[미국특허]
Methods for delivering insulin preparations 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-038/28
A61K-009/00
A61M-025/10
A61M-005/00
A61M-031/00
A61K-038/26
A61K-045/06
A61M-025/04
출원번호
US-0339108
(2014-07-23)
등록번호
US-9457065
(2016-10-04)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
16인용 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 insulin to a patient, said method comprising: providing an oral solid insulin 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
1. A method for delivering insulin to a patient, said method comprising: providing an oral solid insulin 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;delivering the solid insulin 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 insulin into the blood stream from the intestinal wall by degradation of the of the tissue penetrating member. 2. A method as in claim 1, wherein the insulin reaches a Cmax in a shorter time period than a time period to achieve a Cmax for an extravascularly injected dose of insulin. 3. A method as in claim 2, wherein a tmax for the insulin released from therapeutic preparation is less than about 80% of a tmax for the extravascularly injected dose of insulin. 4. A method as in claim 2, wherein a tmax for the insulin released from the therapeutic preparation is less than about 50% of a tmax for the extravascularly injected dose of insulin. 5. A method as in claim 2, wherein a tmax for the insulin released from the therapeutic preparation is less than about 30% of a tmax for the extravascularly injected dose of insulin. 6. A method as in claim 2, wherein a tmax for the insulin released from the preparation is less than about 10% of a tmax for the extravascularly injected dose of insulin. 7. A method as in claim 1, wherein the solid dosage insulin comprises a biodegradable material which degrades within the intestinal wall to release insulin into the blood stream. 8. A method as in claim 7, wherein the biodegradable material comprises PGLA, a sugar or maltose. 9. A method as in claim 7, wherein the solid dosage insulin comprises at least one pharmaceutical excipient. 10. A method as in claim 9, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. 11. A method as in claim 10, wherein the binder comprises PEG. 12. A method as in claim 1, wherein a weight percent of insulin in the solid dosage insulin comprises between about 2 to 15%. 13. A method as in claim 1, further comprising retaining the solid dosage within the intestinal wall after insertion. 14. A method as in claim 13, wherein retaining comprises anchoring at least one of a barb or an inverse taper shape of the solid dosage insulin in the intestinal tissue. 15. A method as in claim 1, wherein the solid dosage insulin has sufficient stiffness to be advanced completely into the intestinal wall by such application of mechanical force. 16. A method as in claim 1, wherein the solid dosage insulin produces a long-term release of insulin. 17. A method as in claim 16, wherein the solid dosage insulin produces a long-term release of insulin to produce a selectable t½. 18. A method as in claim 1, wherein the t½ is about 12 hours. 19. A method as in claim 1, wherein the solid dosage insulin carries about 1 to 50 units of insulin. 20. A method as in claim 1, wherein the solid dosage insulin carries about 4 to 9 units of insulin. 21. A method as in claim 1, wherein the solid dosage insulin further comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder. 22. A method as in claim 21, wherein the incretin comprises a glucagon-like peptide-1 (GLP-1), a GLP-1 analogue, exenatide, liraglutide, albiglutide, taspoglutide or a gastric inhibitory polypeptide (GIP). 23. A method as in claim 21, wherein the incretin comprises exenatide and the dose is in a range from about 1 to 10 μg. 24. A method as in claim 21, wherein the incretin comprises liraglutide and the dose is in a range from about 0.1 to 1 mg.
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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