Interactive method of providing analysis of potency and purity of pharmaceutical compounds

• US 7,197,405 B1
• Filed: 02/04/2005
• Issued: 03/27/2007
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: DynaLabs LLC
• Original Assignee: Medpro Holdings, LLC
• Inventors: Pruett, Earl Michael, Odegard, Russell D.
• Primary Examiner(s): Barbee; Manuel L.
• Application Number:
  US11/051,419
• Time in Patent Office: 781 Days
• Field of Search: 702/22, 702/27, 702/28, 702/30, 702/32, 702/127, 250/339.07, 250/371, 250/301, 250/339.12, 250/390.07, 356/51, 356/70, 356/239.6
• US Class Current: 702/30
• CPC Class Codes: G01N 21/33 using ultraviolet light G01N21/39 takes precedence
• CPC Class Codes: G01N 21/359 using near infrared light

Abstract

A computer facilitated, interactive method of requesting an spectrographic analysis of a sample having an unknown concentration or purity, performing an energy absorbance analysis of the sample to obtain spectrographic data regarding the analysis and comparing the spectrographic data to a stored spectrographic data regarding the analyses of the samples having a predetermined concentration and purity to determine the concentration or purity of the sample having an unknown concentration or purity. The requester can electronically request the analysis and monitor the progress of the analysis. The results of the analysis are electronically transmitted to the requester in real time.

Claims

1. A method of providing a service to a requester of determining the concentration of at least one constituent in an extemporaneously compounded sample having an unknown concentration for the requester, comprising the steps of:

accepting a request from the requester for determining a concentration of at least one constituent in an extemporaneously compounded sample having at least one constituent at an unknown concentration;

performing a spectrographic analysis of a sample having the at least one constituent at at least one predetermined concentration, said spectrographic analysis providing identifying data for a range of concentrations of the at least one constituent;

storing the obtained spectrographic analysis of the sample having the at least one constituent at at least one predetermined concentration in a retrievable form in a database comprising identifying data of ranges of concentrations of at least one constituent;

performing a spectrographic analysis of the extemporaneously compounded sample having at least one constituent at an unknown concentration, said spectrographic analysis providing identifying data for at least one concentration of the at least one constituent;

comparing the spectrographic analysis of the extemporaneously compounded sample having at least one constituent at an unknown concentration to the spectrographic analysis of the sample having the at least one constituent at at least one predetermined concentration stored in a retrievable form;

mathematically calculating a concentration of the at least one constituent in the extemporaneously compounded sample having at least one constituent at an unknown concentration from the comparison of the recited spectrographic analyses data; and

transmitting the calculated concentration of the at least one constituent of the extemporaneously compounded sample having at least one constituent at an unknown concentration to the requester.

2. The method of of claim 1 further comprising the step of compiling a database of determined spectrographic analyses of samples having at least one known constituent at at least one known concentration.

3. The method of claim 2 wherein each recited spectrographic analysis expands the database of determined spectrographic analyses of samples having at least one known constituent at at least one concentration.

4. The method of claim 1 wherein the step of transmitting the calculated concentration of the at least one constituent in the extemporaneously compounded sample having at least one constituent at an unknown concentration to a requester comprises transmitting the calculated concentration through an electronic medium.

5. The method of claim 4 wherein the electronic medium further comprises electronic mail.

6. The method of claim 4 wherein the electronic medium further comprises an interactive website.

7. The method of claim 1 wherein the step of performing a spectrographic analysis of a sample having the at least one constituent at at least one predetermined concentration further comprises performing a spectrographic analysis using NIR energy absorbance technology.

8. The method of claim 1 wherein the step of performing a spectrographic analysis of a sample having the at least one constituent at at least one predetermined concentration further comprises performing a spectrographic analysis using UV light absorbance technology.

9. The method of claim 1 wherein the step of performing a spectrographic analysis of a sample having the at least one constituent at a predetermined concentration further comprises performing a spectrographic analysis of a sample having a predetermined concentration using NIR energy absorbance technology and UV light absorbance technology.

10. The method of claim 1 wherein the step of performing a spectrographic analysis of an extemporaneously compounded sample having at least one constituent at an unknown concentration further comprises performing a spectrographic analysis using NIR energy absorbance technology.

11. The method of of claim 1 wherein the step of performing a spectrographic analysis of an extemporaneously compounded sample having at least one constituent at an unknown concentration further comprises performing a spectrographic analysis using UV light absorbance technology.

12. The method of claim 1 wherein the step of performing a spectrographic analysis of an extemporaneously compounded sample having at least one constituent at an unknown concentration further comprises performing a spectrographic analysis using NIR energy absorbance technology and UV light absorbance technology.

13. The method of claim 1 further comprising the step of analyzing the extemporaneously compounded sample having at least one constituent at an unknown concentration to determine the sterility and purity of the sample.

14. The method of claim 1 wherein the at least one constituent of the extemporaneously compounded sample having at least one constituent at an unknown concentration is a known constituent.

15. The method of claim 1 wherein the at least one constituent of the extemporaneously compounded sample having at least one constituent at an unknown concentration is unknown.

16. A method of identifying at least one constituent and determining the concentration thereof, in a compounded sample having at least one unknown constituent at an unknown concentration comprising the steps of:

performing a spectrographic analysis of a compounded sample having at least one unknown constituent at an unknown concentration;

obtaining data regarding the spectrographic analysis of the compounded sample having at least one unknown constituent at an unknown concentration, said data comprising at least one energy absorbance concentration curve;

comparing the at least one energy absorbance curve resulting from the spectrographic analysis of the compounded sample having at least one unknown constituent at a unknown concentration to at least one energy absorbance curve resulting from a spectrographic analysis of at least one sample having at least one predetermined constituent at at least one predetermined concentration which was stored in a retrievable form;

identifying the at least one unknown constituent in the compounded sample having an at least one unknown constituent at an unknown concentration from the energy absorbance curve obtained from the spectrographic analysis of the compounded sample and mathematically calculating the concentration thereof from data derived from the recited comparison of the energy absorbance concentration curves; and

transmitting the identity of the at least one unknown or the calculated concentration thereof or both to a requester.

17. The method of claim 16 comprising the further step of transmitting the identity of the at least one unknown constituent or the calculated concentration or both said identity and said calculated concentration to the requester through an electronic medium.

18. The method of claim 17 wherein the step of transmitting the identity of the at least one unknown constituent or the calculated concentration or both the identity of the at least one unknown constituent and the calculated concentration through an electronic medium is performed by electronic mail.

19. The method of claim 17 wherein the step of transmitting the identity of the unknown constituent and the calculated concentration or both the identity and the calculated concentration is performed through a website posting.

20. The method of claim 16 further comprising the steps of performing a spectrographic analysis of at least one sample having at least one predetermined constituent at at least one predetermined concentration using near-infrared energy absorbance technology and storing said spectrographic analysis in a retrievable form.

21. The method of claim 16 further comprising the steps of performing a spectrographic analysis of the at least one sample having at least one predetermined constituent at at least one predetermined concentration using ultraviolet light absorbance technology and storing said spectrographic analysis in a retrievable form.

22. The method of claim 16 further comprising the steps of performing a spectrographic analysis of a sample having at least one predetermined constituent at at least one predetermined concentration using near-infrared energy absorbance technology and ultraviolet light absorbance technology and storing said spectrographic analysis in a retrievable form.

23. The method of claim 16 wherein the spectrographic analysis of a compounded sample having at least one unknown constituent at an unknown concentration is conducted using near-infrared energy absorbance technology.

24. The method of claim 16 wherein the spectrographic analysis of a compounded sample having at least one unknown constituent at an unknown concentration is conducted using ultraviolet light absorbance technology.

25. The method of claim 16 wherein spectrographic analysis of a compounded sample having an at least one unknown constituent at an unknown concentration is conducted using near-infrared energy absorbance technology and ultraviolet light absorbance technology.

26. The method of claim 16 further comprising the step of analyzing the sample having at least one unknown constituent at an unknown concentration for purity and sterility.

27. A method of determining the identity or concentration or both of at least one constituent in a sample having at least one unknown constituent or unknown concentration or both, for a requester, comprising the steps of:

accepting a request for determining and reporting to the requester the identity or concentration or or both of a sample having at least one unknown constituent or unknown concentration or both;

performing a spectrographic analysis of a sample having at least one predetermined constituent at at least one predetermined concentration, said spectrographic analysis performed by a technology selected from the group of technologies consisting of NIR energy absorbance technology, UV light absorbance technology and a combination of NIR energy absorbance technology and UV light absorbance technology;

obtaining energy absorbance curve data regarding the at least one predetermined constituent and the at least one predetermined concentration from the spectrographic analysis of the sample having at least one predetermined constituent at at least one predetermined concentration;

storing the obtained energy absorbance curve data from the analysis of the sample having at least one predetermined constituent at at least one predetermined concentration in a database of obtained energy absorbance curves obtained from spectrographic analysis of one or more samples having at least one predetermined constituent at at least one predetermined concentration;

receiving a sample having at least one unknown constituent or unknown concentration or both, said sample having no associated identifying indicia required for determining the identity or concentration or both of the at least one constituent;

performing a spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both, said spectrographic analysis performed by a technology selected from the group of technologies consisting of NIR energy absorbance technology, UV light absorbance technology and a combination of NIR energy absorbance technology and UV light absorbance technology;

obtaining energy absorbance curve data regarding the at least one unknown constituent or unknown concentration or both from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or or both;

comparing the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or or both to the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one predetermined constituent at at least one predetermined concentration stored in the database;

identifying the at least one unknown constituent in the sample having at least one unknown constituent or unknown concentration or both or calculating a concentration of the at least one unknown constituent, or both, in the sample having at least one unknown constituent or unknown concentration or both from the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both; and

transmitting the identity of the at least one unknown constituent or the calculated concentration or both of the sample having at least one unknown constituent or unknown concentration or both to the requester through an electronic medium selected from the group of electronic media consisting of electronic mail, an interactive website, telephone transmission, facsimile transmission or any combination thereof.

28. The method of claim 27 further comprising electronic tracking of the steps of:

accepting a request for determining and reporting to the requester the concentration or both of a sample having at least one unknown constituent or unknown concentration or both;

performing a spectrographic analysis of a sample having at least one predetermined constituent at at least one predetermined concentration, said spectrographic analysis performed by a technology selected from the group of technologies consisting of NIR energy absorbance technology, UV light absorbance technology and a combination of NIR energy absorbance technology and UV light absorbance technology;

obtaining energy absorbance curve data regarding the at least one predetermined constituent and the at least one predetermined concentration from spectrographic analysis of the sample having at least one predetermined constituent at at least one predetermined concentration;

storing the obtained energy absorbance curve data from the analysis of the sample having at least one predetermined constituent at at least one predetermined concentration in a database of energy absorbance curves obtained from spectrographic analysis of one or more samples having at least one predetermined constituent at at least one predetermined concentration;

receiving a sample having at least one unknown constituent or unknown concentration or both, said sample having no associated identifying indicia required for determining the identity or concentration or both of the at least one constituent;

performing a spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both, said spectrographic analysis performed by a technology selected from the group of technologies consisting of NIR energy absorbance technology, UV light absorbance technology and a combination of NIR energy absorbance technology and UV light absorbance technology;

obtaining energy absorbance curve data regarding the at least one unknown constituent or unknown concentration or both from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both;

comparing the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both to the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one predetermined constituent at at least one predetermined concentration stored in the database;

identifying the at least one unknown constituent in the sample having at least one unknown constituent or unknown concentration or both or calculating a concentration of the at least one unknown constituent, or both, in the sample having at least one unknown constituent or unknown concentration or both from the energy absorbance curve data obtained from the spectrographic analysis of the sample having at least one unknown constituent or unknown concentration or both; and

transmitting the identity of the at least one unknown constituent or the calculated concentration or both of the sample having at least one unknown constituent or unknown concentration or both to the requester through an electronic medium selected from the group of electronic media consisting of electronic mail, an interactive website, telephone transmission, facsimile transmission or any combination thereof.

29. The method of claim 28 wherein the electronic tracking further comprises tracking through an interactive website.

30. A data processing system for managing a process for determining the identity or concentration or both of at least one constituent in a sample having at least one unknown constituent or unknown concentration or both, comprising:

a computer processor for processing data; and

computer software configured to perform data processing functions comprising;

a). determining spectrographical data regarding at least one constituent and concentration of a sample having at least one known constituent at a known concentration;

b). storing in a database the spectrographical data regarding at least one constituent and concentration of a sample having a at least one known concentration or purity;

c). determining spectrographical data regarding at least one constituent or a concentration or both of a sample having an unknown constituent or unknown concentration or both, said sample being devoid of any identifying indicia required to identify at least one constituent or determine concentration thereof;

d.) comparing the determined spectrographical data regarding the at least one constituent or concentration or both of the sample having at least one unknown constituent or unknown concentration or both to the spectrographical data in the database of spectrographical data regarding the at least one constituent and concentration of samples having at least one known constituent and known concentration;

e). applying an appropriate equation to calculate the concentration of the at least one constituent in the sample having at least one unknown constituent or unknown concentration or both or identifying said at least one constituent, or both, from the comparison of the spectrographical data in the database of spectrographical data regarding the at least one constituent and concentration of samples having at least one known constituent at a known concentration; and

f.) communicating the calculated concentration of the at least one constituent in the sample having at least one unknown constituent or unknown concentration or both.

31. The data processing system of claim 30 wherein the computer software configured to perform data processing functions includes the data processing function of processing a request for the determining spectrographical data of a sample having at least one unknown constituent or unknown concentration or both.

32. The data processing system of claim 30 wherein the data processing function of communicating the calculated concentration of the at least one constituent in a sample having at least one unknown constituent or unknown concentration or both further comprises communicating the calculated concentration by an electronic medium.

33. The data processing system of claim 32 wherein the electronic medium is electronic mail.

34. The data processing system of claim 32 wherein the electronic medium is an interactive website.

35. The data processing system of claim 30 wherein the computer software configured to perform data processing functions is configured to expand the database as a result of the performance of the steps of determining spectrographical data at least one known constituent at a known concentration of a sample having at least one known constituent at a known concentration and determining spectrographical data regarding at least one unknown constituent or unknown concentration or both of a sample having at least one unknown constituent or unknown concentration or or both.