Therapeutic agent preparations 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-009/00
A61K-009/48
C12P-021/08
A61M-029/00
A61M-005/32
A61M-025/10
A61M-005/00
A61K-031/155
C07K-016/24
A61M-031/00
A61K-039/00
출원번호
US-0539019
(2012-06-29)
등록번호
US-9402807
(2016-08-02)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
22인용 특허 :
45
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 fabricated with infliximab, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases infliximab into the blood stream from
1. A therapeutic preparation fabricated with infliximab, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases infliximab 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 infliximab. 2. The preparation of claim 1, wherein a tmax for the infliximab released from the therapeutic preparation is 80% of a tmax for the extravascularly injected dose of infliximab. 3. The preparation of claim 1, wherein a tmax for the infliximab released from the therapeutic preparation is 50% of a tmax for the extravascularly injected dose of infliximab. 4. The preparation of claim 1, wherein a tmax for the infliximab released from the therapeutic preparation is 30% of a tmax for the extravascularly injected dose of infliximab. 5. The preparation of claim 1, wherein a tmax for the infliximab released from the therapeutic preparation is 10% of a tmax for the extravascularly injected dose of infliximab. 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 orally delivered in a swallowable biodegradable capsule. 9. The preparation of claim 8, 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. 10. The preparation of claim 9, wherein the delivery means comprises a 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. 11. The preparation of claim 1, wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release infliximab into the blood stream. 12. The preparation of claim 1, wherein the biodegradable material comprises polylactic-co-glycolic acid, a sugar or maltose. 13. The preparation of claim 1, wherein the preparation comprises at least one pharmaceutical excipient. 14. The preparation of claim 13, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 15. The preparation of claim 14, wherein the binder comprises polyethylene glycol. 16. The preparation of claim 1, wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release infliximab into the blood stream. 17. The preparation of claim 16, wherein the biodegradable material comprises maltose or polylactic-co-glycolic acid. 18. The preparation of claim 1, wherein a weight percent of infliximab in the tissue penetrating member comprises between 8 to 12 percent. 19. 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. 20. The preparation of claim 19, wherein the retaining feature comprises at least one of a barb or an inverse taper shape of the tissue penetrating member. 21. The preparation of claim 1, wherein the infliximab is contained in the tissue penetrating member in a shaped section. 22. The preparation of claim 21, wherein the shaped section has a cylinder or pellet shape. 23. The preparation of claim 1, wherein the tissue penetrating member has a stiffness to be advanced completely into the intestinal wall by the application of a force to the tissue penetrating member. 24. The preparation of claim 1, wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is at least five times greater than a Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. 25. The preparation of claim 24, wherein the Cmax achieved by delivering the preparation by insertion into the intestinal wall is at least 100 times greater than the Cmax achieved when the preparation is delivered orally without insertion into the intestinal wall. 26. The preparation of claim 1, wherein the preparation is configured to produce a release of infliximab of at least 6 hours. 27. The preparation of claim 1, wherein the preparation is configured produce a release of infliximab to produce a selectable t1/2. 28. The preparation of claim 27, wherein the t1/2 is 40 days. 29. The preparation of claim 1, wherein a dose of infliximab in the preparation is in a range from 1 to 10 mg. 30. The preparation of claim 29, wherein a dose of infliximab in the preparation is 5 mg. 31. A therapeutic preparation fabricated with infliximab, the preparation shaped as a solid tissue penetrating member shaped and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases infliximab into the bloodstream from the intestinal wall to achieve a t1/2 that is greater than a t1/2 for orally ingested infliximab that is not inserted into the intestinal wall. 32. The preparation of claim 31, wherein the t1/2 of the infliximab inserted into the intestinal wall is at least 10 times greater than the t½ for the orally ingested infliximab that is not inserted into the intestinal wall.
Wright Jeremy C. (Los Altos CA) Eckenhoff James B. (Los Altos CA) Maruyama Frederick H. (San Jose CA) Peery John R. (Stanford CA), Delivery system comprising means for controlling internal pressure.
Lewkowicz,Shlomo; Gat,Daniel; Kraizer,Yehudit; Gilad,Zvika; Leuw,David; Meron,Gavriel; Glukhovsky,Arkady, Device and method for examining a body lumen.
Hugemann Berhhard (Frankfurt am Main DEX) Schuster Otto (Bad Soden DEX), Device for the release of substances at defined locations in the alimentary tract.
Pasricha Pankaj J. (Columbia MD) Kalloo Anthony N. (Glenndale MD), Device for treating gastrointestinal muscle disorders and other smooth muscle dysfunction.
Imran, Mir; Herrmann, Peter; Syed, Baber; Williams, Timothy H.; Ong, Chang Jin; Method, Greg, Device, system and methods for the oral delivery of therapeutic compounds.
Prausnitz, Mark R.; Allen, Mark G.; Henry, Sebastien; McAllister, Devin V.; Ackley, Donald E.; Jackson, Thomas, Devices and methods for enhanced microneedle penetration of biological barriers.
Yokoi,Takeshi; Takizawa,Hironobu; Segawa,Hidetake; Adachi,Hideyuki, Encapsulated medical device and method of examining, curing, and treating internal region of body cavity using encapsulated medical device.
Lehmann Grard (Neuville de Poitou FRX) Metais Jol (Monts Sur Guesnes FRX) Meunier Jean-Francois (Noisy le Grand FRX) Gautier Jean-Philippe (Ozoir la Ferriere FRX), Implantable drug-dispensing capsule and system facilitating its use.
Truex Buehl E. (Glendora CA) Gibson Scott R. (Granada Hills CA) Weinberg Alvin H. (Moorpark CA), Implantable medical device having shielded and filtered feedthrough assembly and methods for making such assembly.
Brister, Mark C.; Quintana, Nelson; Patel, Kaushik A.; Drake, Neil R.; Llevares, Antonio C.; Markovic, Dubravka; Rasdal, Andrew P.; VandenBerg, Amy D. L., Intragastric device.
Saffran Murray (Toledo OH) Neckers Douglas C. (Perrysburg OH), Method of use of polymers containing cross-linked azo bonds for releasing therapeutic agents into the lower gastrointest.
Nicolaides Ernest D. (Ann Arbor MI) Tinney Francis J. (Ann Arbor MI) Kaltenbronn James S. (Ann Arbor MI) DeJohn Dana E. (Ann Arbor MI) Lunney Elizabeth A. (Ann Arbor MI) Roark W. Howard (Ann Arbor MI, Modified tripeptides.
Eckenhoff ; deceased James B. ; Holladay Leslie A. ; Leonard ; Jr. John Joseph ; Leung Iris K. M. ; Tao Sally A. ; Magruder Judy A. ; Carr John P. ; Wright Jeremy, Peptide/protein suspending formulations.
Imran, Mir, Therapeutic agent preparations comprising etanercept for delivery into a lumen of the intestinal tract using a swallowable drug delivery device.
Imran, Mir, Therapeutic agent preparations comprising exenatide for delivery into a lumen of the intestinal tract using a swallowable drug delivery device.
Imran, Mir, Therapeutic agent preparations comprising insulin for delivery into a lumen of the intestinal tract using a swallowable drug delivery device.
Imran, Mir, Therapeutic agent preparations comprising liraglutide for delivery into a lumen of the intestinal tract using a swallowable drug delivery device.
Imran, Mir, Therapeutic agent preparations comprising pramlintide for delivery into a lumen of the intestinal tract using a swallowable drug delivery device.
Imran, Mir A.; Herrmann, Peter; Syed, Baber; Williams, Timothy H.; Ong, Chang Jin; Method, Greg, Device, system and methods for the oral delivery of therapeutic compounds.
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