Pharmaceutical composition for use as a laxative

Abstract

The invention relates to a pharmaceutical composition which is suitable in particular for use as purgative (cathartic), where the composition comprises in combination and in each case in pharmaceutically effective amounts (A) senna fruit dry extract and (B) plantago seeds ( plantaginis ovatae semen ). The composition can advantageously be manufactured by fluidized bed granulation. The composition is in particular free of guar gum, is dust-free, is dispersible in water and has a pleasant taste and can be supplemented straightforwardly with vitamins, minerals, trace elements and the like.

1 . A pharmaceutical composition for use as a purgative, where the composition comprises, a non-agglomerating combination, under standard conditions, and in each case in pharmaceutically effective amounts:
 a) a senna fruit dry extract; and   b) plantago seeds ( plantaginis ovatae semen ).   
     
     
         2 . The composition of  claim 1 , where the senna fruit dry extract comprises at least 3% by weight, based on the senna fruit dry extract, of hydroxyanthracene derivatives, calculated as sennoside B. 
     
     
         3 . The composition of  claim 1 , where the senna fruit dry extract comprises 3 to 30% by weight, based on the senna fruit dry extract, of hydroxyanthracene derivatives, calculated as sennoside B. 
     
     
         4 . The composition of  claim 1 , where the senna fruit dry extract comprises a drug/extract ratio of at least 2:1. 
     
     
         5 . The composition of  claim 1 , where the senna fruit dry extract comprises fruit from the group of plants consisting of Alexandria senna plant, Tinnevelly senna plant, and mixtures thereof. 
     
     
         6 . The composition of  claim 1 , where the composition comprises at least 1%, by weight, based on the composition, of senna fruit dry extract. 
     
     
         7 . The composition of  claim 1 , where the composition comprises at least 0.1%, by weight, based on the composition, of sennoside hydroxyanthracene derivative. 
     
     
         8 . The composition of  claim 1 , comprising 20 to 90%, by weight, based on the total composition weight, of plantago seed. 
     
     
         9 . The composition of  claim 1  comprising granules. 
     
     
         10 . The composition of  claim 9  further comprising at least one granule former. 
     
     
         11 . The composition of  claim 10 , comprising 3 to 30%, by weight, based on the total composition weight, of said granule former. 
     
     
         12 . The composition of  claim 1  further comprising at least one member of the group consisting of colorants, flavorings, flavor enhancers and aromatizing agents, sweeteners, acidifiers, preservatives, stabilizers and costabilizers, electrolytes, minerals, mineral substances, vitamins, fillers, flow agents and processing aids, and mixtures of the aforementioned materials. 
     
     
         13 . The composition of  claim 1  comprising an average particle size in the range from 50 to 400 μm. 
     
     
         14 . The composition of  claim 1 , comprising at least 55%, by weight, of the particles of the composition having a particle size in the range from 50 to 1000 μm, where the maximum distribution curve is at particle sizes in the range from 65 to 500 μm. 
     
     
         15 . The composition of  claim 1 , comprising the following particle size distribution:
 a) more than 99%, by weight, of the particles of the composition have a size less than 2000 μm; and   b) more than 94%, by weight, of the particles of the composition have a size less than 1000 μm; and   c) more than 50%, by weight, of the particles of the composition have a size less than 500 μm; and   d) fewer than 10%, by weight, of the particles of the composition have a size less than 63 μm;   where all the aforementioned weight data are in each case based on the dry weight of the total composition.   
     
     
         16 . The composition of  claim 1  comprising a bulk density in the range from 250 to 650 g/l. 
     
     
         17 . A method for manufacturing a non-agglomerating pharmaceutical composition, under standard conditions, for use as a purgative comprising:
 a) combining pharmaceutically effective amounts of a senna fruit dry extract and plantago seeds ( plantaginis ovatae semen );   b) adjusting the particle sizes of said senna fruit dry extract and said plantago seeds; and   c) granulating said combination in the presence of at least one granule former.   
     
     
         18 . A method for treating a mammal suffering from an obstipation, said method comprising: administering a pharmaceutically effective amount of a non-agglomerating laxative composition, under standard conditions, said laxative composition comprising in combination and in pharmaceutically effective amounts each
 a) a senna fruit dry extract; and   b) plantago seeds ( plantaginis ovatae semen ).   
     
     
         19 . The method of  claim 18 , where the cathartic composition is administered orally. 
     
     
         20 . The method of  claim 18 , where the cathartic composition is administered as aqueous suspension or solution.