# US 11,026,885 B2 · Bioerodible silicon-based devices for delivery of therapeutic agents > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,026,885 B2 - Document ID: US11026885B2 - Status: Granted - Kind: B2 - Application number: 15/147,203 - Filed: 2016-05-05 - Published: 2016-08-25 - Granted: 2021-06-08 - Earliest claimed: 2010-11-01 - Assignees: Eyepoint Pharmaceuticas, Inc. - Applicants: Paul Ashton; Leigh T. Canham; Christian Barnett - Inventors: Paul Ashton; Leigh T. Canham; Christian Barnett - Web page: https://patentgrep.com/patent/US11026885B2 ## CPC - A61K 9/0051: {Ocular inserts or implants} - A61K 9/0024: {Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue (compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L)} - A61K 9/143: {with inorganic compounds} - A61K 38/1709: {from mammals} - A61K 38/28: Insulins - A61K 38/47: acting on glycosyl compounds (3.2), e.g. cellulases, lactases - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61L 27/025: {Other specific inorganic materials not covered by A61L27/04 - A61L27/12} - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 27/56: Porous materials, {e.g. foams or sponges} - A61P 27/02: Ophthalmic agents - A61P 27/06: Antiglaucoma agents or miotics - C07K 16/22: against growth factors {; against growth regulators} - A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces - C12Y 302/01017: Lysozyme (3.2.1.17) - 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) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - 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) - C12Y: ENZYMES ## Abstract This invention discloses bioerodible devices, such as implants for delivering therapeutic agents, particularly large molecules such as proteins and antibodies, in a controlled manner. The devices comprise a porous silicon-based carrier material impregnated with the therapeutic agent. The device may be used in vitro or in vivo to deliver the therapeutic agent, preferably in a controlled fashion over an intended period of time such as over multiple days, weeks or months. The device may be used for treating or preventing conditions of a patient such as chronic diseases. ## Claims ### Claim 1 A method of administering a sustained-release therapeutic agent, comprising contacting a bioerodible porous silicon-based carrier material preloaded in a syringe with an aqueous solution comprising the therapeutic agent and administering the carrier material to a patient, wherein the bioerodible porous silicon-based carrier material wherein the carrier material comprises at least one large molecule therapeutic agent disposed in pores of the carrier material, wherein the therapeutic agent is a protein, and either: a) the pores have an average pore size from about 15 nm to about 40 nm and the therapeutic agent has a molecular weight from about 100,000 to about 200,000 amu, or b) the pores have an average pore size from about 25 nm to about 40 nm and the therapeutic agent has a molecular radius from about 6 nm to about 8 nm. ### Claim 2 (depends on 1) The method of claim 1, wherein contacting the bioerodible porous silicon-based carrier material with the therapeutic agent comprises drawing the therapeutic agent into the syringe. ### Claim 3 (depends on 1) The method of claim 1, wherein, after administration, the therapeutic agent is released from the bioerodible porous silicon-based carrier material to the patient over the course of up to four months. ### Claim 4 (depends on 1) The method of claim 1, wherein the bioerodible porous silicon-based carrier material has a pore-therapeutic agent differential selected from about 3.0 to about 5.0 nm. ### Claim 5 (depends on 1) The method of claim 1, wherein the therapeutic agent is ranibizumab or etanercept. ### Claim 6 (depends on 1) The method of claim 1, wherein the antibody is bevacizumab or adalimumab. ### Claim 7 (depends on 1) The method of claim 1, wherein the bioerodible silicon-based carrier material is amorphous. ### Claim 8 (depends on 1) The method of claim 1, wherein the bioerodible porous silicon-based carrier material has a porosity in the range of about 40% to about 80%. ### Claim 9 (depends on 1) The method of claim 1, wherein the average pore size of the bioerodible porous silicon-based carrier material is in the range of 2-50 nm. ### Claim 10 (depends on 1) The method of claim 1, wherein a length of the bioerodible porous silicon-based carrier material measured at its longest point is between 1 and 500 microns. ### Claim 11 (depends on 10) The method of claim 10, wherein the length of the bioerodible porous silicon-based carrier material as its longest point is between 2 and 100 microns. ### Claim 12 (depends on 1) The method of claim 1, wherein the average pore size of the bioerodible porous silicon-based carrier material is about 15 nm to about 40 nm, and the therapeutic agent has a molecular weight from about 100,000 to about 200,000 amu. ### Claim 13 (depends on 1) The method of claim 1, wherein the average pore size of the bioerodible porous silicon-based carrier material is about 25 nm to about 40 nm, and the therapeutic agent has a molecular radius from about 6 to about 8 nm. ### Claim 14 (depends on 1) The method of claim 1, wherein the average pore size of the bioerodible porous silicon-based carrier material is about 2 nm to about 10 nm and the therapeutic agent has a molecular weight from about 5,000 to about 50,000 amu. ### Claim 15 (depends on 1) A method of treating or preventing a condition in a patient comprising preparing a sustained-release drug delivery device according to the method of claim 1, and administering the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material to the patient. ### Claim 16 (depends on 1) The method of claim 1, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material is administered to the surface of the skin or eye of the patient. ### Claim 17 (depends on 1) The method of claim 1, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material is administered subconjunctivally, intraperitoneally, intramuscularly, intravitreally, subcutaneously, or subretinally. ### Claim 18 (depends on 1) The method of claim 1, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material is administered into the eye. ### Claim 19 (depends on 18) The method of claim 18, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material is administered within the aqueous of the eye. ### Claim 20 (depends on 18) The method of claim 18, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material is administered within the vitreous of the eye. ### Claim 21 (depends on 18) The method of claim 18, wherein the patient has a condition that affects the eye. ### Claim 22 (depends on 21) The method of claim 21, wherein the condition is selected from glaucoma, macular degeneration, diabetic macular edema, geographic atrophy and age-related macular degeneration. ### Claim 23 (depends on 18) The method of claim 18, wherein the bioerodible porous silicon-based carrier material comprising at least one protein disclosed in the pores of the carrier material releases the protein into the eye over the course of 1 day to 12 months. ### Claim 24 (depends on 1) The method of claim 1, wherein contacting the a bioerodible porous silicon-based carrier material with the therapeutic agent comprises contacting the bioerodible porous silicon-based carrier material with a solution comprising the therapeutic agent.