JPWO2021122925A5 - - Google Patents

Claims (26)

A medicament for preventing or correcting selenium deficiency in a patient, the medicament comprising a solution provided in a flexible container, the solution comprising at least one of selenate and/or selenoamino acids. A pharmaceutical product characterized by: The medicament according to claim 1, wherein the selenoamino acid is selenomethionine or selenocysteine. Medicament according to claim 1 or 2 , wherein the selenate and/or selenoamino acid is stable in solution for at least 3 months when stored at a temperature of 1 to 50°C. Medicament according to claim 1 or 2, wherein the selenate and/or selenoamino acid is stable for at least 6 months at a temperature of about 18°C to 25°C. 5. Medicament according to claim 4, wherein the selenate and/or selenoamino acid is stable in solution for at least 24 hours. A medicament according to any one of claims 1 to 5 , wherein the solution is a sterile solution. 7. The solution according to any one of claims 1 to 6 , wherein the solution comprises a selenate and is selected from the group consisting of sodium selenate , potassium selenate, barium selenate and ammonium selenate. medicines. Claim 1, wherein the solution comprises at least one additional trace element selected from the group comprising zinc, iron, copper, manganese, chromium, iodine, fluoride and molybdenum. - The drug described in any one of 7 . The medicament according to any one of claims 1 to 8 , wherein the solution contains an acid. 10. A medicament according to claim 9, 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 9, wherein the concentration of the organic acid is in the range of 50mM to 400mM. 10. A medicament according to claim 9 , wherein the solution comprises malic acid. The medicament according to any one of claims 1 to 12 , wherein the solution has an acidic pH. A medicament according to claim 13, wherein the solution has an acidic pH ranging from 1 to 4. Medicament according to any one of claims 1 to 14 , wherein the solution is free of macronutrients selected from the group consisting of carbohydrates, proteins and lipids. A medicament according to any one of claims 1 to 15 , wherein the solution is configured for parenteral administration . Medicament according to any one of claims 1 to 16 , wherein the solution contains selenate and/or selenoamino acids in an amount corresponding to 10 to 200 μg of selenium. 18. Any one of claims 1 to 17 , 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. Medicines listed in. 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 at least one chamber contains a selenate and a lipid formulation. The medicament according to claim 18 , comprising /or a selenoamino acid. 20. Medicament according to claim 18 or 19, wherein electrolytes and/or vitamins are present in at least the first, second and/or third chamber. 20. Medicament according to claim 18 or 19 , wherein a solution containing selenate and/or selenoamino acids is present in the fourth chamber. 20. A medicament according to claim 18 or 19 , wherein the solution comprises selenate or sodium selenate. The solution is as follows:
a. dissolving selenate and/or selenoamino acids in a liquid medium to produce a solution having a selenium concentration of 0.28 to 28 mg/L;
b. Optionally, the solution is adjusted to an acidic pH by providing an organic acid , and optionally at least one selected from the group comprising zinc, iron, copper, manganese, chromium, iodine, fluoride and molybdenum. adding additional trace elements; and
c. A method for preparing a medicament for preventing or correcting selenium deficiency in a patient according to any one of claims 1 to 22 , prepared by a step comprising sterilizing the solution . 24. The method of claim 23, wherein sterilizing the solution is by heat sterilization. A sterile solution for use as a medicament to prevent or correct selenium deficiency in a patient, the solution being configured for oral administration and comprising at least one selected from the group comprising selenate and/or selenoamino acids . Sterile solution containing the compound. Sterile solution for use as a medicament according to claim 25, wherein the selenoamino acid is selenomethionine and/or selenocysteine.