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US 12,751,947 B2Granted
Oral liquid formulation of apixaban
AssigneeLiqmeds Worldwide Limited
InventorsManish Umrethia, Chintan Pansara
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Abstract
Disclosed herein relates to an oral liquid formulation of apixaban and more specifically an oral liquid formulation of apixaban comprising a therapeutically effective amount of apixaban, a salt or prodrug thereof; one or more viscosifying agents; one or more buffering agents to provide a formulation pH of from about 3.5 to about 4.5, and one or more pharmaceutically acceptable excipients. Also disclosed herein relates to a process for preparing an oral liquid formulation of apixaban and a method of using the same.
Claims21
An oral liquid formulation, consisting of:
- particulate apixaban in an amount of about 1 mg/mL;
- a thickening agent comprising xanthan gum in an amount of from about 3.5 mg/mL to about 5.5 mg/mL;
- a buffering agent comprising citric acid in an amount of about 12.25 mg/mL, and sodium citrate in an amount of about 10.5 mg/mL;
- a pH of from 3.5 to 4.5;
- an antifoaming agent comprising simethicone in an amount of from about 2.5 mg/mL to about 5 mg/mL;
- a viscosifying agent comprising sorbitol in an amount of about 200 mg/mL;
- one or more pharmaceutically acceptable excipients comprising a sweetening agent, a preservative, a flavoring agent, or a combination thereof;
- a vehicle comprising glycerin in an amount of about 200 mg/mL and water;
- and
- a total apixaban impurity content of not more than 1% after storage of the oral liquid formulation at 25° C.±2° C./60±5% relative humidity up to 12 months.
7 more elements
Dependencies are inferred from the claim text.