Claims for Patent: 10,335,463

Summary for Patent: 10,335,463

Title:	Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
Abstract:	Embodiment 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:	15/824,976
Patent Claims:	1. A method for delivering growth hormone 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 growth hormone preparation operably coupled to the actuator, the growth hormone preparation comprising a therapeutically effective dose of growth hormone, 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 growth hormone 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 Growth hormone in the Growth hormone preparation comprises between about 2 to 10%. 6. The method of claim 1, wherein a dose of growth hormone in the Growth hormone preparation is in a range from about 0.1 to 4 mg. 7. The method of claim 6, wherein the dose of growth hormone is in a range from about 0.2 to 1 mg. 8. The method of claim 1, wherein the growth hormone is somatropin. 9. The method of claim 1, wherein the growth hormone preparation further comprises at least one pharmaceutical excipient. 10. The method of claim 9, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 11. The method of claim 10, wherein the binder comprises PEG. 12. The method of claim 1, further comprising retaining the growth hormone preparation within the intestinal wall after insertion. 13. The method of claim 12, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the growth hormone preparation in the intestinal wall. 14. The method of claim 1, wherein delivering the growth hormone preparation comprises applying a force to the growth hormone preparation. 15. The method of claim 14, wherein the growth hormone preparation is advanced completely into the intestinal wall by such application of force. 16. The method of claim 1, wherein the growth hormone preparation produces a long-term release of growth hormone. 17. The method of claim 16, wherein the long term release of growth hormone is in a range of about 12 to 48 hours. 18. The method of claim 1, wherein the release of grown hormone is used to treat growth hormone deficiency in a child. 19. The method of claim 18, wherein the growth hormone deficiency is associated with growth failure in the child. 20. The method of claim 1, wherein the release of grown hormone is used to treat growth hormone deficiency in an adult. 21. The method of claim 1, wherein upon insertion, the preparation releases growth hormone into the bloodstream from the intestinal wall to achieve a t1/2 that is greater than a t1/2 for orally ingested growth hormone that is not inserted into the intestinal wall. 22. The preparation of claim 21, wherein the t1/2 of the growth hormone inserted into the intestinal wall is at least about 10 times greater than the t1/2 for the orally ingested growth hormone that is not inserted into the intestinal wall. 23. A method for treating a growth hormone deficiency in a patient, the method comprising: swallowing a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration and a growth hormone preparation operably coupled to the actuator, the growth hormone preparation comprising a therapeutically effective dose of growth hormone, 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; actuating the actuator responsive to a condition in the intestine to deliver the growth hormone preparation into the wall of the small intestine; and utilizing the released growth hormone to treat the condition associated with growth hormone deficiency. 24. The method of claim 23, wherein the released growth hormone is used to treat growth hormone deficiency in a child. 25. The method of claim 24, wherein the growth hormone deficiency is associated with growth failure in the child. 26. The method of claim 23, wherein the released growth hormone is used to treat growth hormone deficiency in an adult. 27. A method for delivering growth hormone 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 growth hormone preparation comprising a therapeutically effective dose of growth hormone, the grown hormone preparation positioned to be moved be actuation of the actuator, 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 growth hormone preparation into the wall of the small intestine.

Details for Patent 10,335,463

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	June 23, 1987	10,335,463	2030-12-23
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	October 16, 1986	10,335,463	2030-12-23
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	February 04, 1999	10,335,463	2030-12-23
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	October 08, 1996	10,335,463	2030-12-23
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	August 29, 2000	10,335,463	2030-12-23
Emd Serono, Inc.	SAIZEN	somatropin	For Injection	019764	January 16, 2007	10,335,463	2030-12-23
Ferring Pharmaceuticals Inc.	ZOMACTON	somatropin	For Injection	019774	May 25, 1995	10,335,463	2030-12-23