Combined pharmaceutical composition

Abstract

The present invention relates to a physicochemically stable pharmaceutical composition, in a unit dose characterized in that it comprises effective amounts of the active ingredients thiamine (Vitamin B1), pyridoxine (Vitamin B6), a flavonoid such as quercetin and a polyphenol such as curcumin, or their pharmaceutically acceptable salts in combination with pharmaceutically acceptable excipients, for the prevention of the formation and/or trapping of advanced glycation end products (glyoxal, methylglyoxal, N-carboxymethyl-lysine, N-carboxyethyl-lysine, pyrraline, pentosidine, lysine dimer, etc.), which can be used in the treatment and/or prevention of complications of diabetes mellitus (diabetic neuropathy, nephropathy and retinopathy). The pharmaceutical composition of the invention is presented orally, preferably in capsule, pill or sachet for oral administration.

1 . A stable pharmaceutical, physicochemical composition, in a unit dose, characterized in that it comprises the active ingredients of Vitamin B1 group selected from thiamine hydrochloride, thiamine diphosphate, thiamine triphosphate or its pharmaceutically acceptable salts, vitamin B6 selected from pyridoxine, pyridoxal, pyrodoxamine, pyritinol, pyrithioxin, dipyridoxolyldisulfide, pyridoxine disulfide or its pharmaceutically acceptable salts, a flavonoid selected from quercetin or its pharmaceutically acceptable salts and a polyphenol selected from curcumin or its pharmaceutically acceptable salts, in combination with pharmaceutically acceptable excipients and preservatives. 
     
     
         2 . A pharmaceutical composition according to  claim 1  wherein vitamin B1 is thiamine hydrochloride. 
     
     
         3 . A pharmaceutical composition according to  claim 1  wherein vitamin B1 is thiamine diphosphate. 
     
     
         4 . A pharmaceutical composition according to  claim 1  wherein vitamin B1 is thiamine triphosphate. 
     
     
         5 . A pharmaceutical composition according to  claim 1  wherein vitamin B1 is an active form of thiamine. 
     
     
         6 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyridoxine hydrochloride. 
     
     
         7 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyridoxal phosphate. 
     
     
         8 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyritinol. 
     
     
         9 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyrithioxin. 
     
     
         10 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyridoxamine. 
     
     
         11 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is dipyridoxolyldisulfide. 
     
     
         12 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is pyridoxindisulfide. 
     
     
         13 . A pharmaceutical composition according to  claim 1  wherein vitamin B6 is an active form of pyridoxine. 
     
     
         14 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin. 
     
     
         15 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-4′-glucoside. 
     
     
         16 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-galactoside. 
     
     
         17 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-glucoside. 
     
     
         18 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-rhamnoside. 
     
     
         19 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-rhamnoglucoside. 
     
     
         20 . A pharmaceutical composition according to  claim 1  wherein the flavonoid is quercetin-3-arabinoside.