Swallowable drug delivery device and methods of drug delivery
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61M-031/00
A61K-031/155
A61M-005/20
A61K-038/26
A61K-038/27
A61K-038/28
A61K-009/48
A61M-005/168
A61K-038/22
A61K-045/06
A61K-038/29
A61K-009/00
A61K-038/17
A61M-005/172
A61M-005/14
A61M-005/142
출원번호
US-0250937
(2016-08-30)
등록번호
US-10179228
(2019-01-15)
발명자
/ 주소
Imran, Mir
출원인 / 주소
Rani Therapeutics, LLC
대리인 / 주소
Wilson Sonsini Goodrich & Rosati
인용정보
피인용 횟수 :
1인용 특허 :
76
초록▼
Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device compri
Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. 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. An ingestible device suitable for swallowing into a lumen of a gastrointestinal tract of a patient, the lumen having a lumen wall, the device comprising: a capsule sized to pass through the intestinal tract;a preparation comprising a solid therapeutic agent comprising a protein or polypeptide dis
1. An ingestible device suitable for swallowing into a lumen of a gastrointestinal tract of a patient, the lumen having a lumen wall, the device comprising: a capsule sized to pass through the intestinal tract;a preparation comprising a solid therapeutic agent comprising a protein or polypeptide disposed in the capsule, the preparation shaped as a tissue penetrating member and configured to be inserted into a wall of a small intestine, the preparation comprising at least one protein or polypeptide which would chemically degrade if released within the lumen of the gastrointestinal tract; anda release element operably coupled to the therapeutic agent preparation, the release element configured to release the solid therapeutic agent from the capsule into the wall of the small intestine responsive to a condition in the small intestine, wherein when the preparation is released into the wall of the small intestine, chemical degradation of the protein or polypeptide in the lumen is inhibited. 2. The device of claim 1, wherein the tissue penetrating member comprises a biodegradable material configured to biodegrade in tissue to release the therapeutic agent into the wall of the small intestine. 3. The device of claim 2, wherein the biodegradable material comprises a sugar, a biodegradable polymer or PGLA. 4. The device of claim 1, wherein the release element comprises a material configured to degrade upon exposure to a selected pH in the gastrointestinal tract. 5. The device of claim 4, wherein the selected pH is greater than about 7.4. 6. The device of claim 1, further comprising an actuator coupled to the release element for advancing the tissue penetrating member into the wall of the small intestine, the actuator configured to be actuated by release of the release element. 7. The device of claim 6, wherein the actuator comprises an expandable member disposed within the capsule, the expandable member having a first and second compartment separated by a releasable valve which releases upon exposure to fluid in the intestinal tract;a first reactant contained in one of the compartments and a second reactant contained in the other compartment, wherein when the valve release, the reactants mix to produce a gas which expands the expandable member; anda delivery member for advancing the tissue penetrating member into the wall of the small intestine, the delivery member operably coupled to the expandable member and the tissue penetrating member. 8. The device of claim 7, wherein the delivery member comprises a piston or a plunger. 9. The device of claim 7, wherein the release element comprises the releasable valve. 10. The device of claim 1, wherein the protein or polypeptide preparation comprises a therapeutic agent. 11. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of insulin for the treatment of diabetes or a glucose regulation disorder. 12. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of an incretin for the treatment of diabetes or a glucose regulation disorder. 13. The device of claim 12, 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). 14. The device of claim 10, wherein the therapeutic comprises a combination of therapeutic agents for the treatment of diabetes or a glucose regulation disorder. 15. The device of claim 14, wherein the combination comprises a therapeutically effective dose of an incretin and a therapeutically effective dose of a biguanide. 16. The device of claim 15, wherein the incretin comprises exenatide and the biguanide comprises metformin. 17. The device of claim 15, wherein the dosages of the incretin and the biguanide are matched to produce an improved level of blood glucose control for an extended period. 18. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of growth hormone. 19. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of parathyroid hormone for the treatment of osteoporosis or a thyroid disorder. 20. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of antibiotic. 21. The device of claim 10, wherein the therapeutic agent comprises a therapeutically effective dose of an antiviral compound. 22. The device of claim 21, wherein the antiviral compound comprises a protease inhibitor. 23. The device of claim 1, wherein the protein or polypeptide comprises a gamma globulin. 24. The device of claim 23, wherein the gamma globulin comprises an antibody and the antibody is delivered is delivered into the wall of the small intestine with minimal or no loss in binding affinity or specificity to a target antigen site.
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이 특허에 인용된 특허 (76)
Kink, John A.; Worledge, Katherine L.; Stafford, Douglas C., Antibodies to cytokines in the prevention and treatment of inflammatory bowel disease.
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 A.; Herrmann, Peter; Syed, Baber; Williams, Timothy H.; Ong, Chang Jin; Method, Greg, Device, system and methods for the oral delivery of therapeutic compounds.
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.
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