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 pharmaceutical composition that comprises:
a) 5 mg/ml of baclofen or a salt thereof;
b) 0.12% (w/v) of citric acid (anhydrous);
c) 0.5% (w/v) of hydroxyethyl cellulose;
d) 5% (w/v) of propylene glycol;
e) 0.15% (w/v) of simethicone emulsion (30%);
f) 0.1% (w/v) of sodium benzoate;
g) 0.2% (w/v) of sucralose; and
h) water,
wherein a pH of the pharmaceutical composition is between 3.0 and 6.0, and
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 room temperature.
2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition further 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 further 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 further comprises a coloring agent, a flavoring agent, or a combination thereof.
5. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises 0.0002% (w/v) of D&C Yellow No. 10.
6. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises 0.000038% (w/v) of FD&C Red No. 40.
7. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises 0.0500% (w/v) of flavor grape 59.266/A.
8. The pharmaceutical composition of claim 1 , wherein the pH of the pharmaceutical composition is about 3.6 to 4.6.
9. The pharmaceutical composition of claim 1 , wherein the pH of the pharmaceutical composition is about 4.0 to 4.3.