Solid pharmaceutical preparation containing levothyroxine

Abstract

The invention relates to a solid pharmaceutical preparation comprising levothyroxine sodium, gelatine, citric acid and a filler. The solid pharmaceutical preparation has an improved stability.

1 . Solid pharmaceutical preparation comprising levothyroxine sodium, gelatine, citric acid and a filler. 
     
     
         2 . Solid pharmaceutical preparation according to  claim 1 , characterized in that it comprises liothyronine sodium. 
     
     
         3 . Solid pharmaceutical preparation according to  claim 1 , characterized in that the filler is a sugar alcohol such as sorbitol or mannitol dulcitol, xylitol or ribitol, preferably sorbitol or mannitol, particular preferably mannitol, a sugar such as glucose, fructose, mannose, lactose, saccharose or maltose, preferably lactose, saccharose or maltose, particular preferably lactose, a starch such as potato starch, rice starch, maize starch or pregelatinized starch, preferably maize starch or pregelatinized starch, particular preferably maize starch, a cellulose such as powdered cellulose or microcrystalline cellulose, preferably microcrystalline cellulose, or a mixture thereof. 
     
     
         4 . Solid pharmaceutical preparation according to  claim 3 , characterised in that the filler is mannitol and/or maize starch. 
     
     
         5 . Solid pharmaceutical preparation according to  claim 1 , characterized in that it further comprises an antioxidant selected from the group consisting of tocopherol, propyl gallate, tertiary butylhydroquinone, butylated hydroxyanisole and butylated hydroxytoluene, preferably hydroxyanisole or butylated hydroxytoluene, particular preferably butylated hydroxytoluene. 
     
     
         6 . Solid pharmaceutical preparation according to  claim 1 , characterised in that it is in granule, pellet, capsule or tablet form. 
     
     
         7 . Solid pharmaceutical preparation according to  claim 6 , characterised in that it is a tablet. 
     
     
         8 . Solid pharmaceutical preparation according to  claim 1 , characterised in that at least one disintegrating agent is present. 
     
     
         9 . Solid pharmaceutical preparation according to  claim 8 , characterized in that the disintegrating agent is sodium starch glycolate, or carboxymethylcellulose sodium or a mixture thereof. 
     
     
         10 . Solid pharmaceutical preparation according to  claim 9 , characterized in that the disintegrating agent present is carboxymethylcellulose sodium. 
     
     
         11 . Solid pharmaceutical preparation according to  claim 1 , characterised in that it comprises 1 to 10% by weight of gelatine, 0.1 to 3% by weight citric acid, 50 to 80% by weight of mannitol or lactose, 10 to 30% by weight maize starch. 
     
     
         12 . Solid pharmaceutical preparation according to  claim 11 , characterised in that it comprises 0.05 to 0.5% by weight butylated hydroxytoluene. 
     
     
         13 . Process for the production of a solid pharmaceutical preparation according to  claim 7 , characterized in that
 (a) levothyroxine sodium and optionally liothyronine sodium is/are suspended in an aqueous gelatine solution,   (b) the suspension obtained by step (a) is sprayed onto the filler in a fluidized bed granulation and dried to form granules,   (c) the granules obtained by step (b) is collected and optionally,   (d) a disintegrant and optionally a lubricant is/are mixed with the granules obtained by step (c), and   (e) the mixture obtained by step (d) is compressed to give tablets.   
     
     
         14 . Process for the production of a solid pharmaceutical preparation according to  claim 13 , characterized in that citric acid and, if present, the antioxidant is dissolved in the aqueous gelatine solution used in step (a) or is admixed with the granules in step (d). 
     
     
         15 . Process for the preparation of a solid pharmaceutical preparation according to  claim 13 , characterised in that the granules or the tablets are provided with a coating.