Hydrocortisone acetate suppository formulation for treatment of disease
Inventors
Davagian, Jennifer J. • Devarajan, Raj
Assignees
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Publication Number
US-12115252-B2
Publication Date
2024-10-15
Expiration Date
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.
Core Innovation
The invention provides hydrocortisone acetate–colloidal silicon dioxide suppository formulations comprising about 0.5% to about 5% by weight hydrocortisone acetate and about 0.1% to about 5% by weight colloidal silicon dioxide in a glyceride base comprising lecithin, wherein the formulation has a melting temperature in the range of about 35°C to about 39°C. The described formulations are configured as suppositories for gastrointestinal inflammatory conditions.
The formulation is related to delivering hydrocortisone acetate in a way that provides rectal-fluid–responsive release and improved consistency in release behavior. The document relates the formulation behavior to rectal fluid exposure and describes dissolution and release profiles.
The formulations are also characterized as providing release independent of melting temperature and improved patient retention. In addition to the compositional formulation, the document describes rectal delivery device shapes for enhanced contact with rectal mucosa, including ring-shaped medicated components, tree-shaped medicated components, medicated filaments, medicated film/fabric, medicated sponge, and water-soluble shells.
Claims Coverage
The provided independent claim specifies one inventive core: a hydrocortisone acetate/colloidal silicon dioxide suppository formulation with quantitative composition constraints and a melting temperature range. Dependent claims further narrow the dosage form, glyceride base composition, and release upon exposure to rectal fluid.
Hydrocortisone acetate and colloidal silicon dioxide in a lecithin glyceride base at 35 to 39°C melting temperature
A formulation comprising about 0.5% to about 5% by weight hydrocortisone acetate, about 0.1% to about 5% by weight colloidal silicon dioxide, and a glyceride base comprising lecithin, wherein the formulation has a melting temperature in the range of about 35°C to about 39°C.
Across the claim set provided, the inventive core is the hydrocortisone acetate and colloidal silicon dioxide formulation in a lecithin-containing glyceride base with a melting temperature of about 35°C to about 39°C, and dependent claims narrow composition loadings, specify suppository form and weight, and require hydrocortisone acetate release upon exposure to rectal fluid.
Stated Advantages
Improved patient retention.
Reduced absorption variability.
Rectal-fluid–responsive release independent of melting temperature.
Documented Applications
Suppository formulations for gastrointestinal inflammatory conditions, including ulcerative colitis, ulcerative proctitis, Crohn's disease, and inflammatory bowel disease (IBD).
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