Swallowable drug delivery device and method of delivery

• US 10,039,908 B2
• Filed: 10/06/2014
• Issued: 08/07/2018
• Est. Priority Date: 12/24/2009
• Status: Active Grant

• Current Assignee: RaNA Therapeutics Inc. (Sanofi )
• Original Assignee: RaNA Therapeutics Inc. (Sanofi )
• Inventors: Imran, Mir
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US14/507,579
• Publication Number:
  US 20150025496A1
• Time in Patent Office: 1,401 Days
• Field of Search: 6048901, 6048911
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• 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 38/17 from animals; from humans enzyme inhibitors A61K38/005
• 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 38/2235 Secretins
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 38/27 Growth hormone [GH], i.e. somatotropin
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 38/29 Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• 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: A61M 2005/1401 Functional features
• CPC Class Codes: A61M 2005/14284 with needle insertion means
• CPC Class Codes: A61M 2210/106 Small intestine
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• 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 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/168 Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body flow control in general G05D7/00
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61P 19/10 : for osteoporosis
• CPC Class Codes: A61P 3/08 : for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 5/18 : of the parathyroid hormones

Abstract

Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. 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 therapeutic agent into a wall of the small intestine of a patient, the method comprising:

swallowing a drug delivery device comprising a capsule, an expandable member and a therapeutic agent preparation shaped as a solid tissue penetrating member, the tissue penetrating member coupled to the expandable member by an advancement member that advances the tissue penetrating member into the wall of the small intestine upon expansion of the expandable member, an end of the advancement member detachably engaging a non-tissue penetrating end of the tissue penetrating member, wherein the end of the advancement member engaging the tissue penetrating member has a larger horizontal surface area than the non-tissue penetrating end of the tissue penetrating member; and

expanding the expandable member responsive to a condition in the small intestine to apply a force to a solid surface of the tissue penetrating member using the advancement member so as to insert the tissue penetrating member into the wall of the small intestine where it remains and degrades to release the therapeutic agent into the patient'"'"'s blood stream.

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 therapeutic agent comprises a therapeutically effective dose of insulin for treatment of diabetes or a glucose regulation disorder;

the method further comprising;

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

5. The method of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of an incretin for treatment of diabetes or a glucose regulation disorder;

the method further comprising;

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

6. The method of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide for treatment of diabetes or a glucose regulation disorder;

the method further comprising;

using the doses of delivered incretin and biguanide to control a blood glucose level of the patient.

7. The method of claim 6, wherein the incretin comprises exenatide and the biguanide comprises metformin.

8. The method of claim 7, wherein the dose of the incretin is matched to the dose of biguanide to produce an improved level of blood glucose control for an extended period.

9. The method of claim 8, wherein the extended period is up to about a day.

10. The method of claim 1, wherein the expandable member comprises an expandable balloon.

11. A method for delivering a therapeutic agent into a wall of the small intestine of a patient, the method comprising:

swallowing a drug delivery device comprising a capsule, an expandable member and a therapeutic agent preparation shaped as a tissue penetrating member having a shaft and a tissue penetrating end, the tissue penetrating member coupled to the expandable member by an advancement member that advances the tissue penetrating member into the wall of the small intestine upon expansion of the expandable member, an end of the advancement member detachably engaging a non-tissue penetrating end of the tissue penetrating member, wherein the end of the advancement member engaging the tissue penetrating member has a larger horizontal surface area than the non-tissue penetrating end of the tissue penetrating member; and

expanding the expandable member responsive to a condition in the small intestine to apply a force to a surface of the tissue penetrating member using the advancement member so as to insert the tissue penetrating member into the wall of the small intestine where it remains and degrades to release the therapeutic agent into the patient'"'"'s blood stream.

12. The method of claim 11, wherein the condition is a selected pH.

13. The method of claim 12, wherein the pH is above about 7.1.

14. The method of claim 11, wherein the therapeutic agent comprises a therapeutically effective dose of insulin for treatment of diabetes or a glucose regulation disorder;

the method further comprising;

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

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

the method further comprising;

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

16. The method of claim 11, wherein the expandable member comprises an expandable balloon.

17. A method for delivering a therapeutic agent into a wall of the small intestine of a patient, the method comprising:

swallowing a drug delivery device comprising a capsule, an expandable member and a therapeutic agent preparation shaped as a tissue penetrating member;

the expandable member disposed in the capsule; and

expanding the expandable member responsive to a condition in the small intestine to apply a force to a solid surface of the therapeutic agent preparation so as to insert the tissue penetrating member into the wall of the small intestine where it remains and degrades to release the therapeutic agent into the patient'"'"'s blood stream, and wherein when the expandable member expands it breaks apart at least a portion of the capsule.

18. The method of claim 17, wherein the expandable member is a balloon.