Carbohydrate medical solution and sulphite stabilisator in a multiple compartment container and use thereof

Abstract

The invention relates to a multiple compartment container for sterile medical solutions, particularly solutions for peritoneal dialysis containing a carbohydrate stabilisation compound, a carbohydrate medical solution containing said carbohydrate stabilisation compound and a method for the preparation thereof.

1 . Multiple compartment container for sterile medical solutions, wherein said solutions are present in two or more compartments, and at least one of said solutions comprises a carbohydrate compound, characterised in that at least one sulphite compound is present in one or more of said compartments.  
     
     
         2 . Multiple compartment container according to  claim 1 , wherein said sulphite compound is selected from the group consisting of HSO 3   − , S 2 O 5   2− or SO 3   2− , having a positive counter ion or mixtures thereof, preferably NaHSO 3 , Na 2 S 2 O 5  or Na 2 SO 3  or a mixture thereof.  
     
     
         3 . Multiple compartment container according  claim 1  or  2 , wherein said sulphite compound is a monosulphite compound, the total amount of monosulphite compound in said container being equal to 0.01-10 mmol, per liter of the total amount of solution in said container, preferably 0.05-1 mmol, per liter of the total amount of solution in said container, most preferably 0.05-0.5 mmol, per liter of the total amount of solution in said container.  
     
     
         4 . Multiple compartment container according to  claim 1  or  2 , wherein said sulphite compound is a disulphite compound, the total amount of disulphite compound in said container being equal to 0.005-5 mmol per liter of the total amount of solution in said container, preferably 0.025-0.5 mmol, per liter of the total amount of solution in said container, most preferably 0.025-0.25 mmol, per liter of the total amount of solution in said container.  
     
     
         5 . Multiple compartment container according to  claim 3  or  4 , wherein the pH of the mixed solution in said container is between 5.0-8.0, more preferably between 6.0-8.0, most preferably between 7.0-7.5.  
     
     
         6 . Multiple compartment container according to any of claims  1 - 5 , wherein said carbohydrate is glucose and the total amount of glucose in said container is about 4% by weight of the total amount of solution in said container.  
     
     
         7 . Multiple compartment container according  claims 1  to  6 , wherein said carbohydrate compound is not present in all compartments, preferably in only one of two compartments in a two compartment bag or in only two of three compartments in a three compartment bag.  
     
     
         8 . Multiple compartment container according  claim 7 , wherein the pH of said compartments containing said carbohydrate compound is between 2.0 and 7,5, preferably between 2.0 and 5,5, more preferably between 3 and 4 and most preferably about 3,2.  
     
     
         9 . Multiple compartment container according to  claim 7  or  8 , wherein said sulphite is a monosulphite compound and wherein said concentration monosulphite after mixing of said different solutions give rise to a final solution with a concentration of monosulphite compound of 0.01-10 mM, preferably 0.05-1 mM, most preferably 0.025-0.25 mM.  
     
     
         10 . Multiple compartment container according to  claim 7  or  8 , wherein said sulphite is a disulphite compound and wherein said concentration disulphite after mixing of said different solutions give rise to a final solution with a concentration of disulphite compound of 0.005-5 mM, preferably 0.025-0.5 mM, most preferably 0.025-0.25 mM.  
     
     
         11 . Multiple compartment container according to any of  claims 7  to  10 , wherein said carbohydrate compound is glucose and said container is a three compartment bag and wherein the concentration of glucose after mixing of said different solutions give rise to a final solution in the range of 1.5 to 4%, preferably about 1.5, 2.5 or 4% by weight of glucose based of the total amount of final solution.  
     
     
         12 . Multiple compartment container according to any of claims  1 - 11 , wherein said container is sterilised using heat treatment.  
     
     
         13 . Multiple compartment container according to any of claims  1 - 12 , wherein said multiple compartment container contains medical solutions for preparing a final solution for peritoneal dialyses by mixing two or more of said medical solutions.  
     
     
         14 . A sterile medical solution comprising a carbohydrate compound, at least one sulphite compound selected from the group consisting of HSO 3   − , S 2 O 5   2−  or SO 3   2− , having a positive counter ion or mixtures thereof, preferably NaHSO 3 , Na 2 S 2 O 5  or Na 2 SO 3  or a mixture thereof, wherein said sulphite compound is a monosulphite compound, present in a concentration of between 0.01-10 mM or a disulphite compound, present in a concentration of between 0.005-5 mM.  
     
     
         15 . A sterile medical solution according to  claim 14 , wherein said sulphite compound is a monosulphite compound, present in a concentration of preferably 0.05-1 mM, most preferably 0.05-0.5 mM.  
     
     
         16 . A sterile medical solution according to  claim 14  or  15 , wherein said solution is heat sterilised.  
     
     
         17 . A sterile medical solution according to any of claims  14 - 16 , wherein said solution is a solution for peritoneal dialysis.  
     
     
         18 . A sterile medical solution according to any of claims  14 - 17 , wherein said solution is used in a three compartment container.  
     
     
         19 . A method of stabilising a carbohydrate containing sterile medical solution wherein in that at least one sulphite compound is added to said solution in a concentration of preferably 0.05-1 mM, most preferably 0.05-0.5 mM if said sulphite component is a monosulphite compound, and in a concentration of 0.005-5 mM, preferably 0.025-0.5 mM, most preferably 0.025-0.25 mM if said sulphite component is a disulphite compound.  
     
     
         20 . A method according to  claim 19 , wherein said sulphite compound is selected from the group consisting of HSO 3   − , S 2 O 5   2−  or SO 3   2− , having a positive counter ion or mixtures thereof, preferably NaHSO 3 , Na 2 S 2 O 5  or Na 2 SO 3  or a mixture thereof.  
     
     
         21 . A method according to  claim 19  or  20 , wherein said solution is heat sterilised.  
     
     
         22 . Use of a carbohydrate containing sterile medical solution according to any of claims  14 - 18  for the preparation of a multiple compartment container according to any of claims  1 - 13 .