Methods for delivering insulin preparations into a lumen of the intestinal tract using a swallowable drug delivery device

Patent metadata

Field	Value
Publication number	US-9457065-B2
Application number	US-201414339108-A
Country	US
Kind code	B2
Filing date	Jul 23, 2014
Priority date	Dec 23, 2010
Publication date	Oct 4, 2016
Grant date	Oct 4, 2016

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 insulin to a patient, said method comprising:
providing an oral solid insulin dosage shaped as a tissue penetrating member having a pointed tip, the tissue penetrating member configured to be carried by a swallowable capsule and penetrate and be inserted into an intestinal wall, wherein upon ingestion the capsule advances to the small intestine of the patient;
delivering the solid insulin dosage into the wall of the small intestine by an application of mechanical force upon a surface of the tissue penetrating member from an expandable member operably coupled to the tissue penetrating member wherein upon insertion into the intestinal wall, the tissue penetrating member remains to release insulin into the blood stream from the intestinal wall by degradation of the of the tissue penetrating member.

2. A method as in claim 1 , wherein the insulin reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of insulin.

3. A method as in claim 2 , wherein a tmax for the insulin released from therapeutic preparation is less than about 80% of a tmax for the extravascularly injected dose of insulin.

4. A method as in claim 2 , wherein a tmax for the insulin released from the therapeutic preparation is less than about 50% of a tmax for the extravascularly injected dose of insulin.

5. A method as in claim 2 , wherein a tmax for the insulin released from the therapeutic preparation is less than about 30% of a tmax for the extravascularly injected dose of insulin.

6. A method as in claim 2 , wherein a tmax for the insulin released from the preparation is less than about 10% of a tmax for the extravascularly injected dose of insulin.

7. A method as in claim 1 , wherein the solid dosage insulin comprises a biodegradable material which degrades within the intestinal wall to release insulin into the blood stream.

8. A method as in claim 7 , wherein the biodegradable material comprises PGLA, a sugar or maltose.

9. A method as in claim 7 , wherein the solid dosage insulin comprises at least one pharmaceutical excipient.

10. A method as in claim 9 , wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

11. A method as in claim 10 , wherein the binder comprises PEG.

12. A method as in claim 1 , wherein a weight percent of insulin in the solid dosage insulin comprises between about 2 to 15%.

13. A method as in claim 1 , further comprising retaining the solid dosage within the intestinal wall after insertion.

14. A method as in claim 13 , wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the solid dosage insulin in the intestinal tissue.

15. A method as in claim 1 , wherein the solid dosage insulin has sufficient stiffness to be advanced completely into the intestinal wall by such application of mechanical force.

16. A method as in claim 1 , wherein the solid dosage insulin produces a long-term release of insulin.

17. A method as in claim 16 , wherein the solid dosage insulin produces a long-term release of insulin to produce a selectable t½.

18. A method as in claim 1 , wherein the t½ is about 12 hours.

19. A method as in claim 1 , wherein the solid dosage insulin carries about 1 to 50 units of insulin.

20. A method as in claim 1 , wherein the solid dosage insulin carries about 4 to 9 units of insulin.

21. A method as in claim 1 , wherein the solid dosage insulin further comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder.

22. A method as in claim 21 , 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).

23. A method as in claim 21 , wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 μg.

24. A method as in claim 21 , wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg.

Assignees

• Rani Therapeutics Llc

Inventors

• Imran Mir

Classifications

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K38/26

  Glucagons · CPC title

• A61K38/28 Primary

  Insulins · CPC title

• 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

• A61M31/002 Primary

  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) · CPC title