SOFT CAPSULE BASED ON STARCH AND A METHOD AND DEVICE FOR THE PRODUCTION THEREOF

• US 20110319503A1
• Filed: 03/03/2010
• Published: 12/29/2011
• Est. Priority Date: 03/03/2009
• Status: Active Grant

• Current Assignee: InnoGEL AG
• Original Assignee: InnoGEL AG
• Inventors: Muller, Rolf, Innerebner, Federico
• Granted Patent: US 9,339,474 B2
• Time in Patent Office: Days
• US Class Current: 514/778
• CPC Class Codes: A61J 3/072 Sealing capsules, e.g. rendering them tamper-proof
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61J 3/077 Manufacturing capsule shells
• CPC Class Codes: A61K 9/4816 Wall or shell material
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: B29C 2043/486 cooperating with rollers or drums
• CPC Class Codes: B29C 43/003 characterised by the choice of material
• CPC Class Codes: B29C 43/44 Compression means for making articles of indefinite length
• CPC Class Codes: B29C 43/48 Endless belts
• CPC Class Codes: B29K 2003/00 Use of starch or derivatives as moulding material
• CPC Class Codes: C08L 2666/26 Natural polymers, natural resins or derivatives thereof according to C08L1/00 - C08L5/00, C08L89/00, C08L93/00, C08L97/00 or C08L99/00
• CPC Class Codes: C08L 3/00 Compositions of starch, amylose or amylopectin or of their derivatives or degradation products
• CPC Class Codes: C08L 3/02 Starch; Degradation products thereof, e.g. dextrin
• CPC Class Codes: C08L 3/04 Starch derivatives , e.g. crosslinked derivatives
• CPC Class Codes: C08L 3/08 Ethers

Abstract

A method for producing starch soft capsules comprises the following steps: preparing a mixture comprising starch, plasticizer and water, wherein more than 50 weight percent of the starch is present in the form of particles of granular starch; shaping the mixture to form a film in a shaping process; solidifying the mixture by increasing the temperature of the mixture during and/or after the shaping process by more than 5° C.; and shaping the film to form a soft capsule. Soft capsules produced by this method have starch particles bonded to one another. A device for performing this method comprises a shaping device to enable shaping of the starch material to form a film, and a heating device to perform a heat treatment to destructure the starch during and/or after the shaping. It comprises a rotary die device.

Claims

1-16. -16. (canceled)

17. A method for producing a soft capsule based on starch comprising:

shaping a mixture comprising starch to form a film wherein more than 50 weight percent of said starch in a liquid phase is present as particles of granular starch; and

increasing temperature by more than 5°

C. to solidify said mixture by destructuring said granular starch thereby producing soft capsules from said film wherein said increasing temperature occurs during or after said shaping and wherein said granular starch is destructured to no more than stage 2.2 and wherein 50-60% of said granular starch is not birefringent in a polarization microscope.

18. The method of claim 17 wherein said mixture has a dynamic viscosity of <

3000 Pas.

19. The method of claim 17 wherein said mixture has a water content during solidification which is reduced by up to 25 weight percent.

20. The method of claim 17 wherein said starch has a molecular weight which is not significantly impaired and a M_w2/M_w1 quotient is >

0.3, where M_w1 is a weight-average molecular weight distribution of said starch used and M_w2 is a weight-average molecular weight distribution of said starch in said soft capsule produced.

21. A soft capsule prepared by the method of claim 20 comprising:

a) >

40 weight percent of the dry soft capsule, after subtracting the plasticizer and starch;

b) 15-70 weight percent of the dry soft capsule plasticizer;

c) 0.1-50 weight percent of the total soft capsule water;

d) up to 50 weight percent of the dry mixture, after subtracting the plasticizer and thickener; and

e) up to 10 weight percent of the dry soft capsule, after subtracting the plasticizer, carrageen and carrageenans;

wherein the soft capsule comprises starch particles bonded to one another.

22. The soft capsule of claim 21 wherein M_w2 is at least 500,000 g/mol.

23. A soft capsule prepared by the method of claim 17 comprising:

a) >

40 weight percent of the dry soft capsule, after subtracting the plasticizer and starch;

b) 15-70 weight percent of the dry soft capsule plasticizer;

c) 0.1-50 weight percent of the total soft capsule water,

d) up to 50 weight percent of the dry mixture, after subtracting the plasticizer and thickener; and

e) up to 10 weight percent of the dry soft capsule, after subtracting the plasticizer, carrageen and carrageenans;

wherein the soft capsule comprises starch particles bonded to one another.

24. The soft capsule of claim 23 wherein said soft capsule comprises a matrix of particles of destructured starch bonded to one another.

25. The soft capsule of claim 23 wherein said starch in said soft capsule shell amounts to at least 30%, which is present in the form of particles after dissolving the soft capsule for 30 min at 70°

C. and can be recovered by sedimentation.

26. The soft capsule of claim 23 dry soft capsule shell has a proportion of at least 25 weight percent solids content, which can be recovered after dissolving the soft capsule at 70°

C. by sedimentation.

27. A device for producing the soft capsule of claim 23

wherein the device comprises:

a shaping device to enable shaping of a starch material to form a film;

a heating device to perform a heat treatment for destructuring of the starch during and/or after the shaping; and

a rotary die device arranged downstream from the heating device

28. The device of claim 27 wherein the heating device comprises a rotating process part.

29. The device of claim 28 wherein the rotating process part comprises a heatable rotating drum.

30. The device of claim 29 wherein the heatable rotating drum can be heated to a minimal temperature of at least 25°

C., preferably at least 50°

C.

31. The device of claim 27 wherein the device comprises a means for regulating water content of the film during and/or after shaping.

32. The device of claim 27 comprising a means for covering the starch material for at least 30% of a circumference of the rotating process part.

33. The device of claim 32 comprising a belt revolving together with a rotating process part revolving at a same angular velocity as a rotating process part.

34. The device of claim 27 wherein the shaping device is a spreader box.

35. A method for producing a soft capsule comprising:

preparing a mixture comprising;

more than 40 weight percent, after subtracting plasticizer and starch, wherein more than 50 weight percent of said starch in said mixture is present as particles of granular starch; and

15-70 weight percent of a dry mixture plasticizer;

15-90 weight percent of the total mixture water;

up to 50 weight percent of the dry mixture, after subtracting the plasticizer and thickener; and

up to 10 weight percent of the dry mixture, after subtracting the plasticizer, carrageen and carrageenans;

shaping said mixture to form a film in a shaping process;

solidifying said mixture by increasing temperature of said mixture by more than 5°

C. either during or after said shaping process; and

shaping said film to form a soft capsule comprising particles of destructured starch.

36. The method of claim 35 wherein said dry mixture further comprises additives and adjuvants.

37. The method of claim 35 wherein the mixture has a dynamic viscosity of <

3000 Pas.

38. The method of claim 35 wherein the water content of the mixture during solidification is reduced by up to 25 weight percent.

39. The method of claim 35 wherein the starch has a molecular weight which is not significantly impaired and an M_w2/M_w1 quotient is >

0.3, where M_w1 is a weight-average molecular weight distribution of the starch used and M_w2 is a weight-average molecular weight distribution of the starch in the soft capsule produced.

40. A soft capsule based on starch prepared by the method of claim 35 comprising:

>

40 weight percent of the dry soft capsule, after subtracting the plasticizer and starch;

15-70 weight percent of the dry soft capsule plasticizer;

0.1-50 weight percent of the total soft capsule water;

up to 50 weight percent of the dry mixture, after subtracting the plasticizer and thickener; and

up to 10 weight percent of the dry soft capsule, after subtracting the plasticizer, carrageen and carrageenans,

wherein the soft capsule comprises starch particles bonded to one another.

41. The soft capsule of claim 40 wherein the soft capsule comprises a matrix of particles of destructured starch bonded to one another.

42. The soft capsule of claim 40 wherein the starch in the soft capsule shell amounts to at least 30%, which is present in the form of particles after dissolving the soft capsule for 30 min at 70°

C. and can be recovered by sedimentation.

43. The soft capsule of claim 40 wherein the dry soft capsule shell has a proportion of at least 25 weight percent solids content, which can be recovered after dissolving the soft capsule at 70°

C. by sedimentation.

44. The soft capsule of claim 40 wherein the starch has an M_w2 of least 500,000 g/mol.

45. A device for producing soft capsules of claim 40 wherein the device comprises:

a shaping device to enable shaping of a starch material to form a film;

a heating device to perform a heat treatment for destructuring of the starch during and/or after the shaping; and

a rotary die device arranged downstream from the heating device.

46. The device of claim 45 wherein the heating device comprises a rotating process part.

47. The device of claim 46 wherein the rotating process part is a heatable rotating drum.

48. The device of claim 47 wherein the heatable rotating drum can be heated to a minimal temperature of at least 25°

C.

49. The device of claim 45 wherein the device comprises a means for regulating water content of the film during and/or after shaping.

50. The device of claim 45 comprising a means for covering the starch material for at least 30% of the circumference of the rotating process part.

51. The device of claim 50 wherein the rotating process part is a belt revolving together with the rotating process part, revolving at the same angular velocity as the rotating process part.

52. The device according of claim 45 wherein the shaping device is a spreader box.