Electrolyte purgative

Abstract

The invention relates to compositions for use in purgatives, to purgatives comprising such compositions, and to methods for inducing purgation of the colon. The composition may comprise at least one water-soluble sodium salt; at least one water-soluble minimally degradable sugar in an amount, by weight, of from about 1 to about 3 times the weight of sodium ions in said composition; at least one water-soluble potassium salt in an amount, by weight, of from about 0.05 to about 1 time the weight of said sodium salt in said composition; and at least one water-soluble magnesium salt, wherein the weight of magnesium ions in said composition is from 0.1 to about 10 times the weight of sodium ions in said composition.

What is claimed is: 
     
         1 . A composition for use in a purgative, the composition comprising:
 (i) at least one water-soluble sodium salt;   (ii) at least one water-soluble minimally degradable sugar in an amount, by weight, of from about 1 to about 3 times the weight of sodium ions in said composition;   (iii) at least one water-soluble potassium salt in an amount, by weight, of from about 0.05 to about 1 times the weight of said sodium salt in said composition; and   (iv) at least one water-soluble magnesium salt, wherein the weight of magnesium ions in said composition is from about 0.1 to about 10 times the weight of sodium ions in said composition.   
     
     
         2 . The composition of  claim 1 , wherein the minimally degradable sugar is selected from the group consisting of xylose, xylotriose, xylooligosaccharides, fructooligosaccharides, fructosans, galactooligosaccharides, other oligosaccharides, and mixtures thereof. 
     
     
         3 . The compositions of  claim 1 , wherein the water-soluble sodium salt is selected from the group consisting of sodium chloride, sodium gluconate, sodium citrate, sodium aspartate and mixtures thereof. 
     
     
         4 . The composition of  claim 1 , wherein the water-soluble potassium salt is selected from the group consisting of potassium chloride and potassium tartrate. 
     
     
         5 . The composition of  claim 1 , wherein the water-soluble magnesium salt is selected from the group consisting of magnesium sulfate, magnesium citrate and magnesium phosphate. 
     
     
         6 . The composition of  claim 1  further comprising at least one additive selected from the group consisting of a flavouring ingredient, a detergent stool-softening agent, citrate, lactate, acetate, trace elements and nutritional elements. 
     
     
         7 . The composition of  claim 1  in the form of a soup or soup-like composition, tablet, gel cap, capsule or sachet. 
     
     
         8 . A purgative, comprising a hypertonic aqueous solution of the composition of  claim 1 . 
     
     
         9 . The purgative of  claim 8  in the form of a unit dose having a volume of from about 0.2 to 0.5 L and wherein the sodium salt or salts are present in an amount from about 1 to about 10 g per unit dose, the minimally degradable sugar or sugars in an amount of from about 2 to about 20 g, the potassium salt or salts in an amount of from about 0.5 to about 5 g and the magnesium salt or salts in an amount of from about 1 to about 10 g per unit dose of the purgative. 
     
     
         10 . A method of inducing purgation of the colon of a patient in need thereof, comprising administering to said patient a composition of  claim 1  in an amount effective to induce purgation of the patient's colon. 
     
     
         11 . A method of inducing purgation of the colon of a patient in need thereof, comprising administering to the patient a composition of a purgative of  claim 8  in an amount effective to induce purgation of the patient's colon. 
     
     
         12 . A method for treatment or prevention of one or more of a member selected from the group consisting of lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache and convulsions, comprising administering to a patient in need of such treatment a composition of  claim 1  whereby lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions is treated or prevented. 
     
     
         13 . A method for treatment or prevention of one or more of a member selected from the group consisting of lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache and convulsions, comprising administering to a patient in need of such treatment a purgative of  claim 8 , whereby lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions is treated or prevented. 
     
     
         14 . A method for the treatment or prevention of acute gastrointestinal infections, comprising administering to a patient in need of such treatment a composition of  claim 1 , whereby acute gastrointestinal infection is treated or prevented. 
     
     
         15 . A method for the treatment or prevention of acute gastrointestinal infections, comprising administering to a patient in need of such treatment a purgative of  claim 8 , whereby acute gastrointestinal infection is treated or prevented. 
     
     
         16 . A method for the treatment or prevention of constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome, comprising administering to a patient in need of such treatment a composition of  claim 1 , whereby constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome is treated or prevented. 
     
     
         17 . A method for the treatment or prevention of constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome, comprising administering to a patient in need of such treatment a purgative of  claim 8 , whereby constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome is treated or prevented. 
     
     
         18 . A method for pre-colonoscopic or pre-surgical lavage, comprising administering to a patient a composition of  claim 1 . 
     
     
         19 . A composition for use in a purgative, the composition comprising: (i) at least one water-soluble sodium salt; (ii) at least one water-soluble degradable sugar in an amount, by weight, of from about 1 to about 3 times the weight of sodium ions in said composition; (iii) at least one water-soluble potassium salt in an amount, by weight, of from about 0.05 to about 1 times the weight of said sodium salt in said composition; and (iv) at least one water-soluble magnesium salt, wherein the weight of magnesium ions in said composition is from about 0.1 to about 10 times the weight of sodium ions in said composition. 
     
     
         20 . A composition of  claim 19  wherein the degradable sugar is selected from the group consisting of glucose, L-glucose, sucrose, fructose, galactose, lactose, mannitol and lactulose. 
     
     
         21 . A purgative, comprising a hypertonic aqueous solution of the composition of  claim 19 . 
     
     
         22 . A method of inducing purgation of the colon of a patient in need thereof, comprising administering to said patient in the absence of diathermy a composition of  claim 19  in an amount effective to induce purgation of the patient's colon. 
     
     
         23 . A method of inducing purgation of the colon of a patient in need thereof, comprising administering to the patient in the absence of diathermy a purgative of  claim 21  in an amount effective to induce purgation of the patient's colon. 
     
     
         24 . A method for the treatment or prevention of one or more of a member selected from the group consisting of lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache and convulsions, comprising administering to a patient in need of such treatment in the absence of diathermy a composition of  claim 19 , whereby lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions are treated or prevented. 
     
     
         25 . A method for the treatment or prevention in the absence of diathermy of one or more of a member selected from the group consisting of lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache and convulsions, comprising administering to a patient in need of such treatment in the absence of diathermy a composition of a purgative of  claim 21 , whereby lavage-associated hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions are treated or prevented. 
     
     
         26 . A method for the treatment or prevention of acute gastrointestinal infections, comprising administering to a patient in need of such treatment in the absence of diathermy a composition of  claim 19 , whereby acute gastrointestinal infection is treated or prevented. 
     
     
         27 . A method for the treatment of prevention of acute gastrointestinal infections, comprising administering to a patient in need of such treatment in the absence of diathermy a purgative of  claim 21 , whereby acute gastrointestinal infection is treated or prevented. 
     
     
         28 . A method for the treatment or prevention of constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome, comprising administering to a patient in need of such treatment in the absence of diathermy a composition of  claim 19 , whereby constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome is treated or prevented. 
     
     
         29 . A method for the treatment or prevention of constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome, comprising administering to a patient in need of such treatment in the absence of diathermy a purgative of  claim 21 , whereby constipation, acute constipation, chronic constipation or constipation predominant irritable bowel syndrome is treated or prevented. 
     
     
         30 . A method for pre-colonoscopic or pre-surgical lavage, comprising administering to a patient in the absence of diathermy a composition of  claim 19 . 
     
     
         31 . The method of  claim 30 , wherein the method is selected from among a simple purgative, an electrolyte replacement lavage, a barium enema preparation, a CT “virtual colonoscopy”, a radiological application, an electrolyte replacement lavage, an electrolyte replacement lavage for acute gastrointestinal infection, a treatment for acute or chronic constipation and related symptoms or a treatment for constipation predominant irritable bowel syndrome, a regular laxative, or a treatment or prevention of lavage-associate hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions. 
     
     
         32 . A method for pre-colonoscopic or pre-surgical lavage, comprising administering to a patient in the absence of diathermy a purgative of  claim 21 . 
     
     
         33 . The method of  claim 32 , wherein the method is selected from among a simple purgative, an electrolyte replacement lavage, a barium enema preparation, a CT “virtual colonoscopy”, a radiological application, an electrolyte replacement lavage, an electrolyte replacement lavage for acute gastrointestinal infection, a treatment for acute or chronic constipation and related symptoms or a treatment for constipation predominant irritable bowel syndrome, a regular laxative, or a treatment or prevention of lavage-associate hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions. 
     
     
         34 . A method for pre-colonoscopic or pre-surgical lavage, comprising administering to a patient a purgative of  claim 8 . 
     
     
         35 . The method of  claim 34 , wherein the method is selected from among a simple purgative, an electrolyte replacement lavage, a barium enema preparation, a CT “virtual colonoscopy”, a radiological application, an electrolyte replacement lavage, an electrolyte replacement lavage for acute gastrointestinal infection, a treatment for acute or chronic constipation and related symptoms or a treatment for constipation predominant irritable bowel syndrome, a regular laxative, or a treatment or prevention of lavage-associate hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions. 
     
     
         36 . The method of  claim 18 , wherein the method is selected from among a simple purgative, an electrolyte replacement lavage, a barium enema preparation, a CT “virtual colonoscopy”, a radiological application, an electrolyte replacement lavage, an electrolyte replacement lavage for acute gastrointestinal infection, a treatment for acute or chronic constipation and related symptoms or a treatment for constipation predominant irritable bowel syndrome, a regular laxative, or a treatment or prevention of lavage-associate hyponatremia, hypoosmolality, nausea, malaise, vomiting, headache or convulsions.