# US 10,478,396 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 10,478,396 B2 - Document ID: US10478396B2 - Status: Granted - Kind: B2 - Application number: 15/879,308 - Filed: 2018-01-24 - Published: 2018-08-16 - Granted: 2019-11-19 - Earliest claimed: 2010-12-23 - Assignees: Rani Therapeutics, LLC - Applicants: Rani Therapeutics, LLC - Inventors: Mir Imran - Web page: https://patentgrep.com/patent/US10478396B2 ## CPC - A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration} - 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)} - A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2) - A61K 38/29: Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides - 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 25/1011: {Multiple balloon catheters} - A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) - A61M 37/0015: {by using microneedles} - A61K 9/4858: {Organic compounds} - A61K 9/4866: {Organic macromolecular compounds} - 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 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0061: {Methods for using microneedles} - 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) - 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)} ## 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 therapeutic preparation comprising parathyroid hormone (PTH), the preparation shaped as a solid tissue penetrating member and configured to penetrate and be inserted into an intestinal wall after oral ingestion, wherein upon insertion, the preparation releases PTH into the blood stream from the intestinal wall by degradation of the tissue penetrating member, wherein the tissue penetrating member has sufficient stiffness to be advanced completely into the intestinal wall by the application of a force to the tissue penetrating member, wherein a dose of PTH in the preparation is in a range from about 10 to 30 μg, wherein the preparation is adapted to be orally delivered in a swallowable capsule, and wherein the preparation is adapted to be operably coupled to delivery means having a first configuration and a second configuration, the preparation being contained within the capsule in the first configuration and advanced out of the capsule and into the intestinal wall in the second configuration. ### Claim 2 (depends on 1) The preparation of claim 1, wherein all of the preparation is in solid form. ### Claim 3 (depends on 1) The preparation of claim 1, wherein the delivery means comprises a least one expandable balloon having an expanded and a non-expanded state and the first configuration is the non-expanded state and the second configuration is the expanded state. ### Claim 4 (depends on 1) The preparation of claim 1, wherein the preparation comprises a biodegradable material which degrades within the intestinal wall to release PTH into the blood stream. ### Claim 5 (depends on 4) The preparation of claim 4, wherein the biodegradable material comprises polylactic-co-glycolic acid (PLGA), a sugar or maltose. ### Claim 6 (depends on 1) The preparation of claim 1, wherein the preparation comprises at least one pharmaceutical excipient. ### Claim 7 (depends on 6) The preparation of claim 6, wherein the at least one pharmaceutical excipient comprises at least one of a binder, a preservative or a disintegrant. ### Claim 8 (depends on 7) The preparation of claim 7, wherein the binder comprises polyethylene glycol (PEG). ### Claim 9 (depends on 1) The preparation of claim 1, wherein the tissue penetrating member comprises a biodegradable material which degrades within the intestinal wall to release PTH into the blood stream. ### Claim 10 (depends on 9) The preparation of claim 9, wherein the biodegradable material comprises maltose or PLGA. ### Claim 11 (depends on 1) The preparation of claim 1, wherein a weight percent of PTH or in the tissue penetrating member comprises between about 1 to 2%. ### Claim 12 (depends on 1) The preparation of claim 1, wherein the tissue penetrating member includes a retaining feature for retaining the tissue penetrating member within the intestinal wall after insertion. ### Claim 13 (depends on 12) The preparation of claim 12, wherein the retaining feature comprises at least one of a barb or an inverse taper shape of the tissue penetrating member. ### Claim 14 (depends on 1) The preparation of claim 1, wherein the PTH is contained in the tissue penetrating member in a shaped section. ### Claim 15 (depends on 14) The preparation of claim 14, wherein the shaped section has a cylinder or pellet shape. ### Claim 16 (depends on 1) The preparation of claim 1, wherein the preparation is configured to produce a long-term release of PTH. ### Claim 17 (depends on 16) The preparation of claim 16, wherein the long-term release of PTH is about 12 hours.