# US 11,298,373 B1 · Bowel cleansing chemical composition and associated use therefore

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- Number: US 11,298,373 B1
- Document ID: US11298373B1
- Status: Granted
- Kind: B1
- Application number: 16/721,688
- Filed: 2019-12-19
- Granted: 2022-04-12
- Earliest claimed: 2018-12-20
- Assignees: Endologic LLC
- Applicants: Zamir Brelvi; Kamal Dutta
- Inventors: Zamir Brelvi; Kamal Dutta
- Web page: https://patentgrep.com/patent/US11298373B1

## CPC

- A61K 31/765: Polymers containing oxygen
- 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 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)}
- A61K 31/255: of sulfoxy acids or sulfur analogues thereof
- 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 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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)

## Abstract

A GRAS list chemical composition (containing only GRAS list approved ingredients) including a water-based bowel cleansing solution (either in concentrate form or diluted form) to clean a gastrointestinal (GI) tract before and/or during performance of an endoscopy procedure such as a colonoscopy, enteroscopy, upper gastrointestinal endoscopy, and small bowel capsule endoscopy, for example. The GRAS list bowel cleansing chemical composition includes at least one of a chemical composition as a liquid, tablet or powder concentrate that can be added to sterile water or other solution by the end-user to make the chemical composition solution; and a pre-mixed chemical composition solution diluted in up to 1000 ml of sterile water.

## Claims

### Claim 1

A bowel cleansing chemical composition, said chemical composition comprising: a plurality of GRAS list ingredients including
a safe and effective quantity of sterile water;
a safe and effective quantity of PEG 3350 equal to about 1.5 to 6 percent weight/volume;
a safe and effective quantity of sodium docusate equal to about 0.048 percent weight/volume; and
a safe and effective quantity of simethicone equal to about 0.048 to 3 percent weight/volume.

### Claim 2 (depends on 1)

The chemical composition of claim 1, wherein said chemical composition is a homogenous concentrated liquid solution.

### Claim 3 (depends on 1)

The chemical composition of claim 1, wherein said chemical composition is a homogenous diluted pre-mixed liquid solution.

### Claim 4

A bowel cleansing chemical composition for cleansing a bowel of a patient, said chemical composition comprising: a plurality of GRAS list ingredients including
a safe and effective quantity of sterile water equal to less than 99 percent weight/volume;
a safe and effective quantity of PEG 3350 equal to about 1.5 to 6 percent weight/volume;
a safe and effective quantity of sodium docusate equal to about 0.048 percent weight/volume; and
a safe and effective quantity of simethicone equal to about 0.048 to 3 percent weight/volume.

### Claim 5 (depends on 4)

The chemical composition of claim 4, wherein said chemical composition is a homogenous concentrated liquid solution.

### Claim 6 (depends on 4)

The chemical composition of claim 4, wherein said chemical composition is a homogenous diluted pre-mixed liquid solution.

### Claim 7

A method of utilizing a bowel cleansing chemical composition for cleansing a bowel of a patient, said method comprising the steps of:
providing a plurality of GRAS list ingredients including a safe and effective quantity of sterile water equal to less than 99 percent weight/volume; a safe and effective quantity of PEG 3350 equal to about 1.5 to 6 percent weight/volume; a safe and effective quantity of sodium docusate equal to about 0.048 percent weight/volume; and a safe and effective quantity of simethicone equal to about 0.048 to 3 percent weight/volume; and
applying the chemical composition to a bowel target area during an endoscopy or colonoscopy procedure.

### Claim 8 (depends on 7)

The method of claim 7, wherein said chemical composition is a homogenous concentrated liquid solution.

### Claim 9 (depends on 7)

The method of claim 7, wherein said chemical composition is a homogenous diluted pre-mixed liquid solution.