Electrolyte purgative

• US 8,679,549 B2
• Filed: 06/29/2012
• Issued: 03/25/2014
• Est. Priority Date: 03/04/2002
• Status: Expired due to Term

• Current Assignee: The Rite-Prep Unit Trust
• Original Assignee: Anthony Wettstein
• Inventors: Borody, Thomas Julius, Ramrakha, Sanjay, Saxon, John, Wettstein, Anthony
• Primary Examiner(s): Liu, Sue
• Assistant Examiner(s): Holt, Andriae M
• Application Number:
  US13/539,092
• Publication Number:
  US 20120282339A1
• Time in Patent Office: 634 Days
• Field of Search: 424/722, 424/679, 424/680, 424/697, 514/54, 514/892
• US Class Current: 424/722
• 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. A method of inducing purgation of the colon of a patient in need thereof, comprising administering to the patient a purgative composition in an amount effective to induce purgation of the patient'"'"'s colon, wherein the purgative composition comprises:

a purgative composition comprising;

(i) 1-10 gram per unit dose of at least one water-soluble sodium salt;

(ii) 2-20 gram per unit dose of at least one water-soluble minimally degradable sugar;

(iii) 0.5 to 5 gram per unit dose of at least one water-soluble potassium salt;

(iv) 1-10 gram per unit dose of at least one water-soluble magnesium salt; and

(v) a detergent stool softening agent;

wherein the composition is a hypertonic composition in the form of a unit dose having a volume of from about 0.2 to 0.5 L,

and wherein the minimally degradable sugar comprises a xylose, a xylotriose, a mannitol, or a mixture thereof.

2. The method 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.

3. The method of claim 1, wherein the water-soluble potassium salt is selected from the group consisting of potassium chloride and potassium tartrate and mixtures thereof.

4. The method of claim 1, wherein the water-soluble magnesium salt is selected from the group consisting of magnesium sulfate, magnesium citrate and magnesium phosphate and mixtures thereof.

5. The method of claim 1, wherein the detergent stool softening agent is a sodium picosulfate, a bisacodyl or a combination thereof.

6. The method of claim 1, further comprising at least one composition or additive selected from the group consisting of a flavoring ingredient, citrate, lactate, acetate, a trace element and a nutritional element.

7. The method of claim 1, further comprising a flavoring ingredient, a citrate, a lactate, an acetate, a trace element and a nutritional element.

8. The method of claim 1, wherein the purgative composition is in the form of, or formulated as, a fluid, a soup or soup-like composition, tablet, gel cap, capsule or sachet.

9. The method of claim 1, wherein:

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

(ii) the at least one water-soluble minimally degradable sugar comprises a xylose;

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

or (iv) the at least one water-soluble magnesium salt comprises magnesium sulfate.

10. The method of claim 1, further comprising one or more compositions or additives selected from the group consisting of 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 and a biotin.

11. The method of claim 1, wherein the purgative composition is in the form of a tablet.

12. The method of claim 1, wherein the purgative composition is in the form of a tablet comprising a core comprising the sodium, potassium and magnesium salts.

13. The method of claim 1, wherein the purgative composition is in the form of a tablet comprising a coating comprising the minimally degradable sugar.

14. The method of claim 1, wherein the purgative composition is in the form of a tablet comprising:

a core comprising the sodium, potassium and magnesium salts; and

a coating comprising the minimally degradable sugar(s);

wherein the coating surrounds the core.

15. The method of claim 1, 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; and

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

16. The method of claim 1, 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

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.

17. The method of claim 1, wherein the purgative composition is administered in combination with a sodium picosulfate or a bisacodyl.

18. A method of inducing purgation of the colon of a patient in need thereof, comprising administering to the patient a purgative composition in an amount effective to induce purgation of the patient'"'"'s colon, wherein the purgative composition comprises:

a purgative composition comprising;

(i) 1-10 gram per unit dose of at least one water-soluble sodium salt;

(ii) 2-20 gram per unit dose of at least one water-soluble minimally degradable sugar;

(iii) .5 to 5 gram per unit dose of at least one water-soluble potassium salt; and

(iv) 1-10 gram per unit dose of at least one water-soluble magnesium salt;

wherein the composition is a hypertonic composition in the form of a unit dose having a volume of from about 0.2 to 0.5 L,

and wherein the minimally degradable sugar comprises a xylose, a xylotriose, a mannitol, or a mixture thereof.