Claims for Patent: 10,300,010

Summary for Patent: 10,300,010

Title:	Methods for delivering entanercept 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:	15/815,499
Patent Claims:	1. A method for delivering Etanercept to a patient, the method comprising: providing a solid Etanercept dosage shaped as a tissue penetrating member having a pointed tip, the tissue penetrating member configured to be carried by a swallowable capsule and penetrate and be inserted into an intestinal wall, wherein upon ingestion, the capsule advances to the small intestine of the patient; and delivering the solid Etanercept dosage into the wall of the small intestine by an application of mechanical force upon a surface of the tissue penetrating member from an actuator operably coupled to the tissue penetrating member wherein upon insertion into the intestinal wall, the tissue penetrating member remains to release Etanercept into the blood stream from the intestinal wall by degradation of the of the tissue penetrating member. 2. A method as in claim 1, wherein actuator comprises an expandable member or an expandable balloon. 3. A method as in claim 1, wherein the Etanercept reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of Etanercept. 4. A method as in claim 3, wherein a tmax for the Etanercept released from the solid dosage is less than about 50% of a tmax for the extravascularly injected dose of Etanercept. 5. A method as in claim 3, wherein a tmax for the Etanercept released from the solid dosage is less than about 30% of a tmax for the extravascularly injected dose of Etanercept. 6. A method as in claim 3, wherein a tmax for the Etanercept released from the solid dosage is less than about 10% of a tmax for the extravascularly injected dose of Etanercept. 7. A method as in claim 1, wherein the solid dosage Etanercept comprises a biodegradable material which degrades within the intestinal wall to release Etanercept into the blood stream. 8. A method as in claim 7, wherein the biodegradable material comprises PGLA, a sugar or maltose. 9. A method as in claim 1, wherein the solid dosage Etanercept comprises at least one pharmaceutical excipient. 10. A method as in claim 9, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 11. A method as in claim 10, wherein the binder comprises PEG. 12. The method of claim 1, wherein a weight percent of Etanercept in the solid dosage comprises between about 8 to 12%. 13. The method of claim 1, wherein a dose of Etanercept in the solid dosage is in a range from about 1 to 5 mg. 14. The method of claim 13, wherein the dose of Etanercept in the solid dosage is in a range from about 2 to about 4 mg. 15. A method as in claim 1, further comprising retaining the solid dosage Etanercept within the intestinal wall after insertion. 16. The method of claim 1, wherein the Etanercept solid dosage produces a long-term release of Etanercept. 17. The method of claim 16, wherein the long term release is over a period of about 6 to 24 hours. 18. The method of claim 1, further comprising: using the dose of delivered Etanercept to treat an autoimmune disease in the patient. 19. The method of claim 18, where the autoimmune disease is rheumatoid arthritis. 20. The method of claim 18, where the autoimmune disease is psoriatic arthritis. 21. The method of claim 18, where the autoimmune disease is ankylosing spondylitis. 22. The method of claim 18, where the autoimmune disease is juvenile idiopathic arthritis.

Details for Patent 10,300,010

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