Multi-phase, multi-compartment capsular delivery apparatus and methods for using same

• US 7,670,612 B2
• Filed: 03/19/2004
• Issued: 03/02/2010
• Est. Priority Date: 04/10/2002
• Status: Active Grant

• Current Assignee: Innercap Technologies Incorporated
• Original Assignee: Innercap Technologies Incorporated
• Inventors: Miller, Fred H.
• Primary Examiner(s): Wax; Robert A
• Assistant Examiner(s): Sasan; Aradhana
• Application Number:
  US10/804,576
• Publication Number:
  US 20050008690A1
• Time in Patent Office: 2,174 Days
• Field of Search: 424/451, 424/400
• US Class Current: 424/400
• 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: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/4808 characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence

Abstract

A multi-compartment capsule, comprising, a first receiving chamber comprising at least one ingredient having a first physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; and a second receiving chamber comprising at least one ingredient having a second physical state, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral; wherein said first physical state of said ingredient of said first receiving chamber being different from said second physical state of said ingredient of said second receiving chamber; and said ingredient of said first receiving chamber being different from said ingredient of said second receiving chamber.

Claims

1. A multi-compartment capsule comprising:

a first receiving chamber comprising at least one oil ingredient in immediate release form, wherein said oil ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement; and

a second receiving chamber containing only solid ingredients and comprising at least one active ingredient in a solid state, formulated in a manner allowing for a time-delayed dissolution and release of said solid active ingredient, wherein said ingredient is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral,

wherein the ingredients of said first receiving chamber is different from the ingredients of said second receiving chamber, and wherein the multi-compartment capsule is a hard shell capsule.

2. A multi-compartment capsule as defined in claim 1, wherein said first receiving chamber comprises no dead volume space.

3. A multi-compartment capsule as defined in claim 1, wherein said solid active ingredient is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, a suppository, an ointment, a paste, an emulsion and a cream.

4. A multi-compartment capsule as defined in claim 1,

further comprising a third receiving chamber comprising at least one ingredient selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral.

5. A multicompartment capsule as defined in claim 1,

wherein said first receiving chamber is a primary capsule and said second receiving chamber is a secondary capsule,

said primary capsule comprising an internal periphery sufficient for receiving said ingredient and said secondary capsule therein,

wherein the primary and secondary capsules are hard shell capsules.

6. A multi-compartment capsule as defined in claim 5, wherein said primary and said secondary capsules each comprise a base and a corresponding cap, wherein said cap is configured to provide a sealing relationship when engaging said base.

7. A multi-compartment capsule as defined in claim 5, wherein said primary capsule comprises no dead volume space.

8. A multi-compartment capsule as defined in claim 5, wherein said oil ingredient of said primary capsule is a pharmaceutical, wherein said active ingredient of said secondary capsule is a pharmaceutical.

9. A multi-compartment capsule as defined in claim 5, wherein said oil ingredient of said primary capsule and/or said active ingredient of said secondary capsule is a vitamin.

10. A multi-compartment capsule as defined in claim 5, wherein said secondary capsule is received in said primary capsule.

11. A multi-compartment capsule according to claim 1, wherein the second receiving chamber contains Glucosamine/Chondroitin and the first receiving chamber contains Vitamin E.

12. A multi-compartment capsule according to claim 11, wherein the Glucosamine/Chondroitin is in a solid physical state and the Vitamin E is in a liquid physical state.

13. A multi-compartment capsule according to claim 1, wherein the second receiving chamber contains S-adenosylmethionine (SAMe) and the first receiving chamber contains Vitamin E.

14. A multi-compartment capsule according to claim 13, wherein the S-adenosylmethionine (SAMe) is in a solid physical state and the Vitamin E is in a liquid physical state.

15. A multi-compartment capsule according to claim 1, wherein the second receiving chamber contains Curcumin, Holy Basil, Zinc and the first receiving chamber contains Omega 3 Fatty Acids DHA &

EPA.

16. A multi-compartment capsule according to claim 15, wherein the Curcumin, Holy Basil, Zinc is in a solid physical state and the Omega 3 Fatty Acids DHA &

EPA is in a liquid physical state.

17. A multi-compartment capsule according to claim 1, wherein the second receiving chamber contains Vitamin C and the first receiving chamber contains Vitamin E.

18. A multi-compartment capsule according to claim 1, wherein said ingredient of said first receiving chamber and/or said ingredient of said second receiving chamber is a vitamin.

19. A multi-compartment capsule according to claim 1, wherein said oil ingredient of said first receiving chamber is incompatible with said active ingredient of said second receiving chamber.

20. A multi-compartment capsule according to claim 1, wherein said oil ingredient of said first receiving chamber is pharmaceutically incompatible with said active ingredient of said second receiving chamber.

21. A multi-compartment capsule as defined in claim 1, the multi-compartment capsule provides for stability and sufficient shelf-life of the ingredients to make the multi-compartment capsule fit for human consumption.

22. A multi-compartment capsule as defined in claim 1, wherein said capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

23. A multi-compartment capsule as defined in claim 1, wherein the release of the solid ingredient is delayed by a time-release coating.

24. A multi-compartment capsule as defined in claim 1, wherein said second receiving chamber is enveloped by said first receiving chamber.

25. A multi-compartment capsule as defined in claim 24, wherein the solid active ingredient in the second receiving chamber is caffeine.

26. A multi-compartment capsule as defined in claim 24, wherein the release of the solid ingredient is delayed by a time-release coating.

27. A multi-compartment capsule as defined in claim 26, wherein the second receiving chamber comprises a time-release coating.

28. A multi-compartment capsule as defined in claim 24, wherein the solid ingredient is encapsulated with a time-release coating.

29. A multi-compartment capsule as defined in claim 1, wherein the oil is selected from the group consisting of a herbal oil, a marine oil, a vitamin oil, an extract, and mixtures of any of the foregoing.

30. A multi-compartment capsule, comprising:

a first receiving chamber comprising an active oil ingredient selected from the group consisting of a nutraceutical, a vitamin, and a dietary supplement in immediate release form; and

a second receiving chamber containing only solid ingredients and comprising at least one active ingredient in a solid state and formulated in a manner allowing for a time-delayed dissolution and release of said solid active ingredient, wherein said active ingredient of said first receiving chamber is different from said at least one active ingredient of said second receiving chamber and not present in said second receiving chamber, said second receiving chamber being located within said first receiving chamber, and the multi-compartment capsule is a hard shell capsule.

31. A multi-compartment capsule as defined in claim 30, wherein the release of the solid ingredient is delayed by a time-release coating.

32. A multi-compartment capsule as defined in claim 30, wherein the solid ingredient is encapsulated with a time-release coating.

33. A multi-compartment capsule, comprising:

a first receiving chamber comprising at least one oil in immediate release form; and

a second receiving chamber containing only solid ingredients and comprising at least one active ingredient in a solid state and formulated in a manner allowing for a time-delayed dissolution and release of said solid active ingredient, wherein the ingredients contained in said first receiving chamber are different from the ingredients of said second receiving chamber, and wherein said second receiving chamber is enveloped by said first receiving chamber, and wherein the multi-compartment capsule is a hard shell capsule.

34. A multi-compartment capsule as defined in claim 33, wherein the release of the solid ingredient is delayed by a time-release coating.

35. A multi-compartment capsule as defined in claim 33, wherein the solid ingredient is encapsulated with a time-release coating.

36. A multi-compartment capsule, comprising:

a first receiving chamber comprising at least one active ingredient in an oil in immediate release form; and

a second receiving chamber containing only solid ingredients and comprising at least one active ingredient in a solid state, and means for allowing for a time-delayed dissolution and release of said solid active ingredient,

wherein (A) said active ingredient of said first receiving chamber is different from said active ingredient of said second receiving chamber and not present in said second receiving chamber, and (B) the multi-compartment capsule is a hard shell capsule.

37. A multi-compartment capsule as defined in claim 36, wherein said first receiving chamber comprises no dead space.

38. A multi-compartment capsule as defined in claim 36,

further comprising a base and a corresponding cap, wherein said cap is configured to provide, a sealing relationship when engaging said base.

39. A multi-compartment capsule as defined in, claim 38, wherein said cap is configured to reduce dead volume space within said first receiving chamber.

40. A multi-compartment capsule as defined in claim 38, further comprising a filling material introduced into said cap to reduce dead volume space within said first receiving chamber.

41. A multi-compartment capsule as defined in claim 36, wherein said ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

42. A multi-compartment capsule as defined in claim 41, wherein said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

43. A multi-compartment capsule as defined in claim 41, wherein said solid is selected from the group consisting of a pill, a tablet, a powder, granulation, flakes, a troche, and a suppository.

44. A multi-compartment capsule as defined in claim 36, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber comprises a pharmaceutical.

45. A multi-compartment capsule as defined in claim 36, wherein said ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

46. A multi-compartment capsule as defined in claim 36, wherein at least one of said receiving chambers comprises a time-release coating.

47. A multi-compartment capsule as defined in claim 36, further comprising a third receiving chamber comprising at least one ingredient.

48. A multi-compartment capsule as defined in claim 47, wherein said ingredient in said third receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

49. A multi-compartment capsule as defined in claim 48, wherein said ingredient in said third receiving chamber is different than the ingredients in said first and said second receiving chamber.

50. A multi-compartment capsule as defined in claim 48 or 49, wherein said ingredient in said third receiving chamber is at a different physical state from the physical states of the ingredients in said first and said second receiving chamber.

51. A multi-compartment capsule as defined in claim 36, wherein the second receiving chamber contains Fluoxetine and the first receiving chamber contains Vitamin E.

52. A multi-compartment capsule as defined in claim 36, wherein the second receiving chamber contains Rofecoxib and the first receiving chamber contains Vitamin E.

53. A multi-compartment capsule as defined in claim 36, wherein the second receiving chamber contains Diphenhydramine Hydrochloride and the first receiving chamber contains Vitamin E.

54. A multi-compartment capsule as defined in claim 36, wherein the second receiving chamber contains Celecoxib and the first receiving chamber contains Ibuprofen.

55. A multi-compartment capsule according to claim 54, wherein the Celecoxib is in a solid physical state and the Ibuprofen is in a liquid physical state.

56. A multi-compartment capsule as defined in claim 36, wherein said active ingredient of said first receiving chamber is a pharmaceutical, and wherein said active ingredient of said second receiving chamber is a pharmaceutical.

57. A multi-compartment capsule as defined in claim 36, wherein said active ingredient of said first receiving chamber and/or said active ingredient of said second receiving chamber is a vitamin.

58. A multi-compartment capsule as defined in claim 36, wherein said active ingredient of said first receiving chamber is incompatible with said active ingredient of said second receiving chamber.

59. A multi-compartment capsule as defined in claim 36, wherein said active ingredient of said first receiving chamber is pharmaceutically incompatible with said active ingredient of said second receiving chamber.

60. The multi-compartment capsule as defined in claim 36, wherein the multi-compartment capsule provides for stability and sufficient shelf-life of the ingredients to make the multi-compartment capsule fit for human consumption.

61. A multi-compartment capsule as defined in claim 36, wherein the means is a time-release coating.

62. A multi-compartment capsule as defined in claim 36, wherein the means is a time-release coating encapsulating the solid ingredient.

63. A multi-compartment capsule as defined in claim 36, wherein the means is a time-release coating encapsulating the solid ingredient.

64. A multi-compartment capsule as defined in claim 36, wherein said capsule is formed of a material selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, oleoresin, polyvinylacetate, hydroxypropyl methyl cellulose, polymerisates of acrylic or methacrylic esters, polyvinylacetate-phtalate and combinations thereof.

65. A multi-compartment capsule as defined in claim 36, wherein said second receiving chamber is enveloped by said first receiving chamber.

66. A multi-compartment capsule as defined in claim 65, wherein the means is a time-release coating.

67. A multi-compartment capsule as defined in claim 65, wherein the means is a time-release coating encapsulating the solid ingredient.

68. A multicompartment capsule as defined in claim 67, wherein the second receiving chamber comprises a time-release coating.

69. A multi-compartment capsule as defined in claim 65, wherein the solid active ingredient in the second receiving chamber is caffeine.

70. A multi-compartment capsule as defined in claim 36, wherein the oil is selected from the group consisting of a herbal oil, a marine oil, a vitamin oil, an extract, and mixtures of any of the foregoing.

71. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of:

providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber;

introducing into said second receiving chamber only solid ingredients including at least one active ingredient in a solid state, formulated in a manner allowing for a time-delayed dissolution and release of said solid ingredient, wherein said ingredient introduced into said second receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, a dietary supplement and a mineral;

introducing into said first receiving chamber at least one oil ingredient in immediate release form, wherein said oil ingredient introduced into said first receiving chamber is selected from the group consisting of a nutraceutical, a vitamin, and a dietary supplement, wherein the active ingredients of said second receiving chamber are different from the active ingredients of said first receiving chamber; and

positioning said cap in sealing relationship with said base,

wherein the multi-compartment capsule is a hard shell capsule.

72. An encapsulation process as defined in claim 71, further comprising the step of reducing dead volume space within said primary capsule.

73. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of:

providing a primary capsule having a base and a cap;

providing a secondary capsule having a base and a cap;

introducing only solid ingredients including at least one active ingredient in a solid state into said secondary capsule, formulated in a manner allowing for a time-delayed dissolution and release of said solid ingredient;

positioning said cap of said secondary capsule in sealing relationship with said base;

introducing at least one oil ingredient selected from the group consisting of a nutraceutical, a vitamin, and a dietary supplement in immediate release form into said primary capsule, wherein the active ingredients of said secondary capsule are different from the ingredients of said primary capsule;

introducing said secondary capsule into said base of said primary capsule; and

positioning said cap of said primary capsule in sealing relationship with said base, wherein the multi-compartment capsule is a hard shell capsule.

74. An encapsulation process as defined in claim 73, further comprising the step of reducing dead volume space within said primary capsule.

75. An encapsulation process as defined in claim 73, further comprising the step of adding a filler material into said secondary capsule selected from the group consisting of gelatin, starch, casein, chitosan, soya bean protein, safflower protein, alginates, gellan gum, carrageenan, xanthan gum, phtalated gelatin, succinated gelatin, cellulosephtalate-acetate, polyvinylacetate, hydroxypropyl methyl cellulose, oleoresin, polyvinylacetate-phtalate, polymerisates of acrylic or methacrylic esters and combinations thereof.

76. An encapsulation process as defined in claim 73, wherein at least one cap of said capsules comprises a configuration sufficient for reducing dead volume space within the primary capsule.

77. An encapsulation process as defined in claim 73, wherein said ingredient introduced into said primary and secondary capsules is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

78. An encapsulation process as defined in claim 73, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, and a suppository.

79. An encapsulation process as defined in claim 73, wherein said oil ingredient in said primary capsule comprises a pharmaceutical and said active ingredient in said secondary capsule is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

80. An encapsulation process as defined in claim 73, wherein said oil ingredient introduced into said primary capsule and said active ingredient in said secondary capsule is a pharmaceutical.

81. An encapsulation process as defined in claim 73, wherein at least one of said capsules comprises a time-release coating.

82. An encapsulation process as defined in claim 73, further comprising the steps of:

providing a tertiary capsule having a base and a cap;

introducing at least one ingredient having a third physical state into said tertiary capsule;

positioning said cap of said secondary capsule in sealing relationship with said base; and

introducing said tertiary capsule into said base of said secondary capsule.

83. An encapsulation process as defined in claim 82, wherein said ingredient in said tertiary capsule is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

84. An encapsulation process as defined in claim 83, wherein said ingredient in said tertiary capsule is different from the other ingredients of the other capsules.

85. An encapsulation process as defined in claim 83 or 84, wherein the ingredients are pharmaceuticals.

86. An encapsulation process as defined in claim 82, wherein said tertiary capsule comprises a time-release coating.

87. An encapsulation process as defined in claim 73 or claim 82, wherein at least one of said capsules further comprise a soft elastic capsule formed of a material selected from the group consisting of glycerin and sorbitol.

88. An encapsulation process as defined in claim 87, wherein said soft elastic capsule includes an antimicrobial selected from the group consisting of paraben and sorbic acid.

89. An encapsulation process as defined in claim 73, wherein said ingredient introduced in said primary capsule comprises a moisture content in the range of about 0% to 6% by weight.

90. An encapsulation process as defined in claim 73, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

91. An encapsulation process as defined in claim 90, wherein said lubricant is selected from the group consisting of aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.

92. An encapsulation process as defined in claim 73, wherein said oil ingredient of said secondary capsule is a pharmaceutical, wherein said active ingredient of said primary capsule is a pharmaceutical.

93. An encapsulation process as defined in claim 73, wherein said active ingredient of said secondary capsule and/or said oil ingredient of said primary capsule is a vitamin.

94. An encapsulation process for forming a multi-compartment capsule, said process comprising the steps of:

providing a capsule comprising a cap, a base configured having a longitudinally extending body including a length and at least one dividing wall formed along said length of said extending body, said dividing wall adapted to form a first receiving chamber and a second receiving chamber;

introducing only solid ingredients including at least one non-excipient ingredient in a solid state into said second receiving chamber, formulated in a manner allowing for a time-delayed dissolution and release of said solid ingredient;

introducing at least one non-excipient oil ingredient into said first receiving chamber in immediate release form, wherein said non-excipient ingredients of said second receiving chamber are different from the non-excipient ingredients of said first receiving chamber and not present in said first receiving chamber; and

positioning said cap in sealing relationship with said base,

wherein the multi-compartment capsule is a hard shell capsule.

95. An encapsulation process as defined in claim 94, further comprising the step of reducing dead volume space within said capsule.

96. An encapsulation process as defined in claim 94, wherein said cap comprises a configuration sufficient for reducing dead volume space within said capsule.

97. An encapsulation process as defined in claim 94, wherein said non-excipient ingredient in said first receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

98. An encapsulation process as defined in claim 94, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, and a suppository.

99. An encapsulation process as defined in claim 94, wherein said non-excipient ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

100. An encapsulation process as defined in claim 94, wherein said solid is selected from the group consisting of a pill, a tablet, a capsule, a powder, granulation, flakes, a troche, and a suppository.

101. An encapsulation process as defined in claim 94, wherein said non-excipient ingredient in said first receiving chamber comprises a pharmaceutical and said ingredient in said second receiving chamber is selected from the group consisting of a pharmaceutical.

102. An encapsulation process as defined in claim 94, wherein said non-excipient ingredient in said first receiving chamber comprises a pharmaceutical and said non-excipient ingredient in said second receiving chamber is selected from the group consisting of a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

103. An encapsulation process as defined in claim 94, wherein said non-excipient ingredient in said first receiving chamber comprises a pharmaceutical and said non-excipient ingredient in said second receiving chamber is also a pharmaceutical.

104. An encapsulation process as defined in claim 94, wherein said first receiving chamber comprises a time-release coating.

105. An encapsulation process as defined in claim 94 or 104, wherein said second receiving chamber comprises a time-release coating.

106. An encapsulation process as defined in claim 94, further comprising the steps of:

positioning a second dividing wall along said length of said extending body of said base, said second dividing wall adapted to form a third receiving chamber; and

introducing at least one ingredient having a physical state into said third receiving chamber.

107. An encapsulation process as defined in claim 106, wherein said ingredient introduced into said third receiving chamber is selected from the group consisting of a pharmaceutical, a biotechnical, a nutraceutical, a vitamin, a dietary supplement and a mineral.

108. An encapsulation process as defined in claim 106, wherein said ingredient introduced into said third receiving chamber is a pharmaceutical.

109. An encapsulation process as defined in claim 106 or 108, wherein all of the ingredients are pharmaceuticals.

110. An encapsulation process as defined in claim 94 or 106, wherein said primary and secondary capsules contain at least one pharmaceutically acceptable lubricant in the range of about 0% to 10% by weight.

111. An encapsulation process as defined in claim 110, wherein said lubricant is selected from the group consisting of aluminiumstearate, calciumstearate, magnesiumstearate, tinstearate, talc, sodium lauryl sulfate, lecithins, mineral oils, stearic acid, silicones and combinations thereof.