Spectroscopic pharmacy verification and inspection system

• US 20050288906A1
• Filed: 06/29/2004
• Published: 12/29/2005
• Est. Priority Date: 06/29/2004
• Status: Abandoned Application

• Current Assignee: Duquesne University of the Holy Spirit
• Original Assignee: Duquesne University of the Holy Spirit
• Inventors: Anderson, Carl A., Drennen, James K. III
• Application Number:
  US10/879,388
• Publication Number:
  US 20050288906A1
• Time in Patent Office: Days
• US Class Current: 702/189
• CPC Class Codes: G01N 21/3563 for analysing solids; Preparation of samples therefor
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 21/9508 Capsules; Tablets
• CPC Class Codes: G01N 2201/129 Using chemometrical methods

Abstract

An apparatus for verifying the identity, quality and/or quantity of each product unit, such as, for example, a dosage unit of a pharmaceutical dispensed into a container, which includes an analyzing device, such as a spectrometer, and a control device for controlling the analyzing device. The invention is integrated with background art automated counting and dispensing systems such that product units may be individually analyzed and verified prior to being placed into the container.

Claims

1. A method for verifying the identity of a product unit comprising the steps of:

analyzing each product unit to obtain a signature;

comparing said signature from each product unit to a known signature; and

indicating if the signature of any analyzed product unit did not match said known signature.

2. The method of claim 1 wherein said signature for each product unit is a spectral signature obtained by analysis of said product unit with a spectrometer.

3. The method of claim 2 wherein said spectrometer provides a vibrational or electronic spectrum of said analyzed product units.

4. The method of claim 3 wherein said product unit is a pharmaceutical dosage unit.

5. The method of claim 4 wherein said pharmaceutical dosage unit is dispensed into a prescription vial after said dosage unit is analyzed by said spectrometer.

6. The method of claim 1 wherein said known signature is a reference mathematical model.

7. The method of claim 6 wherein said mathematical model is based on the sampling of a plurality of product units having known variations.

8. The method of claim 7 wherein said known variations are due to the manufacturing process of said product unit.

9. The method of claim 8 wherein said comparing step utilizes a principle component analysis which takes into account spectral variance.

10. The method of claim 1 further comprising the step of providing a database of known signatures and a product quality model for each type of product unit.

11. An apparatus for dispensing one or more product units into a container comprising:

a product unit counting device;

an analyzing device integrated with said product unit counting device, such that each product unit dispensed from said product unit counting device is analyzed by said analyzing device; and

a control device for controlling said analyzing device.

12. The apparatus of claim 11 wherein said control device performs the functions of:

sending a signal to said analyzing device to commence analysis of said product unit;

receiving data from said analyzing device representing an analyzed signature associated with said product unit; and

sending a signal to said analyzing device to cease analysis of said product unit.

13. The apparatus of claim 12 wherein said control device performs the functions of:

receiving information regarding the expected identity of said product units;

retrieving a signature known to be associated with said identified product units;

receiving an analyzed signature obtained from each of said product units;

comparing said known signature with each of said analyzed signatures to verify a match therebetween within a certain degree of confidence; and

indicating if the analyzed signature for any of said product units did not match said known signature.

14. The apparatus of claim 13 further comprising a database from which said signature known to be associated with said identified product units is retrieved.

15. The apparatus of claim 14 wherein said analysis device is a spectrometer for obtaining vibrational or electronic spectra and wherein said analyzed signature and said known signature are spectra.

16. The apparatus of claim 15 wherein said known signature is a reference mathematical model of a plurality of spectra from a plurality of samples of said product unit.

17. The apparatus of claim 16 wherein said mathematical model is based on the sampling of a plurality of product unit samples having known variations.

18. The apparatus of claim 17 wherein said known variations are due to the variations in the manufacturing process of said product unit.

19. The apparatus of claim 18 wherein said comparing step utilizes a principle component analysis which takes into account spectral variance.

20. The apparatus of claim 11 further comprising a database of known signatures for each type of product unit.

21. The apparatus of claim 11 wherein said container is a prescription vial.

22. The apparatus of claim 11 wherein said product unit is a pharmaceutical dosage unit.

23. In an apparatus for counting and dispensing one or more product units into a container comprising a product unit counting device and a control therefore, an improvement comprising:

an analyzing device integrated with said product unit counting device, such that each product unit dispensed from said product unit counting device is analyzed by said analyzing device; and

a control device for controlling said analyzing device.

24. The improvement of claim 23 wherein said control device performs the functions of:

sending a signal to said analyzing device to commence analysis of said product unit;

receiving data from said analyzing device representing an analyzed signature associated with said product unit; and

sending a signal to said analyzing device to cease analysis of said product unit.

25. The improvement of claim 24 wherein said control device performs the functions of:

receiving information regarding the expected identity of said product units;

retrieving a signature known to be associated with said identified product units;

receiving an analyzed signature which is obtained from each of said product units;

comparing said known signature with each of said analyzed signatures to verify a match therebetween within a certain degree of confidence; and

indicating if the analyzed signature for any of said product units did not match said known signature.

26. The improvement of claim 25 further comprising a database from which said signature known to be associated with said identified product units is retrieved.

27. The improvement of claim 26 wherein said analyzing device is a vibrational or electronic spectrometer and wherein said analyzed signature and said known signature are spectra.

28. The improvement of claim 27 wherein said known signature is represented by a product quality model of a plurality of spectra from a plurality of samples of said product unit.

29. The improvement of claim 28 wherein said mathematical model is based on the sampling of a plurality of product unit samples having known variations.

30. The improvement of claim 29 wherein said known variations are due to the manufacturing process of said product unit.

31. The improvement of claim 30 wherein said comparing step utilizes a principle component analysis which takes into account spectral variance.

32. The improvement of claim 31 further comprising a database of known signatures for each type of product unit.

33. The improvement of claim 32 wherein said container is a prescription vial and further wherein said product unit is a pharmaceutical dosage unit.

34. A system for verifying the identify of a product unit comprising:

an analyzing device for analyzing each one of a plurality of product units to obtain a unique signature; and

a control component for controlling said analyzing device and for receiving said signature therefrom.

35. The system of claim 34 wherein said analyzing device is a spectrometer.

36. The system of claim 35 wherein said spectrometer is a vibrational or electronic spectrometer and wherein said analyzed signature is a spectrum.

37. The system of claim 34 wherein said control component is a computer having a data connection with said analyzing device.

38. The system of claim 34 further comprising an interface component.

39. The system of claim 34 further comprising a database containing known signatures for a plurality of known product units.

40. The system of claim 39 wherein said known signatures are mathematical product quality models of spectra obtained from a plurality of samples of each of said known product units having known variations.

41. The system of claim 40 wherein said control component performs a mathematical match between said analyzed signature and said known signature.

42. The system of claim 41 wherein said mathematical match utilizes a principle component analysis which takes into account spectral variance.