Method for delivering exenatide to a patient in need thereof
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-038/26
A61M-025/10
A61M-005/00
A61K-009/00
A61K-038/28
A61K-045/06
A61M-031/00
A61K-009/48
출원번호
US-0620827
(2015-02-12)
등록번호
US-9511121
(2016-12-06)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
16인용 특허 :
54
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 method for delivering Exenatide to a patient in need thereof, the method comprising: providing a solid Exenatide dosage shaped as a tissue penetrating member that is enclosed in a swallowable capsule comprising materials which protect the solid Exantide dosage from degradation within the intest
1. A method for delivering Exenatide to a patient in need thereof, the method comprising: providing a solid Exenatide dosage shaped as a tissue penetrating member that is enclosed in a swallowable capsule comprising materials which protect the solid Exantide dosage from degradation within the intestinal tract;ingesting the solid Exenatide dosage, wherein the dosage is not degraded in the intestinal tract prior to insertion into an intestinal wall;penetrating the solid Exenatide dosage into the intestinal wall after oral ingestion by the application of mechanical force on the tissue penetrating member wherein the tissue penetrating member is retained within the intestinal wall; and,degrading the solid Exenatide dosage within intestinal wall to release the Exenatide into the intestinal wall and then into the blood stream. 2. The method of claim 1, wherein the Exenatide released from the solid dosage reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of Exenatide. 3. The method of claim 2, wherein a tmax for the Exenatide released from solid dosage is less than about 80% of a tmax for the extravascularly injected dose of Exenatide. 4. The method of claim 2, wherein a tmax for the Exenatide released from the solid dosage is less than about 50% of a tmax for the extravascularly injected dose of Exenatide. 5. The method of claim 2, wherein a tmax for the Exenatide released from the solid dosage is less than about 30% of a tmax for the extravascularly injected dose of Exenatide. 6. The method of claim 2, wherein a tmax for the Exenatide released from the solid dosage is less than about 10% of a tmax for the extravascularly injected dose of Exenatide. 7. The method of claim 1, wherein the solid dosage Exenatide is inserted into a wall of the small intestine. 8. The method of claim 1, wherein penetrating comprises operably coupling the solid dosage Exenatide to a delivery means having a first configuration wherein the solid dosage Exenatide is within the capsule and a second configuration wherein the solid-dosage Exenatide is advanced out of the capsule and into the intestinal wall. 9. The method of claim 8, wherein penetrating comprises expanding at least one expandable balloon from the first to the second configuration. 10. The method of claim 1, wherein the solid dosage Exenatide 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 1, wherein a weight percent of Exenatide in the tissue penetrating member Exenatide comprises between about 0.1 to 11%. 13. The method of claim 1, wherein the tissue penetrating member is retained in the intestinal wall by of means of at least one of a barb or an inverse tapered shape of the tissue penetrating member. 14. The method of claim 1, wherein the tissue penetrating member is advanced completely into the intestinal wall. 15. The method of claim 1, wherein the solid dosage Exenatide produces a release of Exenatide over 12 hours. 16. The method of claim 1, wherein a dose of Exenatide in the solid dosage is in a range of about 1 to 10 mcg. 17. The method of claim 1, wherein the solid dosage Exenatide further comprises a therapeutically effective dose of another incretin for the treatment of diabetes or a glucose regulation disorder. 18. The method of claim 17, wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). 19. The method of claim 17, wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg. 20. The method of claim 1, wherein the solid dosage Exenatide further comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder. 21. The method of claim 20, wherein the dose of insulin in the preparation is in a range from about 1 to 50 units of insulin. 22. The method of claim 21, wherein the dose of insulin is in a range from about 4 to 9 units of insulin. 23. The method of claim 1, further comprising degrading the capsule material in response to a selected pH in the intestinal tract so as to cause the solid dosage Exenatide to be inserted into the intestinal wall. 24. The method of claim 23, wherein the pH is in a range from about 7 to 8. 25. The method of claim 23, wherein the capsule materials comprise at least one of methacrylate or ethyl acrylate.
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, Therapeutic preparation comprising somatostatin or somatostatin analogoue 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.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.