Claims for Patent: 10,493,253

Summary for Patent: 10,493,253

Title:	Therapeutic agent preparations into a lumen of the intestinal tract using a swallowable drug delivery device
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 within the wall to release the drug to produce a therapeutic effect. The preparation can be coupled to an actuator 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.
Inventor(s):	Imran; Mir (Los Altos Hills, CA)
Assignee:	Rani Therapeutics, LLC (San Jose, CA)
Application Number:	16/265,629
Patent Claims:	1. A therapeutic agent preparation for delivery into a lumen of a gastrointestinal tract, the lumen having a lumen wall, the preparation comprising a therapeutically effective dose of at least one therapeutic agent, wherein the preparation is shaped and configured to be contained in a swallowable capsule and operably coupled to an actuator having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advances out of the capsule and penetrates into the lumen wall in the second configuration so as to deliver the therapeutic agent into the lumen wall. 2. The preparation of claim 1, wherein the lumen is a stomach and the preparation is configured to degrade within a wall of the stomach. 3. The preparation of claim 1, wherein the preparation comprises at least one pharmaceutical excipient. 4. The preparation of claim 1, wherein the preparation is configured to have a selectable surface area to volume ratio to achieve a selectable rate of release of the therapeutic agent in the lumen wall. 5. The preparation of claim 1 wherein an amount of the therapeutic agent within the preparation to produce a desired therapeutic effect is less than an amount to produce a corresponding effect if the agent was orally delivered without containment in the swallowable enclosure. 6. The preparation of claim 1, wherein the preparation is configured to be delivered within a lumen of a tissue penetrating member. 7. The preparation of claim 1, wherein at least a portion of the preparation is shaped as a tissue penetrating member advanceable into the lumen wall, the tissue penetrating member having a pointed tip. 8. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder. 9. The preparation of claim 8, wherein the dose of insulin is in a range from about 4 to 9 units of insulin. 10. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder. 11. The preparation of claim 10, 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). 12. The preparation of claim 11, wherein the incretin comprises exenatide and wherein the therapeutic agent comprises a therapeutically effective dose of exenatide, the dose being in a range from about 1 to 10 .mu.g. 13. The preparation of claim 11, wherein the incretin comprises liraglutide and wherein the therapeutic agent comprises a therapeutically effective dose of exenatide, the dose being in a range from about 1 to 2 mg. 14. The preparation of claim 1, wherein the therapeutic agent comprises a combination of therapeutic agents for the treatment of diabetes or a glucose regulation disorder. 15. The preparation of claim 14, wherein the combination comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide. 16. The preparation of claim 15, wherein the incretin comprises exenatide and the biguanide comprises metformin. 17. The preparation of claim 15, wherein the doses of the incretin and the biguanide are matched to produce an improved level of blood glucose control for an extended period. 18. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of growth hormone. 19. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder. 20. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of a chemotherapeutic agent for treatment of cancer. 21. The preparation of claim 1, wherein the therapeutic agent comprises a therapeutically effective dose of an antiviral compound. 22. A therapeutic preparation for delivery into a lumen of a gastrointestinal tract, the lumen having a lumen wall, the preparation comprising a therapeutically effective dose of at least one therapeutic agent, wherein at least a portion of the preparation is shaped as a tissue penetrating member advanceable into the lumen wall, the tissue penetrating member having a pointed tip, wherein the preparation is configured to be contained in a swallowable enclosure and operably coupled to an actuator having a first configuration and a second configuration, the preparation being contained within the enclosure in the first configuration and advanced out of the enclosure and into the lumen wall in the second configuration so as to deliver the therapeutic agent into the lumen wall. 23. The preparation of claim 22, wherein the lumen is a stomach and the preparation is configured to degrade within a wall of the stomach. 24. The preparation of claim 22, wherein the preparation comprises at least one pharmaceutical excipient. 25. The preparation of claim 22, wherein the preparation is configured to have a selectable surface area to volume ratio to achieve a selectable rate of release of the therapeutic agent in the lumen wall. 26. The preparation of claim 22, wherein an amount of the therapeutic agent within the preparation to produce a desired therapeutic effect is less than an amount to produce a corresponding effect if the agent was orally delivered without containment in the swallowable enclosure. 27. The preparation of claim 22, wherein the preparation is configured to be delivered within a lumen of the tissue penetrating member. 28. The preparation of claim 22, wherein the therapeutic agent comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder. 29. The preparation of claim 22, wherein the therapeutic agent comprises a therapeutically effective dose of growth hormone, a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder, a therapeutically effective dose of a chemotherapeutic agent for the treatment of cancer, or a therapeutically effective dose of an antiviral compound.

Details for Patent 10,493,253

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431	04/15/2014		2029-12-24
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2029-12-24