JPWO2021122923A5 - - Google Patents

Claims (30)

A medicament for preventing or correcting selenium deficiency in a patient, the medicament comprising at least one selenium compound in the form of Se(IV) , the solution containing 0.5 ppm to 8 ppm dissolved oxygen (DO ). The medicament according to claim 1, wherein the at least one selenium compound is selected from the group consisting of sodium selenite, selenite and selenium dioxide. Medicament according to claim 1 or 2 , wherein the DO stabilizes selenium compounds in the form of Se(IV) for at least 3 months in solution when stored at temperatures between 1 and 50°C. A medicament according to any one of claims 1 to 3, wherein the DO stabilizes the selenium compound in solution at a temperature of about 18°C to 25°C for at least 6 months. 5. A medicament according to claim 4, wherein the DO stabilizes the selenium compound in solution for at least 24 months. A medicament according to any one of claims 1 to 5 , wherein the solution is a sterile solution. Pharmaceutical product according to any one of claims 1 to 6 , wherein the DO concentration in the solution is equal to or greater than 0.5 ppm throughout the shelf life of the pharmaceutical product. 8. A pharmaceutical product according to claim 7, wherein the DO concentration in the solution is equal to or greater than 1 ppm throughout the shelf life of the pharmaceutical product. Pharmaceutical product according to any one of claims 1 to 8 , wherein the DO concentration in the solution upon sterilization is at least 6 ppm. A medicament according to any one of claims 1 to 9 , wherein the flexible container further comprises a headspace having a gas composition comprising oxygen. A medicament according to any one of claims 1 to 10 , wherein the solution comprises sodium selenite. The medicament according to any one of claims 1 to 11 , wherein the solution has an acidic pH. A medicament according to claim 12, wherein the solution has an acidic pH ranging from 1 to 4. The medicament according to any one of claims 1 to 13 , wherein the solution contains an acid. 15. A medicament according to claim 14, wherein the acid is an organic acid selected from the group consisting of malic acid, tartaric acid, citric acid, maleic acid and fumaric acid. The medicament according to claim 14, wherein the concentration of the organic acid is 100mM to 400mM. A medicament according to any one of claims 1 to 16 , wherein the solution comprises malic acid. Medicament according to any one of claims 1 to 17 , wherein the solution is free of macronutrients selected from the group consisting of carbohydrates, proteins and lipids. 19. The solution according to any one of claims 1 to 18 , wherein the solution comprises at least one additional trace element selected from the group comprising zinc , iron, copper, manganese, chromium, iodine, fluoride and molybdenum. Pharmaceutical products. A medicament according to any one of claims 1 to 19 , wherein the solution is configured for parenteral administration . Medicament according to any one of claims 1 to 20 , wherein the solution comprises at least one selenium compound in the form of Se(IV) in an amount corresponding to 10 to 200 μg of selenium. 3. Medicament according to claim 1 or 2, wherein the solution is contained in one chamber of a multi-chamber container having at least 2, at least 3, at least 4, at least 5 or at least 6 chambers. The container includes at least a first chamber containing a carbohydrate formulation, a second chamber containing an amino acid formulation, and a third chamber containing a lipid formulation , wherein the at least one chamber contains between 0.5 ppm and 0.5 ppm. 23. Medicament according to claim 22 , comprising at least one selenium compound in the form of Se(IV) in the presence of 8 ppm oxygen. 24. Medicament according to claim 22 or 23, wherein electrolytes and/or vitamins are present in at least the first, second and/or third chamber. 24. Medicament according to claim 22 or 23 , wherein a solution comprising at least one selenium compound in the form of Se(IV) in the presence of 0.5 ppm to 8 ppm dissolved oxygen (DO) is present in the fourth chamber. 24. A medicament according to claim 22 or 23 , wherein the solution comprises sodium selenite. The solution is as follows:
a . dissolving at least one selenium compound in the form of Se(IV) in a liquid medium to produce a solution having a selenium concentration of 0.28 to 28 mg/L;
b. an organic acid selected from the group consisting of malic acid, tartaric acid, citric acid, maleic acid and fumaric acid, and/or zinc, iron, copper, optionally alone or together with selenium compounds in the form of Se(IV); , further dissolving at least one additional trace element selected from the group consisting of , manganese, chromium, iodine, fluoride and molybdenum;
c. adjusting the solution to a dissolved oxygen concentration of 0.5 ppm to 8 ppm; and
d. A method for preparing a medicament for preventing or correcting selenium deficiency in a patient according to claim 1 or 2, which is prepared by the step of sterilizing the solution . 28. A pharmaceutical product according to claim 27, wherein sterilizing the solution is by heat sterilization. A sterile solution for use as a medicine to prevent or correct selenium deficiency in a patient, the solution being configured for oral administration and comprising at least one selenium compound in the form of Se(IV), the solution comprising: A sterile solution containing dissolved oxygen (DO). 30. A sterile solution for use as a medicament according to claim 29, wherein the at least one selenium compound is selected from the group consisting of sodium selenite, selenite and selenium dioxide.