MULTI-COMPONENT PHARMACEUTICAL DOSAGE FORM

• US 20100119597A1
• Filed: 01/18/2010
• Published: 05/13/2010
• Est. Priority Date: 07/30/1999
• Status: Active Grant

• Current Assignee: Capsugel Belgium NV (Lonza Group AG)
• Original Assignee: Capsugel Belgium NV (Lonza Group AG)
• Inventors: Clarke, Allan J., Kift, Ron, Lightfoot, Donald, Harris, Geoffrey Arthur, Ofsharick, Thomas, Fonio, Teodoro, Szymczack, Margaret Mary, McGinley, Shane
• Granted Patent: US 8,440,224 B2
• Time in Patent Office: Days
• US Class Current: 424/454
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• 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: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

A multi-component pharmaceutical dosage form comprising a plurality of drug substance—containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.

Claims

1. to 37. (canceled)

38. A multi-component dosage form comprising:

a plurality of sub-units disposed in end-to-end relationship, each of the plurality of sub-units selected from a group consisting of (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer;

a first joint formed between a first sub-unit of the plurality of sub-units and a second sub-unit of the plurality of sub-units, the first joint comprising a plug formed as a unitary part of the first sub-unit and a socket formed as a unitary part of the second sub-unit; and

a second joint formed between the second sub-unit and a third sub-unit of the plurality of sub-units, the second joint comprising a plug formed as a unitary part of the second sub-unit and a socket formed as a unitary part of the third sub-unit.

39. The multi-component dosage form according to claim 38, wherein the plug formed as a unitary part of the first sub-unit is disposed adjacent a first axial end of the first sub-unit and the first sub-unit further includes a socket formed as a unitary part of the first-sub-unit disposed adjacent a second axial end of the first sub-unit.

40. The multi-component dosage form according to claim 38, wherein the second sub-unit is a solid sub-unit comprising a matrix of a polymer.

41. The multi-component dosage form according to claim 40, wherein the third sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein and containing a first drug-substance.

42. The multi-component dosage form according to claim 41, wherein the first sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein and containing a second drug-substance.

43. The multi-component dosage form according to claim 42, wherein the first drug-substance differs in composition and/or release characteristics from the second drug-substance.

44. The multi-component dosage form according to claim 38, further including a third joint formed between the first sub-unit and a fourth sub-unit of the plurality of sub-units, the third joint comprising a socket formed as a unitary part of the first sub-unit and a plug formed as a unitary part of the fourth sub-unit.

45. The multi-component dosage form according to claim 44, wherein:

the first sub-unit is a capsule compartment sub-unit comprising a first cavity including an open end and a closed end and the fourth sub-unit is a capsule compartment sub-unit comprising a second cavity including an open end and a closed end; and

the open end of the first cavity of the first sub-unit is disposed adjacent the open end of the second cavity of the fourth sub-unit and the first and second cavities form a combined cavity configured to contain a drug-substance therein.

46. The multi-component dosage form according to claim 45, wherein the second and third sub-units are capsule compartment sub-units respectively comprising at least one cavity formed therein and containing a drug-substance.

47. The multi-component dosage form according to claim 45, wherein the second sub-unit is a solid sub-unit comprising a matrix of a polymer and the third sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein and containing a drug-substance.

48. The multi-component dosage form according to claim 44, wherein the fourth sub-unit is a solid sub-unit comprising a matrix of a polymer.

49. The multi-component dosage form according to claim 48, wherein the third sub-unit is a solid sub-unit comprising a matrix of a polymer.

50. The multi-component dosage form according to claim 49, wherein the second sub-unit is a capsule compartment sub-unit comprising a cavity formed therein and containing a drug-substance and the first sub-unit is a solid sub-unit comprising a matrix of a polymer.

51. The multi-component dosage form according to claim 40, wherein the second sub-unit comprises a through-hole formed therein extending from a first axial end of the second sub-unit to a second axial end of the second sub-unit.

52. A multi-component dosage form comprising:

a plurality of sub-units disposed in end-to-end relationship, each of the plurality of sub-units selected from a group consisting of (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units respectively comprising a matrix of a polymer;

a first joint formed between a first sub-unit of the plurality of sub-units and a second sub-unit of the plurality of sub-units, the first joint comprising a first socket formed as a unitary part of the first sub-unit and a first plug formed as a unitary part of the second sub-unit; and

a second joint formed between the second sub-unit and a third sub-unit of the plurality of sub-units, the second joint comprising a second plug formed as a unitary part of the second sub-unit and a second socket formed as a unitary part of the third sub-unit;

wherein the second sub-unit includes a first section having a closed end and an open end, a second section having a closed end and an open end, and a sub-unit joint formed between the first and second sections of the second sub-unit adjacent the respective open ends.

53. The multi-component dosage form according to claim 52, wherein the first plug is disposed adjacent the closed end of the first section of the second sub-unit and the second plug is disposed adjacent the closed end of the second section of the second sub-unit.

54. The multi-component dosage form according to claim 52, wherein the sub-unit joint comprises a plug and socket joint.

55. The multi-component dosage form according to claim 54, wherein the plug and socket joint comprises interlocking tenon parts.

56. The multi-component dosage form according to claim 52, wherein the second sub-unit is a capsule compartment sub-unit having a first cavity formed therein and defined by the first and second sections of the second sub-unit, the first cavity containing a first drug-substance.

57. The multi-component dosage form according to claim 56, wherein the first sub-unit is a capsule compartment sub-unit having a second cavity formed therein and containing a second drug-substance, the first drug-substance differing in composition and/or release characteristics from the second drug-substance.

58. The multi-component dosage form according to claim 57, wherein the third sub-unit is a capsule compartment sub-unit having a third cavity formed therein and containing a third drug-substance, wherein the third drug-substance differs in composition and/or release characteristics from the first drug-substance and/or the second drug-substance.

59. The multi-component dosage form according to claim 57, wherein the third sub-unit is a solid sub-unit comprising a matrix of a polymer.

60. The multi-component dosage form according to claim 52, wherein the first and/or second joints further comprise a weld.

61. A multi-component dosage form comprising:

first and second sub-units disposed in end-to-end relationship along a line that defines an axial direction, the first and second sub-units selected from a group consisting of (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer; and

a first joint formed between the first and second sub-units comprising a first plug formed as a unitary part of the first sub-unit and a first socket formed as a unitary part of the second sub-unit;

wherein the first sub-unit includes an outer wall having an outer diameter that is radially larger than an outer diameter of the first plug and the second sub-unit includes an outer wall having an outer diameter that is radially larger than an outer diameter of the first socket; and

wherein the first joint interconnects the first and second sub-units together such that the relative axial position between the first and second sub-units is solely deliminated by engaging outer wall axial end parts of the respective first and second sub-units.

62. The multi-component dosage form according to claim 61, wherein the first joint further comprises a ridge and groove connection configured to lock the first and second sub-units together as the first and second sub-units are forced together against their natural resiliency.

63. The multi-component dosage form according to claim 61, wherein the first joint further includes a friction fit between the first and second sub-units.

64. The multi-component dosage form according to claim 61, wherein the first joint further includes a snap fit between the first and second sub-units.

65. The multi-component dosage form according to claim 61, wherein the first joint further includes a screw fit between the first and second sub-units.

66. The multi-component dosage form according to claim 61, wherein:

the first plug is substantially cylindrical;

the first socket is substantially cylindrical; and

an outer wall dimension of the first plug is greater than an inner wall dimension of the first socket.

67. The multi-component dosage form according to claim 61, further including:

a third sub-unit disposed in end-to-end relationship with the first and second sub-units along the line that defines the axial direction, the third sub-unit selected from a group comprising (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer; and

a second joint formed between the first and third sub-units comprising a second plug formed as a unitary part of the third sub-unit and a second socket formed as a unitary part of the first sub-unit;

wherein the outer diameter of the outer wall of the first sub-unit is radially larger than an outer diameter of the second socket and the third sub-unit includes an outer wall having an outer diameter that is radially larger than an outer diameter of the second plug; and

wherein the second joint interconnects the first and third sub-units together such that the relative axial position between the first and third sub-units is solely deliminated by engaging outer wall axial end parts of the respective first and third sub-units.

68. The multi-component dosage form according to claim 67, wherein the first plug is formed adjacent a first axial end of the first sub-unit and the second socket is formed adjacent a second axial end of the first sub-unit.

69. The multi-component dosage form according to claim 61, further including:

a third sub-unit disposed in end-to-end relationship with the first and second sub-units along the line that defines the axial direction, the third sub-unit selected from a group comprising (i) capsule compartment sub-units respectively comprising at least one cavity formed therein and being configured to release a drug-substance contained within the at least one cavity into a gastro-intestinal environment and (ii) solid sub-units comprising a matrix of a polymer; and

a second joint formed between the first and third sub-units comprising a second plug formed as a unitary part of the first sub-unit and a second socket formed as a unitary part of the third sub-unit;

wherein the outer diameter of the outer wall of the first sub-unit is radially larger than an outer diameter of the second plug and the third sub-unit includes an outer wall having an outer diameter that is radially larger than an outer diameter of the second socket; and

wherein the second joint interconnects the first and third sub-units together such that the relative axial position between the first and third sub-units is solely deliminated by engaging outer wall axial end parts of the respective first and third sub-units.

70. The multi-component dosage form according to claim 69, wherein the first plug is formed adjacent a first axial end of the first sub-unit and the second plug is formed adjacent a second axial end of the first sub-unit.

71. The multi-component dosage form according to claim 69, wherein the first sub-unit is a solid sub-unit comprising a matrix of a polymer.

72. The multi-component dosage form according to claim 71, wherein:

the second sub-unit is capsule compartment sub-unit comprising at least one cavity formed therein containing a first drug-substance; and

the third sub-unit is a capsule compartment sub-unit comprising at least one cavity formed therein containing a second drug-substance.

73. The multi-component dosage form according to claim 72, wherein the first drug-substance differs in composition and/or release characteristics from the second drug-substance.

74. The multi-component dosage form according to claim 72, wherein the second sub-unit is configured to release the first drug-substance into the gastro-intestinal environment according to a first release characteristic and the third sub-unit is configured to release the second drug-substance into the gastro-intestinal environment according to a second release characteristic different from the first release characteristic.

75. The multi-component dosage form according to claim 72, wherein first sub-unit is a solid sub-unit comprising a matrix of a polymer and at least one drug-substance.