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

• US 20070239367A1
• Filed: 03/22/2007
• Published: 10/11/2007
• Est. Priority Date: 02/05/2004
• Status: Active Grant

• Current Assignee: DynaLabs LLC
• Original Assignee: Medpro Holdings, LLC
• Inventors: Coates, John, Pruett, Earl, Odegard, Russell
• Granted Patent: US 7,660,678 B2
• Time in Patent Office: Days
• 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 having a desired concentration or purity at the site of preparation of the sample, comprising the steps of:

preparing a sample having a desired concentration or purity;

introducing the sample into an analytical apparatus, said apparatus being locatable at the site of preparation of the sample and comprising apparatus for performing a spectral analysis;

performing a spectral analysis of sample having a desired concentration or purity with said apparatus;

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;

determining a concentration or purity of the sample having desired concentration or purity through 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 1 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 the sample using NIR energy absorption technology.

7. 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 UV-vis light 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 the sample using NIR energy absorption technology and 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 an unknown concentration or purity further comprises performing a spectral analysis of a sample having a predetermined concentration or purity using NIR energy absorption technology.

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

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

14. 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.

15. The method of claim 14 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.

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

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

performing a spectral analysis of a 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;

preparing a sample having a desired concentration or purity;

performing a spectral analysis of a sample having an unknown concentration or purity, said spectral analysis being performed at a site of preparation or administration of the sample having a desired concentration or purity;

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.

18. The method of claim 17 wherein the spectral analysis of a sample having a desired concentration or purity is performed with a portable device using near-infrared energy absorption technology.

19. The method of claim 17 wherein the spectral analysis of a sample having a desired concentration or purity is performed with a portable device using ultraviolet-visible light absorption technology.

20. The method of claim 17 wherein the site of preparation of the sample is also the site of administration of the sample to a patient.

21. The method of claim 17 wherein spectral analysis of a sample having a desired concentration or purity is performed with a portable device using near-infrared energy absorption technology and ultraviolet-visible light absorption technology.

22. The method of claim 17 wherein the sample having a desired concentration or purity is an extemporaneously compounded pharmaceutical preparation.

23. A system for confirming the concentration or purity of a sample having a desired concentration or purity, comprising:

a master unit comprising a computer, apparatus for determining the spectral data regarding a known or unknown sample, and a database of stored spectral data;

a portable unit comprising apparatus for determining the spectral data regarding a known or unknown sample;

apparatus for transferring data between said master unit and said portable unit; and

software for operating said master unit and said portable unit.

24. The system of claim 23 wherein the portable unit further comprises a computer.

25. The system of claim 23 wherein said portable unit further comprises a database of store spectral data.

26. An apparatus for performing an analysis of a chemical compound to determine a spectral signature of the compound comprising:

at least one light source;

at least one spectrometer for making spectral measurements; and

a sample holder having at least one optical channel of approximately 0.01 mm to approximately 10.0 mm.

27. The apparatus of claim 26 wherein said measurements are made in wavelength regions of approximately 200 nm approximately 2500 nm.

28. The apparatus of claim 26 further comprising a computer.

29. The apparatus of claim 28 further comprising a database of stored spectral data.

30. The apparatus of claim 26 wherein the path lengths provide for a range of approximately 0 to 1.5 absorbance.

31. The apparatus of claim 26 wherein the at least one light source generates radiation from 200 nm to 2500 nm.