COMPOSITIONS FOR BOWEL PREPARATION AND METHODS OF USE THEREOF

• US 20120021064A1
• Filed: 09/27/2011
• Published: 01/26/2012
• Est. Priority Date: 03/27/2009
• Status: Abandoned Application

• Current Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Original Assignee: Salix Pharmaceuticals Limited (Bausch Health Cos., Inc.)
• Inventors: Patton, Stephana
• Application Number:
  US13/246,287
• Publication Number:
  US 20120021064A1
• Time in Patent Office: Days
• US Class Current: 424/606
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to formulations and kits for gastrointestinal cleansing and to therapeutic methods thereof.

Claims

1. A method of cleansing the GI tract of a subject, comprising:

administering about 48 mg of sodium phosphate with about 2 L of aqueous solution to a subject who has not recently had a kidney biopsy indicating kidney damage due to excess phosphate.

2. A method of cleansing the GI tract of a subject, comprising:

determining weather a subject is a candidate for a sodium phosphate GI cleanser;

providing about 48 mg of sodium phosphate to a subject; and

instructing the subject to ingest the sodium phosphate with 2 L of aqueous solution.

3. The method of claim 2, wherein determining comprises a biopsy of the kidney, wherein if the biopsy shows damage to the kidney due to too much phosphate, the subject is not a candidate for a sodium phosphate GI cleanser.

4. A method of determining if a subject is a candidate for cleansing the GI tract with sodium phosphate comprising:

determining the phosphate levels in a kidney of the subject;

wherein normal levels of phosphate in the kidney indicates that the subject is a candidate for cleansing of the GI tract with sodium phosphate.

5. The method of claim 4, wherein a biopsy is performed to obtain a sample of the kidney from the subject.

6. The method of claim 4, further comprising administering to a subject determined to be a candidate about 48 mg of sodium phosphate with about 2 L of aqueous solution.

7. A method of determining if a subject is a candidate for cleansing the GI tract with sodium phosphate comprising:

determining if the subject has normal renal function;

wherein normal renal function indicates that the subject is a candidate for cleansing of the GI tract with sodium phosphate.

8. The method of claim 7, wherein normal renal function is characterized by creatinine clearance of greater than or equal to 30 mL/minute.

9. The method of claim 8, wherein further comprising administering to a subject determined to be a candidate about 48 mg of sodium phosphate with about 2 L of aqueous solution.

10. A method of determining if a subject is a candidate for cleansing the GI tract with sodium phosphate comprising:

determining if the subject is a candidate for sodium phosphate purgative cleansing by one or more of;

determining age, determining renal function, or determining phosphate level of the kidney; and

administering to a subject determined to be a candidate about 48 mg of sodium phosphate with about 2 L of aqueous solution.

11. The method of claim 10, wherein if a subject is determined to be of increased age, they are not a candidate.

12. The method of claim 10, wherein determined to have abnormal levels of phosphate in the kidney they are not a candidate.

13. The method of claim 10, if a subject has renal function characterized by creatinine clearance of greater than or equal to 30 mL/minute they are a candidate.