IN-LINE DEAERATION PROCESS FOR THE PRODUCTION OF SELF-SUPPORTING FILM PRODUCTS

• US 20110274795A1
• Filed: 05/05/2010
• Published: 11/10/2011
• Est. Priority Date: 05/05/2010
• Status: Abandoned Application

• Current Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Original Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Inventors: DAILEY, Patrick, MYERS, Garry L., SLOMINSKI, Greg, BOGUE, Beuford A.
• Application Number:
  US12/774,292
• Publication Number:
  US 20110274795A1
• Time in Patent Office: Days
• US Class Current: 426/231
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• 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: B01F 33/12 Mixers in which the mixing of the components is achieved by natural convection
• CPC Class Codes: B29B 7/32 with non-movable mixing or kneading devices
• CPC Class Codes: B29B 7/847 Removing of gaseous components before or after mixing
• CPC Class Codes: B29C 43/24 Calendering

Abstract

The present invention provides processes and systems for preparing self-supporting film-forming compositions. The process generally includes the steps of: (a) providing a self-supporting film-forming matrix including an edible polymer component and a fluid carrier selected from the group consisting of water organic solvents and combinations thereof: (b) degassing the matrix via the steps of: (i) directing a flow of the matrix having a first density through at least one volume reduction device: and (ii) increasing the density of the matrix to form a second density. The present invention further includes the addition of actives to the matrix so as to provide an active-containing degassed film forming matrix.

Claims

1. A process for preparing a degassed film-forming matrix comprising the steps of:

(a) providing a film-forming pre-mix comprising an edible polymer component and a fluid carrier selected from the group consisting of water, organic solvents, and combinations thereof;

(b) mixing the pre-mix with an active component to form a film-forming matrix; and

(c) degassing said film-forming matrix to provide a degassed matrix having an increased density, said degassing step comprising directing a flow of said film forming matrix having a first density through at least one volume reduction device,

wherein the flow through said volume reduction device increases the density of the matrix to form a matrix having a second density, said second density being higher than said first density.

2. The process of claim 1, wherein said step of degassing said film-forming matrix is performed prior to pumping said matrix through a metering pump.

3. The process of claim 1, wherein said step of degassing said film-forming matrix is performed after pumping said matrix through a metering pump.

4. The process of claim 1, further comprising the step of degassing said pre-mix prior to the step (b) of mixing the pre-mix with an active component.

5. The process of claim 1, further comprising the step of forming a wet film comprising said resultant degassed matrix wherein said active component is uniformly distributed throughout.

6. The process of claim 1, further comprising the step of determining a gas bubble content subsequent to said step of degassing, and comparing said determined gas bubble content with a predetermined acceptable gas bubble content.

7. The process of claim 6, further comprising the step of determining whether additional degassing is required based upon said comparison.

8. The process of claim 1, wherein the step of degassing is conducted at a low pressure.

9. The process of claim 1, wherein the step of degassing is conducted in a vacuum.

10. The process of claim 1, wherein the step of degassing further comprises directing the matrix through a plurality of in-series volume reduction devices.

11. The process of claim 10, wherein each of said in-series reduction devices provides a higher density than said first density of said matrix.

12. The process of claim 1, wherein said step of degassing further comprises directing the matrix through a plurality in-parallel volume reduction devices.

13. The process of claim 12, wherein each of said in-parallel reduction devices provides a higher density than said first density of said matrix.

14. The process of claim 1, further comprising the step of repeating said degassing step until a desired level of degassing is reached in said degassed matrix.

15. The process of claim 1, wherein the degassing step is performed in-line.

16. A process for preparing a self-supporting film-forming composition comprising:

(a) providing a film-forming matrix comprising an edible polymer component and a fluid carrier selected from the group consisting of water, organic solvents, and combinations thereof;

(b) degassing said matrix, comprising the steps of;

(i) directing a flow of said matrix having a first density through at least one volume reduction device;

(ii) increasing the density of the matrix to yield a flow of a resultant degassed matrix;

(c) mixing the resultant degassed matrix with an active component to form a degassed matrix.

17. The process of claim 16, wherein said step of degassing said matrix is performed prior to pumping said matrix through a metering pump.

18. The process of claim 16, wherein said step of degassing said matrix is performed after pumping said matrix through a metering pump.

19. The process of claim 16, further comprising the step of (d) degassing said degassed matrix having a uniform distribution of said active component therein.

20. The process of claim 16, further comprising the step of forming a wet film comprising said resultant degassed matrix wherein said active component is uniformly distributed throughout.

21. The process of claim 16, further comprising the step of determining a gas bubble content subsequent to degassing, and comparing said determined gas bubble content with a predetermined acceptable gas bubble content

22. The process of claim 21, further comprising the step of determining whether additional degassing is required based upon said comparison.

23. The process of claim 16, wherein the step of degassing is conducted at a low pressure.

24. The process of claim 16, wherein the step of degassing is conducted in a vacuum.

25. The process of claim 16, wherein the step of degassing further comprises directing the matrix through a plurality of in-series volume reduction devices.

26. The process of claim 25, wherein each of said in-series reduction devices provides a higher density than said first density of said matrix.

27. The process of claim 16, wherein the step of degassing further comprises directing the matrix through a plurality in-parallel volume reduction devices.

28. The process of claim 27, wherein each of said in-parallel reduction devices provides a higher density than said first density of said matrix.

29. The process of claim 16, further comprising the step of repeating the degassing step until a desired level of degassing is reached in said degassed matrix.

30. The process of claim 16, wherein the degassing step is performed in-line.

31. A process for preparing a self-supporting film-forming composition comprising:

(a) providing a film-forming matrix comprising an edible polymer component and a fluid carrier selected from the group consisting of water, organic solvents, and combinations thereof;

(b) degassing said film-forming matrix by directing a flow of said film-forming matrix having a first density through at least one volume reduction device, said device comprising a plurality of porous deaerating channels, so as to form a film-forming matrix having a second density, said second density being higher than said first density; and

(c) mixing said film-forming matrix having a second density with an active component to form an active-containing degassed film-forming matrix.

32. The process of claim 31, wherein said step of degassing said matrix is performed prior to pumping said matrix through a metering pump.

33. The process of claim 31, wherein said step of degassing said matrix is performed after pumping said matrix through a metering pump.

34. The process of claim 31, further comprising the step of (d) degassing said active-containing degassed film-forming matrix.

35. The process of claim 31, further comprising the step of forming a wet film from said active-containing degassed film-forming matrix.

36. The process of claim 31, further comprising the step of determining whether additional degassing of said active-containing degassed film-forming matrix is required.

37. The process of claim 31, wherein the step of degassing is conducted at a low pressure.

38. The process of claim 31, wherein the step of degassing is conducted in a vacuum.

39. The process of claim 31, wherein the step of degassing is performed in-line.

40. The process of claim 31, wherein the step of degassing further comprises directing the film-forming matrix through a plurality of volume reduction devices in series.

41. The process of claim 31, wherein the step of degassing further comprises directing the film-forming matrix through a plurality of volume reduction devices in parallel.

42. The process of claim 31, wherein said porous deaerating channels are formed of a hydrophobic membrane, said membrane being permeable to a gas and impermeable to a non-gaseous material.

43. A process for preparing a self-supporting film-forming composition comprising:

(a) forming a matrix including an edible polymer component and;

a fluid carrier;

(b) degassing said matrix comprising the steps of;

directing a flow of said matrix having a first density through at least one volume reduction device, said volume reduction device including a rotatable surface, so as to form a film-forming matrix having a second density, said second density being higher than said first density; and

(c) mixing the resultant film-forming matrix having a second density with an active component to form an active-containing degassed film-forming matrix.

44. The process of claim 43, wherein said step of degassing said matrix is performed prior to pumping said matrix through a metering pump.

45. The process of claim 43, wherein said step of degassing said matrix is performed after pumping said matrix through a metering pump.

46. The process of claim 43, further comprising the step of (d) degassing said active-containing degassed film-forming matrix.

47. The process of claim 43, further comprising the step of forming a wet film from said active-containing degassed film-forming matrix.

48. The process of claim 43, further comprising the step of determining whether additional degassing of said active-containing degassed film-forming matrix is required.

49. The process of claim 43, wherein said step of degassing is performed at a low pressure.

50. The process of claim 43, wherein said step of degassing is performed in a vacuum.

51. The process of claim 43, wherein said step of degassing is performed in-line.

52. The process of claim 43, wherein said step of degassing further comprises directing the matrix through a plurality of volume reduction devices in series.

53. The process of claim 43, wherein said step of degassing further comprises directing the matrix through a plurality of rotating plates in parallel.

54. A system for forming edible film, comprising:

(a) a first mixer for combining at least one self-supporting film forming matrix, including an edible polymer component and at least one fluid carrier;

(b) at least one volume reduction device for degassing said matrix; and

(c) at least one second mixer to combine a quantity of a degassed matrix with a quantity of an active component to form an active-containing degassed matrix having a uniform distribution of said active therein.

55. The system of claim 54, further comprising a metering pump for pumping a desired amount of matrix from said first mixer to said second mixer, and wherein said volume reduction device is disposed at a location between said first mixer and said metering pump.

56. The system of claim 54, further comprising a metering pump for pumping a desired amount of matrix from said first mixer to said second mixer, and wherein said volume reduction device is disposed at a location between said metering pump and said second mixer.

57. The system of claim 54, further comprising a second volume reduction device for degassing said active-containing degassed matrix.

58. The system of claim 54, further comprising a wet film forming device for forming a self-supporting edible film from said active-containing degassed matrix.

59. The system of claim 54, wherein said volume reduction device comprises at least one rotatable surface.

60. The system of claim 54, wherein said volume reduction device comprises a plurality of porous channels comprising a membrane, wherein said membrane is permeable to a gas and impermeable to a non-gaseous material.