Claims
- 1. An apparatus for detecting a spectroscopic characteristic of a pharmaceutical mixture, the apparatus comprising:
a hopper for containing a mixture of two or more pharmaceutical components; a spectrometer mounted to said hopper, the spectrometer measuring a spectroscopic characteristic of the contents of said hopper, the spectrometer having associated therewith a transmitter, the transmitter operable to wirelessly transmit information indicative of the spectroscopic characteristic; and a processing device not physically coupled to said spectrometer and not physically coupled to said transmitter, said processing device wirelessly receiving the information from the transmitter.
- 2. The apparatus of claim 1, wherein said processing device is remote from said spectrometer.
- 3. The apparatus of claim 1, wherein said processing device is remote from said transmitter.
- 4. The apparatus of claim 1, wherein the processing device is operable to determine a homogeneity of the mixture from the information.
- 5. The apparatus of claim 1, wherein the processing device is operable to determine a moisture content of the mixture from the information.
- 6. The apparatus according to claim 1, wherein the apparatus includes a plurality of spectrometers mounted to said hopper, each spectrometer having associated therewith a transmitter operable to wirelessly transmit information indicative of the spectroscopic characteristic, and wherein the processing device wirelessly receives information from each of the transmitters.
- 7. The apparatus according to claim 1,
wherein the hopper includes an input for receiving the mixture, and output for dispensing the mixture, and wherein the mixture follows a transmission path between the input and the output, and wherein the spectrometers are spaced apart along the transmission path.
- 8. The apparatus according to claim 1,
wherein the hopper includes an input for receiving the mixture, and output for dispensing the mixture, and wherein the mixture follows a transmission path between the input and the output, and wherein the spectrometers are spaced apart along a plane perpendicular to the transmission path.
- 9. An apparatus for detecting the homogeneity of a pharmaceutical mixture, the apparatus comprising:
a hopper for containing a mixture of two or more pharmaceutical components, said hopper being situated within a production line of preparation of a pharmaceutical dosage form from said mixture; a spectrometer mounted to said hopper, the spectrometer measuring spectroscopic characteristics of the contents of said hopper; and a processing device not physically coupled to said spectrometer, said processing device being adapted to analyze information regarding said spectroscopic characteristics of said hopper contents and derive therefrom information regarding the homogeneity of said mixture of pharmaceutical components; wherein said spectrometer measures spectroscopic characteristics of the contents of said hopper and wirelessly sends information regarding said spectroscopic characteristics to said processing device, and said processing device derives, from said spectroscopic information, information regarding the homogeneity of said mixture of pharmaceutical components.
- 10. The apparatus of claim 9, wherein said processing device is remote from said spectrometer.
- 11. The apparatus of claim 9, wherein said processing device is remote from said transmitter.
- 12. The apparatus of claim 9, wherein said device for measuring spectroscopic characteristics comprises a transmitter coupled thereto for wirelessly sending said information regarding said spectroscopic characteristics, and wherein said processing device comprises a receiver coupled thereto for wirelessly receiving said information regarding said spectroscopic characteristics.
- 13. The apparatus of claim 12, wherein said information regarding said spectroscopic characteristics is converted to digital signals prior to being wirelessly sent to said processing device.
- 14. The apparatus of claim 12, further comprising a display device coupled to said processing device for display of said information regarding the homogeneity of said mixture of pharmaceutical components.
- 15. The apparatus of claim 9, wherein said hopper comprises an aperture, and wherein said measuring device is mounted to said hopper adjacent said aperture.
- 16. The apparatus of claim 9, wherein said spectrometer comprises a light source for irradiating said contents of said hopper and at least one detector for detecting radiation reflected off, or transmitted through said mixture.
- 17. The apparatus of claim 16, wherein said at least one detector is on a side of said hopper proximate to said light source for detecting Light reflected off said mixture.
- 18. The apparatus of claim 16, wherein said at least one detector is on a side of said hopper remote from said light source for detecting light transmitted through said mixture.
- 19. The apparatus of claim 16, wherein said light source emits radiation in multiple wavelengths, said apparatus further comprising a filter for restricting passage of light through said filter in only a specific predetermined range of wavelengths.
- 20. The apparatus of claim 19, wherein said filter is situated between said light source and said mixture, such that said filtering means allows passage of light in only a specific predetermined range of wavelengths to pass to said mixture.
- 21. The apparatus of claim 19, wherein said filter is situated between said mixture and said at least one detector, such that said filter allows passage of only a specific predetermined range of wavelengths reflected off or transmitted through said mixture to pass to said at least one detector.
- 22. The apparatus of claim 19, wherein said filter is at least one linear variable filter.
- 23. The apparatus of claim 22, further comprising a solid state translation device operatively connected to said at least one linear variable filter and configured for moving said at least one linear variable filter.
- 24. The apparatus of claim 23., wherein said at least one detector comprises a plurality of detectors.
- 25. The apparatus of claim 23, wherein said solid state translation device is a piezoelectric bimorph.
- 26. The apparatus of claim 25, further comprising a lever device coupling said piezoelectric bimorph to said at least one linear variable filter and configured for amplifying a movement of said at least one linear variable filter relative to a movement of said piezoelectric bimorph.
- 27. The apparatus of claim 22, wherein said detector is at least one array detector.
- 28. The apparatus of claim 22, wherein said detector is at least one diode.
- 29. The apparatus of claim 19, wherein the filter is a bandpass filter.
- 30. The apparatus of claim 29, wherein the filter includes a plurality of bandpass filters.
- 31. The apparatus of claim 19, wherein said filter is a grating.
- 32. The apparatus of claim 19, wherein said grating is a diffraction grating.
- 33. The apparatus of claim 16, wherein said light source emits light in only a specific predetermined range of wavelengths, and wherein said at least one detector detects light reflected off or transmitted through said mixture in said specific predetermined range of wavelengths.
- 34. The apparatus of claim 16, wherein said light source emits light in multiple wavelengths, and wherein each of said at least one detector detects light reflected off or transmitted through said mixture in only a specific predetermined range of wavelengths.
- 35. The apparatus of claim 9, wherein said measuring device sends information regarding said spectroscopic characteristics to said processing device through infrared radiation or near infrared radiation.
- 36. An apparatus for determining spectroscopic characteristics of one or more components, comprising:
a hopper for adding one or more components to a tableting/encapsulation machine, the hopper having an aperture fitted with a window, one side of the window forming a portion of an interior surface of the hopper; a light source for transmitting a beam of light, the beam impinging the window, and then a detector, the detector optically connected to the beam of light and converting the beam of light into a digital signal; a transmitter for receiving the digital signal from the detector and sending the digital signal to a processor via a wireless link; and a processor for analyzing a spectroscopic characteristic of the one or more components based on the digital signal.
- 37. The apparatus of claim 36, wherein said transmitter is coupled to said processor, the transmitter receiving the profile from the processor and transmitting the spectroscopic characteristics as a second digital signal to a receiver via a wireless link.
- 38. The apparatus of claim 36, wherein the one or more components form a mixture, and wherein the spectroscopic characteristic is indicative of the homogeneity of the mixture.
- 39. The apparatus of claim 36, wherein the spectroscopic characteristic is indicative of a moisture content of the one or more components.
- 40. A method for determining the homogeneity of a pharmaceutical mixture in a hopper., comprising the steps of:
feeding a mixture of at least two pharmaceutical substances into a hopper, the hopper having a window, one face of the window forming a portion of an interior surface of the hopper and the window optically connected to a light source; projecting light from said light source onto said mixture; receiving information from a detector that is optically connected to the window as the pharmaceutical mixture is being mixed; and analyzing the information from the detector; and determining the homogeneity of the pharmaceutical mixture.
- 41. The apparatus of claim 9, wherein the mixture is a granulation.
- 42. The apparatus of claim 9, wherein the mixture is a dry blend.
- 43. The method of claim 40, wherein the mixture is a granulation.
- 44. The method of claim 40, wherein the mixture is a dry blend.
- 45. A method for detecting a spectroscopic characteristic of a pharmaceutical mixture in a hopper, comprising the steps of:
feeding a mixture of one or more pharmaceutical components into a hopper; measuring a spectroscopic characteristic of the contents of said hopper with a spectrometer mounted to said hopper, transmitting the spectroscopic characteristic to a processing device via a transmitter, the transmitter associated with the spectrometer and operable to wirelessly transmit information indicative of the spectroscopic characteristic.
- 46. The method of claim 45 further comprising the step of receiving, via a wireless connection, the spectroscopic characteristic at a processing device, the processing device not physically coupled to said spectrometer and not physically coupled to said transmitter.
- 47. The method of claim 46, wherein said processing device is remote from said spectrometer.
- 48. The method of claim 46, wherein said processing device is remote from said transmitter.
- 49. The method of claim 46, further comprising the step of determining a homogeneity of the mixture from the spectroscopic characteristic.
- 50. The method of claim 46, further comprising the step of determining a moisture content of the mixture from the spectroscopic characteristic
- 51. The method of claim 46, wherein the spectrometer further comprises a plurality of spectrometers; and wherein the transmitter further comprises a plurality of transmitters each transmitter associated with at least on one of the spectrometers; and wherein the step of receiving further comprises receiving a plurality of spectroscopic characteristics from each of the transmitters.
- 52. The method of claim 51, wherein the hopper includes an input for receiving the mixture, and output for dispensing the mixture; wherein the mixture follows a transmission path between the input and the output; and wherein the spectrometers are spaced apart along the transmission path.
- 53. The method of claim 51, wherein the hopper includes an input for receiving the mixture, and an output for dispensing the mixture; wherein the mixture follows a transmission path between the input and the output; and wherein the spectrometers are spaced apart along a plane perpendicular to the transmission path.
- 54. The method of claim 45, further comprising the step of pre-treating, with a pre-treatment technique, the spectroscopic characteristic.
- 55. The method of claim 54, wherein pre-treatment technique is selected from the group consisting of: a baseline correction, a normalization of the spectral data, a first derivative on the spectral data, a second derivative on the spectral data, a multiplicative scatter correction on the spectral data, a smoothing transform on the spectral data, a Savitsky-Golay first derivative, a Savitsky-Golay second derivative, a mean-centering, a Kubelka-Munk transform, and a conversion from reflectance/transmittance to absorbence.
- 56. The method of claim 45, further comprising applying a data reduction technique to the spectroscopic characteristic.
- 57. The method of claim 45, wherein the data reduction technique is selected from the group consisting of: partial least squares, a neural net, a classical least squares, a principal component regression, and a multiple linear regression.
- 58. The method of claim 55, further comprising applying a data reduction technique to the pre-treated spectroscopic characteristic.
- 59. The method of claim 58, wherein the data reduction technique is selected from the group consisting of a partial least squares, a neural net, a classical least squares, a principal component regression, and a multiple linear regression.
- 60. The apparatus of claim 9, further comprising a tableting press for tableting the mixture, the tableting press located downstream from the hopper and coupled to an output of the hopper.
- 61. The apparatus of claim 9, further comprising a mixer for mixing two or more pharmaceutical compositions, the mixer located upstream from the hopper and coupled to an input of the hopper.
- 62. The apparatus of claim 9, further comprising an encapsulating press for encapsulating mixture, the encapsulating press located downstream from the hopper and coupled to an output of the hopper.
- 63. The apparatus of claim 60, wherein the hopper is integrated into the tableting press.
- 64. The apparatus of claim 61, wherein the mixer is integrated into the hopper.
- 65. The apparatus of claim 62, wherein the hopper is integrated into the encapsulating press.
- 66. The apparatus of claim 16, wherein said light source is capable of illuminating a plurality of positions in a neck region of said hopper
- 67. The apparatus of claim 66, wherein said light source includes a fiber optic bundle for illuminating said plurality of positions.
- 68. The apparatus of claim 67, wherein said light source includes a plurality of near-infrared light emitting diodes, each for illuminating a respective position of the plurality of positions.
- 69. The apparatus of claim 67, wherein said at least one detector is disposed in said neck region for detecting light reflected off or transmitted through said mixture.
- 70. The apparatus of claim 69, wherein each of said at least one detector is configured for detecting a respective wavelength of light.
- 71. The apparatus of claim 67, further comprising:
a plurality of optical fibers spaced apart on the neck for receiving radiation reflected off or transmitted through said mixture and delivering said respective radiation to said at least one detector; and a switching device coupled to each of the plurality of optical fibers and to the at least one detector, the switching device configured to connect one of said respective optical fiber at a time to said at least one detector.
- 72. The apparatus of claim 1, further comprising at least one second spectrometer and wherein said spectrometer and each of said at least one second spectrometer include a respective light source-for irradiating a portion of said contents of said hopper at a respective position.
- 73. The apparatus of claim 72, wherein said spectrometer and each of said at least one second spectrometer are disposed at a respective position on said hopper.
- 74. The apparatus of claim 73, wherein each of said respective position is at a respective longitudinal level of said hopper so as to enable a determination of stratification in said mixture.
- 75. The apparatus of claim 72, wherein each said light source includes a respective individual optical fiber of a common fiber optic bundle light source.
- 76. The apparatus of claim 75, further comprising a filter device for restricting passage of light from the common fiber optic bundle light source through said filter to a predetermined wavelength or range of wavelengths.
- 77. The apparatus of claim 72, wherein said spectrometer and each of said at least one second spectrometer include a respective detector for detecting respective radiation reflected off or transmitted through said mixture.
- 78. The apparatus of claim 72, wherein each of said respective light source are disposed at a respective position in a neck region of said hopper.
- 79. The apparatus of claim 78, wherein each of said respective light source includes a near-infrared light emitting diode.
- 80. The apparatus of claim 78, further comprising a plurality of detectors disposed in said neck region for detecting light reflected off or transmitted through said mixture.
- 81. The apparatus of claim 80, wherein the plurality of detectors are each configured for detecting a respective wavelength of light.
Parent Case Info
[0001] This application claims priority from U.S. Provisional Application No. 60/369,823 filed on Apr. 4, 2002, the entire disclosure of which is hereby incorporated by reference.
Provisional Applications (1)
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Number |
Date |
Country |
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60369823 |
Apr 2002 |
US |