# US 2024/0197630 A1 · Hydrocortisone Acetate Suppository Formulation For Treatment Of Disease

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2024/0197630 A1
- Document ID: US20240197630A1
- Status: Published application
- Kind: A1
- Application number: 18/588,996
- Filed: 2024-02-27
- Published: 2024-06-20
- Earliest claimed: 2015-03-12
- Assignees: Cristcot LLC
- Applicants: Cristcot LLC
- Inventors: Jennifer J. Davagian; Raj Devarajan
- Web page: https://patentgrep.com/patent/US20240197630A1

## CPC

- A61K 9/025: {characterised by shape or structure, e.g. hollow layered, coated}
- A61K 9/0031: {Rectum, anus}
- A61K 9/02: Suppositories; Bougies; Bases therefor; {Ovules}(apparatus for making A61J3/08; devices for introducing into the body A61M31/00)
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A61M 31/007: {Injectors for solid bodies, e.g. suppositories}
- A61P 1/06: Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
- A61M 2210/1064: Large intestine
- A61M 2210/1067: Anus
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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.

## Claims

### Claim 1

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.

### Claim 2 (depends on 1)

The method of claim 1, wherein the base is melted using a hot stir plate and water bath.

### Claim 3 (depends on 1)

The method of claim 1, wherein the base is melted using low shear sweep or side scrape mixing, or a combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, wherein the base is melted at a temperature between about 50° C. and about 60° C.

### Claim 5 (depends on 1)

The method of claim 1, wherein mixing the colloidal silicon dioxide with the base is performed using a mesh.

### Claim 6 (depends on 5)

The method of claim 5, wherein the mesh is a square shape mesh.

### Claim 7 (depends on 5)

The method of claim 5, wherein the mixing is performed at a mixing speed of between about 3000 RPM and about 3500 RPM.

### Claim 8 (depends on 5)

The method of claim 5, wherein the mixing is maintained at a temperature of between about 50° C. and about 60° C.

### Claim 9 (depends on 1)

The method of claim 1, wherein adding hydrocortisone acetate to the batch comprises mixing the hydrocortisone acetate with the batch using a homogenizer.

### Claim 10 (depends on 9)

The method of claim 9, wherein the homogenizer is set at between about 4000 RPM to about 4500 RPM.

### Claim 11 (depends on 9)

The method of claim 9, wherein the homogenizer is equipped with a square shape mesh.

### Claim 12 (depends on 9)

The method of claim 9, wherein the mixing is performed at a temperature of between about 50° C. and about 60° C.