# US 12,600,763 B2 · Compositions and methods for the delivery of therapeutic biologics for treatment of disease > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,600,763 B2 - Document ID: US12600763B2 - Status: Granted - Kind: B2 - Application number: 17/883,427 - Filed: 2022-08-08 - Published: 2022-12-08 - Granted: 2026-04-14 - Earliest claimed: 2019-09-13 - Assignees: Halozyme Hypercon, Inc. - Applicants: Halozyme Hypercon, Inc. - Inventors: Paul Brown; Tyler L Carter; Lyndon Fitzgerald Charles, Jr.; Chase Spenser Coffman; Daniel Benjamin Dadon; Lisa Liu; Sadiqua Shadbar; Chaitanya Sudrik; Yi Tang; Shankul Vartak - Web page: https://patentgrep.com/patent/US12600763B2 ## CPC - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - C07K 16/00: Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies - A61K 9/10: Dispersions; Emulsions - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters - A61P 35/00: Antineoplastic agents - A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00) - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present disclosure provides compositions and methods for treating a disease or condition in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a composition comprising a plurality of particles comprising at least one therapeutic biologic suspended in a pharmaceutically acceptable liquid carrier. ## Claims ### Claim 1 A pharmaceutically effective composition comprising particles suspended in a carrier comprising fatty acid esters, wherein a plurality of the particles comprise at least one antibody or a fragment thereof, wherein the total weight percent of the at least one antibody or the fragment thereof in the plurality of particles is greater than 65%, and wherein the composition further comprises a hyaluronan degrading agent. ### Claim 2 (depends on 1) The composition of claim 1, wherein the carrier comprises fatty acid ethyl esters. ### Claim 3 (depends on 1) The composition of claim 1, wherein the carrier comprises ethyl oleate. ### Claim 4 (depends on 1) The composition of claim 1, wherein the particles have less than 10% aggregation of the at least one antibody or the fragment thereof. ### Claim 5 (depends on 1) The composition of claim 1, wherein the particles have less than 5% aggregation of the at least one antibody or the fragment thereof. ### Claim 6 (depends on 1) The composition of claim 1, wherein the particles have less than 3% aggregation of the at least one antibody or the fragment thereof. ### Claim 7 (depends on 1) The composition of claim 1, wherein the particles have a circularity from 0.80 to 1.00. ### Claim 8 (depends on 1) The composition of claim 1, wherein the particles have less than 3% residual moisture by weight. ### Claim 9 (depends on 1) The composition of claim 1, wherein the particles have greater than 70% of the at least one antibody or the fragment thereof by weight. ### Claim 10 (depends on 1) The composition of claim 1, wherein the particles have greater than 80% of the at least one antibody or the fragment thereof by weight. ### Claim 11 (depends on 1) The composition of claim 1, wherein the particles have less than 3% change in charge variants of the at least one antibody or the fragment thereof. ### Claim 12 (depends on 1) The composition of claim 1, wherein the particles further comprise at least one excipient selected from a carbohydrate, a pH adjusting agent, a salt, a chelator, a mineral, a polymer, a surfactant, a protein stabilizer, an emulsifier, an antiseptic, an amino acid, an antioxidant, a protein, an organic solvent, a paraben, a bactericide, a fungicide, a vitamin, a preservative, a nutrient media, analgesic, or a combination thereof. ### Claim 13 (depends on 1) The composition of claim 1, wherein the concentration of the at least one antibody or the fragment thereof in the composition is from 300 mg/mL to 650 mg/mL. ### Claim 14 (depends on 1) The composition of claim 1, wherein the concentration of the at least one antibody or the fragment thereof in the composition is from 400 mg/mL to 650 mg/mL. ### Claim 15 (depends on 1) The composition of claim 1, wherein the composition has a viscosity of less than 100 mPa·s. ### Claim 16 A pharmaceutically effective composition comprising particles suspended in a carrier comprising ethyl oleate, wherein a plurality of the particles comprise at least one antibody or fragment thereof, and have diameters in the range of 10 μm to 50 μm, wherein the total weight percent of the at least one antibody or fragment thereof in the plurality of particles is greater than 65%, wherein the concentration of the at least one antibody or the fragment thereof in the composition is from 300 mg/mL to 650 mg/mL, and wherein the composition further comprises a hyaluronan degrading agent. ### Claim 17 (depends on 1) The composition of claim 1, wherein the carrier comprises propylene glycol diesters. ### Claim 18 (depends on 1) The composition of claim 1, wherein the hyaluronan degrading agent is a hyaluronidase.