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WO 2015/095185 Al 25 June 2015 (25.06.2015) W P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2015/095185 Al 25 June 2015 (25.06.2015) W P O P C T (51) International Patent Classification: (72) Inventors: JAKLENEC, Ana; 23 Sidney Street, Apart A23L 1/302 (2006.01) A23L 1/00 (2006.01) ment 201, Cambridge, MA 02139 (US). XU, Xian; 33 A23L 1/304 (2006.01) A23L 1/22 (2006.01) Middlesex Circle, Apartment 15, Waltham, MA 02452 (US). WOOD, Lowell, L., Jr.; 989 112th Avenue NE, (21) International Application Number: #23 10, Bellevue, WA 98004 (US). ECKHOFF, Philip, PCT/US2014/070583 A.; 4230 105th Avenue NE, Kirkland, WA 98033 (US). (22) International Filing Date: GATES, William; One Microsoft Way, Redmond, WA 16 December 2014 (16. 12.2014) 98052-6399 (US). NIKOLIC, Boris; 1107 1st Avenue, Apartment 1502, Seattle, WA 98101 (US). LANGER, (25) Filing Language: English Robert, S.; 98 Montvale Road, Newton, MA 02459 (US). (26) Publication Language: English (74) Agents: PABST, Patrea, L. et al; Pabst Patent Group (30) Priority Data: LLP, 1545 Peachree Street, N.E., Suite 320, Atlanta, GA 61/916,485 16 December 201 3 (16. 12.2013) US 30309 (US). 62/036,405 12 August 2014 (12.08.2014) US (81) Designated States (unless otherwise indicated, for every 62/066,55 1 2 1 October 2014 (21. 10.2014) US kind of national protection available): AE, AG, AL, AM, (71) Applicants: MASSACHUSETTS INSTITUTE OF AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, TECHNOLOGY [US/US]; 77 Massachusetts Avenue, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, Cambridge, MA 02139 (US). TOKITAE LLC [US/US]; DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, 11235 S.E. 6th Street, Suite 200, Bellevue, WA 98004 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (US). KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, [Continued on nextpage] (54) Title: FORTIFIED MICRONUTRIENT SALT FORMULATIONS (57) Abstract: Salt formulations, which are resistant to mois ture and cooking conditions, are described herein. The for mulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water- in sol uble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials sta bilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition. w o 2015/095185 Ai III III II II III I I11 III I II i lI II II I III II I II PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, Declarations under Rule 4.17: SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, — as to applicant's entitlement to apply for and be granted TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. a patent (Rule 4.1 7( )) (84) Designated States (unless otherwise indicated, for every — as to the applicant's entitlement to claim the priority of Mnd of regional protection available): ARIPO (BW, GH, the earlier application (Rule 4.1 7(iii)) GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, Published: TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, — with international search report (Art. 21(3)) DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, — before the expiration of the time limit for amending the SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, claims and to be republished in the event of receipt of GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). amendments (Rule 48.2(h)) FORTIFIED MICRONUTRIENT SALT FORMULATIONS FIELD OF THE INVENTION This invention is in the field of fortified salts, particularly micronutrient fortified salts that are thermally stable and release the micronutrients at the desired location in the gastrointestinal tract. BACKGROUND OF THE INVENTION Malnutrition/micronutrient deficiency is a severe problem in the developing world, impacting 870 million people and causing five million child deaths each year. Attempts to address micronutrient deficiency include supplementation and fortifications. Supplementation can provide higher doses of micronutrients to specific individuals in a short amount of time. However, supplementation has limitations, including inability to deliver all the necessary micronutrients, neglecting individuals in non-targeted groups, and low compliance due to the difficulty in storing product under uncontrolled conditions (hot wet warehouses, poor record keeping), difficulties in distributing supplements and convincing end users of the need for regular ingestion. Food fortification has been explored as a means for addressing malnutrition/micronutrient deficiency. However, food fortification is often unaffordable to those people who need it most. Adverse effects, such as sensory qualities of foods, adverse nutrient-nutrient interactions, and poor bioavailability, have also been observed in fortified foods. Salt is a universally consumed product and therefore has the potential to deliver vitamins and minerals to those in developing countries. Fortified salt, also known as iodized salt, is table salt (NaCl) mixed with minute amounts of various salts of iodide, to prevent iodine deficiency. Double fortified salt, which is table salt containing iron and iodide has also been developed. The iron is microencapsulated with stearine to prevent it from reacting with the iodine in the salt. However, adding iron to iodized salt is complicated by a number of chemical, technical, and organoleptic issues, including the tendency of iron to oxide in the presence of air. Salt has also been fortified with potassium fluoride in an attempt to enhance dental health. None of these fortified salts include more labile supplements such as vitamins. All of these formulations involve physical mixing of salt with one or more minerals. However, as discussed above, the undesirable reactivity between vitamins and minerals and other limitations have prevented commercialization of such formulations. Moreover, these formulations do not provide a plurality of micronutrients and are not stable under conditions encountered during food preparation and cooking. Kwan describes a fortified salt containing vitamin A, iron, and iodine. The formulation is a physical mixture of salt and forticants. The formulation also contains surfactants and lipids so that the formulation self-emulsifies. Kwan discloses that an attempt was made to enteric coat vitamin A, but losses of the micronutrient after a three month storage period ranged from 50-99% at both 25°C/20% RH and 45°C/60% RH. Health Salt, sold by Sundar, is a fortified salt containing a plurality of micronutrients, which is allegedly thermally stable. The formulation appears to be a physical mixture of salt and the various micronutrients. Vinodkumar et al.Jnt. J. Vitam. Nutr. Res., 79(5):348-361 (2009), describes manufacturing a multiple micronutrient-fortified salt in a ribbon blender and evaluating the homogeneity of the distribution of the micronutrients in the salt. However, the product costs 2-3 times more than loose salt, black specks of forticants were observed in the product which may turn off consumers, the product had an unusual odor, and it may be difficult to verify analytically some of the micronutrients in the product. There exists a need for compositions that provide a plurality of micronutrients in a safe and effective manner while overcoming the limitations of supplementation and fortification discussed above. Therefore, it is an object of the invention to provide compositions for providing a plurality of heat, moisture and salt labile micronutrients, as well as therapeutic and/or prophylactic agents, and methods of making and using thereof. It is a further object of the invention to provide compositions for providing a plurality of micronutrients, which are stable during food preparation and cooking, and methods of making and using thereof. It is a still further object of the invention to provide compositions for providing a plurality of micronutrients, which are stable during food preparation and cooking, and which release the micronutrients at a desired site in the gastrointestinal tract, and methods of making and using thereof. SUMMARY OF THE INVENTION Formulations which are resistant to moisture and cooking temperatures, and release at a defined pH range, have been developed. The formulations provide particles of micronutrients and vitamins ("MNs") formulated into a stabilizing matrix formed of materials such as sugars, which is then encapsulated within heat resistant pH-sensitive water-insoluble polymers. The formulation can be packaged within a salt shell, sugar shell, or other shell. The pH-sensitive, water-insoluble, thermally stable polymers stabilize the micronutrients, especially in combination with the salt, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, such as pH 1-3, preferably 1-2 as found in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt or other shell substance, eliminating the need for other vitamin supplementation. This is particularly important in populations suffering from severe malnutrition.
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