ELECTROLYTE PURGATIVE

• US 20110223252A1
• Filed: 05/19/2011
• Published: 09/15/2011
• Est. Priority Date: 03/04/2002
• Status: Abandoned Application

• Current Assignee: The Rite-Prep Unit Trust
• Original Assignee: The Rite-Prep Unit Trust
• Inventors: RAMRAKHA, Sanjay, BORODY, Thomas Julius, SAXON, John, WETTSTEIN, Antony
• Application Number:
  US13/111,736
• Publication Number:
  US 20110223252A1
• Time in Patent Office: Days
• US Class Current: 424/474
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/194 having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
• CPC Class Codes: A61K 31/7004 Monosaccharides having only carbon, hydrogen and oxygen atoms
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/10 Laxatives

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.

Claims

1-36. -36. (canceled)

37. A purgative composition, comprising:

(i) at least one water-soluble sodium salt;

(ii) at least one water-soluble potassium salt, wherein the weight of the water-soluble potassium salt in the composition is from about 0.05 to about 1 times the weight of the sodium salt in the composition; and

(iv) at least one water-soluble magnesium salt, wherein the weight of magnesium salt in the composition is from about 0.1 to about 10 times the weight of the sodium salt in the composition.

38. The purgative composition of claim 37, wherein:

(a) the potassium salt comprises a potassium chloride salt, a potassium citrate salt, a potassium aspartate salt, a potassium phosphate salt, or a potassium sulfate salt or a mixture thereof;

or, (b) the water-soluble sodium salt comprises a sodium chloride, sodium gluconate, sodium citrate, sodium aspartate or a mixture thereof.

39. The purgative composition of claim 37, wherein the water-soluble potassium salt comprises a potassium chloride, a potassium tartrate or a mixture thereof.

40. The purgative composition of claim 37, wherein the water-soluble magnesium salt comprises a magnesium sulfate, a magnesium citrate or a magnesium phosphate or a mixture thereof.

41. The purgative composition of claim 37, further comprising at least one water-soluble minimally degradable sugar in an amount, wherein the total weight of water-soluble minimally degradable sugar in the composition is from about 1 to about 3 times the weight of the sodium salt in the composition.

42. The purgative composition of claim 41, wherein the minimally degradable sugar comprises a mannitol, a xylose, a xylotriose, a xylooligosaccharide, a fructooligosaccharide, a fructosan, a galactooligosaccharides or a mixture thereof.

43. The purgative composition of claim 37, further comprising at least one composition or additive selected from the group consisting of a flavoring ingredient, a detergent stool-softening agent, citrate, lactate, acetate, a trace element and a nutritional element.

44. The purgative composition of claim 37, in the form of, or formulated as:

a medicament, a soup or soup-like composition, a tablet, a gel cap, a capsule, a sachet, a hypertonic aqueous solution or a lavage solution.

45. The purgative composition of claim 37, 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 composition.

46. A method of inducing purgation of the colon of a patient in need thereof, comprising administering to the patient a purgative composition of claim 37, in an amount effective to induce purgation of the patient'"'"'s colon.

47. A method of inducing a pre-surgical lavage of the colon of a patient in need thereof, comprising administering to the patient a purgative composition of claim 37, in an amount effective for pre-surgical lavage of the patient'"'"'s colon.

48. The purgative composition of claim 37, further comprising one or more compositions comprising a citrate, a lactate, an acetate, a calcium, a zinc, a Vitamin B complex, a thiamine, a Vitamin A, a Vitamin C, a Vitamin E, a folic acid or a biotin or a mixture thereof.

49. The purgative composition of claim 37, further comprising a detergent stool-softening agent.

50. The purgative composition of claim 37, further comprising a sodium picosulfate.

51. The purgative composition of claim 37, further comprising a bisacodyl.

52. The purgative composition of claim 37, in the form of:

(a) a tablet, or

(b) a tablet comprising a core comprising the sodium, potassium and magnesium salts;

wherein the coating surrounds the core.

53. The method of claim 46, wherein the purgative composition is administered in combination with a purgative selected from the group consisting of a sodium picosulfate and a bisacodyl.

54. The method of claim 47, wherein the purgative composition is administered in combination with a purgative selected from the group consisting of a sodium picosulfate and a bisacodyl.

55. The method of claim 46, wherein:

the at least one water-soluble sodium salt comprises a sodium chloride, a sodium gluconate, a sodium citrate or a sodium aspartate;

the at least one water-soluble potassium salt comprises a potassium chloride;

or

the at least one water-soluble magnesium salt comprises a magnesium sulfate, a magnesium citrate or a magnesium phosphate.

56. The method of claim 47, wherein:

the at least one water-soluble sodium salt comprises a sodium chloride, a sodium gluconate, a sodium citrate or a sodium aspartate;

the at least one water-soluble potassium salt comprises a potassium chloride;

or

the at least one water-soluble magnesium salt comprises a magnesium sulfate, a magnesium citrate or a magnesium phosphate.