Hydrocortisone acetate suppository formulation for treatment of disease
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Publication Number
US-12097288-B2
Publication Date
2024-09-24
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 disclosed invention relates to a drug delivery element comprising a shell defining an internal cavity configured to contain a medication. The medication contains an active drug ingredient in a first form, where the first form is a semi-solid, and the shell is water soluble and configured to dissolve following placement into a rectum to release the medication.
Upon dissolving in the rectum, the medication is released in a second form different from the first form, where the second form is a liquid. The active drug ingredient is absorbable by a mucosa lining of the rectum, and hydrocortisone acetate is described as the active drug ingredient for gastrointestinal diseases.
The disclosure further describes hydrocortisone acetate suppository formulations comprising hydrocortisone acetate plus colloidal silicon dioxide, with optional oleaginous triglyceride bases and antioxidants. Structural and deployment concepts for rectal placement and contact area are described, including oblong/outer-surface designs and an insertion applicator, as well as embodiments using an expandable ring, tree, filament, film, fabric, or sponge.
Claims Coverage
The provided material contains 1 independent claim with multiple dependent claim refinements, centered on a water-soluble shell drug delivery element that dissolves after rectal placement to release a changed medication form.
Water-soluble shell dissolving in the rectum to release a different liquid form medication
A shell defining an internal cavity configured to contain a medication comprising an active drug ingredient in a first form, the first form being a semi-solid, wherein the shell is water soluble and configured to dissolve following placement into a rectum to release the medication, the medication being released in a second form different from the first form, the second form being a liquid, the active drug ingredient being absorbable by a mucosa lining of the rectum.
Semi-solid medication with hydrocortisone acetate as active drug ingredient
The active drug ingredient is hydrocortisone acetate.
Semi-solid medication further including colloidal silicon dioxide
The medication further includes colloidal silicon dioxide.
Water-soluble shell with selected geometric shapes
The shell has a shape selected from spherical, cylindrical, rectangular, or triangular.
Combination with an insertion device using a barrel and plunger
An insertion device combination is provided wherein the barrel holds the element and a plunger releases the element to administer it.
Coverage is directed to a rectally placed, water-soluble shell that dissolves to release a semi-solid medication in a changed second liquid form with rectal mucosa absorbability, with refinements to hydrocortisone acetate, colloidal silicon dioxide, selected shell geometry, and an insertion device including a barrel and plunger.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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