Method for producing a pharmaceutical product

• US 20060002594A1
• Filed: 06/09/2005
• Published: 01/05/2006
• Est. Priority Date: 06/09/2004
• Status: Abandoned Application

• Current Assignee: GlaxoSmithKline LLC (GSK plc)
• Original Assignee: GlaxoSmithKline LLC (GSK plc)
• Inventors: Clarke, Allan J., Fiesser, Frederick H., Doughty, David George, Wagner, David S.
• Application Number:
  US11/149,022
• Publication Number:
  US 20060002594A1
• Time in Patent Office: Days
• US Class Current: 382/120
• CPC Class Codes: G01N 2021/6417 Spectrofluorimetric devices
• CPC Class Codes: G01N 2021/6423 Spectral mapping, video display
• CPC Class Codes: G01N 2030/8886 Analysis of industrial production processes
• CPC Class Codes: G01N 21/253 for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/31 Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry G01N21/72 takes precedence
• CPC Class Codes: G01N 21/3563 for analysing solids; Preparation of samples therefor
• CPC Class Codes: G01N 21/3581 using far infrared light; using Terahertz radiation
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/6402 Atomic fluorescence; Laser induced fluorescence
• CPC Class Codes: G01N 21/6456 Spatial resolved fluorescence measurements; Imaging
• CPC Class Codes: G01N 21/65 Raman scattering
• CPC Class Codes: G01N 21/9508 Capsules; Tablets
• CPC Class Codes: G01N 30/88 Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86

Abstract

A method is provided for producing pharmaceutical and pharmaceutical-like product. The method provides real-time monitoring of the pharmaceutical product and can provide real-time control. The method monitors the dosage both before and after it has been added to a carrier substrate. The method can provide monitoring of each pharmaceutical product that is processed.

Claims

1. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to each of the carrier substrates by the pharmaceutical machine, wherein said dose confirmation system performs spectroscopy on each of the carrier substrates to determine said amount of the dosage of active agent.

2. The system of claim 1, wherein said dose confirmation system performs said spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

3. The system of claim 1, wherein said spectroscopy is taken from the group consisting essentially of near infrared, mid-infrared, ultraviolet/visible, fluorescence, laser induced fluorescence, Raman, terahertz, photoluminescence, and any combinations thereof.

4. The system of claim 1, further comprising a focal plane array detector for performing chemical imaging using said spectroscopy.

5. The system of claim 1, wherein said dose confirmation system has a camera for obtaining an image of each of the carrier substrates, and wherein said dose confirmation system determines a position of the dosage on each of the carrier substrates based on said image.

6. The system of claim 5, wherein said camera obtains said image as each of said carrier substrates continues to move along the pharmaceutical machine.

7. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product each having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs near infrared spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

8. The system of claim 7, wherein said dose confirmation system performs said near infrared spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

9. The system of claim 7, further comprising a focal plane array detector for performing chemical imaging using said near infrared spectroscopy.

10. The system of claim 7, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

11. The system of claim 10, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

12. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs mid-infrared spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

13. The system of claim 12, wherein said dose confirmation system performs said mid-infrared spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

14. The system of claim 12, further comprising a focal plane array detector for performing chemical imaging using said mid-infrared spectroscopy.

15. The system of claim 12, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

16. The system of claim 15, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

17. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs UV or visible spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

18. The system of claim 17, wherein said dose confirmation system performs said UV or visible spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

19. The system of claim 17, further comprising a focal plane array detector for performing chemical imaging using said UV or visible spectroscopy.

20. The system of claim 17, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

21. The system of claim 20, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

22. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs fluorescence spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

23. The system of claim 22, wherein said dose confirmation system performs said fluorescence spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

24. The system of claim 22, further comprising a focal plane array detector for performing chemical imaging using said fluorescence spectroscopy.

25. The system of claim 22, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

26. The system of claim 25, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

27. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs laser induced fluorescence spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

28. The system of claim 27, wherein said dose confirmation system performs said laser induced fluorescence spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

29. The system of claim 27, further comprising a focal plane array detector for performing chemical imaging using said laser induced fluorescence spectroscopy.

30. The system of claim 27, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

31. The system of claim 30, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

32. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs Raman spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

33. The system of claim 32, wherein said dose confirmation system performs said Raman spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

34. The system of claim 32, further comprising a focal plane array detector for performing chemical imaging using said Raman spectroscopy.

35. The system of claim 32, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

36. The system of claim 35, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

37. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs terahertz spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

38. The system of claim 37, wherein said dose confirmation system performs said terahertz spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

39. The system of claim 37, further comprising a focal plane array detector for performing chemical imaging using said terahertz spectroscopy.

40. The system of claim 37, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

41. The system of claim 40, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

42. A monitoring system for a pharmaceutical machine which produces one or more pharmaceutical product, each pharmaceutical product having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to the pharmaceutical product, wherein said dose confirmation system performs photoluminescence spectroscopy on at least one pharmaceutical product to determine said amount of the dosage of active agent.

43. The system of claim 42, wherein said dose confirmation system performs said photoluminescence spectroscopy while each of the carrier substrates continues to move along the pharmaceutical machine.

44. The system of claim 42, further comprising a focal plane array detector for performing chemical imaging using said photoluminescence spectroscopy.

45. The system of claim 42, wherein said dose confirmation system has a camera for obtaining an image of said at least one pharmaceutical product, and wherein said dose confirmation system determines a position of the dosage based on said image.

46. The system of claim 45, wherein said camera obtains said image as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

47. A method of providing quality control for a pharmaceutical machine comprising:

performing spectroscopy on each pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to each of a plurality of carrier substrates by the pharmaceutical machine based on said spectroscopy.

48. The method of claim 47, wherein said spectroscopy is taken from the group consisting essentially of near infrared, mid-infrared, ultraviolet/visible, fluorescence, laser induced fluorescence, Raman, terahertz, photoluminescence, and any combinations thereof.

49. The method of claim 47, wherein said spectroscopy is performed while each of said plurality of carrier substrates continues to move along the pharmaceutical machine.

50. The method of claim 47, further comprising performing chemical imaging using said spectroscopy with a focal plane array detector.

51. The method of claim 50, further comprising obtaining an image of each of said plurality of carrier substrates and determining a position of said dosage of active agent on each of said plurality of carrier substrates based on said image.

52. The method of claim 51, wherein said image is obtained as each of said plurality of carrier substrates continues to move along the pharmaceutical machine.

53. A method of providing quality control for a pharmaceutical machine comprising:

performing near infrared spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said near infrared spectroscopy.

54. The method of claim 53, wherein said near infrared spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

55. The method of claim 53, further comprising performing chemical imaging using said near infrared spectroscopy with a focal plane array detector.

56. The method of claim 53, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

57. The method of claim 56, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

58. A method of providing quality control for a pharmaceutical machine comprising:

performing mid-infrared spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said mid-infrared spectroscopy.

59. The method of claim 58, wherein said mid-infrared spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

60. The method of claim 58, further comprising performing chemical imaging using said mid-infrared spectroscopy with a focal plane array detector.

61. The method of claim 58, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

62. The method of claim 61, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

63. A method of providing quality control for a pharmaceutical machine comprising:

performing UV or visible spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said UV or visible spectroscopy.

64. The method of claim 63, wherein said UV or visible spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

65. The method of claim 63, further comprising performing chemical imaging using said UV or visible spectroscopy with a focal plane array detector.

66. The method of claim 63, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

67. The method of claim 66, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

68. A method of providing quality control for a pharmaceutical machine comprising:

performing fluorescence spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said fluorescence spectroscopy.

69. The method of claim 68, wherein said fluorescence spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

70. The method of claim 68, further comprising performing chemical imaging using said fluorescence spectroscopy with a focal plane array detector.

71. The method of claim 70, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

72. The method of claim 71, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

73. A method of providing quality control for a pharmaceutical machine comprising:

performing laser induced fluorescence spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said laser induced fluorescence spectroscopy.

74. The method of claim 73, wherein said laser induced fluorescence spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

75. The method of claim 73, further comprising performing chemical imaging using said laser induced fluorescence spectroscopy with a focal plane array detector.

76. The method of claim 73, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

77. The method of claim 76, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

78. A method of providing quality control for a pharmaceutical machine comprising:

performing Raman spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said Raman spectroscopy.

79. The method of claim 78, wherein said Raman spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

80. The method of claim 78, further comprising performing chemical imaging using said Raman spectroscopy with a focal plane array detector.

81. The method of claim 78, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

82. The method of claim 81, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

83. A method of providing quality control for a pharmaceutical machine comprising:

performing terahertz spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said terahertz spectroscopy.

84. The method of claim 83, wherein said terahertz spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

85. The method of claim 83, further comprising performing chemical imaging using said terahertz spectroscopy with a focal plane array detector.

86. The method of claim 85, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one pharmaceutical product based on said image.

87. The method of claim 86, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

88. A method of providing quality control for a pharmaceutical machine comprising:

performing photoluminescence spectroscopy on at least one pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to said at least one pharmaceutical product by the pharmaceutical machine based on said photoluminescence spectroscopy.

89. The method of claim 88, wherein said photoluminescence spectroscopy is performed while said at least one pharmaceutical product continues to move along the pharmaceutical machine.

90. The method of claim 88, further comprising performing chemical imaging using said photoluminescence spectroscopy with a focal plane array detector.

91. The method of claim 88, further comprising obtaining an image of said at least one pharmaceutical product and determining a position of said dosage of active agent on said at least one of said pharmaceutical product based on said image.

92. The method of claim 91, wherein said image is obtained as said at least one pharmaceutical product continues to move along the pharmaceutical machine.

93. A monitoring system for a pharmaceutical machine that produces pharmaceutical product, the pharmaceutical product each having a carrier substrate and a dosage of active agent, the system comprising:

a dose confirmation system operably connected to the pharmaceutical machine, said dose confirmation system determining an amount of the dosage of active agent that has been added to each of the carrier substrates by the pharmaceutical machine, wherein said dose confirmation system performs optical profilometry on each of the carrier substrates to determine said amount of the dosage of active agent.

94. The system of claim 93, wherein said dose confirmation system performs said optical profilometry while each of the carrier substrates continues to move along the pharmaceutical machine.

95. A method of providing quality control for a pharmaceutical machine comprising:

performing optical profilometry on each pharmaceutical product that is processed by the pharmaceutical machine; and

determining an amount of a dosage of active agent that has been added to each of a plurality of carrier substrates by the pharmaceutical machine based on said optical profilometry.

96. The method of claim 95, wherein said optical profilometry is performed while each of said plurality of carrier substrates continues to move along the pharmaceutical machine.