Method of delivering a somatostatin compound into a lumen of the intestinal tract using a swallowable drug delivery device

• US 10,314,892 B2
• Filed: 09/26/2017
• Issued: 06/11/2019
• 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:
  US15/716,259
• Publication Number:
  US 20180015146A1
• Time in Patent Office: 623 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 38/31 Somatostatins
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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 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 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

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 a somatostatin 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 somatostatin preparation operably coupled to the actuator, the somatostatin preparation comprising a therapeutically effective dose of a somatostatin compound comprising somatostatin or a somatostatin analogue, 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 somatostatin preparation into the intestinal wall; and

actuating the actuator responsive to a condition in the small intestine to deliver the somatostatin 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 percent of somatostatin compound in the preparation is in a range between about 0.3 to 8%.

5. The method of claim 1, wherein a dose of somatostatin compound in the somatostatin preparation is in a range from about 50 to 600 mg.

6. The method of claim 5, wherein the dose of somatostatin or somatostatin compound in the somatostatin preparation is in a range from about 50 to 100 mg.

7. The method of claim 1, wherein the somatostatin analogue is octreotide.

8. The method of claim 7, wherein a dose of octreotide in the preparation is in a range from about 10 to 100 μ

g.

9. The method of claim 8, wherein the dose of octreotide in the preparation is in a range from about 20 to 80 μ

g.

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

11. The method of claim 10, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

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

13. The method of claim 12, wherein retaining comprises anchoring a portion of the somatostatin preparation in intestinal wall tissue.

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

15. The method of claim 14, wherein the somatostatin preparation is advanced completely into the intestinal wall by such application of force.

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

17. The method of claim 14, wherein the force is a mechanical force applied a surface of somatostatin preparation.

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

19. The method of claim 18, wherein the long term release is over a period of about 6 to 24 hours.

20. The method of claim 1, further comprising:

using the dose of delivered somatostatin compound to treat a somatostatin responsive condition.

21. The method of claim 20, wherein the somatostatin responsive condition is acromegaly.

22. The method of claim 20, wherein the somatostatin responsive condition is diarrhea associated with carcinoid syndrome, or diarrhea associated with vasoactive intestinal peptide-secreting tumors.