# US 2008/0187619 A1 · Human Milk Fortifiers and Methods for Their Production > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2008/0187619 A1 - Document ID: US20080187619A1 - Status: Published application - Kind: A1 - Application number: 11/662,348 - Filed: 2005-09-02 - Published: 2008-08-07 - Earliest claimed: 2004-09-10 - Assignees: Medela Holding AG - Inventors: Peter Edwin Hartmann; Ching Tat Lai; Jillian Lois Sherriff; Karen Norrie Simmer; Michelle Anne Lewis; Leon Robert Mitoulas; Bronwyn Isabelle Davis - Web page: https://patentgrep.com/patent/US20080187619A1 ## CPC - A61K 35/20: Milk; Whey; Colostrum - A23C 9/206: {Colostrum; Human milk} - A23L 33/40: {Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula} - A61P 3/02: Nutrients, e.g. vitamins, minerals - 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) - A23C: DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; PREPARATION THEREOF (preservation thereof A23B11/00) - A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention relates to a human milk fortifier as well as to several uses and a method for the production of such a fortifier. A particularly beneficial fortifier can be realised in that at least one human component based on a product directly or indirectly derived from human mammary secretion during non-pregnant, pregnant, lactating and/or involuting periods is used, giving rise to an optimally adapted fortifying effect which is particularly useful in the context of feeding preterm infants. ## Claims ### Claim 1 Human milk fortifier comprising at least one human component based on a product directly or indirectly derived from human mammary secretion during at least one of the following periods: non-pregnant period, pregnant period, lactating period, involuting period. ### Claim 2 (depends on 1) Fortifier according to claim 1, wherein it is in substantially dried or liquid, preferentially selectively concentrated, form. ### Claim 3 Fortifier according to any of the preceding claims, wherein the fortifier has been directly or indirectly derived from human mammary secretion from the same individual as the human milk to be fortified. ### Claim 4 Fortifier according to any of the preceding claims, wherein it is in powder form. ### Claim 5 Fortifier according to any of the preceding claims, wherein the human component is enriched with respect to the product as originally and naturally derived from the mammary secretion in at least one of its aqueous and/or nonaqueous natural constituents. ### Claim 6 (depends on 5) Fortifier according to claim 5, wherein these constituents are selected from the following group or combinations thereof: proteins; fats; carbohydrates; vitamins; minerals; hormones; cells; in particular calcium, phosphorus, sIgA, lactoferrin, alpha-lactalbimin, beta casein, kappa casein, c3 complement, c4 complement, zinc, sodium, chloride, fatty acids, oligosaccharides, serum albumin, lactose and/or lysozyme. ### Claim 7 (depends on 5, 6) Fortifier according to any of the claims 5 or 6, wherein at least one of the constituents is an immunologically active component. ### Claim 8 Fortifier according to any of the preceding claims, wherein it is an extract directly or indirectly derived from human mammary secretion. ### Claim 9 Fortifier according to any of the preceding claims, wherein the human component is at least partially, preferably fully heat treated, pasteurised and/or sterilised. ### Claim 10 Fortifier according to any of the preceding claims, wherein it additionally comprises at least one nonhuman-derived component. ### Claim 11 (depends on 10) Fortifier according to claim 10, wherein the nonhuman-derived component is selected from the following group, or combinations thereof: proteins; fats; carbohydrates; vitamins; minerals; hormones; cells; stabilizer; emulsifier; in particular calcium, phosphorus, sIgA, casein, lactoferrin, alpha-lactalbimin, beta casein, kappa casein, c3 complement, c4 complement, zinc, sodium, chloride, fatty acids, oligosaccharides, serum albumin, lactose and/or lysozyme. ### Claim 12 (depends on 10, 11) Fortifier according to any of claims 10 or 11, wherein the nonhuman component is a nonhuman, preferably bovine, milk or milk extract. ### Claim 13 Fortifier according to any of the preceding claims, wherein the human component is based on mammary secretion during lactating periods, and wherein it has been isolated from said mammary secretion during particular stages of mammary secretion such as: after beginning of individual feeding; versus end of individual feeding; lactation phase. ### Claim 14 Milk sample supplied with a fortifier according to any of the preceding claims. ### Claim 15 (depends on 14) Milk sample according to claim 14, wherein the milk is human milk. ### Claim 16 (depends on 15) Human milk sample according to claim 15, wherein the sample has been fortified with a fortifier which has been directly or indirectly derived from human mammary secretion from the same individual as the human milk which is fortified. ### Claim 17 (depends on 14) Milk sample according to claim 14, wherein the fortified milk is based on nonhuman, preferably bovine milk. ### Claim 18 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) A method of providing supplemental nutrients to infants comprising adding a fortifier according to any of the claims 1 to 13 to liquid milk and administering such fortified milk to an infant. ### Claim 19 (depends on 18) A method according to claim 18, wherein the fortified milk is based on human milk, preferably based milk from the same individual as the one having served for the preparation of the fortifier. ### Claim 20 (depends on 18) A method according to claim 18, wherein the fortified milk is based on nonhuman milk, preferably bovine milk or based on a commercial infant milk formula. ### Claim 21 (depends on 18, 19, 20) A method according to any of claims 18 to 20, wherein the fortified milk is administered to a premature, low-birth-weight infant. ### Claim 22 (depends on 18, 19, 20, 21) A method according to one of claims 18 to 21, wherein the fortifier is added in amounts between 0-200 mg per ml milk. ### Claim 23 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) A method for the production of a fortifier according to any of the claims 1 to 13, wherein a product directly or indirectly derived from mammary secretion during non-pregnant, pregnant, lactating and/or involuting periods is at least partially separated in individual or aqueous and/or nonaqueous components or groups of aqueous and/or nonaqueous components. ### Claim 24 (depends on 23) A method according to claim 23, wherein separation of substantially nonaqueous components is carried out either prior to or after the removal of the aqueous part of the mammary secretion. ### Claim 25 (depends on 23, 24) A method according to any of the claims 23 or 24, wherein there is included at least one heat treatment, pasteurisation and/or sterilisation step. ### Claim 26 (depends on 23, 24, 25) A method according to any of the claims 23 to 25, wherein the separation uses methods like freeze drying, centrifugation, chelation, membrane separation, filtration, in particular component specific filtration, ultrafiltration, reverse osmosis, affinity column separation, dialysis, or combinations thereof. ### Claim 27 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13) A method of providing supplemental nutrients or supplemental immunologically active components to an adult, comprising administering a fortifier according to any of the claims 1 to 13 in dried or liquid form.