Extended relief dosage form
A dosage form with a first portion and a second portion. The first portion can be an immediate release portion and can comprise a pain reliever, which can be naproxen or naproxen sodium. The second portion can be an extended release portion and can comprise pseudoephedrine or a pharmaceutically acceptable salt thereof and/or dextromethorphan or a pharmaceutically acceptable salt thereof. The dosage form can optionally comprise a stabilizing agent. The dosage form can be adapted to maintain a therapeutically effective amount of pain reliever, pseudoephedrine, or a pharmaceutically acceptable salt thereof, and/or dextromethorphan, or a pharmaceutically acceptable salt thereof, for at least eight hours.
1. A dosage form comprising:
a. a first portion comprising a pain reliever selected from the group consisting of acetaminophen, ibuprofen, ketoprofen, diclofenac, aspirin, naproxen, pharmaceutically acceptable salts thereof, and combinations thereof; wherein the first portion is an immediate release portion;
b. a second portion comprising pseudoephedrine or a pharmaceutically acceptable salt thereof; dextromethorphan or a pharmaceutically acceptable salt thereof; from about 0.01% to about 8% of a chelating agent; a basic buffering agent sufficient to achieve a pH of about 6.0 to about 8.0; and a hydrophilic polymer; wherein the second portion is an extended release portion; wherein the dosage form comprises a ratio of pseudoephedrine or a pharmaceutically acceptable salt thereof to hydrophilic polymer of from about 0.10 to about 3.0 on a weight basis wherein the dosage form comprises less than about 0.01%, by weight of the dosage form, methcathinone and less than about 0.2%, by weight of the dosage form, 10-keto-dextromethorphan.
2. The dosage form of claim 1 wherein the ratio of pseudoephedrine or a pharmaceutically acceptable salt thereof to hydrophilic polymer is from about 0.75 to about 1.5 on a weight basis.
3. The dosage form of claim 1 wherein the chelating agent is EDTA.
4. The dosage form of claim 3 wherein the second portion further comprising an antioxidant.
5. The dosage form of claim 1 wherein the dosage form comprises less than about 0.005%, by weight of the dosage form, methcathinone.
6. The dosage form of claim 4 wherein the antioxidant is selected from the group consisting of ascorbyl palmitate, ascorbic acid, propyl gallate, alpha-tocopherol, butylated hydroxytoluene, butylated hydroxyanisole, tert-butyl hydroquinone, acetyl cysteine, and combinations thereof.
7. The dosage form of claim 4 wherein the second portion comprises from about 0.001% to about 3% of the antioxidant.
8. The dosage form of claim 4 wherein the second portion comprises from about 0.01% to about 1.5% of the antioxidant.
9. The dosage form of claim 1 wherein the hydrophilic polymer is a hydroxypropyl methylcellulose with a viscosity of from about 10,000 cP to about 250,000 cP.
10. The dosage form of claim 1 wherein the dosage form comprises less than about 2 ppm iron.