# US 11,304,895 B2 · Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

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- Number: US 11,304,895 B2
- Document ID: US11304895B2
- Status: Granted
- Kind: B2
- Application number: 16/412,952
- Filed: 2019-05-15
- Published: 2019-11-28
- Granted: 2022-04-19
- Earliest claimed: 2010-12-23
- Assignees: Rani Therapeutics, LLC
- Applicants: Rani Therapeutics, LLC
- Inventors: Mir Imran
- Web page: https://patentgrep.com/patent/US11304895B2

## CPC

- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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 38/21: Interferons {[IFN]}
- A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00)
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- 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)}
- A61M 2210/106: Small intestine
- 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)}

## Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Many embodiments provide a swallowable device for delivering the agents. Particular embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. Embodiments also provide various drug preparations that are configured to be contained within the capsule, advanced from the capsule into the intestinal wall and degrade to release the drug into the bloodstream to produce a therapeutic effect. The preparation can be operably coupled to delivery means having a first configuration where the preparation is contained in the capsule and a second configuration where the preparation is advanced out of the capsule into the intestinal wall. 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

A method for delivering Interferon to a patient, the method comprising:
administering to the patient by swallowing an enclosure having an interior, a delivery means, and a therapeutic preparation coupled to the delivery means, the therapeutic preparation comprising a therapeutically effective dose of Interferon, the delivery means having a first configuration and a second configuration, the preparation being contained within the interior in the first configuration and advanced out of the interior and into a gastro-intestinal (GI) lumen wall of the patient in the second configuration so as to deliver the preparation into the GI lumen wall, the preparation supplied in the enclosure in a shaped form configured to be delivered from the enclosure into the GI lumen wall by application of force on the preparation; and
triggering the delivery means responsive to a condition in the GI lumen to deliver the therapeutic preparation from the enclosure into the GI lumen wall.

### Claim 2 (depends on 1)

The method of claim 1, wherein the delivery means comprises at least one expandable member having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state.

### Claim 3 (depends on 2)

The method of claim 2, wherein the at least one expandable member comprises an expandable balloon.

### Claim 4 (depends on 1)

The method of claim 1, wherein the GI lumen is the patient's stomach and the therapeutic preparation degrades within a wall of the stomach to release the therapeutically effective dose of Interferon into the patient's blood stream.

### Claim 5 (depends on 1)

The method of claim 1, wherein the GI lumen is the patient's small intestine and the therapeutic preparation degrades within a wall of the small intestine to release the therapeutically effective dose of Interferon into the patient's blood stream.

### Claim 6 (depends on 1)

The method of claim 1, wherein the condition in the GI lumen is a presence of a selected GI fluid.

### Claim 7 (depends on 6)

The method of claim 6, wherein the selected GI fluid is that found in the stomach.

### Claim 8 (depends on 6)

The method of claim 6, wherein the selected GI fluid is that found in the small intestine.

### Claim 9 (depends on 1)

The method of claim 1, wherein the condition in the GI lumen is a pH.

### Claim 10 (depends on 9)

The method of claim 9, wherein the pH is a pH above about 7.1.

### Claim 11 (depends on 1)

The method of claim 1, wherein the therapeutic preparation further comprises at least one pharmaceutical excipient.

### Claim 12 (depends on 11)

The method of claim 11, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative, or a disintegrant.

### Claim 13 (depends on 1)

The method of claim 1, wherein a weight percent of Interferon in the therapeutic preparation is between about 0.1% to about 3%.

### Claim 14 (depends on 1)

The method of claim 1, wherein a weight percent of Interferon in the therapeutic preparation is between about 0.05% to about 0.2%.

### Claim 15 (depends on 1)

The method of claim 1, wherein the therapeutic preparation is advanced completely into the GI lumen wall in the second configuration.

### Claim 16 (depends on 1)

The method of claim 1, wherein the therapeutic preparation produces a long-term release of Interferon.

### Claim 17 (depends on 1)

The method of claim 1, wherein the preparation is configured to produce a long-term release of Interferon to produce a selectable t ½.

### Claim 18 (depends on 17)

The method of claim 17, wherein the preparation is configured to produce a t ½ of about 12 hours.

### Claim 19 (depends on 1)

The method of claim 1, wherein the therapeutically effective dose of Interferon in the therapeutic preparation is in a range of about 0.03 mg to about 25 mg of Interferon.

### Claim 20 (depends on 1)

The method of claim 1, wherein the enclosure comprises a swallowable capsule.

### Claim 21 (depends on 20)

The method of claim 20, wherein the swallowable capsule comprises a material which is degradable within a selected GI fluid.

### Claim 22 (depends on 21)

The method of claim 21, further comprising: degrading wherein the material of the capsule is configured to degrade in response to exposure to the selected GI fluid so as trigger the delivery means.

### Claim 23 (depends on 22)

The method of claim 22, wherein the selected GI fluid is that found in the stomach.

### Claim 24 (depends on 22)

The method of claim 22, wherein the selected GI fluid is that found in the small intestine.

### Claim 25 (depends on 22)

The method of claim 22, wherein the selected GI fluid has a pH in a range from about 7 to about 8.