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US 12,576,026 B2Granted
Formulations of nebivolol
OwnerVinayak Dinesh Dendukuriinventor
Life of this patent
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Abstract
Formulations of Nebivolol are provided. One formulation includes 0.05 to 10% (w/w) of Nebivolol or a pharmaceutically acceptable salt thereof, 0.4 to 10% (w/w) of a solubilizer, and 5 to 90% (w/w) of a sweetener. The formulation has a pH in the range of 3 to 7. A reconstituted formulation including the formulation with a liquid vehicle is also provided. Also provided are processes of preparing the formulations.
Claims5
A formulation of powder for oral solution, said formulation comprising:
- a. from 0.05 to 10% (w/w) of nebivolol hydrocholoride as the sole active agent;
- b. from 0.4 to 10% (w/w) of a solubilizer selected from cyclodextrin, propylene glycol, polyethylene glycol, polysorbate 20, polysorbate 80, sorbitan monooleate, poloxamer, and sodium lauryl sulfate;
- c. from 5 to 90% (w/w) of one or more sweetener selected from the group consisting of glucose, fructose, sucrose, xylitol, tagatose, sucralose, maltitol, isomaltulose, isomaltulose, lactitol, sorbitol, erythritol, trehalose, maltodextrin, polydextrose, inulin, erythritol, acesulfame, and salts thereof, alitame, aspartame, neotame, sodium cyclamate, saccharin and salts thereof;
- and
- d. from 0.05 to 20% (w/w) of a preservative selected from the group consisting of ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene, sodium benzoate, sodium bisulfate, sodium metabisulfite, sodium sulfite, methyl paraben, propylparaben, benzoic acid, potassium sorbate, and combinations thereof,
- wherein upon reconstitution with a liquid vehicle selected from the group consisting of water, ethyl alcohol, syrup, beverage, juices, and combinations thereof, the liquid formulation obtained has a pH from 3 to 7 and;
- has less than 1% (w/w) of impurities at the end of storage for at least 30 days.
4 more elements
A powder formulation for oral solution comprising:
- a. from 0.1 to 1% (w/w) of nebivolol hydrochloride as the sole active agent;
- b. from 4 to 10% (w/w) of sodium lauryl sulfate;
- c. from 7 to 90% (w/w) of sorbitol;
- d. from 0.5 to 1% (w/w) of sodium benzoate,
- e. from 1 to 5% (w/w) of a flavoring agent,
- wherein upon reconstitution with 0.1 to 50 ml of a liquid vehicle selected from the group consisting of water, ethyl alcohol, syrup, beverage, juices, or combinations thereof, the liquid formulation obtained has a pH in the range of 3 to 7 and has less than 1% (w/w) of impurities at the end of storage for at least 30 days.
3 more elements
Dependencies are inferred from the claim text.