On-site method of providing analysis of potency and purity of pharmaceutical compounds

• US 7,660,678 B2
• Filed: 03/22/2007
• Issued: 02/09/2010
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: DynaLabs LLC
• Original Assignee: Medpro Holdings, LLC
• Inventors: Coates, John Peter, Pruett, Earl Michael, Odegard, Russell David
• Primary Examiner(s): Barbee; Manuel L
• Application Number:
  US11/726,417
• Publication Number:
  US 20070239367A1
• Time in Patent Office: 1,055 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 21/3577 for analysing liquids, e.g. polluted water
• CPC Class Codes: G01N 21/359 using near infrared light
• CPC Class Codes: G01N 31/00 Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup; Apparatus specially adapted for such methods
• CPC Class Codes: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A computer facilitated method of requesting a spectral analysis of a sample having an unknown concentration or purity, performing an energy absorption analysis of the sample to obtain spectral data regarding the analysis and comparing the spectral data to a stored spectral 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 spectral analysis is performed on site where the sample is prepared or administered using a portable analytical apparatus and provides a real time report of the concentration or purity of the sample. The apparatus requires only a small sample size.

Claims

1. A method of confirming the concentration or purity of a sample of a liquid having a desired concentration or purity, comprising the steps of:

introducing a sample of a liquid having a desired concentration or purity into a liquid sample channel of a hand-held analytical instrument, said hand-held analytical apparatus comprising apparatus for performing a spectral analysis of the sample in at least two liquid sample channels each having a different path length of about 0.025 mm to at least about 1.0 cm;

performing a spectral analysis of sample liquid in said sample channel with said apparatus for performing a spectral analysis;

obtaining data regarding the spectral analysis of the sample;

comparing the data regarding the spectral analysis of the sample having a desired concentration or purity to spectral analyses of samples having a predetermined concentration or purity stored in a retrievable form;

mathematically calculating a concentration or purity of the sample having desired concentration or purity from the comparison; and

confirming whether or not the determined concentration and purity of the sample having a desired concentration and purity is a desired concentration and purity.

2. The method of claim 1 wherein the step of comparing the data regarding the spectral analysis of the sample having a desired concentration or purity to the data regarding the spectral analysis of the sample having a predetermined concentration or purity stored in a retrievable form further comprises the step of comparing the data regarding the spectral analysis of the sample having a desired concentration or purity to the data regarding the spectral analysis of the sample having a predetermined concentration or purity stored in a compiled database of determined spectral analyses of samples having a predetermined concentration or purity.

3. The method of claim 2 wherein the step of performing a spectral analysis of sample having a desired concentration or purity is performed at a site remote from the compiled database of determined spectral analyses of samples having a predetermined concentration or purity.

4. The method of claim 1 wherein the step comparing the data regarding the spectral analysis of the sample having a desired concentration or purity to spectral analyses of samples having a predetermined concentration or purity stored in a retrievable form is performed through an electronic medium.

5. The method of claim 4 wherein the electronic medium is selected from a group of electronic media consisting of direct electrical interfacing, telephonic transmission, wireless communications, and Internet, including WIFI networked communications.

6. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis of a sample in a sample channel having a path length of about 10.0 mm to about at least 1.0 cm using NIR energy absorption technology.

7. The method of claim 6 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis of a sample having a predetermined concentration or purity using NIR energy absorption technology.

8. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis of a sample in a sample channel having a path length of about 0.025 mm to about 10.0 mm using UV-vis light absorption technology.

9. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis using fluorescence technology.

10. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis technology selected from the group of technologies consisting of nephelometry, turbidity, laser light scattering, DNA sequencing, Raman, mid-infrared (IR), TD-NMR, TeraHertz, x-ray and combinations thereof.

11. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis of a sample having a predetermined concentration or purity using UV light absorption technology.

12. The method of claim 1 wherein the step of performing a spectral analysis of a sample having a desired concentration or purity further comprises performing a spectral analysis of the sample using NIR energy absorption technology and UV-vis light absorption technology.

13. The method of claim 1 further comprising the step of analyzing the sample having a desired concentration and purity to determine the sterility and purity of the sample.

14. The method of claim 13 wherein the step of analyzing the sample having a desired concentration and purity to determine the sterility and purity of the sample further comprises using laser light scattering technology.

15. The method of claim 1 wherein the sample having a desired concentration or purity is an extemporaneously compounded pharmaceutical preparation.

16. A method of confirming the concentration or purity of a liquid sample having a desired concentration or purity, comprising the steps of:

performing a spectral analysis of a liquid sample having a predetermined concentration or purity;

obtaining data regarding the spectral analysis of the sample having a predetermined concentration or purity;

storing the obtained spectral data regarding the analysis of the sample having a predetermined concentration or purity in a retrievable form;

introducing a sample of a liquid compound having a desired concentration or purity into a liquid sample channel of a sample cell of a portable analytical instrument, said sample cell comprising at least two different liquid sample channels, each sample channel each comprising a different a path length of between about 0.01 mm to about at least 1.0 cm;

performing a spectral analysis of the sample having a desired concentration or purity in the liquid sample channel of the analytical instrument;

obtaining data regarding the spectral analysis of the sample having a desired concentration or purity;

comparing the data regarding the spectral analysis of the sample having a desired concentration or purity to the data regarding the spectral analysis of the sample having a predetermined concentration or purity which was stored in a retrievable form; and

determining a concentration or purity of the sample having a desired concentration or purity through the comparison to confirm the desired concentration or purity thereof.

17. The method of claim 16 wherein the spectral analysis of a sample having a desired concentration or purity is performed in a liquid sample channel having a path length of about 10 mm to at least about 1.0 cm in a portable analytical instrument using near-infrared energy absorption technology.

18. The method of claim 16 wherein the spectral analysis of a sample having a desired concentration or purity is performed in a liquid sample channel having a path length of approximately 0.025 mm to approximately 10.0 mm in a portable analytical instrument using ultraviolet-visible light absorption technology.

19. The method of claim 18 wherein the sample is about 0.175 microliters to about 70.7 microliters.

20. The method of claim 16 wherein spectral analysis of a sample having a desired concentration or purity is performed with a portable analytical instrument having at least two sample channels using near-infrared energy absorption technology and ultraviolet-visible light absorption technology.

21. The method of claim 16 wherein the sample having a desired concentration or purity is an extemporaneously compounded pharmaceutical preparation.

22. The method of claim 16 wherein the step of introducing a sample of a liquid compound having a desired concentration or purity into a liquid sample channel of an analytical instrument further comprises introducing approximately 100 microliters or less of the liquid compound having a desired concentration or purity into a liquid sample channel of an analytical instrument.