READY TO USE, STERILE, STABLE INJECTION SOLUTION OF 9 - ((1,3-DIHYDROXYPROPAN-2-ILOXY) METHYL) -2-AMIN-1H-PURIN-6 (9H) -ONEONE; CLOSED SYSTEM FOR PACKAGING THE SOLUTION, METHOD FOR ELIMINATING ALKALINE REST OF 9 - ((1,3-DIHYDROXYPROPAN-2-ILOXY) METHYL) -2-AMIN-1H-PURIN-6 (9H) -ONE CRYSTALS,

摘要

The present invention describes a sterile, stable and ready-for-use injectable solution comprising 9-((1,3-dihydroxypropan-2-iloxy)methyl)-2-amino-1H-purin-6(9H)-one in glucose 5% aqueous solution or sodium chloride 0-9% aqueous solution. It also describes a closed system used for packing the solution, which consists of a flexible bag manufactured with a tri-laminated material. The present invention also describes a process for eliminating the residual alkalinity that is present in the 9-((1,3-dihydroxypropan-2-iloxy)methyl)-2-amino-1H-purin-6(9H)-one, so obtaining crystals that are free from alkaline residues and suitable for the direct preparation of the solution. The present invention relates to the medical and therapeutic areas, mainly for treating immunodepressed patients carrying viral infections.