Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device

Patent metadata

Field	Value
Publication number	US-2018093084-A1
Application number	US-201715832464-A
Country	US
Kind code	A1
Filing date	Dec 5, 2017
Priority date	Dec 23, 2010
Publication date	Apr 5, 2018
Grant date	—

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.

First claim

What is claimed is:

1 . A method for delivering a natalizumab compound into the wall of the small intestine, the method comprising:
swallowing a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration and a natalizumab preparation operably coupled to the actuator, the natalizumab preparation comprising a therapeutically effective dose of a natalizumab compound comprising somatostatin, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration so as to deliver the natalizumab preparation into the intestinal wall; and actuating the actuator responsive to a condition in the small intestine to deliver the natalizumab preparation into the wall of the small intestine.

2 . The method of claim 1 , wherein the condition is a selected pH.

3 . The method of claim 2 , wherein the pH is above about 7.1.

4 . The method of claim 1 , wherein a weight per cent of natalizumab compound in the preparation is in a range between about 8 to 12%.

5 . The method of claim 1 , wherein a dose of natalizumab compound in the natalizumab preparation is in a range from about 1 to 5 mg.

6 . The method of claim 5 , wherein the dose of natalizumab or somatostatin compound in the somatostatin preparation is about 2-4 mg.

7 . The method of claim 6 , wherein the dose of natalizumab or somatostatin compound in the somatostatin preparation is about 3 mg.

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

9 . The method of claim 1 , wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

10 . The method of claim 1 , further comprising retaining the natalizumab preparation within the intestinal wall after insertion.

11 . The method of claim 10 , wherein retaining comprises anchoring a portion of the natalizumab preparation in intestinal wall tissue.

12 . The method of claim 1 , wherein delivering the natalizumab preparation comprises applying a force to the natalizumab preparation.

13 . The method of claim 12 , wherein the natalizumab preparation is advanced completely into the intestinal wall by such application of force.

14 . The method of claim 12 , wherein the Natalizumab preparation is advanced through the intestinal wall by such application of force.

15 . The method of claim 14 , wherein the force is a mechanical force applied to a surface of natalizumab preparation.

16 . The method of claim 1 , wherein the natalizumab preparation produces a long-term release of the natalizumab compound.

17 . The method of claim 16 , wherein the long term release is up to about 40 days.

18 . The method of claim 1 , further comprising:
using the dose of delivered natalizumab compound to treat an autoimmune disease.

19 . The method of claim 18 , wherein the autoimmune disease is multiple sclerosis.

20 . The method of claim 18 , wherein the autoimmune disease is Crohn's disease.

Assignees

• Rani Therapeutics Llc

Inventors

• Imran Mir

Classifications

• A61K38/27 Primary

  Growth hormone [GH], i.e. somatotropin · CPC title

• A61K9/4808

  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) · CPC title

• C07K16/18

  against material from animals or humans · CPC title

• A61M37/0015 Primary

  by using microneedles · CPC title

• C07K16/2848

  against integrin beta3-subunit-containing molecules, e.g. CD41, CD51, CD61 · CPC title