Edible holographic products, particularly pharmaceuticals and methods and apparatus for producing same

• US 20060068006A1
• Filed: 09/14/2005
• Published: 03/30/2006
• Est. Priority Date: 08/05/1999
• Status: Active Grant

• Current Assignee: Dimensional Foods Corporation
• Original Assignee: Dimensional Foods Corporation
• Inventors: Begleiter, Eric
• Granted Patent: US 7,083,805 B2
• Time in Patent Office: Days
• US Class Current: 424/464
• CPC Class Codes: A61J 2205/20 Colour codes
• CPC Class Codes: A61J 2205/40 by shape or form, e.g. by using shape recognition
• CPC Class Codes: A61J 3/005 Coating of tablets or the like coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006
• CPC Class Codes: A61J 3/007 Marking tablets or the like apparatus for printing on tablets or the like B41F17/36
• CPC Class Codes: A61J 3/10 into the form of compressed tablets tablet presses B30B11/00
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2886 having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• CPC Class Codes: B30B 11/08 co-operating with moulds carried by a turntable
• CPC Class Codes: B30B 11/14 co-operating with moulds on a movable carrier other than a turntable or a rotating drum
• CPC Class Codes: B30B 15/065 Press rams
• CPC Class Codes: G03H 1/0244 Surface relief holograms replicating hologram without interference recording G03H1/0276
• CPC Class Codes: G03H 2001/0055 in advertising or decorative art
• CPC Class Codes: G03H 2270/10 Composition

Abstract

An edible product such as a unit dosage form of a pharmaceutically active substance includes a layer of a material that can receive and retain a high resolution microrelief that can convey information. The microrelief is themo-formable, preferably formed from an aqueous solution of HPMC and/or HPC plus a plasticizer and colorant. Other additives such as strengtheners, surfactants and adherents may be used depending on the application. The materials are selected and proportioned to control the fading or change in color of the visual image or effect produced by the relief to indicate exposure to an unacceptable degree of heat or humidity. The dosage form can be the relief-containing layer itself with the pharmaceutical carried therein. In a preferred form, the layer is an outer coating over a core containing the pharmaceutically active substance. Coated tablets are configured to resist twinning. To produce such dosage forms, the coated core is transported in unison with a flexible mold or transfer plate that can heat-replicate the microrelief on the outer layer of the dosage form, followed by a cooling and release of the transfer plate from the coating.

Claims

1-28. -28. (canceled)

29. A method of producing a microrelief on an ingestible dosage form having a core which can contain a pharmaceutically active substance and a pharmaceutically acceptable carrier, comprising the steps of:

a. coating said core with a layer of a thermo-formable material that can receive and retain a holographic diffraction pattern;

b. providing a plate having a holographic diffraction pattern formed on at least a portion of a first surface thereof;

c. transporting said coated cores to a position opposite said first surface;

d. heating at least one of said plate and said coating during or prior to the time when they are in said opposed relationship;

e. pressing said first surface into said coating to replicate said holographic diffraction pattern in said coating;

f. cooling said coating thus replicated; and

g. demolding said first plate surface from said coating.

30. The holographic dosage form production method of claim 29 wherein said coating is pan coating and further comprising the step of controlling twinning of said coated tablets.

31. The holographic dosage form production method of claim 30 wherein said twinning control comprises forming said core with at least one curved face that receives said coating and said pressing.

32. The holographic dosage form production method of claim 31 wherein said curvature is sufficient to resist twinning, but not sufficient to distort the holographic image pressed into in said coating.

33. The holographic dosage form production method of claim 32 wherein said core face is generally circular and, measured as an angle in a plane through the face, the curvature is in the range of about 0.6 radian to about 0.9 radian.

34. The holographic dosage form production method of claim 30 wherein said twinning control comprises forming said core with a recess within at least one face of said coat, said recess having a generally flat bottom that receives said coating layer.

35. The holographic dosage form production method of claim 34 wherein said recess is sufficiently shallow that said pressing transfers said holographic pattern reliably.

36. The holographic dosage form production method of claim 35 wherein said recess is less than about 0.01 mm.

37. The holographic dosage form production method of claim 29 wherein said coating includes said thermo-formable material bonding reliably with said core.

38. The holographic dosage form production method of claim 29 or 37 wherein said thermo-formable material is selected from the group consisting of:

gelatin, hydroxypropylmethylcellulose (HPMC), hydroxyproplycellulose (HPC), modified food starches, waxes, vegetable gums and combinations thereof.

39. The holographic dosage form production methods of claim 38 wherein said material includes solids of a modified cellulose, a plasticizer, and a colorant.

40. The holographic dosage form production method of claim 38 wherein said coating produces a layer in the range of 0.25% to 7.25% of the weight of said dosage form.

41. The holographic dosage form production method of claim 29 wherein said plate providing comprises continuously advancing a belt of a semi-flexible material containing said pattern on at least one surface thereof in coordinating with said transporting of said coated dosage forms.

42. The holographic dosage form production method of claim 41 wherein said semi-flexible material is selected from the group consisting of:

a thin sheet metal, rubber, a laminate of thin sheet metal and a layer of a resilient backing material opposite said first surface, and a rubber and metal composite.

43. The holographic dosage form production method of claim 42 wherein said thin sheet metal is a nickel composite with a thickness of 1 mils to 5 mils, and said holographic diffraction pattern is electroformed on said first surface.

44. The holographic dosage form production method of claims 29 or 41 wherein said transporting also aligns said coated cores.

45. The holographic dosage form production method of claim 41 or 43 wherein said coated core facing said plate during said pressing is non-planar, and said belt flexibility is sufficient to allow said belt to conform to said non-planar coating desiring said pressing.

46. The holographic dosage form production method of claim 41 wherein said transporting comprises conveying of a linear array of said coated cores in a parallel, closely spaced relationship with a portion of said belt, and moving said belt in coordination with said conveying.

47. The holographic dosage form production method of claim 46 wherein said heating is a rapid, localized heating of said belt during said pressing.

48. The holographic dosage form production method of claim 47 wherein said heating raises the temperature of said diffraction pattern on said belt to a temperature in the range of 90-150°

C.

49. The holographic dosage form production method of claim 47 wherein said pressing comprises a brief deflection of said heated belt that places said diffraction pattern in said coating to create said replication of said diffraction pattern in said coating.

50. The holographic dosage form production method of claims 29 or 47 wherein said pressing occurs for about 0.3 to 3.0 second.

51. The holographic dosage form production method of claim 46 wherein said cooling is a rapid, localized cooling that begins immediately after said pressing has formed said diffraction pattern in said coating.

52. The holographic dosage form production method of claim 51 wherein said demolding comprises a resumption of said mutually spaced relationship between said coating as said coated and said belt as they continue to move in coordination, after said cooling has begun.

53. Apparatus for the continuous production of a hologram on an ingestible dosage form having a core which can contain a pharmaceutically active substance and which has been coated with a thin layer of a thermo-formable, comprising,

a conveyor that carries the coated cores in a first direction,

a plate containing a holographic diffraction pattern on one surface thereof facing the coated cores on said conveyor, said plate being movable along said first direction in coordination with said carrying of said conveyor and with said one surface spaced from said coated cores,

a heater for rapidly raising the temperature of one of said plate and said coating to a level where said coating is formable, apparatus for pressing said one surface into said coating after said heating to replicate said diffraction pattern on said coating,

a cooler to rapidly lower the temperature of said coating to stabilize said diffraction pattern in said coating, and

apparatus to separate said one surface from said coating.

54. The apparatus of claim 53 wherein said plate comprises an continuous belt of a semi-flexible material with said one surface facing outwardly.

55. The apparatus of claim 54 wherein said diffraction pattern is formed on at least portions of said one surface.

56. The apparatus of claim 54 wherein said conveyor includes means for holding said coated cores in a pre-selected array and said diffractive pattern is formed on raised or recessed portions of said belt that align with said coated cores during said pressing.

57. The apparatus of claim 54 wherein said belt is formed of a material selected from the group consisting of:

thin sheet metal, rubber, thin sheet metal with a backing layer of a resilient material, or mixtures thereof.

58. The apparatus of claim 54 wherein said separating apparatus comprises at least one guide member positioned to direct at least one of said belt and said conveyor to separate from another to help in demolding.

59. The apparatus of claim 53 wherein said heater comprises a source of radiant electromagnetic energy directed before said pressing apparatus at one of said belt and said thin layer facing said belt.

60. The apparatus of claim 53 wherein said cooler comprises a jet of a refrigerated fluid directed onto said belt following said pressing.

61. The apparatus of claim 53 wherein said pressing apparatus comprises belt guides that deflect a portion of said belt into said thin layer following passage through said heater.

62. The apparatus of claim 53 wherein said pressing apparatus comprises an actuator disposed after said heater to reciprocate into and out of contact with said belt opposite said first surface to print said diffraction pattern in said coating.

63. An edible product in dosage form comprising an active substance to be ingested and a material bearing a diffraction relief pattern, wherein said pattern is formed in said layer as an interference pattern produced by laser light.

64. A pharmaceutical dosage form according to claim 63, wherein said laser light is constituted by two laser light beams split from a single laser light source.

65. A pharmaceutical dosage form according to claim 63, further comprising a core containing said active substance, said material is in the form of a layer overlying said core.

66. A pharmaceutical dosage form according to claim 63 which consists essentially of said material and said active substance therein.

69. A method of producing an optical pattern on an outer surface of an edible article, where the optical pattern interacts with incident light to produce a visible image or effect, comprising the steps of:

providing a laser;

causing said laser to emit first and second beams of light; and

causing said first and second beams of light to interfere to produce an interference pattern on a surface of the edible article, and wherein the interference pattern produces the optical pattern on the outer surface of the edible article.

70. The method of claim 69, wherein said interference pattern is comprised of light intensity maxima and minima.

71. The method of claim 70, wherein the optical pattern is comprised of a plurality of grooves produced by lines of minimum light intensity in said interference pattern, and a plurality of ridges produced by lines of maximum light intensity in said interference pattern.

72. The method of claim 71, wherein the optical pattern is a microrelief.