Claims for Patent: 8,980,822

Summary for Patent: 8,980,822

Title:	Therapeutic agent preparations comprising pramlintide for delivery 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 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.
Inventor(s):	Imran; Mir (Los Altos Hills, CA)
Assignee:	Rani Therapeutics, LLC (San Jose, CA)
Application Number:	13/538,783
Patent Claims:	1. A therapeutic preparation comprising pramlintide, the preparation shaped as a solid tissue penetrating member having a dart-like structure, the preparation configured to be contained in an oval shaped swallowable capsule to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases pramlintide into the blood stream from the intestinal wall to achieve a C.sub.max in a shorter time period than a time period to achieve a C.sub.max for an extravascularly injected dose of pramlintide. 2. The preparation of claim 1, wherein a t.sub.max for the pramlintide released from the therapeutic preparation is about 80% of a t.sub.max for the extravascularly injected dose of pramlintide. 3. The preparation of claim 1, wherein a t.sub.max for the pramlintide released from the therapeutic preparation is about 50% of a t.sub.max for the extravascularly injected dose of pramlintide. 4. The preparation of claim 1, wherein a t.sub.max for the pramlintide released from the therapeutic preparation is about 30% of a t.sub.max for the extravascularly injected dose of pramlintide. 5. The preparation of claim 1, wherein a t.sub.max for the pramlintide released from the therapeutic preparation is about 10% of a t.sub.max for the extravascularly injected dose of pramlintide. 6. The preparation of claim 1, wherein the preparation is adapted for insertion into the wall of the small intestine. 7. The preparation of claim 1, wherein the extravascular injection is a subcutaneous injection or an intramuscular injection. 8. The preparation of claim 1, wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, 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. 9. The preparation of claim 8, wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. 10. The preparation of claim 1, wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release pramlintide into the blood stream. 11. The preparation of claim 1, wherein the biodegradable material comprises PGLA, a sugar or maltose. 12. The preparation of claim 1, wherein the preparation comprises at least one pharmaceutical excipient. 13. The preparation of claim 12, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 14. The preparation of claim 13, wherein the binder comprises PEG. 15. The preparation of claim 1, wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release pramlintide into the blood stream. 16. The preparation of claim 15, wherein the biodegradable material comprises maltose or PGLA. 17. The preparation of claim 1, wherein a weight percent of pramlintide in the tissue penetrating member comprises between about 0.1 to 1%. 18. The preparation of claim 1, wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. 19. The preparation of claim 18, wherein the retaining feature comprises at least one of a barb or an inverse taper shape of the tissue penetrating member. 20. The preparation of claim 1, wherein the tissue penetrating member includes a shaped section in which the pramlintide is contained, wherein the shaped section has a cylinder or pellet shape. 21. The preparation of claim 1, wherein the tissue penetrating member has sufficient stiffness to be advanced completely into the intestinal wall by the application of a force to the tissue penetrating member. 22. The preparation of claim 1, wherein the C.sub.max achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a C.sub.max achieved when the preparation is delivered orally without insertion into the intestinal wall. 23. The preparation of claim 22, wherein the C.sub.max achieved by delivering the preparation by insertion into the intestinal wall is at least about 10 times greater than the C.sub.max achieved when the preparation is delivered orally without insertion into the intestinal wall. 24. The preparation of claim 1, wherein the preparation is configured to produce a long-term release of pramlintide. 25. The preparation of claim 24, wherein the preparation is configured produce a long-term release of pramlintide to produce a selectable t.sub.1/2. 26. The preparation of claim 25, wherein the t.sub.1/2 is about 10 hours. 27. The preparation of claim 1, wherein a dose of pramlintide in the preparation is in a range from about 15 to 120 .mu.g. 28. The preparation of claim 1, wherein the therapeutic preparation further comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder. 29. The preparation of claim 28, wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). 30. The preparation of claim 28, wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 .mu.g.

Details for Patent 8,980,822

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Llc	TANZEUM	albiglutide	For Injection	125431	04/15/2014		2030-12-23