Hydrocortisone Acetate Suppository Formulation For Treatment Of Disease
AssigneeCristcot LLC
InventorsJennifer J. Davagian, Raj Devarajan
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Abstract
The present invention relates, in various embodiments, to formulations comprising hydrocortisone and silicon dioxide. In additional embodiments, the invention relates to suppositories comprising hydrocortisone and silicon dioxide. The formulations of the present invention are useful for administration to patients who have gastrointestinal diseases and disorders such as, for example, inflammatory bowel disease.
Claims28
-4. (canceled)
A suppository comprising 85 mg to 95 mg hydrocortisone acetate, a suspending/dispersing agent, and an oleaginous base, wherein the suppository releases at least about 80% of the hydrocortisone acetate by about 180 minutes following exposure to dissolution media comprising a buffered 5% w/v sodium lauryl sulfate solution having a final pH in the range of about 6.8-7.0.
A suppository comprising 85 mg to 95 mg hydrocortisone acetate, a suspending/dispersing agent, and an oleaginous base, wherein the suppository has a melting temperature in the range of about 35° C. to about 41° C.
The suppository of claim 23, wherein the suspending/dispersing agent is colloidal silicon dioxide or alginic acid.
Dependencies are inferred from the claim text.