Patent EA-001443-B1 (EA)
Title: Non-aqueous colonic purgative formulations
Inventor: JACOB LEONARD S
IPC: A61K31/19
Filed: 1998-03-30
Abstract: 1. An orally administerable non-aqueous composition capable of inducing purgation of the colon of a patient comprising a purgative effective amount of a non-aqueous admixture of a salt selected from the group consisting of phosphates, sulfates and magnesium and natrium tartrates and mixtures, thereof. 2. An orally administerable non-aqueous composition capable of inducing purgation of the colon of a patient comprising a purgative effective amount of a non-aqueous admixture of a salt selected from the group consisting of Mg3(PO4)2, MgHPO4, Mg(H2PO4)2, MgSO4, MgCl2, Na2SO4, natrium tartrate, potassium tartrate, magnesium tartrate and mixtures, thereof. 3. The composition according to claim 1 or 2 wherein said salt is a phosphate salt. 4. The composition according to claim 1 or 2 wherein said phosphate salt is selected from the group consisting of monobasic magnesium phosphate, dibasic magnesium phosphate and tribasic magnesium phosphate. 5. The composition of claim 3 wherein said phosphate salt is dibasic magesium phosphate or a mixture of dibasic magenesium phosphate and monobasic magnesium phosphate. 6. The composition of claim 1 or 2 wherein said salt is included in an amount ranging from about 0.05 grams per kilogram body weight to about 2.0 grams per kilogram body weight of said patient. 7. The composition of claim 4 wherein said magnesium phosphate salt is included in an amount ranging from about 0.1 to about 1.2 grams per kilogram body weight of said patient. 8. The composition of claim 4 wherein said magnesium phosphate salt is dibasic magnesium phosphate included in an amount ranging from about 0.2 to about 0.7 grams per kilogram body weight of said patient. 9. The composition of claim 1 or 2 further comprising a buffering agent selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate. 10. The composition of claim 4 further comprising a buffering agent selected from the group consisting of magnesium hydroxide, aluminum hydroxide, calcium carbonate and magnesium carbonate. 11. The composition of claim 1 or 2 further comprising a dispersal agent selected from the group consisting of anhydrous lactose, microcrystalline cellulose and ACDI-SOL. 12. The composition of claim 10 further comprising a dispersal agent selected from the group consisting of anhydrous lactose, microcrystalline cellulose and ACDI-SOL. 13. The composition of claim 1 or 2 further comprising a binding agent selected from the group consisting of non-ionic detergents, mechanical adhesives and microcrystalline cellulose. 14. The composition of claim 10 further comprising a binding agent selected from the group consisting of non-ionic detergents, mechanical adhesives and microcrystalline cellulose. 15. A method of inducing purgation of the colon in a patient comprising the steps of: (a) preparing a non-aqueous admixture of a purgative salt selected from the group consisting of phosphates, sulfates and magnesium and natrium tartrates and mixtures, to form a purgative formulation;  (b) forming an orally administrable dosage form of said purgative formulation; (c) orally administering a purgative effective dosage of said formulation to a patient; and (d) allowing said administered dosage to induce purgation. 16.A method of inducing purgation of the colon in a patient comprising the steps of: (a) preparing a non-aqueous admixture of a purgative salt selected from the group consisting of Mg3(PO4)2, MgHPO4, Mg(H2PO4)2, MgSO4, MgCl2, Na2SO4, natrium tartrate, potassium tartrate, magnesium tartrate and mixtures, thereof to form a purgative formulation; (b) forming an orally administrable dosage form of said purgative formulation; (c) orally administering a purgative effective dosage of said formulation to a patient; and (d) allowing said administered dosage to induce purgation. 17. The method of claim 15 or 16 wherein step (a) further includes the step of adding to said purgative formulation at least one member selected from the group consisting of buffering agents, detergent agents and binders. 18. The method of claim 15 or 16 wherein said orally administrable dosage form is selected from the group consisting of gelatin capsules and tablets. 19. The method of claim 15 or 16 wherein the admixture formed in step (a) includes a purgative salt selected from the group consisting of dibasic magnesium phosphate, monobasic magnesium phosphate and mixtures, thereof. 20. The method of claim 19 wherein said purgative salt is dibasic magnesium phosphate included in an amount ranging from about 0.2 grams per kilogram body weight to 12.0 grams per kilogram body weight. 21. The method of claim 19 wherein said purgative salt is a mixture of dibasic magnesium phosphate and monobasic magnesium phosphate included in an amount ranging from about 0.2 grams per kilogram body weight to 12.0 grams per kilogram body weight. 22. The method of claim 20 wherein said dibasic magnesium phosphate is administered at a rate of from about 0.2 grams per kilogram body weight to 0.7 grams per kilogram body weight. 23. The method of claim 15 or 16 wherein step c) is repeated at least once. 24. The method of claim 19 wherein step c) is repeated at least once. 25. An orally administerable non-aqueous composition capable of inducing purgation of the colon of a patient comprising a purgative effective amount of a nonaqueous admixture of a salt selected from the group consisting of phosphates, sulfates and magnesium and natrium tartrates and mixtures in combination with a purgative effective amount of at least one natrium phosphate salt selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate and tribasic sodium phosphate. 26. The composition according to claim 25 wherein said composition further includes an effective amount of at least one composition selected from the group consisting of aqueous sodium phosphate salts, polyethyleneglycol, aqueous polyethyleneglycol, aqueous solutions of sodium sulfate, sodium bicarbonate, sodium chloride or potassium chloride, Mg(OH)2, citrate salts such as magnesium citrate, lactate salts such as magnesium lactate, sorbite, magnesium carbonate hydroxide, phenolpththalein, bisacodyl, methylcellulose, sodium carbomethyl cellulose, psyllium, tragacanth, bran, potassium sodium tartrate, castor oil, senna, cascara sagrada, aloe, danthrone, dioctyl sodium sulfosuccinate, dioctyl calcium sulfosuccinate, mineral oil, and mixtures , thereof. 27. An orally administerable non-aqueous composition capable of inducing purgation of the colon of a patient comprising a purgative effective amount of a nonaqueous admixture of a sodium phosphate salt selected from the group consisting of monobasic sodium phosphate, dibasic sodium phosphate and tribasic sodium phosphate in combination with an effective amount of at least one composition selected from the group consisting of aqueous sodium phosphate salts, polyethyleneglycol, aqueous polyethyleneglycol, aqueous solutions of sodium sulfate, sodium bicarbonate, sodium chloride or potassium chloride, Mg(OH)2, citrate salts such as magnesium citrate , lactate salts such as magnesium lactate, sorbitol, magnesium carbonate hydroxide , phenolpththalein, bisacodyl, methylcellulose, sodium carbomethyl cellulose, psyllium, tragacanth, bran, potassium sodium tartrate, castor oil, senna, cascara sagrada, aloe, danthrone, dioctyl sodium sulfosuccinate, dioctyl calcium sulfosuccinate, minerol oil, and mixtures, thereof.