Aspartame and citrate flavored phosphate salt laxative

Abstract

The present invention provides compositions, kits, and methods suitable for cleansing the colon before colonoscopy. The compositions include a phosphate salt and a flavorant that includes aspartame and a citrate. The kits include the previously mentioned compositions and also may include suitable containers, packaging, relief wipes, and instructions for use. The methods may include administering orally to a subject an aqueous preparation including monobasic sodium phosphate, dibasic sodium phosphate, aspartame, and citric acid.

1 . A composition for colonic cleansing comprising: 
 a flavorant comprising aspartame and a citrate; and    a phosphate salt.    
   
   
       2 . The composition of  claim 1 , where the composition further comprises a flavoring selected from the group consisting of natural fruit flavors, artificial fruit flavors, and combinations thereof.  
   
   
       3 . The composition of  claim 1 , where the citrate comprises citric acid and potassium citrate and the composition further comprises maltodextrin, natural flavor, acesulfame potassium, lemon juice solids, and artificial color.  
   
   
       4 . The composition of  claim 1 , where the phosphate salt comprises at least one salt selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate, and combinations thereof.  
   
   
       5 . The composition of  claim 1 , where the phosphate salt is present as a liquid comprising water and from 0.05 to 1.5 gram/mL of monobasic sodium phosphate and from 0.02 to 0.6 gram/mL of dibasic sodium phosphate.  
   
   
       6 . The composition of  claim 1 , where the phosphate salt is present as a liquid comprising water and from 0.4 to 1 gram/mL of monobasic sodium phosphate and from 0.13 to 0.25 gram/mL of dibasic sodium phosphate.  
   
   
       7 . The composition of  claim 1 , where the phosphate salt is present as a liquid comprising water and 0.48 gram/mL of monobasic sodium phosphate and 0.18 gram/mL of dibasic sodium phosphate.  
   
   
       8 . The composition of  claim 5 , where from 15 to 75 mL of the liquid is combined with from 1 to 10 grams of the flavorant.  
   
   
       9 . The composition of  claim 5 , where from 40 to 50 mL of the liquid is combined with from 4 to 5 grams of the flavorant, 
 where the citrate comprises citric acid.    
   
   
       10 . The composition of  claim 5 , where from 40 to 50 mL of the liquid is combined with from 1 to 3 grams of the flavorant, and 
 the flavorant comprises aspartame, citrates, and artificial lemon flavoring.    
   
   
       11 . The composition of  claim 5 , where about 45 mL of the liquid is combined with 2.0 g+/−10% by weight of the flavorant, and 
 the flavorant comprises aspartame, citrates, and artificial lemon flavoring.    
   
   
       12 . The composition of  claim 1 , further comprising ascorbic acid or a salt thereof.  
   
   
       13 . The composition of  claim 1 , where the flavorant further comprises ascorbic acid or a salt thereof.  
   
   
       14 . The composition of  claim 5 , further comprising from 0.25 g/L to 50 g/L of ascorbic acid or a salt thereof.  
   
   
       15 . The composition of  claim 1 , further comprising a gelling agent.  
   
   
       16 . A kit for colonic cleansing, comprising: 
 monobasic sodium phosphate,    dibasic sodium phosphate, and    a flavorant comprising aspartame and a citrate.    
   
   
       17 . The kit of  claim 16 , where the monobasic sodium phosphate and the dibasic sodium phosphate are present as at least one aqueous solution.  
   
   
       18 . The kit of  claim 16 , where the monobasic sodium phosphate and the dibasic sodium phosphate are present as an aqueous solution present in at least one plastic bottle.  
   
   
       19 . The kit of  claim 16 , where the flavorant further comprises a flavoring selected from the group consisting of natural fruit flavors, artificial fruit flavors, and combinations thereof.  
   
   
       20 . The kit of  claim 16 , where the aspartame and the citric acid are in a powdered form.  
   
   
       21 . The kit of  claim 16 , where the aspartame and the citric acid are in a powdered form and are present in a container formed from at least one material selected from the group consisting of plastic, foil, paper, and combinations thereof.  
   
   
       22 . The kit of  claim 16 , further comprising ascorbic acid or a salt thereof in a powdered form.  
   
   
       23 . The kit of  claim 16 , further comprising a gelling agent in a powdered form.  
   
   
       24 . The kit of  claim 16 , further comprising a container in which to combine the monobasic sodium phosphate, the dibasic sodium phosphate, the aspartame, and the citric acid with water.  
   
   
       25 . The kit of  claim 24 , further comprising instructions to combine the monobasic sodium phosphate, the dibasic sodium phosphate, and the flavorant with water.  
   
   
       26 . The kit of  claim 24 , further comprising at least one anorectal wipe, the anorectal wipe wetted with an aqueous solution including a local anesthetic and a skin protectant.  
   
   
       27 . A kit for colonic cleansing, comprising: 
 a screw-top jar having a lid, comprising: 
 two screw-top plastic bottles, each containing about 45 mL of an aqueous solution, the aqueous solution including about 21.6 g of monobasic sodium phosphate and about 8.1 g of dibasic sodium phosphate,  
 two packets, each enclosing from 1 to 6 grams of a powder that comprises aspartame and a citrate,  
 four envelopes, each enclosing an anorectal wipe, the anorectal wipes including a substrate wetted with an aqueous solution including an anesthetic.  
   
   
   
       28 . The kit of  claim 27 , where the two packets each enclose 2.0 g+/−10% by weight of the flavorant, 
 where the flavorant comprises aspartame, citrates, and artificial lemon flavoring.    
   
   
       29 . A method for colonic cleaning, comprising: 
 administering orally to a subject an aqueous preparation including monobasic sodium phosphate, dibasic sodium phosphate, aspartame, and a citrate.    
   
   
       30 . The method of  claim 29 , where from 0.4 to 0.85 grams of monobasic sodium phosphate and from 0.1 to 0.5 grams of dibasic sodium phosphate are ingested per kilogram of body weight.  
   
   
       31 . The method of  claim 29 , further comprising administering additional liquids to the subject.  
   
   
       32 . The method of  claim 31 , where the additional liquids comprise oral re-hydration salts.  
   
   
       33 . The method of  claim 29 , where the administering is performed prior to a colonoscopy procedure.  
   
   
       34 . The method of  claim 29 , where the administering is performed prior to a radiological procedure.  
   
   
       35 . The method of  claim 29 , where the administering is performed prior to a surgical procedure.  
   
   
       36 . The method of  claim 29 , where the aqueous preparation further comprises ascorbic acid or a salt thereof.  
   
   
       37 . The method of  claim 29 , where the aqueous preparation further comprises from 0.25 g/L to 50 g/L of ascorbic acid or a salt thereof.  
   
   
       38 . The method of  claim 29 , where the aqueous preparation further comprises a gelling agent.