Claims for Patent: 9,492,378

Summary for Patent: 9,492,378

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:	14/500,547
Patent Claims:	1. A method for delivering Etanercept to a patient, said method comprising: providing an oral 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 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 expandable member 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. The method of claim 1, wherein the Etanercept released into the blood stream from the solid dosage Etanercept reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of Etanercept. 3. The method of claim 2, wherein a tmax for the Etanercept released from the solid dosage Etanercept is less than about 80% of a tmax for the extravascularly injected dose of Etanercept. 4. The method of claim 2, wherein a tmax for the Etanercept released from the solid dosage Etanercept is less than about 50% of a tmax for the extravascularly injected dose of Etanercept. 5. The method of claim 2, wherein a tmax for the Etanercept released from the solid dosage Etanercept is less than about 30% of a tmax for the extravascularly injected dose of Etanercept. 6. The method of claim 2, wherein a tmax for the Etanercept released from the solid dosage Etanercept is less than about 10% of a tmax for the extravascularly injected dose of Etanercept. 7. The method of claim 1, wherein the tissue penetrating member is inserted into a wall of the small intestine. 8. The method of claim 1, wherein the solid dosage Etanercept comprises a biodegradable material which degrades within the intestinal wall to release Etanercept into the blood stream. 9. The method of claim 8, wherein the biodegradable material comprises PGLA, a sugar or maltose. 10. The method of claim 1, wherein the solid dosage Etanercept comprises at least one pharmaceutical excipient. 11. The method of claim 10, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 12. The method of claim 11, wherein the binder comprises PEG. 13. The method of claim 1, wherein a weight percent of Etanercept in the solid dosage Etanercept comprises between about 8 to 12%. 14. The method of claim 1, wherein a dose of etanercept in the solid dosage Etanercept is in a range from about 1 to about 5 mg. 15. The method of claim 14, wherein the dose of etanercept is about 3 mg. 16. The method of claim 14, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the solid dosage Etanercept in the intestinal tissue. 17. The method of claim 1, further comprising retaining the solid dosage Etanercept within the intestinal wall after insertion. 18. The method of claim 1, wherein the solid dosage Etanercept has sufficient stiffness to be advanced completely into the intestinal wall by such application of force. 19. The method of claim 1, wherein the solid dosage Etanercept produces a long-term release of Etanercept. 20. The method of claim 1, wherein a Cmax achieved by delivering the solid dosage Etanercept into the intestinal wall is at least about 100 times greater than a Cmax achieved when the solid dosage Etanercept is delivered orally without insertion into the intestinal wall.

Details for Patent 9,492,378

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