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 method of treating spasticity in a subject comprising administering to the subject a liquid oral pharmaceutical composition, wherein the liquid oral pharmaceutical composition 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 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 method of claim 1 , wherein the liquid oral 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 method of claim 1 , wherein the liquid oral 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 method of claim 1 , wherein the liquid oral 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 method of claim 1 , wherein the liquid oral pharmaceutical composition further comprises a coloring agent, a flavoring agent, or a combination thereof.
6. The method of claim 1 , wherein the liquid oral pharmaceutical composition comprises 0.0002% (w/v) of D&C Yellow No. 10.
7. The method of claim 1 , wherein the liquid oral pharmaceutical composition comprises about 0.000038% (w/v) of FD&C Red No. 40.
8. The method of claim 1 , wherein the liquid oral pharmaceutical composition comprises 0.0500% (w/v) of flavor grape 59.266/A.
9. The method of claim 1 , wherein the pH of the liquid oral pharmaceutical composition is between 3.6 and 4.6.
10. The method of claim 1 , wherein the pH of the liquid oral pharmaceutical composition is 4.0 to 4.3.
11. The method of claim 1 , wherein treating spasticity comprises alleviating one or more muscle symptoms selected from spasms, pain, stiffness, tightness, or cramping.
12. The method of claim 11 , wherein the one or more muscle symptoms are caused by multiple sclerosis.
13. The method of claim 1 , wherein the subject is a human.
14. The method of claim 13 , wherein the human is a child.
15. The method of claim 13 , wherein the human is an adult or elderly.
16. The method of claim 13 , wherein the human has multiple sclerosis.