plurality of piezoelectric droplet jet nozzle dispensers; a power source; electronic control circuitry means and/or detecting means capable of communicating with a medicament dispensing means for regulating the amount and time interval for dispensing of the medicament into the gastrointestinal tract by the medicament dispensing means; and a non-digestible outer protective shell housing, e.g., the medicament reservoir, medicament dispensing means and electronic control circuitry means. A plurality of the nozzle dispensers of the medicament dispensing means can be positioned tangentially to a surface of the housing such that during release of a medicament, the capsule is caused to rotate and/or translate so as to discharge the medicament homogeneously onto tissue sites of interest. In addition, by using multiple nozzles and releasing medicament at high speed, this facilitates medicament absorption by the intestines in the gastrointestinal tract.

Claims

1. An ingestible capsule for dispensing a medicament at or near tissue sites of interest, the capsule comprising:

a medicament reservoir for storing the medicament;

medicament dispensing means for dispensing and/or stopping the dispensing of the medicament from the medicament reservoir, the medicament dispensing means having one or more piezoelectric droplet jet nozzle dispensers;

control means communicating with the medicament dispensing means to regulate the amount and/or time interval for dispensing the medicament, the control means having means of storing and/or updating data specific to a medicament release profile; and

a power source for providing power to one or more components of the capsule.

2. The capsule of claim 1, further comprising sensor means for sensing one or more biological conditions;

wherein the sensor means cooperates with the control means to selectively dispense the medicament according to the medicament release profile, and/or to determine and/or modify such medicament release profile.

3. The capsule of claim 2, wherein the biological condition sensed by the sensor means is selected from a group consisting of pH level, presence or absence of bacteria or enzymes, anatomical location at or near the tissue site of interest, and the presence or absence of blood.

4. The capsule of claim 1, further comprising wireless communication means for transmitting and/or receiving signals to and from a remote communications means, wherein upon receiving a signal from the remote communications means, the wireless communication means cooperates with the control means so as to modify and/or dispense the medicament according to the medicament release profile.

5. The capsule of claim 1, wherein the capsule is used to administer a medicament intended to treat a disease selected from a group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

6. The capsule of claim 1, wherein the capsule is used to administer a medicament intended to treat Crohn'"'"'s Disease or Ulcerative Colitis and the medicament is selected from a group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant medicaments, immunomodulators, probiotics and antibiotics.

7. The capsule of claim 1, wherein the capsule has a housing that is manufactured from at least one material selected from a group consisting of Pellethane®

2363 polyetherurethane series of materials, Elasthane polyetherurethane, PurSil®

, and CarboSil®

.

8. The capsule of claim 1, further comprising rotational sensor means for sensing when the capsule has rotated about its axis a defined amount and cooperating with the control means to selectively stop dispensing the medicament.

9. The capsule of claim 1, wherein the electronic control circuitry means further comprises a real-time clock to provide a reference for elapsed traveling time of the capsule within the gastrointestinal tract.

10. The capsule of claim 1, wherein one or more of the nozzle dispensers are positioned tangentially to the surface of a housing to the capsule so that during discharge of the medicament, the capsule is caused to rotate and to discharge the medicament homogeneously onto the tissue sites of interest.

11. A method for dispensing a medicament in the gastrointestinal tract of a mammal, the gastrointestinal tract having tissue sites of interest, the method comprising:

orally administering an ingestible capsule accommodating the medicament;

dispensing the medicament according to a medicament release profile at least substantially at the tissue sites of interest,

wherein the capsule includes (i) a medicament reservoir for storing the medicament, (ii) medicament dispensing means for dispensing and/or stopping the dispensing of the medicament from the medicament reservoir, the medicament dispensing means having a number of piezoelectric droplet jet nozzle dispensers, (iii) control means for regulating the amount and/or time interval for dispensing of the medicament, the control means having means for storing and/or updating data specific to a medicament release profile, and (iv) a power source for powering, as needed, components of the capsule.

12. The method of claim 11, wherein the capsule has sensor means for sensing one or more biological conditions in the gastrointestinal tract, the sensor means communicating with the control means so as to effectuate the dispensing of the medicament according to the medicament release profile, and/or to determine or modify the medicament release profile.

13. The method of claim 12, wherein the biological condition sensed by the sensor means is selected from a group consisting of pH level, presence or absence of bacteria or enzymes, anatomical location in the gastrointestinal tract and the presence63 or absence of blood.

14. The method of claim 11, wherein the capsule has wireless communication means for transmitting and/or receiving signals to and from a second remote communications means, and wherein upon receipt of a signal from the second communications means, the wireless communication means communicates with the control means so as to modify and/or dispense the medicament according to the medicament release profile.

15. The method of claim 11, wherein the method is employed to administer a medicament for the treatment of a disease selected from a group consisting of inflammatory bowel disease, celiac disease and intestinal cancer.

16. The method of claim 11, wherein the method is employed to administer a medicament for the treatment of Crohn'"'"'s Disease or Ulcerative Colitis and the medicament is selected from a group consisting of aminosalicylates, corticosteroids, biologics, anti-coagulant medicaments, immunomodulators, probiotics and antibiotics.

17. The method of claim 11, wherein the capsule has a housing that is manufactured from at least one material selected from a group consisting of Pellethane®

2363 polyetherurethane series of materials, Elasthane polyetherurethane, PurSil®

, and CarboSil®

.

18. The method of claim 11, further comprising rotational sensor means for sensing when the capsule has rotated about its axis a defined amount and communicating with the control means, so that the control means transmits a signal to the dispensing means to stop dispensing the medicament.

19. The method of claim 11, wherein the control means includes a real-time clock to provide a reference for elapsed traveling time of the capsule.

20. The method of claim 11, wherein one or more of the nozzle dispensers are positioned tangentially to the surface of a housing to the capsule such that during discharge of the medicament, the capsule is caused to rotate and/or translate so as to discharge the medicament homogeneously onto one or more tissue sites of interest.

21. A capsule comprising:

storing means for storing a medicament; and

dispensing means for dispensing the medicament,

wherein the medicament is retained by one or more micelles so as to be dispensable in accordance with a medicament release profile.

22. The capsule of claim 21, wherein the micelles aid in the absorption of medicament at one or more tissue sites of interest.

23. A capsule comprising:

storing means for storing one or more medicaments;

dispensing means for dispensing one or more medicaments; and

detecting means for detecting at least one peristaltic contraction,

wherein one or more medicaments are retained via said capsule so as to be dispensed in response to one or more peristaltic contractions.