Effervescent laxatives

• US 6,444,198 B1
• Filed: 02/07/2002
• Issued: 09/03/2002
• Est. Priority Date: 02/22/1999
• Status: Expired due to Term

• Current Assignee: GlaxoSmithKline LLC (GlaxoSmithKline PLC)
• Original Assignee: Smithkline Beecham Corporation (Smithkline Beecham PLC)
• Inventors: Mandel, Kenneth G., Daggy, Bruce P.
• Primary Examiner(s): Reamer, James H
• Application Number:
  US10/071,638
• Publication Number:
  US 20020085990A1
• Time in Patent Office: 208 Days
• Field of Search: 424/78.01
• US Class Current: 424/78.01
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence

Abstract

The present invention is directed to a novel osmotic/effervescent system for the treatment of constipation and fecal impaction in a human or mammal in need thereof.

Claims

1. A pharmaceutical formulation comprising an osmotic amount of polyethylene glycol (PEG) 3350, or PEG 4000, and a pharmaceutically acceptable effervescent coupling system.

2. The formulation according to claim 1 wherein the effervescent couple comprises about 10 to about 30% of the total weight of the formulation.

3. The formulation according to claim 1 wherein the effervescent couple comprises an acid component selected from citric acid, tartaric acid, adipic acid, fumaric acid, malic acid, or acid salts thereof, or mixtures thereof.

4. The formulation according to claim 1 wherein the effervescent couple comprises an alkaline component selected from sodium, potassium or calcium (bi) carbonates or sodium glycine carbonate.

5. The formulation according to claim 1 which further comprises one or more flavoring, colouring and sweetening agents.

6. The formulation according to claim 1 wherein the PEG is present in an amount of 7.5 to 30 grams per unit dose.

7. The formulation according to claim 1 wherein the PEG is present in an amount of 10 to 20 grams per unit dose.

8. A method of treating constipation in a mammal in need therof, which method comprises administering to said mammal an effective amount of a formulation according to claim 1.

9. A method of treating fecal impaction in a mammal in need thereof, which method comprises administering to said mammal an effective amount of a formulation according to claim 1.

10. The formulation according to claim 1 wherein the formulation is in a unit dose sachet.

11. The formulation according to claim 2 wherein the formulation is in a unit dose sachet.

12. The formulation according to claim 5 wherein the formulation is in a unit dose sachet.

13. The formulation according to claim 6 wherein the formulation is in a unit dose sachet.

14. The formulation according to claim 8 wherein the formulation is in a unit dose sachet.