Claims for Patent: 9,844,505

Summary for Patent: 9,844,505

Title:	Methods for delivering etanercept 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 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:	15/274,155
Patent Claims:	1. A method for delivering Etanercept into the wall of the small intestine, the method comprising: swallowing a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration and a Etanercept preparation operably coupled to the actuator, the Etanercept preparation comprising a therapeutically effective dose of Etanercept, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the lumen wall in the second configuration so as to deliver the Etanercept preparation into the lumen wall; and actuating the actuator responsive to a condition in the small intestine to deliver the Etanercept 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 a weight per cent of Etanercept in the solid dosage Etanercept comprises between about 8 to 12%. 5. The method of claim 1, wherein the dose of Etanercept is in the preparation is in a range from about 1 to 5 mg. 6. The method of claim 5, wherein the dose of Etanercept is in the preparation is in a range from about 3 mg. 7. The method of claim 1, wherein the Etanercept preparation comprises at least one pharmaceutical excipient. 8. The method of claim 7, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 9. The method of claim 1, further comprising retaining the Etanercept preparation within the intestinal wall after insertion. 10. The method of claim 9, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the Etanercept preparation in intestinal wall tissue. 11. The method of claim 1, wherein delivering the Etanercept preparation comprises applying a force to the Etanercept preparation. 12. The method of claim 11, wherein the Etanercept preparation is advanced completely into the intestinal wall by such application of force. 13. The method of claim 11, wherein the force is a mechanical force applied a surface of Etanercept preparation. 14. The method of claim 1, wherein the Etanercept preparation produces a long-term release of Etanercept. 15. The method of claim 14, wherein the long term release is over a period of about 6 to 24 hours. 16. The method of claim 1, further comprising: using the dose of delivered Etanercept to treat an autoimmune disease. 17. The method of claim 16, where the autoimmune disease is rheumatoid arthritis. 18. The method of claim 16, where the autoimmune disease is psoriatic arthritis. 19. The method of claim 16, where the autoimmune disease is ankylosing spondylitis. 20. The method of claim 16, where the autoimmune disease is juvenile idiopathic arthritis.

Details for Patent 9,844,505

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2030-12-23
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2030-12-23
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2030-12-23
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2030-12-23
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	09/14/2017		2030-12-23
Immunex Corporation	ENBREL	etanercept	Injection	103795			2030-12-23
Immunex Corporation	ENBREL	etanercept	Injection	103795	03/05/2020		2030-12-23