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Last Updated: December 15, 2024

Claims for Patent: 11,260,064

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Summary for Patent: 11,260,064

Title:	Stable corticosteroid compositions
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.
Inventor(s):	Kasina Ramalingeswar
Assignee:	VIROPHARMA BIOLOGICS LLC
Application Number:	US16244219
Patent Claims:	2. The pharmaceutical composition of claim 1 , wherein the composition comprises less than 0.3% impurities formed by oxidative degradation after one month of storage.3. The pharmaceutical composition of claim 2 , wherein the composition does not discolor after one month of storage.4. The pharmaceutical composition of claim 1 , wherein the composition comprises less than 0.3% impurities formed by oxidative degradation and does not discolor after two months of storage.5. The pharmaceutical composition of claim 1 , wherein the composition comprises less than 0.3% impurities formed by oxidative degradation and does not discolor after three months of storage.6. The pharmaceutical composition of claim 1 , wherein after two months of storage the composition comprises less than 0.2% impurities formed by oxidative degradation.7. The pharmaceutical composition of claim 2 , wherein the impurities formed by oxidative degradation comprise 21-dehydrobudesonide.8. The pharmaceutical composition of having a pH of between about 4 and about 5.2.9. The pharmaceutical composition of claim 1 , further comprising a preservative.10. The pharmaceutical composition of claim 9 , wherein the preservative is selected from sodium benzoate and potassium sorbate.11. The pharmaceutical composition of claim 1 , wherein the combination of the ascorbic acid and the salt of ascorbate is present in an amount of from about 0.1% to about 0.5% w/w of the composition.

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