Method for delivering exenatide into a lumen of the intestinal tract using a swallowable drug delivery device

• US 10,029,080 B2
• Filed: 10/31/2016
• Issued: 07/24/2018
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: RaNA Therapeutics Inc.
• Original Assignee: RaNA Therapeutics Inc.
• Inventors: Imran, Mir
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US15/339,722
• Publication Number:
  US 20170043144A1
• Time in Patent Office: 631 Days
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: 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
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: 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
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: 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
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: 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 vaccination appliances for veterinary use A61D1/025 ; 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; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics

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

1. A method for delivering Exenatide 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 Exenatide preparation operably coupled to the actuator, the Exenatide preparation comprising a therapeutically effective dose of Exenatide, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the lumen wall in the second configuration so as to deliver the Exenatide preparation into the lumen wall; and

actuating the actuator responsive to a condition in the small intestine to deliver the Exenatide 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 the dose of Exenatide is in the preparation is in a range from about 1 to 10 μ

g.

5. The method of claim 1, further comprising:

using the dose of delivered Exenatide to control a blood glucose level of a patient without injecting Exenatide into the patient.

6. The method of claim 1, wherein the Exenatide preparation comprises a therapeutically effective dose of another therapeutic agent for the treatment of diabetes or another glucose regulation disorder.

7. The method of claim 6, wherein the other therapeutic agent comprises a therapeutically effective dose of insulin.

8. The method of claim 7, wherein the dose of insulin in the preparation is in a range from about 1 to 50 units of insulin.

9. The method of claim 8, wherein the dose of insulin is in a range from about 4 to 9 units of insulin.

10. The method of claim 7, further comprising:

using the dose of delivered Exenatide and insulin to control a blood glucose level of a patient without injecting insulin into the patient.

11. The method of claim 6, wherein the other therapeutic agent comprises a therapeutically effective dose of an incretin for the treatment of diabetes or another glucose regulation disorder.

12. The method of claim 11, wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP).

13. The method of claim 12, wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg.

14. The method of claim 11, further comprising:

using the dose of delivered Exenatide and incretin to control a blood glucose level of a patient without injecting incretin into the patient.

15. The method of claim 6, wherein the other therapeutic agent comprises metformin.

16. The method of claim 15, further comprising

using the dose of delivered Exenatide and the metformin to control a blood glucose level of a patient without injecting incretin into the patient.

17. The method of claim 15, wherein the doses of the Exenatide and the metformin in the preparation are matched to produce an improved level of blood glucose control for an extended period.

18. The method of claim 17, wherein a dose of Exenatide in the preparation is in a range of about 1 to 10 μ

g and a dose of metformin in the preparation is in a range of about 1 to 3 grams.

19. The method of claim 17, wherein the extended period is up to about a day.

20. The method of claim 17, wherein the extended period is up to about a week.