Active ingredient containing stabilised solid medicinal forms and methods for the production thereof

Abstract

The invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.

What is claimed: 
     
         1 . A non-effervescent solid medicinal form comprising:
 (i) 5 to 50% by weight of a moisture-sensitive active ingredient, wherein said moisture-sensitive active ingredient is not trimagnesium dicitrate; and   (ii) 20-50% by weight of trimagnesium dicitrate acting as a drying agent that stabilizes the moisture-sensitive active ingredient against hydrolysis during storage;   wherein said solid medicinal form comprises a tablet or granule, further wherein said solid medicinal form exhibits a relative equilibrium moisture, measured at 25° C., of at most 20%.   
     
     
         2 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form further comprises 5 to 30% of weight of a microcrystalline cellulose. 
     
     
         3 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form exhibits a relative equilibrium moisture, measured at 25° C., of at most 15%. 
     
     
         4 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form exhibits a drying loss, measured at 120° C./30 min, of at most 6%. 
     
     
         5 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form is a tablet. 
     
     
         6 . The non-effervescent solid medicinal form of  claim 5 , wherein said tablet comprises at least one further excipient selected from the group consisting of lactose, mannitol, xylitol, lubricants, disintegrants, silica, and combinations thereof. 
     
     
         7 . The non-effervescent solid medicinal form of  claim 6 , wherein said lubricant is selected from magnesium stearate, stearic acid and combinations thereof 
     
     
         8 . The non-effervescent solid medicinal form of  claim 6 , wherein said disintegrant is selected from the group consisting of such as cross-linked povidone, cross-linked carboxymethyl-cellulose, and combinations thereof 
     
     
         9 . The non-effervescent solid medicinal form of  claim 5 , wherein said tablet is a film tablet. 
     
     
         10 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form is a granule. 
     
     
         11 . The non-effervescent solid medicinal form of  claim 1 , wherein said solid medicinal form is packaged together with an external drying agent in a tight packaging that is substantially impermeable to water.