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;
a suspending agent comprising about 2 mg/mL to about 3.5 mg/mL xanthan gum and about 20 mg/mL of a combination of microcrystalline cellulose and sodium carboxymethylcellulose;
one or more buffering agents; and
one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprise a preservative;
wherein the liquid oral pharmaceutical suspension has a pH of 3.5 to 5.0, wherein the composition is stable for at least 6 months when stored at 40° C. and 25% relative humidity.
2. The liquid oral pharmaceutical composition according to claim 1 , wherein the one or more buffering agents are selected from the group consisting of sodium acetate, sodium citrate, ammonium sulfate, sodium phosphate, disodium hydrogen phosphate, potassium citrate, citric acid monohydrate, trisodium citrate dihydrate, and combinations thereof.
3. The liquid oral pharmaceutical suspension according to claim 1 , further comprising one or more sweetening agents, one or more flavoring agents, one or more vehicles, or combinations thereof.
4. The liquid oral pharmaceutical composition according to claim 1 , wherein the preservative is selected from the group consisting of benzyl alcohol, chloro-butanol, chloro-cresol, alkyl esters of paraben, phenol, phenyl ethanol, propylene glycol, chloroform, benzoic acid, potassium sorbate, sodium benzoate, and combinations thereof.
5. The liquid oral pharmaceutical suspension according to claim 3 , wherein the one or more sweetening agents are selected from the group consisting of sucralose, sucrose, glycerol, liquid glucose, sorbitol, maltitol, saccharin sodium, aspartame, and combinations thereof.
6. The liquid oral pharmaceutical composition according to claim 3 , wherein the one or more flavoring agents are selected from the group consisting of essential oils, fruit flavors, and combinations thereof.
7. The liquid oral pharmaceutical suspension according to claim 6 , wherein the essential oil is selected from the group consisting of peppermint oil, orange oil, lemon oil and combinations thereof.
8. The liquid oral pharmaceutical suspension according to claim 6 , wherein the fruit flavour is selected from the group consisting of peppermint flavour, raspberry flavour, strawberry flavour, tutti-fruit flavour, and combinations thereof.
9. The liquid oral pharmaceutical suspension according to claim 3 , wherein the one or more vehicles are aqueous vehicle selected from the group consisting of purified water, hydro alcoholic, a polyhydric alcohol, a buffer, and combinations thereof.
10. The liquid oral pharmaceutical composition according to claim 1 , wherein the composition has a single max impurity of 0.06% or less and total impurities of 0.10% or less.
11. The liquid oral pharmaceutical composition according to claim 1 , wherein the composition exhibits less than 0.05% of impurity A and less than 0.25% of total impurity.
12. The liquid oral pharmaceutical suspension of claim 1 , wherein the one or more buffering agents comprise citric acid monohydrate and tri-sodium citrate dihydrate.
13. The liquid oral pharmaceutical suspension according to claim 1 , comprising:
zonisamide in an amount of about 20 mg/mL;
xanthan gum in an amount of about 3.5 mg/mL;
a combination of microcrystalline cellulose and sodium carboxymethylcellulose in an amount of about 20 mg/mL;
sodium benzoate in an amount of about 1.0 mg/mL;
one or more buffering agents comprising citric acid monohydrate and tri-sodium citrate dihydrate;
one or more sweetening agents;
one or more flavoring agents; and
purified water.