Stable corticosteroid compositions
AssigneeViropharma Biologics LLC
InventorRamalingeswar Kasina
Life of this patent
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Abstract
The invention relates to pharmaceutical compositions comprising a corticosteroid and an antioxidant. The invention further relates to methods of treating, preventing, or alleviating the symptoms of and inflammation associated with inflammatory diseases and conditions of the gastrointestinal tract comprising administering the pharmaceutical compositions comprising a corticosteroid and an antioxidant.
Claims32
-22. (canceled)
A pharmaceutical composition comprising budesonide, a viscosity modifying agent, and ascorbate and wherein the pharmaceutical composition has a pH of between about 4 and about 5.2.
A pharmaceutical composition comprising:
- budesonide;
- and
- ascorbate in an amount from about 0.05% to about 0.5% w/w of the composition;
- wherein the pharmaceutical composition has a pH of between about 4 and about 5.2, wherein the pharmaceutical composition has less than 0.3% 21 dehydrobudesonide (21 DHB).
-52. (canceled)
A pharmaceutical composition comprising:
- a) budesonide in an amount of from about 0.001 to about 0.1% w/w of the composition;
- b) ascorbic acid and/or ascorbate in an amount of from about 0.05% to about 0.5% w/w of the composition;
- c) maltodextrin;
- d) disodium EDTA;
- e) citric acid;
- f) sodium citrate;
- g) Polysorbate 80;
- h) sodium benzoate;
- i) an optional flavoring agent, an optional sweetener, or combination thereof;
- or
- j) an aqueous liquid vehicle.
A pharmaceutical composition comprising:
- a) budesonide in an amount of from about 0.001 to about 0.1% w/w of the composition;
- b) a viscosity modifier in an amount of from about 0-10% w/w, wherein the viscosity modifier comprises carboxymethylcellulose, carbomer, HPMC, HEC, or a combination thereof;
- c) maltodextrin in an amount of from about 1 to about 50% w/w of the composition;
- d) disodium EDTA in an amount of from about 0.005 to about 1% w/w of the composition;
- e) citric acid in an amount of from about 0.01 to about 1% w/w of the composition;
- f) sodium citrate in an amount of from about 0.01 to about 1% w/w of the composition;
- g) Polysorbate 80 in an amount from about 0.001 to about 0.01% w/w of the composition;
- h) sodium benzoate in an amount from about 0 to about 1% w/w of the composition;
- i) ascorbate in an amount of from about 0.05% to about 0.5% w/w of the composition;
- j) a flavoring agent, sweetener, or combination thereof, and
- k) water;
- wherein the pharmaceutical composition comprises less than 0.3% impurities formed by oxidative degradation, and wherein the pharmaceutical composition is for oral administration.
Dependencies are inferred from the claim text.