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

• US 10,004,783 B2
• Filed: 12/19/2016
• Issued: 06/26/2018
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: RaNA Therapeutics Inc. (Sanofi )
• Original Assignee: RaNA Therapeutics Inc. (Sanofi )
• Inventors: Imran, Mir
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US15/383,730
• Publication Number:
  US 20170100459A1
• Time in Patent Office: 554 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 38/22 Hormones derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• 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: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004
• 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 31/007 Injectors for solid bodies, e.g. suppositories
• 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 Pramlintide into a wall of an intestine, the method comprising:

swallowing a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration and a solid dart-like Pramlintide preparation operably coupled to the actuator, the Pramlintide preparation comprising a therapeutically effective dose of Pramlintide, 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 and

actuating the actuator responsive to a condition in the intestine to deliver the Pramlintide 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 intestine is the small intestine.

5. The method of claim 1, wherein a weight per cent of Pramlintide in the Pramlintide preparation comprises between about 3 to 6%.

6. The method of claim 1, wherein a dose of Pramlintide in the Pramlintide preparation is in a range from about 0.1 to 1 mg.

7. The method of claim 6, wherein the dose of Pramlintide is about 6 mg.

8. The method of claim 7, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant.

9. The method of claim 8, wherein the binder comprises PEG.

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

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

12. The method of claim 11, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the Pramlintide preparation in the intestinal tissue.

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

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

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

16. The method of claim 1, further comprising:

using the dose of delivered Pramlintide to control a blood glucose level of a patient.

17. The method of claim 1, wherein the Pramlintide preparation comprises a therapeutically effective dose of another therapeutic agent for the control of diabetes or other blood glucose regulation disorder.

18. The method of claim 17, wherein the other therapeutic agent comprises a therapeutically effective dose of insulin.

19. The method of claim 18, wherein the dose of insulin in the preparation is in a range from about 1 to 50 units of insulin.

20. The method of claim 1, further comprising:

using the dose of delivered Pramlintide and other therapeutic agent to control a blood glucose level of a patient.