Oral pharmaceutical composition comprising Zonisamide and process of preparation thereof
The present invention relates to the pharmaceutical composition comprising Zonisamide and one or more pharmaceutically acceptable excipients and also relates to the process for the preparation of the pharmaceutical composition comprising Zonisamide.
1 . A liquid oral pharmaceutical suspension, comprising:
zonisamide in an amount of about 20 mg/mL, wherein the zonisamide is the only active pharmaceutical ingredient in the liquid oral pharmaceutical suspension;
about 2 mg/mL to about 3.5 mg/mL of xanthan gum, or about 20 mg/mL of a combination of sodium carboxymethylcellulose (Na-CMC) and microcrystalline cellulose;
water;
one or more buffering agents, wherein the one or more buffering agents comprise sodium citrate, potassium citrate, citric acid monohydrate, trisodium citrate dihydrate, sodium phosphate, or disodium hydrogen phosphate;
sucralose;
strawberry flavor; and
a preservative, wherein the preservative comprises sodium benzoate;
wherein the liquid pharmaceutical composition has a pH of 3.5 to 5.0,
wherein the suspension has 0.10% or less of total impurities when stored at 40° C. and 25% relative humidity for at least 1 month.
2 . The liquid oral pharmaceutical suspension according to claim 1 , wherein the one or more buffering agents are selected from sodium phosphate, or disodium hydrogen phosphate.
3 . The liquid oral pharmaceutical suspension according to claim 1 , wherein the buffering agents are citric acid monohydrate, and tri-sodium citrate dihydrate.
4 . The liquid oral pharmaceutical suspension according to claim 1 , wherein the suspension has a single max impurity of 0.06% or less.
5 . The liquid oral pharmaceutical suspension according to claim 1 , wherein the suspension exhibits less than 0.05% of impurity A.
6 . The liquid oral pharmaceutical suspension according to claim 1 , further comprising a wetting agent.
7 . The liquid oral pharmaceutical suspension of claim 1 , wherein the sodium benzoate is present at a concentration of about 1 mg/mL or about 2 mg/mL.
8 . The liquid oral pharmaceutical suspension of claim 3 , wherein the citric acid monohydrate is present at about 3.7 mg/mL and the tri-sodium citrate dihydrate is present at about 3.6 mg/mL.
9 . The liquid oral pharmaceutical suspension of claim 1 , wherein the pH is 4.2, 4.3, 4.4, or 4.5.