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.
Claims12
A method of making a formulation comprising hydrocortisone acetate, colloidal silicon dioxide, and a semi-synthetic glyceride base comprising saturated C8-C18 triglyceride fatty acids and lecithin, the method comprising:
- melting a semi-synthetic glyceride base comprising saturated C8-C18 triglyceride fatty acids and lecithin;
- adding colloidal silicon dioxide to the melted base to produce a batch, wherein adding the colloidal silicon dioxide to the melted base comprises mixing the colloidal silicon dioxide with the base to hydrate the colloidal silicon dioxide;
- and
- adding hydrocortisone acetate to the batch, thereby producing a formulation comprising hydrocortisone acetate, colloidal silicon dioxide, and a semi-synthetic glyceride base comprising saturated C8-C18 triglyceride fatty acids and lecithin,
- wherein the formulation comprises about 0.5% to about 5% by weight hydrocortisone acetate, about 0.1% to about 5% by weight colloidal silicon dioxide and the semi-synthetic glyceride base comprising saturated C8-C18 triglyceride fatty acids and lecithin.
Dependencies are inferred from the claim text.