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; a chelating agent; dextromethorphan or a pharmaceutically acceptable salt thereof; 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 less than about 0.01%, by weight of the dosage form, methcathinone;
wherein the dosage form comprises less than about 0.2%, by weight of the dosage form, 10-keto-dextromethorphan.
2. 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.
3. The dosage form of claim 1 wherein the basic buffering agent is selected from the group consisting of meglumine, glycine, sodium carbonate, calcium carbonate, sodium bicarbonate, phosphate buffer, magnesium hydroxide, and combinations thereof.
4. The dosage form of claim 1 wherein the second portion comprises from about 0.5% to about 3% of the chelating agent.
5. The dosage form of claim 4 wherein the chelating agent is selected from the group consisting of EDTA, citric acid, malic acid, tartaric acid, lactic acid, aspartic acid, glutamic acid, lysine, sodium hexametaphosphate, salts thereof, and combinations thereof.
6. The dosage form of claim 1 wherein the second portion further comprises from about 0.1% to about 1% of the antioxidant.
7. The dosage form of claim 6 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.
8. The dosage form of claim 1 wherein the dosage form comprises less than about 2 ppm iron.
9. 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; a stabilizing agent selected from the group consisting of a chelating agent, an antioxidant, and combinations thereof;
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 less than about 0.01%, by weight of the dosage form, methcathinone.
10. The dosage form of claim 9 , 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.
11. The dosage form of claim 9 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.
12. The dosage form of claim 11 wherein the second portion comprises from about 0.001% to about 3% of the antioxidant.
13. The dosage form of claim 12 wherein the second portion comprises from about 0.01% to about 1.5% of the antioxidant.
14. The dosage form of claim 12 wherein the second portion comprises from about 0.01% to about 8% of a chelating agent.
15. The dosage form of claim 14 wherein the chelating agent is selected from the group consisting of EDTA, citric acid, malic acid, tartaric acid, lactic acid, aspartic acid, glutamic acid, lysine, sodium hexametaphosphate, salts thereof, and combinations thereof.
16. The dosage form of claim 15 wherein the chelating agent is EDTA.
17. The dosage form of claim 9 wherein the second portion further comprises dextromethorphan or a pharmaceutically acceptable salt thereof.
18. The dosage form of claim 9 wherein the hydrophilic polymer is a hydroxypropyl methylcellulose with a viscosity of from about 10,000 cP to about 250,000 cP.
19. The dosage form of claim 9 wherein the dosage form comprises less than about 0.005%, by weight of the dosage form, methcathinone.