SUSPENSIONS AND DILUENTS FOR METRONIDAZOLE AND BACLOFEN
Suspensions of metronidazole or baclofen and/or salts or ester derivative thereof, such as metronidazole benzoate, are disclosed. The suspension my include metronidazole or baclofen, and/or a salt or ester derivative thereof a hydrocolloid stabilizer, simethicone emulsion, a buffer, such as sodium citrate, (dihydrate), a preservative, a thickening agent, a sweetener, and water.
1 . A liquid oral pharmaceutical composition of baclofen or a salt thereof, comprising:
a) 5 mg/ml of baclofen or a salt thereof;
b) citric acid (anhydrous);
c) hydroxyethyl cellulose;
d) propylene glycol;
e) sodium benzoate; and;
f) water,
wherein a pH of the liquid oral pharmaceutical composition is between 3.0 and 6.0, and
wherein the liquid oral pharmaceutical composition retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at room temperature.
2 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at 38-42° C.
3 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition retains less than +/−5% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at 15-30° C.
4 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition retains less than +/−2% variation of baclofen concentration measured by a USP assay for at least 30 days when stored at room temperature.
5 . The pharmaceutical composition of claim 1 , wherein the pH of the pharmaceutical composition is between 3.6 and 4.6.
6 . The pharmaceutical composition of claim 1 , wherein the pH of the pharmaceutical composition is between 4.0 and 4.3.
7 . The pharmaceutical composition of claim 1 , wherein the citric acid is present at 0.12-0.6% (w/v).
8 . The pharmaceutical composition of claim 1 , wherein the citric acid is present at 0.12% (w/v).
9 . The pharmaceutical composition of claim 1 , wherein the sodium benzoate is present at 0.1-0.2% (w/v).
10 . The pharmaceutical composition of claim 1 , wherein the sodium benzoate is present at 0.1% (w/v).
11 . The pharmaceutical composition of claim 1 , wherein the propylene glycol is present at 5% (w/v).
12 . The pharmaceutical composition of claim 1 , wherein the hydroxyethyl cellulose is present at 0.5% (w/v).
13 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises simethicone.
14 . The pharmaceutical composition of claim 13 , wherein the simethicone is a 30% simethicone emulsion and is present at 0.1500-0.250% (w/v).
15 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further comprises a coloring agent, a flavoring agent, a sweetener, or a combination thereof.
16 . The pharmaceutical composition of claim 15 , wherein the pharmaceutical composition comprises a sweetener.
17 . The pharmaceutical composition of claim 16 , wherein the sweetener is one or more of ammonium glycyrrhizate, sucralose, and saccharin sodium.
18 . The pharmaceutical composition of claim 17 , wherein the sweetener is sucralose and
is present at 0.05-0.2% (w/v).
19 . The pharmaceutical composition of claim 15 , wherein the pharmaceutical composition comprises a coloring agent and a flavoring agent.
20 . The pharmaceutical composition of claim 1 , wherein the baclofen or a salt thereof is baclofen.