AQUEOUS PHARMACEUTICAL COMPOSITION OF NITROFURANTOIN
Provided herein are aqueous pharmaceutical compositions of nitrofurantoin for oral administration containing nitrofurantoin as the active pharmaceutical ingredient and one more excipient selected from suspending agents, binders, preservatives, vehicles, sweetening agents, buffering agents and taste masking agents.
1 - 6 . (canceled)
7 . A formulation comprising a uniform composition comprising:
a) nitrofurantoin or its pharmaceutically salt or a polymorph thereof in an amount of 5 mg/mL or 10 mg/mL;
b) a suspending agent comprising magnesium aluminum silicate and carboxymethylcellulose sodium; wherein the magnesium aluminum silicate is in an amount of about 4 mg/mL and carboxymethylcellulose sodium is in an amount of about 20 mg/mL when the concentration of nitrofurantoin is about 5 mg/mL, and magnesium aluminum silicate is in an amount from about 8 mg/mL to about 9 mg/mL and carboxymethylcellulose sodium is in an amount from about 12 mg/mL to about 14 mg/mL when the concentration of nitrofurantoin is about 10 mg/mL;
c) glycerin and/or sorbitol;
d) methyl paraben; and
e) propyl paraben;
wherein the amount of the methyl paraben is at least 6 times that of the propyl paraben;
wherein the ratio of the magnesium aluminum silicate to the carboxymethylcellulose sodium is 0.2:1 to 0.75:1;
wherein pH of the formulation is in a range of 4.5 to 6.5; and
wherein the formulation is an aqueous pharmaceutical suspension suitable for oral administration.
8 . The formulation of claim 7 , wherein the formulation has the nitrofurantoin or its pharmaceutically salt or the polymorph thereof in an amount of 5 mg/ml to 10 mg/ml.
9 . The formulation of claim 8 , wherein lead content is between 3.07 ppm to 5 ppm.
10 . The formulation of claim 7 , wherein pH of the formulation is 5.1 to 5.7.
11 . The formulation of claim 7 , further comprises a taste masking agent in an amount of 0.01 wt. to 2.0 wt. %.
12 . The formulation of claim 7 , wherein the formulation has lead content between 3.07 ppm to 4 ppm.
13 . The formulation of claim 7 , wherein the formulation comprises glycerin and sorbitol.
14 . The formulation of claim 13 , wherein the formulation comprises an equal amount of glycerin and sorbitol.
15 . The formulation of claim 7 , further comprising a buffering agent.
16 . An aqueous pharmaceutical suspension for oral administration comprising a formulation comprising nitrofurantoin or its pharmaceutically salt or polymorph thereof, a suspending agent consisting magnesium aluminum silicate in an amount of about 4 mg/mL and carboxymethylcellulose sodium in an amount of about 20 mg/mL when the concentration of nitrofurantoin is about 5 mg/mL, and magnesium aluminum silicate in an amount from about 8 mg/mL to about 9 mg/mL and carboxymethylcellulose sodium in an amount from about 12 mg/mL to about 14 mg/mL when the concentration of nitrofurantoin is about 10 mg/mL, and in a ratio of magnesium aluminum silicate to carboxymethylcellulose sodium of 0.2:1 to 0.75:1, and lead; wherein for an amount of about 5 mg/ml to 10 mg/ml nitrofurantoin in the aqueous pharmaceutical suspension, the amount of lead is less than 5 ppm.
17 . The aqueous pharmaceutical suspension of claim 16 , wherein the amount of lead is less than 3.5 ppm.
18 . The aqueous pharmaceutical suspension of claim 16 , wherein the nitrofurantoin or its pharmaceutically acceptable salt or the polymorph is in an amount of about 5 mg/ml to 10 mg/ml.
19 . The aqueous pharmaceutical suspension of claim 16 , wherein the suspending agent comprises magnesium aluminum silicate and carboxymethylcellulose sodium.
20 . The aqueous pharmaceutical suspension of claim 16 , wherein the ratio of magnesium aluminum silicate to carboxymethylcellulose sodium is 0.2:1 to 0.75:1.
21 . The aqueous pharmaceutical suspension of claim 16 , wherein pH of the formulation is in a range of 4.5 to 6.5.
22 . The aqueous pharmaceutical suspension of claim 16 , wherein the formulation is a uniform product.
23 . The aqueous pharmaceutical suspension of claim 16 , wherein the formulation further comprises methyl paraben and propyl paraben, wherein the amount of methyl paraben is at least 6 times more than propyl paraben.
24 . The aqueous pharmaceutical suspension of claim 20 , wherein the nitrofurantoin or its pharmaceutically acceptable salt or the polymorph is in an amount of about 5 mg/ml, and the amount of lead is less than 3.5 ppm.
25 . The aqueous pharmaceutical suspension of claim 20 , wherein the nitrofurantoin or its pharmaceutically acceptable salt or the polymorph is in an amount of about 10 mg/ml, and the amount of lead is less than 3.5 ppm.
26 . An aqueous pharmaceutical suspension for oral administration comprising a formulation comprising nitrofurantoin or its pharmaceutically salt or polymorph, a suspending agent consisting of magnesium aluminum silicate in an amount of about 4 mg/mL and carboxymethylcellulose sodium in an amount of about 20 mg/mL when the concentration of nitrofurantoin is about 5 mg/mL, and magnesium aluminum silicate in an amount from about 8 mg/mL to about 9 mg/mL and carboxymethylcellulose sodium in an amount from about 12 mg/mL to about 14 mg/mL when the concentration of nitrofurantoin is about 10 mg/mL; the magnesium aluminum silicate and carboxymethylcellulose sodium being in the ratio of 0.2:1 to 0.75:1:
wherein the aqueous pharmaceutical suspension is a uniform product; and
wherein aqueous pharmaceutical suspension contains from 5 mg/ml to 10 mg/ml nitrofurantoin and contains less than 3.5 ppm Lead as an impurity.