Method for delivering liraglutide preparations into a lumen of the intestinal tract using a swallowable drug delivery device
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-038/26
A61K-009/48
C07K-014/00
A61M-025/10
A61M-005/00
A61K-038/16
A61K-045/00
A61M-031/00
A61K-045/06
출원번호
US-0338796
(2014-07-23)
등록번호
US-9486414
(2016-11-08)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
15인용 특허 :
53
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 Liraglutide to a patient, said method comprising: providing an oral solid Liraglutide 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 in
1. A method for delivering Liraglutide to a patient, said method comprising: providing an oral solid Liraglutide 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 Liraglutide 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 Liraglutide 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 Liraglutide released into the blood stream from the solid dosage Liraglutide reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of Liraglutide. 3. The method of claim 2, wherein a tmax for the Liraglutide released from the solid dosage Liraglutide is less than about 80% of a tmax for the extravascularly injected dose of Liraglutide. 4. The method of claim 2, wherein a tmax for the Liraglutide released from the solid dosage Liraglutide is less than about 50% of a tmax for the extravascularly injected dose of Liraglutide. 5. The method of claim 2, wherein a tmax for the Liraglutide released from the solid dosage Liraglutide is less than about 30% of a tmax for the extravascularly injected dose of Liraglutide. 6. The method of claim 2, wherein a tmax for the Liraglutide released from the solid dosage Liraglutide is less than about 10% of a tmax for the extravascularly injected dose of Liraglutide. 7. The method of claim 1, wherein the solid dosage Liraglutide comprises a biodegradable material which degrades within the intestinal wall to release Liraglutide into the blood stream. 8. The method of claim 7, wherein the biodegradable material comprises PGLA, a sugar or maltose. 9. The method of claim 1, wherein the solid dosage Liraglutide comprises at least one pharmaceutical excipient. 10. The method of claim 9, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 11. The method of claim 10, wherein the binder comprises PEG. 12. The method of claim 1, wherein a weight per cent of Liraglutide in the solid dosage Liraglutide comprises between about 3 to 6%. 13. The method of claim 1, wherein a dose of Liraglutide in the solid dosage Liraglutide is in a range from about 0.1 to 1mg. 14. The method of claim 13, wherein the dose of Liraglutide is about 0.6 mg. 15. The method of claim 1, further comprising retaining the solid dosage Liraglutide within the intestinal wall after insertion. 16. The method of claim 13, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the solid dosage Liraglutide in the intestinal tissue. 17. The method as in claim 1, wherein the solid dosage Liraglutide has sufficient stiffness to be advanced completely into the intestinal wall by such application of mechanical force. 18. The method of claim 1, wherein the solid dosage Liraglutide produces a long-term release of Liraglutide. 19. A method for delivering Liraglutide to a patient, said method comprising: providing a solid Liraglutide dosage in a penetrating form within a swallowable capsule having at least one tissue penetrating member having a lumen; delivering the Liraglutide dosage into a wall of the small intestine from the capsule via the tissue penetrating member lumen and an application of mechanical force on the solid Liraglutide dosage, the delivery of the Liraglutide being effectuated responsive to a condition unique to the small intestine, and wherein the Liraglutide is released into the blood stream from the dosage of Liraglutide in the wall of the small intestine. 20. The method of claim 19, wherein the condition is a pH. 21. The method of claim 19, wherein the Liraglutide dosage is in solid form.
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.
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