# US 10,307,579 B2 · Therapeutic agent preparations for delivery into a lumen of the intestinal tract using a swallowable drug delivery device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,579 B2 - Document ID: US10307579B2 - Status: Granted - Kind: B2 - Application number: 15/832,464 - Filed: 2017-12-05 - Published: 2018-04-05 - Granted: 2019-06-04 - Earliest claimed: 2010-12-23 - Assignees: Rani Therapeutics, LLC - Applicants: Rani Therapeutics, LLC - Inventors: Mir Imran - Web page: https://patentgrep.com/patent/US10307579B2 ## CPC - A61M 37/0015: {by using microneedles} - A61K 38/27: Growth hormone [GH], i.e. somatotropin - A61M 5/00: Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm rests (tube connectors, tube couplings, valves or branch units, specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00) - A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00}) - A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)} - C07K 16/18: against material from animals or humans - C07K 16/2848: {against integrin beta3-subunit-containing molecules, e.g. CD41, CD51, CD61} - A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)} - A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)} - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0061: {Methods for using microneedles} - A61M 2210/1042: Alimentary tract (A61M2210/0618 takes precedence) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract 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. ## Claims ### Claim 1 A method for delivering a natalizumab preparation into the wall of the small intestine, the method comprising: swallowing a drug delivery device comprising a capsule, an actuator having a first configuration and a second configuration and the natalizumab preparation operably coupled to the actuator, the natalizumab preparation comprising a therapeutically effective dose of a natalizumab and being shaped as a solid tissue penetrating member, the preparation being contained within the capsule in the first configuration and advanced out of the capsule to penetrate into the intestinal wall in the second configuration; and actuating the actuator responsive to a condition in the small intestine to penetrate and insert the natalizumab preparation shaped as a solid tissue penetrating member into the wall of the small intestine. ### Claim 2 (depends on 1) The method of claim 1, wherein the condition is a selected pH. ### Claim 3 (depends on 2) The method of claim 2, wherein the pH is above about 7.1. ### Claim 4 (depends on 1) The method of claim 1, wherein a weight percent of natalizumab in the natalizumab preparation is in a range between about 8 to 12%. ### Claim 5 (depends on 1) The method of claim 1, wherein a dose of natalizumab in the natalizumab preparation is in a range from about 1 to 5 mg. ### Claim 6 (depends on 5) The method of claim 5, wherein the dose of natalizumab in the natalizumab preparation is about 2-4 mg. ### Claim 7 (depends on 6) The method of claim 6, wherein the dose of natalizumab in the natalizumab preparation is about 3 mg. ### Claim 8 (depends on 1) The method of claim 1, wherein the natalizumab preparation comprises at least one pharmaceutical excipient. ### Claim 9 (depends on 8) The method of claim 8, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. ### Claim 10 (depends on 1) The method of claim 1, further comprising retaining the natalizumab preparation within the intestinal wall after insertion. ### Claim 11 (depends on 10) The method of claim 10, wherein retaining comprises anchoring a portion of the natalizumab preparation in intestinal wall tissue. ### Claim 12 (depends on 1) The method of claim 1, wherein delivering the natalizumab preparation comprises applying a force to the natalizumab preparation. ### Claim 13 (depends on 12) The method of claim 12, wherein the natalizumab preparation is advanced completely into the intestinal wall by such application of force. ### Claim 14 (depends on 12) The method of claim 12, wherein the natalizumab preparation is advanced through the intestinal wall by such application of force. ### Claim 15 (depends on 14) The method of claim 14, wherein the force is a mechanical force applied to a surface of the natalizumab preparation. ### Claim 16 (depends on 1) The method of claim 1, wherein the natalizumab preparation produces a long term release of natalizumab up to about 40 days. ### Claim 17 (depends on 1) The method of claim 1, further comprising: using the dose of delivered natalizumab to treat an autoimmune disease. ### Claim 18 (depends on 17) The method of claim 17, wherein the autoimmune disease is multiple sclerosis. ### Claim 19 (depends on 17) The method of claim 17, wherein the autoimmune disease is Crohn's disease.