Method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis

Abstract

A method of preparing a medical solution includes the steps of a) providing a solution having one or more acetylated or deacetylated amino sugar/sugars in at least one compartment of a container at a pH of from 2.5 to 5.0, and b) terminal sterilization of the compartment and the contents therein. The solution can be used for manufacturing a medicament for peritoneal dialysis.

1 . A method for preparing a medical solution, comprising the steps of:
 a) providing a solution comprising one or more acetylated or deacetylated amino sugars in at least one compartment of a container, said solution having a pH of 2.0-5.0, and   b) terminal sterilisation of said at least one compartment and the contents therein.   
     
     
         2 . The method according to  claim 1 , wherein the pH is 2.5-3.5, preferably 3.0. 
     
     
         3 . The method according to  claim 1 , wherein said one or more acetylated or deacetylated amino sugar/sugars is/are chosen from N-acetylglucosamine (NAG), galactosamine, N-acetylgalactosamine, mannosamine, and N-acetylmannosamine in the form of monomers, oligomers and/or polymers thereof including chitin, and human glucose-aminoglycans, as well as derivatives thereof. 
     
     
         4 . The method according to  claim 1 , wherein said one or more acetylated or deacetylated amino sugar/sugars is/are present in a concentration of 15-40% by weight, preferably 20-40% by weight, most preferably at least 30% by weight, with the basis of the solution in said at least one compartment. 
     
     
         5 . The method according to  claim 1 , wherein said one or more acetylated or deacetylated amino sugar/sugars is N-acetylglucosamine (NAG). 
     
     
         6 . The method according to  claim 1 , wherein the terminal sterilisation is heat sterilisation at a temperature of at least 100° C., preferably at 121° C., and/or radiation sterilisation. 
     
     
         7 . The method according to  claim 1 , wherein each compartment of the container is delimited from the other/others during the terminal sterilisation, and wherein the terminally sterilised solution containing one or more acetylated or deacetylated amino sugars is/are mixed with a terminally sterilised pH adjusting and diluting solution in at least one other terminally sterilised compartment of the container, thereby finally preparing the medical solution. 
     
     
         8 . The method according to  claim 7 , wherein the pH in the finally prepared medical solution is 6.0-8.0, preferably 7.4. 
     
     
         9 . The method according to  claim 7 , wherein the concentration of acetylated or deacetylated amino sugar/sugars in the finally prepared solution is/are 0.2-15.0% by weight, preferably 0.5-6.0% by weight. 
     
     
         10 . The method according to  claim 1 , wherein physiologically compatible constituents in the form of carbohydrates, preferably glucose, proteins, peptides, and antioxidants are present in one or more of said compartments. 
     
     
         11 . The method according to  claim 1 , wherein the medical solution prepared is a peritoneal dialysis solution. 
     
     
         12 . A solution comprising one or more acetylated or deacetylated amino sugar/sugars and having a pH of 2.0-5.0, preferably 2.5-3.5, most preferably 3.0, wherein said solution is terminally sterilised and contains low levels of cytotoxic degradation products. 
     
     
         13 . The solution according to  claim 12 , wherein said one or more acetylated or deacetylated amino sugar/sugars is/are present in a concentration of 15-40% by weight, preferably 20-40% by weight, most preferably at least 30% by weight. 
     
     
         14 . The solution according to  claim 12 , wherein the acetylated or deacetylated amino sugar/sugars is/are chosen from N-acetylglucosamine (NAG), galactosamine, N-acetylgalactosamine, mannosamine, and N-acetylmannosamine in the form of monomers, oligomers and/or polymers thereof including chitin, and human glucose-aminoglycans, as well as derivatives thereof, and preferably is N-acetylglucosamine. 
     
     
         15 . A container comprising at least one compartment containing a solution according to  claim 12 . 
     
     
         16 . Use of a solution according to  claim 12  for the manufacture of a medicament for peritoneal dialysis, wherein it is mixed with terminally sterilised pH adjusting and diluting solution. 
     
     
         17 . The method according to  claim 8 , wherein the concentration of acetylated or deacetylated amino sugar/sugars in the finally prepared solution is/are 0.2-15.0% by weight, preferably 0.5-6.0% by weight. 
     
     
         18 . The solution according to  claim 13 , wherein the acetylated or deacetylated amino sugar/sugars is/are chosen from N-acetylglucosamine (NAG), galactosamine, N-acetylgalactosamine, mannosamine, and N-acetylmannosamine in the form of monomers, oligomers and/or polymers thereof including chitin, and human glucose-aminoglycans, as well as derivatives thereof. 
     
     
         19 . The solution according to  claim 18 , wherein the acetylated or deacetylated amino sugar is N-acetylglucosamine.