Combination and method including a visual marker for determining compliance with a medication regimen

• US 20020095072A1
• Filed: 01/17/2001
• Published: 07/18/2002
• Est. Priority Date: 01/17/2001
• Status: Active Grant

• Current Assignee: Union Springs Pharmaceuticals, LLC
• Original Assignee: Drug Enhancement Co of America LLC (Xanodyne Pharmaceuticals, Inc.)
• Inventors: Gonzales, Gilbert R., Griggs, Roger D.
• Granted Patent: US 7,062,312 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61K 49/0004 Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions

Abstract

A method and combination including a visual marker for monitoring a patient to determine compliance with a medication regimen. An orally administrable medication composition is provided in combination with a visual marker. When the combination is orally ingested, the marker causes a coloration or discoloration of the oral and/or pharyngeal cavity of a subject. By visually observing the oral and/or pharyngeal cavity of the subject, one can determine whether medication has been ingested based upon the presence or absence of the coloration/discoloration.

Claims

1. A method of monitoring the compliance of a patient in following a medication regimen, said method comprising the steps of:

providing in combination an orally administrable composition, which is part of a medication regimen, and at least one marker, said at least one marker being present in said combination in a form and sufficient amount to cause a coloration of at least a portion of the oral and/or pharyngeal cavity of a patient following ingestion of said combination by said patient; and

visually observing the oral and/or pharyngeal cavity of said patient;

determining the presence or absence of said coloration for determining whether said patient has ingested said combination in compliance with the medication regimen.

2. The method of claim 1 wherein said composition is a medication composition.

3. The method of claim 1 wherein said composition is a placebo composition.

4. The method of claim 1 wherein visually observing the oral and/or pharyngeal cavity of said patient to determine the presence or absence of coloration further comprises the step of directing natural light into the oral and/or pharyngeal cavity of said patient prior to observing the oral and/or pharyngeal cavity of said patient in order to directly observe said coloration.

5. The method of claim 1 wherein visually observing the oral and/or pharyngeal cavity of said patient to determine the presence or absence of coloration further comprises the step of directing an optimal exciting light into the oral and/or pharyngeal cavity of said patient prior to observing the oral and/or pharyngeal cavity of said patient in order to observe said coloration through fluorescence.

6. The method of claim 5 wherein said optimal exciting light is a violet-blue to blue light having a wavelength in a range of from about 430 nm to about 490 nm.

7. The method of claim 1 wherein visually observing said oral and/or pharyngeal cavity comprises visually observing a mucous membrane in said oral and/or pharyngeal cavity.

8. The method of claim 1 wherein said marker is carmine red dye.

9. The method of claim 1 wherein said marker is selected from the group consisting of indigo carmine, methylene blue, tartrazine, laccaic acid, beta-carotene, FD&

C blue 1, FD&

C blue 2, FD&

C green 3, FD&

C red 3, FD&

C red 40, FD&

C yellow 6, and riboflavin.

10. The method of claim 1 further comprising providing multiple markers in said combination, one of said markers causing a coloration of portion of the oral and/or pharyngeal cavity for a longer time than another of the markers, and determining the presence or absence of colorations caused by the multiple markers to determine a time frame in which the combination was ingested.

11. The method of claim 10 wherein one of said multiple markers causes a different coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.

12. The method of claim 1 further comprising providing multiple markers in said combination wherein one of said multiple markers causes a different coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.

13. The method of claim 1 further comprising providing multiple markers in said combination, one of said markers causing a coloration of a portion of the oral and/or pharyngeal cavity detectable with natural light and another of said markers causing coloration detectable with a light which causes fluorescence.

14. The method of claim 1 further comprising providing multiple markers in said combination, the markers being detectable with a light which causes fluorescence, one of said markers causing a different fluorescent coloration of a portion of the oral and/or pharyngeal cavity than the fluorescent coloration caused by the other marker.

16. The combination of claim 15 wherein said at least one marker is applied to the outer surface of said composition.

17. The combination of claim 15 wherein said at least one marker is interspersed throughout said composition.

18. The combination of claim 15 wherein the form of said composition is selected from the group consisting of a chewable tablet, a pill, a capsule, and a liquid.

19. The combination of claim 15 wherein said marker is operable to cause coloration of a mucous membrane of said oral and/or pharyngeal cavity.

20. The combination of claim 15 wherein the half-life of said at least one marker in the human system is comparable to the half-life of said composition in the human system.

21. The combination of claim 15 wherein said at least one marker is carmine red dye.

22. The combination of claim 15 wherein said at least one marker is selected from the group consisting of indigo carmine, methylene blue, tartrazine, laccaic acid, beta-carotene, FD&

C blue 1, FD&

C blue 2, FD&

C green 3, FD&

C red 3, FD&

C red 40, FD&

C yellow 6, and riboflavin.

23. The combination of claim 15 further comprising multiple markers in said combination.

24. The combination of claim 23 wherein one of said multiple markers causes a coloration of portion of the oral and/or pharyngeal cavity for a longer time than another of the markers so that the presence or absence of colorations caused by the multiple markers may be visually observed to determine a time frame in which the combination was ingested.

25. The combination of claim 23 wherein one of said multiple markers causes a different coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.

26. The combination of claim 23 wherein one of said multiple markers causes a coloration of a portion of the oral and/or pharyngeal cavity detectable with natural light and another of said markers causes coloration detectable with a light which causes fluorescence.

27. The combination of claim 23 wherein the multiple markers are detectable with a light which causes fluorescence, one of said markers causing a different fluorescent coloration of a portion of the oral and/or pharyngeal cavity than the fluorescent coloration caused by the other marker.

15. In combination:

an orally administrable composition; and

at least one marker, said marker being present in said combination in a sufficient amount and form to cause a coloration of at least a portion of the oral and/or pharyngeal cavity of a patient following ingestion of said combination by said subject;

said coloration of the oral and/or pharyngeal cavity being visually observable for determining whether said patient has ingested said combination in compliance with a medication regimen.