Pharmaceutical composition

Abstract

A pharmaceutical composition comprising a docusate; an osmotic laxative; and a benzoate.

1 - 16 . (canceled) 
     
     
         17 . A pharmaceutical composition that is in the form of a solution and comprises:
 (a) a docusate in an amount between about 0.05% and about 0.5% w/v;   (b) an osmotic laxative in an amount between about 15% and about 35% w/v; and   (c) a benzoate in an amount between about 0.005% and about 0.5% w/v.   
     
     
         18 . A pharmaceutical composition according to  claim 17 , wherein the docusate is in the form of a salt. 
     
     
         19 . A pharmaceutical composition according to  claim 18 , wherein the docusate is docusate sodium, docusate calcium or docusate potassium. 
     
     
         20 . A pharmaceutical composition according to  claim 19 , wherein the docusate is docusate sodium. 
     
     
         21 . A pharmaceutical composition according to  claim 17 , wherein the docusate is present in an amount between about 0.05% and about 0.11% w/v. 
     
     
         22 . A pharmaceutical composition according to  claim 17 , wherein the osmotic laxative is a sugar alcohol which has osmotic laxative effect. 
     
     
         23 . A pharmaceutical composition according to  claim 22 , wherein the sugar alcohol is sorbitol or lactitol. 
     
     
         24 . A pharmaceutical composition according to  claim 23 , wherein the sugar alcohol is sorbitol. 
     
     
         25 . A pharmaceutical composition according to  claim 17 , wherein the osmotic laxative is present in an amount between about 20% and about 30% w/v. 
     
     
         26 . A pharmaceutical composition according to  claim 17 , wherein the benzoate is sodium benzoate or potassium benzoate. 
     
     
         27 . A pharmaceutical composition according to  claim 26 , wherein the benzoate is sodium benzoate. 
     
     
         28 . A pharmaceutical composition according to  claim 17 , wherein the benzoate is present in an amount between about 0.01% and about 0.025% w/v. 
     
     
         29 . A pharmaceutical composition according to  claim 17 , which further comprises a (C 1 -C 6 )alkyl ester of p-hydroxybenzoic acid in an amount between about 0.01 to about 1% (w/v). 
     
     
         30 . A pharmaceutical composition according to  claim 29 , wherein the (C 1 -C 6 )alkyl ester of p-hydroxybenzoic acid is methyl parahydroxybenzoate. 
     
     
         31 . A pharmaceutical composition according to  claim 17  that is suitable for rectal administration. 
     
     
         32 . A pharmaceutical composition according to  claim 17 , which has a pH between about 5.4 and about 6.0. 
     
     
         33 . A pharmaceutical composition according to  claim 32 , which maintains the pH of between about 5.4 and about 6.0 over a period of about 18 months. 
     
     
         34 . A single use package comprising a single dose of a pharmaceutical composition,
 wherein the pharmaceutical composition is in the form of a solution and comprises:   (a) a docusate in an amount between about 0.05% and about 0.5% w/v;   (b) an osmotic laxative in an amount between about 15% and about 35% w/v; and   (c) a benzoate in an amount between about 0.005% and about 0.5% w/v.   
     
     
         35 . A single use package according to  claim 32 , further comprising a single use container and a nozzle attached to the top of the container.