# US 2019/0167960 A1 · Swallowable drug delivery device and methods of drug delivery

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

- Number: US 2019/0167960 A1
- Document ID: US20190167960A1
- Status: Published application
- Kind: A1
- Application number: 16/201,922
- Filed: 2018-11-27
- Published: 2019-06-06
- Earliest claimed: 2009-12-24
- Assignees: Rani Therapeutics, LLC
- Applicants: Rani Therapeutics, LLC
- Inventors: Mir Imran
- Web page: https://patentgrep.com/patent/US20190167960A1

## CPC

- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61K 9/0065: {Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus}
- A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)}
- A61K 9/4808: {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)}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- A61K 38/17: from animals; from humans {(enzyme inhibitors A61K38/005)}
- A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35)
- A61K 38/2235: {Secretins}
- A61K 38/26: Glucagons
- A61K 38/27: Growth hormone [GH], i.e. somatotropin
- A61K 38/28: Insulins
- A61K 38/29: Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61M 5/168: Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters
- A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure}
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61P 3/08: for glucose homeostasis (pancreatic hormones A61P5/48)
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 5/18: of the parathyroid hormones
- A61P 19/10: for osteoporosis
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/12: Antivirals
- A61P 35/00: Antineoplastic agents
- A61M 5/14276: {specially adapted for implantation}
- A61M 2005/1401: {Functional features}
- A61M 2005/14284: {with needle insertion means}
- A61M 2210/106: Small intestine
- A61M 2230/005: Parameter used as control input for the apparatus
- 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)}
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

## Claims

### Claim 1

(canceled)

### Claim 2

A method for delivering a therapeutic agent to a patient the method' comprising: advancing a solid dosage of therapeutic agent shaped as a tissue penetrating member into a gastro-intestinal wall after oral ingestion by the patient to penetrate the solid dosage of therapeutic agent into the gastro-intestinal wall, wherein the therapeutic agent is released into the blood stream from the solid dosage of therapeutic agent in the gastro-intestinal wall.

### Claim 3 (depends on 2)

The method of claim 2, wherein the therapeutic agent is chemically degraded in a lumen of the gastro-intestinal tract and the agent is delivered into the wall of the gastro-intestinal wall and released into the blood stream with no loss of activity of the agent.

### Claim 4 (depends on 3)

The method of claim 3, wherein an amount of the therapeutic agent within the tissue penetrating member to produce a desired therapeutic effect is less than an amount to produce a corresponding effect if the agent was orally delivered without insertion into the gastro-intestinal wall.

### Claim 5 (depends on 2)

The method of claim 2, wherein the tissue penetrating member is advanced into the gastro-intestinal wall by the application of a force on a surface of the tissue penetrating member.

### Claim 6 (depends on 2)

The method of claim 2, wherein the tissue penetrating member is advanced into the gastro-intestinal wall responsive to a condition in the gastro-intestinal tract.

### Claim 7 (depends on 6)

The method of claim 6, wherein the condition is a pH.

### Claim 8 (depends on 2)

The method of claim 2, wherein the gastro-intestinal wall is the stomach wall.

### Claim 9 (depends on 2)

The method of claim 2, wherein the gastro-intestinal wall is the wall of the small intestine.

### Claim 10 (depends on 2)

The method of claim 2, wherein the solid dosage of therapeutic agent comprises at least one pharmaceutical excipient.

### Claim 11 (depends on 2)

The method of claim 2, wherein the tissue penetrating member comprises a biodegradable material which degrades within the gastro-intestinal wall to release the therapeutic agent into the blood stream.

### Claim 12 (depends on 11)

The method of claim 11, wherein the gastro-intestinal wall is the stomach wall and the tissue penetrating member degrades within the stomach wall to release the therapeutic agent into the blood stream.

### Claim 13 (depends on 11)

The method of claim 11, wherein the gastro-intestinal wall is the wall of the small intestine and the tissue penetrating member degrades within the wall of the small intestine to release the therapeutic agent into the blood stream.

### Claim 14 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder.

### Claim 15 (depends on 14)

The method of claim 14 wherein the dose of insulin is in a range from about 4 to about 9 units of insulin.

### Claim 16 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder.

### Claim 17 (depends on 16)

The method of claim 16, wherein the incretin comprises a glucagon like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP).

### Claim 18 (depends on 16)

The method of claim 16, wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 μg.

### Claim 19 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a combination of therapeutic agents for the treatment of diabetes or a glucose regulation disorder.

### Claim 20 (depends on 19)

The preparation of claim 19, wherein the combination comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide.

### Claim 21 (depends on 20)

The preparation of claim 20, wherein the incretin comprises exenatide and the biguanide comprises metformin.

### Claim 22 (depends on 21)

The preparation of claim 21, wherein the dosages of the incretin and the biguanide are matched to produce an improved level of blood glucose control for an extended period.

### Claim 23 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a therapeutically effective dose of growth hormone for the treatment of a growth disorder,

### Claim 24 (depends on 2)

The method of claim 2, wherein the dose of growth hormone is in a range from about 0.1 to 4 mg.

### Claim 25 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder.

### Claim 26 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises an immune suppressant agent.

### Claim 27 (depends on 2)

The method of claim 2, wherein the therapeutic agent comprises a therapeutically effective dose of a chemotherapeutic agent for the treatment of cancer.

### Claim 28 (depends on 27)

The method of claim 27, wherein the chemotherapeutic agent comprises a cytokine or interferon that is chemically degraded in the GI tract and the agent is delivered into the gastro-intestinal wall with minimal or no loss of immune stimulating ability.

### Claim 29 (depends on 2)

The method of claim 2, wherein therapeutic agent comprises a gamma globulin.

### Claim 30 (depends on 29)

The method of claim 29, wherein the gamma globulin comprises an antibody and the antibody is delivered is delivered into the wall of the gastro-intestinal tract with minimal or no loss in binding affinity or specificity to a target antigen site.

### Claim 31 (depends on 2)

The method of claim 2, wherein the therapeutic agent preparation comprises a therapeutically effective dose of an antiviral compound.

### Claim 32 (depends on 31)

The method of claim 31, wherein the antiviral compound comprises a protease inhibitor.

### Claim 33 (depends on 2)

The method of claim 2, wherein the solid dosage of therapeutic agent is configured to be contained in a swallowable enclosure and operably coupled to an actuator having a first configuration and a second configuration, the solid dosage being contained within the enclosure in the first configuration and advanced out of the enclosure and into the gastro-intestinal wall in the second configuration.