Granted Patent B2

US 12,685,723 · App. 17/975,789 · Granted Jul 21, 2026

Inventors: Swati Nagar (Amreli, IN); Sandip P. Mehta (Ahmedabad, IN); Manish Umrethia (Ahmedabad, IN); Jayanta Kumar Mandal (Ahmedabad, IN); Sandeep Pal (Ahmedabad, IN)

Assignee: Azurity Pharmaceuticals, Inc.

A61K31/423A61K9/0053A61K9/0095A61K9/08A61K9/10A61K47/12A61K47/24A61K47/26A61K47/36A61K47/38A61K47/46

Abstract

Claims (18)

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.

Assignments (9)

Priority Claims (1)

Continuity (3)

References Cited (76)