# US 2019/0167631 A1 · Taxane- and Taxoid-Protein Compositions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167631 A1 - Document ID: US20190167631A1 - Status: Published application - Kind: A1 - Application number: 16/271,363 - Filed: 2019-02-08 - Published: 2019-06-06 - Earliest claimed: 2010-02-03 - Assignees: OncBioMune, L.L.C. - Applicants: OncBioMune, L.L.C. - Inventors: Jonathan F. Head; Robert L. Elliott - Web page: https://patentgrep.com/patent/US20190167631A1 ## CPC - A61K 31/337: having four-membered rings, e.g. taxol - 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)} - A61K 38/1808: {Epidermal growth factor [EGF] urogastrone} - A61K 38/2257: {Prolactin} - A61K 38/38: Albumins - A61K 38/40: Transferrins, e.g. lactoferrins, ovotransferrins - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/42: Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61K 47/643: {Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]} - A61K 47/644: {Transferrin, e.g. a lactoferrin or ovotransferrin} - A61P 35/00: Antineoplastic agents - A61P 35/02: specific for leukemia - 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) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Compositions comprising a taxane or taxoid, such as paclitaxel, and a protein, such as albumin or a metal-transferrin, such as gallium-transferrin, can be prepared by combining an aqueous protein solution with a second solution containing the taxane or taxoid, a non-ionic surfactant, and an alcohol; adjusting the pH of the combined solutions to between about 7.9 and about 8.3; and purifying the pH-adjusted solution to remove solutes having a molecular weight less than 10,000 Da. Such compositions can be prepared that are substantially free of non-ionic surfactants, such as Cremophor EL, and are useful in the treatment of cancers, such as breast cancer. ## Claims ### Claim 1 A method for preparing a composition, comprising combining (A) a first aqueous solution comprising a protein; and (B) a second solution comprising (i) a taxane or taxoid; (ii) a non-ionic surfactant; and (iii) an alcohol, to provide a third aqueous solution; adjusting the pH of the third aqueous solution to between about 7.9 and about 8.3; and purifying the pH-adjusted third aqueous solution to remove solutes having a molecular weight less than 10,000 Da. ### Claim 2 (depends on 1) The method of claim 1, wherein the protein is albumin, transferrin, metal-transferrin, prolactin, or an epidermal growth factor. ### Claim 3 (depends on 1) The method of claim 1, wherein the protein is albumin. ### Claim 4 (depends on 1) The method of claim 1, wherein the protein is metal-transferrin. ### Claim 5 (depends on 4) The method of claim 4, wherein the metal-transferrin is gallium-transferrin, iron-transferrin, indium-transferrin, zinc-transferrin, manganese-transferrin, platinum-transferrin, or a mixture thereof. ### Claim 6 (depends on 1) The method of claim 1, wherein the taxane or taxoid is paclitaxel, docetaxel, or mixtures thereof. ### Claim 7 (depends on 1) The method of claim 1, wherein the non-ionic surfactant comprises ethoxylated castor oil. ### Claim 8 (depends on 1) The method of claim 1, wherein the pH of the third solution is adjusted by adding a base. ### Claim 9 (depends on 8) The method of claim 8, wherein the base is a hydroxide base. ### Claim 10 (depends on 9) The method of claim 9, wherein the hydroxide base is sodium hydroxide, potassium hydroxide, lithium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, barium hydroxide, or mixtures thereof. ### Claim 11 (depends on 1) The method of claim 1, wherein pH-adjusted third solution is purified by dialysis against a buffer solution using a dialysis membrane having a molecular weight cutoff of 10,000 Da. ### Claim 12 (depends on 11) The method of claim 11, wherein the buffer solution comprises Hank's Balanced Salt Solution. ### Claim 13 (depends on 11) The method of claim 11, wherein the dialysis is repeated at least two times. ### Claim 14 (depends on 1) The method of claim 1, wherein the purified pH-adjusted third solution is filter sterilized. ### Claim 15 (depends on 1) A composition prepared according to claim 1. ### Claim 16 A composition comprising (i) a protein; (ii) a taxane or taxoid; and (iii) a pharmaceutically acceptable diluent, wherein the taxane or taxoid either (a) is bonded with the protein via a direct bond between the taxane or taxoid and the protein; or (b) forms a complex with the protein. ### Claim 17 (depends on 16) The composition of claim 16, wherein the protein comprises albumin, transferrin, metal-transferrin, prolactin, or an epidermal growth factor. ### Claim 18 (depends on 16) The composition of claim 16, wherein the protein comprises albumin. ### Claim 19 (depends on 16) The composition of claim 16 wherein the protein comprises metal-transferrin. ### Claim 20 (depends on 16) The composition of claim 16, wherein the taxane or taxoid is paclitaxel or docetaxel. ### Claim 21 (depends on 19) The composition of claim 19, the metal-transferrin is gallium-transferrin, iron-transferrin, indium-transferrin, zinc-transferrin, manganese-transferrin, platinum-transferrin, or a mixture thereof. ### Claim 22 (depends on 21) The composition of claim 21, the metal-transferrin is gallium-transferrin. ### Claim 23 (depends on 16) The composition claim 16, wherein the taxane or taxoid is bonded with the albumin or metal-transferrin via a direct bond between the taxane or taxoid. ### Claim 24 (depends on 16) The composition of claim 16, wherein the taxane or taxoid forms a complex with the albumin or metal-transferrin. ### Claim 25 (depends on 16) A method for treating a cancer in a patient in need of such treatment comprising providing to the patient a therapeutically effective amount of a composition according to claim 16. ### Claim 26 (depends on 25) The method of claim 25, wherein the cancer is a sarcoma, a lymphoma, a leukemia, a melanoma, a multiple myeloma, pancreatic cancer, esophageal cancer, bladder cancer, testicular cancer, thyroid cancer, brain cancer, gynecologic cancers, pediatric solid tumors, colorectal cancer, prostate cancer, liver cancer, renal cancer, gastric cancer, head and neck cancers, breast cancer, ovarian cancer, colon cancer, or lung cancer. ### Claim 27 (depends on 25) The method of claim 25, wherein the cancer is breast cancer, ovarian cancer, colon cancer, or lung cancer.