[미국특허]
Therapeutic agent preparations comprising etanercept for delivery into a lumen of the intestinal tract using a swallowable drug delivery device
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-039/00
A61M-005/00
A61M-025/10
A61M-031/00
출원번호
US-0539031
(2012-06-29)
등록번호
US-8846040
(2014-09-30)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
36인용 특허 :
27
초록▼
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
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.
대표청구항▼
1. A therapeutic preparation comprising etanercept, 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, wh
1. A therapeutic preparation comprising etanercept, 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 etanercept into the blood stream from the intestinal wall to achieve a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of etanercept. 2. The preparation of claim 1, wherein a tmax for the etanercept released from therapeutic preparation is less than about 80% of a tmax for the extravascularly injected dose of etanercept. 3. The preparation of claim 1, wherein a tmax for the etanercept released from the therapeutic preparation is less than about 50% of a tmax for the extravascularly injected dose of etanercept. 4. The preparation of claim 1, wherein a tmax for the etanercept released from the therapeutic preparation is less than about 30% of a tmax for the extravascularly injected dose of etanercept. 5. The preparation of claim 1, wherein a tmax for the etanercept released from the preparation is less than about 10% of a tmax for the extravascularly injected dose of etanercept. 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 at 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 etanercept into the blood stream. 11. The preparation of claim 10, 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 etanercept 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 etanercept in the tissue penetrating member comprises between about 8 to 12%. 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 etanercept is contained in the tissue penetrating member in a shaped section 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 Cmax achieved by delivering the preparation by insertion into the intestinal wall is substantially greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. 23. The preparation of claim 22, wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is at least about 100 times greater than the Cmax 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 etanercept. 25. The preparation of claim 24, wherein the preparation is configured produce a long-term release of etanercept to produce a selectable t1/2. 26. The preparation of claim 25, wherein the t1/2 is about 40 days. 27. The preparation of claim 1, wherein a dose of etanercept in the preparation is in a range from about 1 to 5 mg. 28. The preparation of clause 27, wherein a dose of etanercept in the preparation is about 3 mg.
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