Pharmaceutical compositions and methods for the prevention of drug misuse

• US 20060039865A1
• Filed: 07/25/2005
• Published: 02/23/2006
• Est. Priority Date: 07/26/2004
• Status: Abandoned Application

• Current Assignee: Victory Pharma, Inc. (Shionogi & Co., Ltd.)
• Original Assignee: Victory Pharma, Inc. (Shionogi & Co., Ltd.)
• Inventors: Preston, David M., Heck, Matthew T., Newman, James W.
• Application Number:
  US11/188,574
• Publication Number:
  US 20060039865A1
• Time in Patent Office: Days
• US Class Current: 424/10.400
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 49/00 Preparations for testing in vivo

Abstract

A pharmaceutical composition including a therapeutic does of an active ingredient susceptible of either intentional or accidental misuse by over-utilization and a sub-therapeutic dose of a compound in an amount sufficient to elicit an undesirable response if the recommended therapeutic dose of the active ingredient is exceeded. A multiple dose pharmaceutical dosage form including an effective amount of an active ingredient for a patient in need of treatment thereof and a urine indicator capable of changing the color of the patient'"'"'s urine when a desired dosage of the active ingredient is exceeded by ingestion of multiple doses in excess of a desired treatment regimen.

Claims

1. A multiple dose pharmaceutical dosage form comprising an effective amount of an active ingredient for a patient in need of treatment thereof and a urine indicator capable of changing the color of the patient'"'"'s urine when a desired dosage of the active ingredient is exceeded by ingestion of multiple doses in excess of a desired treatment regimen.

2. The pharmaceutical composition of claim 1, wherein the indicator is phenazopyridine or pharmaceutically acceptable salts thereof.

3. The pharmaceutical composition of claim 1, wherein the color shift indicator is methylene blue or pharmaceutically acceptable salts thereof.

4. The pharmaceutical composition of claim 1, wherein the indicator is mannosej or pharmaceutically acceptable salts thereof.

5. The pharmaceutical composition of claim 1, wherein the indicator is, melanine, phenolphthalein, phenosulfonphthalein, or pharmaceutically acceptable salts thereof.

6. The pharmaceutical composition of claim 1, wherein the indicator is one or more riboflavins or pharmaceutically acceptable salts thereof.

7. The pharmaceutical composition of claim 1, wherein the indicator is one or more tannins or pharmaceutically acceptable salts thereof.

8. The pharmaceutical dosage form of claim 1, wherein the active ingredient is acetominophen, dextromethorphan, or oxycodone.

9. The pharmaceutical dosage form of claim 1, wherein the urine indicator is present in an amount sufficient to shift color of a patient'"'"'s urine at least 10 nm in the visible spectrum when a desired total dosage of active ingredient is exceeded.

10. The pharmaceutical dosage form of claim 1, wherein the urine indicator is present in an amount 50 mg to 750 mg.

11. The composition of claim 1, wherein the pharmaceutical dosage form is a tablet, capsule, liquid, or suspension.

23. The composition of claim 1, wherein the pharmaceutical dosage form is a tablet, capsule, liquid, or suspension.

12. A method for indicating when a patient ingesting multiple doses of a pharmaceutical dosage form exceeds a desired treatment regimen comprising:

a. observing the color of a patient'"'"'s urine;

b. ingesting one or more doses of a pharmaceutical dosage form including an effective amount of an active ingredient for a patient in need of treatment thereof and a urine color shift indicator capable of changing the color of the patient'"'"'s urine when a desired dosage of the active ingredient is exceeded by ingestion of multiple doses in excess of a desired treatment regimen;

c. observing the color of a patient'"'"'s urine after ingesting one or more of the doses;

d. comparing the color of the patent'"'"'s urine before and after ingesting one or more of the doses to determine if there is a substantial change in color of the patient'"'"'s urine.

13. The method of claim 12, further comprising reducing the number of doses ingested by a patient when it is determined that there is a substantial change in the color of the patient'"'"'s urine before and after administration of one or more doses.

14. The method of claim 12, wherein a substantial change in color of a patient'"'"'s urine is one that represents a color shift of at least 10 nm.

15. The pharmaceutical composition of claim 12, wherein the indicator is phenazopyridine or pharmaceutically acceptable salts thereof.

16. The pharmaceutical composition of claim 12, wherein the color shift indicator is methylene blue or pharmaceutically acceptable salts thereof.

17. The pharmaceutical composition of claim 12, wherein the indicator is mannose or pharmaceutically acceptable salts thereof.

18. The pharmaceutical composition of claim 12, wherein the indicator is melanine phenolphthalein, phenosulfonphthalein, or pharmaceutically acceptable salts thereof.

19. The pharmaceutical composition of claim 12, wherein the indicator is one or more riboflavins or pharmaceutically acceptable salts thereof.

20. The pharmaceutical composition of claim 12, wherein the indicator is one or more tannins or pharmaceutically acceptable salts thereof.

21. The pharmaceutical dosage form of claim 12, wherein the active ingredient is acetominophen, dextromethorphan, or oxycodone.

22. The pharmaceutical dosage form of claim 12, wherein the urine indicator is present in an amount 50 to 750 mg.