IP Library Granted Patent US 11,376,217
Granted Patent B2
US 11,376,217 · App. 16/856,806 · Granted Jul 5, 2022

Hydrocortisone acetate suppository formulation for treatment of disease

Inventors: Jennifer J. Davagian (Acton, MA); Raj Devarajan (Acton, MA)
Assignee: Cristcot LLC
A61K9/025A61K9/0031A61K9/02A61K31/573A61K47/02A61K47/10A61K47/14A61K47/20A61M31/007A61M2210/1064A61M2210/1067
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Quick Facts
Patent No.
US 11,376,217
App. No.
16/856,806
Granted
Jul 5, 2022
Kind
B2
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 (33)

1. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the drug delivery element being sized and shaped to be placed entirely within the rectum, wherein the drug is a formulation comprising hydrocortisone acetate and colloidal silicone dioxide.

2. The element of claim 1 , wherein the first shape is configured for passage through the anus, and the second shape is configured to maintain placement in the rectum for a duration of time.

3. The element of claim 1 , wherein the first shape has less volume or surface area than the second shape.

4. The element of claim 1 , wherein the component is a solid or semi-solid component.

5. The element of claim 1 , wherein the component is configured to unfold or expand to form the second shape.

6. The element of claim 1 , wherein the component includes a ring.

7. The element of claim 6 , wherein the ring is folded into a loop within a loop when the component has the first shape.

8. The element of claim 1 , wherein the component includes a central portion and plural arms extending from the central portion.

9. The element of claim 8 , wherein the central portion and arms are arranged in a tree configuration.

10. The element of claim 8 , wherein the central portion and arms are arranged to allow gas flow through the central portion.

11. The element of claim 8 , wherein the arms are substantially straight.

12. The element of claim 8 , wherein the arms are in the shape of petals.

13. The element of claim 1 , wherein the component comprises a medicated film or fabric.

14. The element of claim 1 , wherein the component includes one or more filaments configured to expose the drug to the tissue.

15. The element of claim 1 , wherein the component is corrugated.

16. The element of claim 1 , wherein the component includes one or more raised bumps on a side of the component.

17. The element of claim 1 in combination with an insertion device, the insertion device comprising a barrel to hold the component when in the first shape, and a plunger to release the component from the barrel to administer the component into the rectum.

18. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the component including a ring, wherein the ring is folded into a loop within a loop when the component has the first shape.

19. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the component including a central portion and plural arms extending from the central portion, wherein the central portion and arms are arranged to allow gas flow through the central portion.

20. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the component including a central portion and plural arms extending from the central portion, wherein the arms are in the shape of petals.

21. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the component including one or more filaments configured to expose the drug to the tissue.

22. A drug delivery element comprising:

a corrugated component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the drug delivery element being sized and shaped to be placed entirely within the rectum.

23. A drug delivery element comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the component including one or more raised bumps on a side of the component, the drug delivery element being sized and shaped to be placed entirely within the rectum.

24. A drug delivery element in combination with an insertion device, comprising:

a component having a first shape external from a rectum and configured to form a second shape internal to the rectum, the second shape having a configuration to expose a drug to tissues of the rectum, the drug delivery element being sized and shaped to be placed entirely within the rectum; and

the insertion device comprising a barrel to hold the component when in the first shape, and a plunger to release the component from the barrel to administer the component into the rectum.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2020
From: DAVAGIAN, JENNIFER J.; DEVARAJAN, RAJ
To: CRISTCOT LLC
Reel/Frame 053279/0450 →
Continuity (3)
Division 15555325
Provisional Application 62131944 · Mar 12, 2015
Related Publication 20200315963A1 · Oct 8, 2020
Cited By (1)
US 12,396,946