Back to results
US 12,685,723 B2Granted
Oral pharmaceutical composition comprising Zonisamide and process of preparation thereof
AssigneeAzurity Pharmaceuticals, Inc.
InventorsSwati Nagar, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, Sandeep Pal
Life of this patent
Estimating the term…
Abstract
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.
Claims9
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.
7 more elements
Dependencies are inferred from the claim text.