Product based on iron bis-glycinate chelate and alginic acid and/or water-soluble salts thereof, formulations thereof, and pharmaceutical uses thereof

Abstract

The object of the present invention is a product obtainable by spray-drying an aqueous solution comprising iron bis-glycinate chelate and alginic acid and/or water-soluble salts thereof, preferably sodium alginate, potassium alginate and/or magnesium alginate, the use of said product for the prevention and/or treatment of anaemia, preferably sideropenic anaemia, in humans, the pharmaceutical formulations containing it, and the use of said formulations for the prevention and/or treatment of anaemia, preferably sideropenic anaemia, in humans.

1 . A product obtainable by spray-drying an aqueous solution comprising iron bis-glycinate chelate and alginic acid and/or water-soluble salts thereof. 
     
     
         2 . The product according to  claim 1 , wherein the alginic acid water-soluble salts are selected from sodium alginate, potassium alginate and/or magnesium alginate. 
     
     
         3 . The product according to  claim 1 , wherein the alginic acid and/or water-soluble salts thereof have a molecular weight comprised between 10,000 and 350,000 Da, preferably between 10,000 and 250,000 Da, and even more preferably between 10,000 and 15,000 Da. 
     
     
         4 . The product according to  claim 1 , wherein the alginic acid and/or water-soluble salts thereof have a molecular weight comprised between 10,000 and 15,000 Da, comprised between 40,000 and 50.000 Da, comprised between 90,000 and 200.000, or comprised between 250,000 and 350.000, more preferably comprised between 10,000 and 15,000 Da. 
     
     
         5 . The product according to  claim 1 , wherein the weight ratio between the iron bis-glycinate chelate and the alginic acid and/or water-soluble salts thereof is comprised in the range of 1-2:1-3, preferably this weight ratio is 1:1, 1:2 or 2:3. 
     
     
         6 . The product according to  claim 1 , wherein the alginic acid and/or water-soluble salts thereof, preferably selected from sodium alginate, potassium alginate and/or magnesium alginate, more preferably sodium alginate, have a molecular weight comprised between 10,000 and 15,000 Da, and wherein the weight ratio between the iron bis-glycinate chelate and the alginic acid and/or water-soluble salts thereof is comprised in the range of 1-2:1-3, preferably it is 1:1, 1:2 or 2:3, more preferably it is 1:1. 
     
     
         7 . The product according to  claim 1 , wherein the aqueous solution used for spray-drying is obtained by a solution of iron bis-glycinate chelate and alginic acid and/or water-soluble salts thereof, preferably sodium alginate, potassium alginate and/or magnesium alginate, in a weight ratio with water of 1:10 and 1:12, respectively. 
     
     
         8 . The product according to  claim 1 , characterised by a particle size of less than 20 μ. 
     
     
         9 . The product according to  claim 1 , wherein the density of the product obtained after spray-drying is comprised between 0.2 g/ml and 0.8 g/ml, preferably between 0.3 g/ml and 0.6 g/ml, and even more preferably between 0.4 g/ml and 0.5 g/ml. 
     
     
         10 . The product according to  claim 1 , further comprising an antioxidant, preferably in an amount lower than 0.5% with respect to the total weight of the iron bis-glycinate chelate and the alginic acid and/or water-soluble salts thereof, and even more preferably in an amount lower than 0.3%, wherein said percentages are referred to the total weight of the iron bis-glycinate chelate and the alginic acid and/or water-soluble salts thereof 
     
     
         11 . A method for preventing and/or treating anaemia in humans, comprising administering to a subject in need thereof the product of  claim 1 . 
     
     
         12 . An oral pharmaceutical form comprising the product according to  claim 1 , optionally together with physiologically acceptable excipients. 
     
     
         13 . The pharmaceutical form according to  claim 12 , in an oral solid form, preferably in the form of a tablet, effervescent tablet, buccal tablet, chewable tablet or capsules. 
     
     
         14 . The pharmaceutical form according to  claim 12 , in an oral semi-solid or liquid form, preferably in the form of an aqueous suspension or oily suspension, or in a solution form. 
     
     
         15 . A method for preventing and/or treating anaemia in humans, comprising administering to a subject in need thereof the pharmaceutical form according to  claim 12 . 
     
     
         16 . The method according to  claim 11 , wherein the anaemia is sideropenic anaemia. 
     
     
         17 . The method according to  claim 15 , wherein the anaemia is sideropenic anaemia. 59130-8043.US01/137668546.1