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Last Updated: October 16, 2019

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Claims for Patent: 9,456,988

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Summary for Patent: 9,456,988
Title:Swallowable drug delivery device and methods of drug delivery
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.
Inventor(s): Imran; Mir (Los Altos Hills, CA)
Assignee: Rani Therapeutics, LLC (San Jose, CA)
Application Number:14/245,679
Patent Claims:1. An ingestible device suitable for swallowing into a lumen of a gastrointestinal tract of a patient, the lumen having a lumen wall, the device comprising: a capsule sized to pass through the intestinal tract; a solid therapeutic agent preparation disposed in the capsule, the solid therapeutic agent preparation shaped as a tissue penetrating member and configured to be inserted into a wall of a small intestine, the solid therapeutic agent preparation comprising at least one therapeutic agent which would chemically degrade if released within the lumen of the gastrointestinal tract; and a release element operably coupled to the therapeutic agent preparation, the release element configured to release the solid therapeutic agent preparation from the capsule into the wall of the small intestine responsive to a condition in the small intestine, wherein when the preparation is released into the wall of the small intestine, chemical degradation of the at least one therapeutic agent in the lumen is inhibited.

2. The device of claim 1, wherein the tissue penetrating member comprises a biodegradable material configured to biodegrade in tissue to release the at least one therapeutic agent into the wall of the small intestine.

3. The device of claim 2, wherein the biodegradable material comprises a sugar, a biodegradable polymer or PGLA.

4. The device of claim 1, wherein the release element comprises a material configured to degrade upon exposure to a selected pH in the gastrointestinal tract.

5. The device of claim 3, wherein the selected pH is greater than about 7.4.

6. The device of claim 1, further comprising an actuator coupled to the release element for advancing the tissue penetrating member into the wall of the small intestine, the actuator configured to be actuated by release of the release element.

7. The device of claim 6, wherein the actuator comprises an expandable member disposed within the capsule, the expandable member having a first and second compartment separated by a releasable valve which releases upon exposure to fluid in the intestinal tract; a first reactant contained in one of the compartments and a second reactant contained in the other compartment, wherein when the valve release, the reactants mix to produce a gas which expands the expandable member; and a delivery member for advancing the tissue penetrating member into the wall of the small intestine, the delivery member operably coupled to the expandable member and the tissue penetrating member.

8. The device of claim 7, wherein the delivery member comprises a piston or a plunger.

9. The device of claim 7, wherein the release element comprises the releasable valve.

10. The device of claim 1, wherein the solid therapeutic agent preparation includes at least a first therapeutic agent and a second therapeutic agent.

11. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder.

12. The device of claim 1, wherein the solid therapeutic preparation comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder.

13. The device of claim 12, 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).

14. The device of claim 1, wherein the solid therapeutic agent preparation comprises a combination of therapeutic agents for the treatment of diabetes or a glucose regulation disorder.

15. The device of claim 14, wherein the combination comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide.

16. The device of claim 15 wherein the incretin comprises exenatide and the biguanide comprises metformin.

17. The device of claim 15, wherein the dosages of the incretin and the biguanide are matched to produce an improved level of blood glucose control for an extended period.

18. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective dose of growth hormone.

19. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder.

20. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective dose of antibiotic.

21. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective dose of an antiviral compound.

22. The device of claim 21, wherein the antiviral compound comprises a protease inhibitor.

23. The device of claim 1, wherein the solid therapeutic agent preparation comprises a therapeutically effective does of an anti-seizure compound.

24. The device of claim 23, wherein the anti-seizure compound comprises furosemide.

25. The device of claim 1, wherein the at least one therapeutic agent comprises a gamma globulin that is chemically degraded in the GI tract.

26. The device of claim 25, wherein the at least one therapeutic agent comprises an antibody.

27. The device of claim 1, wherein the at least one therapeutic agent comprises a polypeptide that is chemically degraded in the GI tract and the agent is delivered into the wall of the small intestine with minimal or no loss in binding affinity or specificity to a target binding site.

28. The device of claim 1, wherein the at least one therapeutic agent preparation comprises a therapeutically effective dose of a chemotherapeutic agent for the treatment of cancer.

29. The device of claim 28, wherein the at least one therapeutic agent comprises a cytokine or interferon that is chemically degraded in the GI tract and the at least one therapeutic agent is delivered into the wall of the small intestine with minimal or no loss in immune stimulating ability.

Details for Patent 9,456,988

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Glaxosmithkline Llc TANZEUM albiglutide INJECTABLE;INJECTION 125431 001 2014-04-15   Start Trial Rani Therapeutics, LLC (San Jose, CA) 2029-12-24 RX search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Rani Therapeutics, LLC (San Jose, CA) 2029-12-24 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Rani Therapeutics, LLC (San Jose, CA) 2029-12-24 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Rani Therapeutics, LLC (San Jose, CA) 2029-12-24 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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