Pharmaceutical compositions and methods for the prevention of drug misuse
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.
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.
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.
23 . The composition of claim 1 , wherein the pharmaceutical dosage form is a tablet, capsule, liquid, or suspension.