HIGHLY-SWELLABLE POLYMERIC FILMS AND COMPOSITIONS COMPRISING THE SAME

• US 20150361234A1
• Filed: 01/28/2014
• Published: 12/17/2015
• Est. Priority Date: 01/29/2013
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: HAFEZI, Hooman, SCHMIDT, Raymond
• Granted Patent: US 11,149,123 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: C08J 2305/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08J 2333/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08J 2433/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08J 5/18 Manufacture of films or sheets
• CPC Class Codes: C08J 9/0061 characterized by the use of several polymeric components
• CPC Class Codes: C08L 101/14 the macromolecular compounds being water soluble or water swellable, e.g. aqueous gels
• CPC Class Codes: C08L 33/02 Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof

Abstract

Highly-swellable polymeric films are provided. Aspects also include ingestible compositions that include the highly-swellable polymeric film and an ingestible component. Aspects further include methods of making and using the compositions.

Claims

1. A highly-swellable polymeric film that rapidly swells without disintegrating upon contact with an aqueous medium.

2. The highly-swellable polymeric film according to claim 1, wherein the film rapidly swells to ten times or greater in volume upon contact with an aqueous medium.

3. The highly-swellable polymeric film according to claim 2, wherein the film swells to ten times or greater in volume within one minute or less upon contact with an aqueous medium.

4. The highly-swellable polymeric film according to claim 1, wherein the film is configured to absorb ten grams or more of water per gram of film upon contact with an aqueous medium.

5. The highly-swellable polymeric film according to claim 1, wherein the film comprises an ionic polymer.

6. The highly-swellable polymeric film according to claim 5, wherein the ionic polymer is a polysaccharide.

7. The highly-swellable polymeric film according to claim 6, wherein the polysaccharide is an alginate.

8. The highly-swellable polymeric film according to claim 7, wherein the film further comprises a carboxyl functional group.

9. The highly-swellable polymeric film according to claim 8, wherein the film comprises a polyacrylic acid.

10. The highly-swellable polymeric film according to claim 1, wherein the film comprises cross-linked polymers.

11. The highly-swellable polymeric film according to claim 1, wherein the film further comprises a porogen.

12. The highly-swellable polymeric film according to claim 1, wherein the film has a thickness of ten microns or greater.

13. The highly-swellable polymeric film according to claim 1, wherein the film is stably associated with an ingestible event indicator.

14. An ingestible composition comprising:

an ingestible component; and

a highly-swellable polymeric film stably associated with the minimally dimensioned component, wherein the highly-swellable polymeric film rapidly swells without disintegrating upon contact with an aqueous medium.

15. The ingestible composition according to claim 14, wherein the highly-swellable polymeric film rapidly swells to ten times or greater in volume upon contact with an aqueous medium.

16. The ingestible composition according to claim 14, wherein the ingestible component comprises circuitry.

17. The ingestible composition according to claim 14, wherein the ingestible component is an ingestible event indicator.

18. The ingestible composition according to claim 17, wherein the ingestible event indicator comprises:

a support;

circuitry associated with the support;

a first material electrically coupled to the circuitry and associated with the support; and

a second material electrically coupled to the circuitry, wherein the second material is associated with the support and is electrically isolated from the first material;

wherein the first and second materials are selected to provide a voltage potential difference when in contact with a conducting fluid.

19. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film covers at least a portion of one of the first material or second material.

20. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film inhibits reaction of at least one of the first material or second material with ambient moisture.

21. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film is conductive when swollen.

22. The ingestible composition according to claim 21, wherein the highly-swellable polymeric film, when swollen, provides for conduction between at least one of the first material and the second material and an aqueous medium in which the composition is present.

23. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film, when swollen, promotes conductive communication between at least one of the first material or the second material and an aqueous medium in which the composition is present.

24. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film covers at least a portion of both the first material and the second material.

25. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film covers at least a portion of the second material.

26. The ingestible composition according to claim 25, wherein the second material is a salt.

27. The ingestible composition according to claim 26, wherein the salt is selected from the group consisting of copper salts, iron salts and silver salts.

28. The ingestible composition according to claim 18, wherein the first material comprises a metal.

29. The ingestible composition according to claim 28, wherein the metal is selected from the group consisting of magnesium, zinc, sodium, lithium and iron and alloys thereof.

30. The ingestible composition according to claim 18, wherein the highly-swellable polymeric film is associated with the support and is configured as a signal amplification that increases a length of a current path between the first and second materials.

31. The ingestible composition according to claim 30, wherein the ingestible composition further comprises an active agent.

32. The ingestible composition according to claim 31, wherein the ingestible composition further comprises a pharmaceutically acceptable carrier.

33. The ingestible composition according to claim 32, wherein the highly-swellable polymeric film is configured to separate the event indicator from the pharmaceutically acceptable carrier upon swelling.

34. A system comprising:

an ingestible composition comprising;

an ingestible component; and

a highly-swellable polymeric film stably associated with the minimally dimensioned component, wherein the film rapidly swells without disintegrating upon contact with an aqueous medium; and

a receiver configured to receive a communication associated with the ingestible component.

35. A method comprising combining an ingestible component and a highly-swellable polymeric film, wherein the film rapidly swells without disintegrating upon contact with an aqueous medium.

36. The method according to claim 35, wherein the ingestible component is an ingestible event indicator.

37. The method according to claim 35, wherein the method comprises stably associating the ingestible component and the film.

38. The method according to claim 35, wherein the method comprises one or more protocols selected from the group consisting of laminating, pressing, stamping, extruding, molding, gluing and coating.

39. The method according to claim 35, wherein at least a portion of the method is automated.