DOSAGE FORMS COMPRISING ACTIVE PHARMACEUTICAL INGREDIENTS
Disclosed herein are dosage forms comprising a combination of: 1) an active pharmaceutical ingredient (API), 2) a cyclodextrin, and 3) a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the drug for the treatment of conditions such as pain.
1 . A solid dosage form comprising a combination of: 1) naproxen or a pharmaceutically acceptable salt thereof, 2) sumatriptan or a pharmaceutically acceptable salt thereof, 3) a cyclodextrin, and 4) a bicarbonate.
2 . The solid dosage form of claim 1 , comprising about 0.001 mg to about 1000 mg of the naproxen or the pharmaceutically acceptable salt thereof.
3 . The solid dosage form of claim 2 , comprising about 20 mg to about 600 mg of the naproxen or the pharmaceutically acceptable salt thereof.
4 . The solid dosage form of claim 3 , comprising about 500 mg of the naproxen or the pharmaceutically acceptable salt thereof.
5 . The solid dosage form of claim 3 , comprising about 60 mg of the naproxen or the pharmaceutically acceptable salt thereof.
6 . The solid dosage form of claim 1 , comprising about 0.001 mg to about 1000 mg of the sumatriptan or the pharmaceutically acceptable salt thereof.
7 . The solid dosage form of claim 6 , comprising about 1 mg to about 200 mg of the sumatriptan or the pharmaceutically acceptable salt thereof.
8 . The solid dosage form of claim 7 , comprising about 85 mg of the sumatriptan or the pharmaceutically acceptable salt thereof.
9 . The solid dosage form of claim 7 , comprising about 10 mg of the sumatriptan or the pharmaceutically acceptable salt thereof.
10 . The solid dosage form of claim 1 , comprising naproxen sodium.
11 . The solid dosage form of claim 1 , comprising sumatriptan succinate.
12 . The solid dosage form of claim 1 , comprising 1) about 500 mg of naproxen sodium and 2) about 85 mg of sumatriptan succinate.
13 . The solid dosage form of claim 1 , comprising 1) about 60 mg of naproxen sodium and 2) about 10 mg of sumatriptan succinate.
14 . The solid dosage form of claim 1 , wherein the cyclodextrin is a sulfobutylether β-cyclodextrin (SBEβCD).
15 . The solid dosage form of claim 14 , wherein the SBEβCD has about 6 to about 7 sulfobutyl ether groups for each molecule of β-cyclodextrin.
16 . The solid dosage form of claim 15 , comprising about 100 mg to about 500 mg of the SBEβCD.
17 . The solid dosage form of claim 16 , comprising about 100 mg to about 175 mg of the SBEβCD.
18 . The solid dosage form of claim 16 , comprising about 100 mg to about 140 mg of the SBEβCD.
19 . The solid dosage form of claim 1 , wherein the bicarbonate comprises sodium bicarbonate.
20 . The solid dosage form of claim 1 , comprising about 400 mg to about 1000 mg of the bicarbonate.
21 . The solid dosage form of claim 19 , comprising about 500 mg of sodium bicarbonate.
22 . The solid dosage form of claim 1 , which is used for the treatment of pain, inflammation, or a related condition, or a combination thereof.