Method and kit for bowel preparation

• US 9,585,937 B2
• Filed: 12/09/2015
• Issued: 03/07/2017
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: MSM Innovations, Inc.
• Original Assignee: MSM Innovations, Inc.
• Inventors: Gorelick, Steven, Schiffman, Michael, Olmstead, Melody, Gorelick, Adam
• Primary Examiner(s): Thomas, Timothy
• Assistant Examiner(s): Rosenthal, Andrew S
• Application Number:
  US14/963,575
• Publication Number:
  US 20160089331A1
• Time in Patent Office: 454 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 36/185 Magnoliopsida (dicotyledons)
• CPC Class Codes: A61K 38/168 from plants
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• 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 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0095 Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006
• 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 present invention provides methods and taste-modifying kits for facilitating cleansing of the gastrointestinal tract of a patient prior to a diagnostic, surgical or therapeutic procedure. The methods and taste-modifying kits can improve patient compliance, and thus, efficacy of the preparation. Specifically, the present methods make the gastrointestinal tract preparation composition palatable for the patient to consume. For example, for a patient preparing to undergo colonoscopy, the present methods make the bowel preparation solution taste significantly less salty.

Claims

1. A taste-modifying kit for facilitating cleansing the gastrointestinal tract of a subject comprising:

a gastrointestinal tract preparation composition having a salty taste, a premeasured amount of at least one pH-modifying agent wherein the amount is sufficient to adjust the pH of the gastrointestinal tract preparation composition to a pH ranging from 1 to 6.9, miraculin, and instruction material indicating that the gastrointestinal tract of the subject is to be cleansed by a method comprising the steps of;

(a) determining the pH of the gastrointestinal tract preparation composition, wherein the pH ranges from 1 to 6.9 or is adjusted to range from 1 to 6.9 using the at least one pH-modifying agent;

(b) providing miraculin to the subject; and

(c) administering orally the gastrointestinal tract preparation composition or a diluted form of the gastrointestinal tract preparation composition to the subject after step (b).

2. The kit of claim 1, wherein the pH-modifying agent is an acid selected from the group consisting of citric acid, acetic acid and ascorbic acid, phosphoric acid, malic acid, succinic acid, formic acid, fumaric acid, maleic acid, adipic acid, butyric acid, glyconic acid, lactic acid, oxalic acid, tartaric acid and mixtures thereof.

3. The kit of claim 1, wherein the pH-modifying agent is selected from the group consisting of ammonium hydroxide, sodium carbonate, potassium carbonate, sodium bicarbonate, carbon dioxide, and mixtures thereof.

4. The kit of claim 1, wherein miraculin comprises miracle fruit, flesh of miracle fruit, miracle fruit granules, miracle berry, miracle berry extracts, miracle fruit tablets, miracle berry tablets, or miraculin produced by a genetically modified organism.

5. The kit of claim 1, wherein the premeasured amount of the pH-modifying agent is sufficient to adjust the pH of the gastrointestinal tract preparation solution to a pH ranging from 3 to 6.4.

6. The kit of claim 1, wherein miraculin is provided to the subject from 1 minute to 1 hour before the gastrointestinal tract preparation composition is administered.

7. The kit of claim 6, wherein miraculin is provided from 5 minutes to 30 minutes before the gastrointestinal tract preparation composition is administered.

8. The kit of claim 1, wherein the gastrointestinal tract preparation composition has a salty taste, and wherein the salty taste is reduced by at least 20% compared to the salty taste of the gastrointestinal tract preparation composition had miraculin not been provided.

9. The kit of claim 1, wherein the gastrointestinal tract is the intestine and the gastrointestinal tract preparation composition is a bowel preparation solution.

10. The kit of claim 9, wherein the intestine is the colon.

11. The kit of claim 1, wherein the gastrointestinal tract is cleansed prior to carrying out a diagnostic, therapeutic and/or surgical procedure on the patient.

12. The kit of claim 1, wherein the gastrointestinal tract is cleansed prior to an endoscopy.

13. The kit of claim 12, wherein the endoscopy is a colonoscopy or sigmoidoscopy.

14. The kit of claim 1, wherein the gastrointestinal tract is cleansed prior to a barium enema examination, capsule endoscopy, virtual colonoscopy, colon surgery or gastrointestinal tract surgery.