Oral drug delivery device with expanding band

Patent metadata

Field	Value
Publication number	US-2023355532-A1
Application number	US-202118245425-A
Country	US
Kind code	A1
Filing date	Sep 15, 2021
Priority date	Sep 16, 2020
Publication date	Nov 9, 2023
Grant date	—

Abstract

The present disclosure provides a drug delivery device. The drug delivery device is taken orally by a patient, and a capsule degrades within the gastrointestinal (GI) tract of the patient. An expanding band coated with a drug and located within the capsule expands and interfaces with the interior of the GI tract, allowing the drug to diffuse through the GI tract. After a period of time, the expanding band degrades and passes through the GI tract.

First claim

What is claimed is:

1 . An oral drug delivery device comprising:
a biodegradable capsule; and an expanding band coiled within the biodegradable capsule, the expanding band comprising:
a substrate;
an interfacing surface on the substrate; and
a solid drug applied to the interfacing surface;
wherein the expanding band is configured to expand after the biodegradable capsule has at least partially degraded, the interfacing surface is configured to interface with an interior of a gastrointestinal tract of a patient, and the expanding band is further configured to degrade within the gastrointestinal tract of the patient.

2 . The oral drug delivery device of claim 1 , wherein the substrate comprises a plurality of substrate pieces.

3 . The oral drug delivery device of claim 2 , wherein the plurality of substrate pieces are coupled together through a biodegradable adhesive.

4 . The oral drug delivery device of claim 2 , wherein the plurality of substrate pieces cooperate to define the interfacing surface.

5 . The oral drug delivery device of claim 1 , wherein the substrate is formed as a single continuous piece.

6 . The oral delivery device of claim 1 , wherein the substrate is composed of at least one of the following materials: thermoplastic polyurethane, polyglycolic acid, polylactic acid, and polycaprolactone.

7 . The oral delivery device of claim 6 , wherein the substrate is composed of blend of two or more of polyglycolic acid, polylactic acid, polycaprolactone, and polyethylene glycol.

8 . The oral drug delivery device of claim 1 , wherein the biodegradable capsule is configured to degrade after a change in pH occurs in an environment surrounding the biodegradable capsule.

9 . The oral drug delivery device of claim 1 , wherein the substrate has a thickness of about 0.1 mm to about 0.3 mm.

10 . The oral drug delivery device of claim 1 , wherein the solid drug is applied to the interfacing surface in a repeating pattern of dots.

11 . The oral drug delivery device of claim 1 , wherein the interfacing surface comprises a mucosal adhesive.

12 . The oral drug delivery device of claim 1 , wherein the solid drug includes at least one of a peptide and a protein.

13 . An oral drug delivery device comprising:
an enteric coating; a plurality of substrate pieces within the enteric coating, wherein the plurality substrate pieces are coupled together; an interfacing surface spanning the plurality of substrate pieces, wherein the interfacing surface is configured to interface with an interior of a gastrointestinal tract of a patient; and a drug applied to the interfacing surface, the drug configured to be absorbed through the interior of the gastrointestinal tract of the patient.

14 . The oral drug delivery device of claim 13 , wherein the plurality of substrate pieces has curved or linear borders.

15 . The oral drug delivery device of claim 13 , wherein the plurality of substrate pieces is coupled together through an adhesive.

16 . The oral drug delivery device of claim 15 , wherein at least one of the plurality of substrate pieces and the adhesive is configured to degrade within the gastrointestinal tract of the patient and to pass through the gastrointestinal tract of the patient.

17 . The oral drug delivery device of claim 15 , wherein at least one of the plurality of substrate pieces and the adhesive is composed of a polymethylmethacrylate, a cellulose ester, or a polyvinyl derivative.

18 . The oral drug delivery device of claim 13 , wherein the plurality of substrate pieces is formed from one of laser cutting and die cutting.

19 . An oral drug delivery device comprising:
a capsule configured to degrade; a substrate coiled within the capsule and configured to at least partially uncoil and degrade after the capsule degrades; an interfacing surface on the substrate, the interfacing surface facing radially outward and configured to interface with an interior of a gastrointestinal tract of a patient; and a drug applied to the interfacing surface and configured to enter a bloodstream of a patient by diffusing through the interior of the gastrointestinal tract of the patient.

20 . The oral drug delivery device of claim 19 , wherein the substrate has a width from 11 mm to 18 mm and a thickness from 0.1 mm to 0.3 mm.

21 . The oral drug delivery device of claim 19 , wherein the interfacing surface comprises a coating on the substrate configured to promote diffusion of the drug through the interior of the gastrointestinal tract of the patient.

22 . The oral drug delivery device of claim 21 , wherein the substrate comprises a plurality of substrate pieces, the plurality of substrate pieces coupled together through a biodegradable adhesive.

23 . The oral drug delivery device of claim 19 , wherein the substrate is formed as a single continuous piece.

24 . The oral delivery device of claim 19 , wherein the substrate is composed of at least one of the following materials: thermoplastic polyurethane, polyglycolic acid, polylactic acid, and polycaprolactone.

25 . The oral drug delivery device of claim 19 , further comprising a wireless communication device and a wireless receiver, the wireless communication device configured to send biological information to the wireless receiver.

26 . The oral drug delivery device of claim 25 , wherein the wireless communication device and the wireless receiver communicate through one of RFID, magneto-acoustics, near field communications, ultrasonic waves, and Bluetooth.

27 . An oral drug delivery device comprising:
a biodegradable capsule; an expandable band; and a solid drug disposed on the expandable band; wherein the oral drug delivery device has:
a loaded configuration in which the expandable band is coiled within the capsule;
an expanded configuration in which the expandable band at least partially uncoils upon degradation of the capsule to place the solid drug in contact with a patient; and
a collapsed configuration in which the expandable band degrades to pass through the patient.

28 . The oral drug delivery device of claim 27 , wherein the expandable band is formed as a single continuous piece.

29 . The oral delivery device of claim 27 , wherein the expandable band is composed of at least one of the following materials: thermoplastic polyurethane, polyglycolic acid, polylactic acid, and polycaprolactone.

30 . A method for delivering a drug to a patient through a drug delivery device comprising:
administering the drug delivery device orally to the patient, the drug delivery device including a capsule, an expandable band coiled within the capsule, and a solid drug disposed on an interfacing surface of the expandable band; degrading the capsule within a small intestine of the patient; uncoiling the expandable band to engage a wall of the small intestine with the interfacing surface to place the solid drug in contact with the small intestine; and delivering the solid drug to the patient through the small intestine.

31 . The method of claim 30 , further comprising degrading the expandable band following the delivering step to collapse the expandable band.

Assignees

• Lilly Co Eli

Inventors

• Hassenpflug Eric Gustin
• Duong Anthony David
• Edwards Erik William
• Fortner Brian R
• Hooks Jr Larry Keith
• Huckaby Steven
• Petrel Trevor Alan
• Clark Sarah Louise

Classifications

• A61K9/4808 Primary

  characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084) · CPC title

• A61K9/7007

  Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence) · CPC title

• A61K9/4891

  Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004) · CPC title

• A61K9/0065

  Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus · CPC title

• A61K38/26

  Glucagons · CPC title