# US 9,433,660 B2 · Method and kit for bowel preparation

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- Number: US 9,433,660 B2
- Document ID: US9433660B2
- Status: Granted
- Kind: B2
- Application number: 13/957,857
- Filed: 2013-08-02
- Published: 2014-02-06
- Granted: 2016-09-06
- Earliest claimed: 2012-08-03
- Assignees: MSM Innovations, Inc.
- Applicants: MSM Innovations, Inc.
- Inventors: Steven Gorelick; Michael Schiffman; Melody Olmstead; Adam Gorelick
- Web page: https://patentgrep.com/patent/US9433660B2

## CPC

- A61K 38/168: {from plants}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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)}
- A61K 36/185: Magnoliopsida (dicotyledons)
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- 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)
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- 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)
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/10: Laxatives
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## 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

### Claim 1

A method for cleansing the gastrointestinal tract of a patient comprising the steps of:
(a) determining the pH of a gastrointestinal tract preparation composition which has a salty taste, and adjusting the pH to range from about 3 to about 6.4;
(b) providing a taste-modifying substance to the patient; and
(c) reducing the salty taste of the gastrointestinal tract preparation composition by at least 20% compared to the salty taste of the gastrointestinal tract preparation composition had the taste-modifying substance not been provided, by administering orally the gastrointestinal tract preparation composition to the patient after step (b), wherein the gastrointestinal tract preparation composition is for preparing the gastrointestinal tract of the patient for an endoscopy, a gastrointestinal tract surgery or a barium enema.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

The method of claim 1, wherein the taste-modifying substance is a sour taste-modifying agent.

### Claim 5 (depends on 4)

The method of claim 4, wherein the sour taste-modifying agent is miraculin.

### Claim 6 (depends on 1)

The method of claim 1, wherein the taste-modifying substance is selected from the group consisting of thaumatin, monellin, mabinlin, brazzein, pentadin, curculin, neuculin, miraculin and mixtures thereof.

### Claim 7 (depends on 1)

The method of claim 1, wherein the taste-modifying substance is provided from about 5 minutes to about 30 minutes before the gastrointestinal tract preparation composition is administered.

### Claim 8 (depends on 2)

The method of claim 2, wherein the intestine is the colon.

### Claim 9 (depends on 1)

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

### Claim 10 (depends on 3)

The method of claim 3, wherein the endoscopy is a colonoscopy or sigmoidoscopy.

### Claim 11 (depends on 1)

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

### Claim 12 (depends on 5)

The method of claim 5, 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.

### Claim 13 (depends on 1)

The method of claim 1, wherein the taste-modifying substance is provided in the form of a capsule, a tablet, a pill, granules, powders, a pellet, a solids mixture, a solution, a dispersion, an emulsion, a paste, an extract, or an isolate from a natural source.

### Claim 14 (depends on 1)

The method of claim 1, wherein the taste-modifying substance is provided to the patient from about 1 minute to about 1 hour before the gastrointestinal tract preparation composition is administered.

### Claim 15 (depends on 14)

The method of claim 14, wherein the taste-modifying substance is provided from about 10 minutes to about 15 minutes before the gastrointestinal tract preparation composition is administered.

### Claim 16 (depends on 1)

The method of claim 1, wherein the salty taste of the gastrointestinal tract preparation composition is reduced by at least about 30%.

### Claim 17 (depends on 16)

The method of claim 16, wherein the salty taste of the gastrointestinal tract preparation composition is reduced by at least about 50%.

### Claim 18 (depends on 17)

The method of claim 17, wherein the salty taste of the gastrointestinal tract preparation composition is reduced by at least about 70%.

### Claim 19 (depends on 1)

The method of claim 1, wherein the step to determine the pH of the gastrointestinal tract preparation composition is carried out prior to or after the step of providing a taste-modifying substance to the patient.

### Claim 20 (depends on 1)

The method of claim 1, wherein the pH ranges from about 4 to about 6.4.

### Claim 21 (depends on 20)

The method of claim 20, wherein the pH is about 4.8.

### Claim 22 (depends on 1)

The method of claim 1, wherein the pH of the gastrointestinal tract preparation composition is adjusted by at least an inorganic acid or an organic acid.

### Claim 23 (depends on 22)

The method of claim 22, wherein the acid is selected from the group consisting of citric acid, acetic acid, ascorbic acid, phosphoric acid, malic acid, succinic acid, formic acid, fumaric acid, maleic acid, or mixtures thereof.

### Claim 24 (depends on 1)

The method of claim 1, wherein the pH of the gastrointestinal tract preparation composition is adjusted by a compound selected from the group of ammonium hydroxide, sodium carbonate, potassium carbonate, sodium bicarbonate, carbon dioxide, and mixtures thereof.

### Claim 25 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition comprises a potassium salt, a sodium salt, a calcium salt, an ammonium salt or mixtures thereof.

### Claim 26 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition comprises at least one sodium phosphate.

### Claim 27 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition comprises sodium chloride, potassium chloride, and sodium bicarbonate (sodium hydrogen carbonate), sodium sulfate or mixtures thereof.

### Claim 28 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition comprises at least one alkali metal salt, and/or at least one alkaline earth metal salt.

### Claim 29 (depends on 28)

The method of claim 28, wherein the alkali metal is sodium or potassium.

### Claim 30 (depends on 28)

The method of claim 28, wherein the alkaline earth metal is magnesium or calcium.

### Claim 31 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition is a solution, and wherein the volume of the gastrointestinal tract preparation composition ranges from about 0.1 liters to about 5 liters.

### Claim 32 (depends on 31)

The method of claim 31, wherein the volume of the gastrointestinal tract preparation composition ranges from about 1 liter to about 4 liters.

### Claim 33 (depends on 1)

The method of claim 1, wherein the gastrointestinal tract preparation composition comprises polyethylene glycol (PEG).