WO2007037803A2 - Lubrifiant hydrosoluble pour coloscopie - Google Patents

Lubrifiant hydrosoluble pour coloscopie Download PDF

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Publication number
WO2007037803A2
WO2007037803A2 PCT/US2006/031356 US2006031356W WO2007037803A2 WO 2007037803 A2 WO2007037803 A2 WO 2007037803A2 US 2006031356 W US2006031356 W US 2006031356W WO 2007037803 A2 WO2007037803 A2 WO 2007037803A2
Authority
WO
WIPO (PCT)
Prior art keywords
colonoscopy
lubricant
methylparaben
acid
water
Prior art date
Application number
PCT/US2006/031356
Other languages
English (en)
Other versions
WO2007037803A3 (fr
Inventor
Eli Ehrenpreis
Original Assignee
Eli Ehrenpreis
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eli Ehrenpreis filed Critical Eli Ehrenpreis
Publication of WO2007037803A2 publication Critical patent/WO2007037803A2/fr
Publication of WO2007037803A3 publication Critical patent/WO2007037803A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0031—Rectum, anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts

Definitions

  • the present invention is directed toward the development of a new agent that enhances the performance of colonoscopy. This enhancement is accomplished by improving the standard lubrication of the tip of the colonoscope that is required during this procedure. [0003] Background of the invention
  • colonoscopy has become a routine method for screening for colon cancer and precancerous lesions (polyps) of the colon. This methodology has been demonstrated to reduce the frequency of advanced colon cancer and to improve overall survival.
  • colonoscopy is recommended every 10 years for all subjects of average risk (no family history of colon cancer, no symptomatology suggestive of colonic disease such as rectal bleeding, altered bowel habits or weight loss) beginning at age 50.
  • Individuals having increased risk for colon cancer are recommended to undergo colonoscopy more frequently and at a younger age.
  • Patients diagnosed with precancerous polyps usually undergo the procedure every 3-5 years.
  • the performance of colonoscopy has become routine in many medical centers around the United States and the rest of the developed world.
  • colonoscopy Although colonoscopy is considered to be safe, a number of potential complications of the procedure exist. These complications include side effects from anesthesia such as hypotension, bradycardia, respiratory depression and mental confusion. Complications of the procedure may also occur due to technical difficulty with the performance of colonoscopy itself. The most severe of these complications is perforation of the colon which occurs in approximately one out of every 2000 procedures performed. Risk factors that predispose to colonic perforation include diverticular disease, prior abdominal or pelvic surgery and severe colitis. Abdominal pain during the procedure and abdominal distention occurring after the procedure are also seen more commonly in patients with diverticular disease, colonic tortuosity, narrowing and angulation.
  • colonoscopes with adjustable degrees of stiffness has been shown to improve passage of the colonoscope past these difficult areas. Practitioners will also utilize a pediatric colonoscope having a smaller diameter and increased flexibility to facilitate the performance of these difficult procedures. Aside from tnese methods, there presently are no other commonly performed maneuvers to facilitate the performance of colonoscopy, particularly in the patient in which difficulty has been encountered.
  • Water-soluble lubricants including glycerin, polyethylene glycol, methylcellulose and others are currently utilized for lubrication needed for the insertion of gloved fingers and medical instruments into body orifices. These substances are commercially available in a viscous, gel-like form. These substances are a mainstay for the simple lubrication required in common medical practice. However, these gels are too viscous for placement through the colonoscope during performance of the procedure.
  • the aforementioned external lubricating products contain some ingredients that are listed on the Generally Recognized as Safe (GRAS) list of the Food and Drug Administration, these products also contain preservatives and other ingredients that are not on the GRAS list.
  • GRAS Generally Recognized as Safe
  • the current invention employs water-soluble lubricants in a liquid form that is easily introduced via a syringe into the biopsy channel of the colonoscope.
  • the substances, instilled by this method internally lubricate the colon, permitting safer and easier passage of the colonoscope.
  • No oil-based ingredients are used thereby eliminating the risk of residue buildup in the biopsy channels of the colonoscope.
  • all of the ingredients of the lubricant of the present invention are listed on the GRAS list of the FDA, thus securing the safety of the product.
  • the substances are regularly instilled during the performance of routine colonoscopy to facilitate performance of the procedure and enhance patient tolerance.
  • the endoscopist may instill additional volumes of the lubricating substances when encountering difficulty in advancement of the colonoscope including angulated portions of the colon, areas with marked diverticular disease, tortuous, redundant or narrowed areas of colon.
  • ingredients may include methylcellulose, sorbitol, sodium citrate and sodium hydroxide.
  • the invention will also include any other water-soluble substances that may be incorporated into future forms of the product that enhance the lubricating quality, stability or safety of the product.
  • the current invention employs water-soluble lubricants in a liquid form that may be easily introduced via a syringe into the biopsy channel of the colonoscope.
  • the substances, instilled by this method, would then internally lubricate the colon, permitting safer and easier passage of the colonoscope.
  • No oil-based ingredients are included, so there will be no risk of residue buildup in the biopsy channels of the colonoscope.
  • all ingredients of the product are contained on the GRAS list of the FDA, thus securing the safety of the product.
  • the substances would regularly be instilled during the performance of routine colonoscopy to facilitate performance of the procedure and enhance patient tolerance. The endoscopist could instill additional
  • cholic acid and desoxycholic acid may be added as emulsifying agents.
  • Calcium, potassium or sodium alginate may be used as stabilizers.
  • high and low molecular weight PEG may be included as an ingredient.
  • PEG 3350 is included as an ingredient. Satisfactory the ⁇ colo ⁇ o£fcop ⁇ including angulated portions of the colon, areas with marked diverticular disease, tortuous, redundant or narrowed areas of colon. Preliminary studies suggest that the ideal volume of each instillation is between 20 and 30 mL and 2-4 instillations are required during each colonoscopy.
  • Another embodiment of the present invention includes the following ingredients by volume: 10% Polyethylene glycol 3350 (Carbowax® PEG 3350),

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

La présente invention concerne un lubrifiant hydrosoluble pour coloscopie constitué d'un mélange d'eau purifiée, de glycérine, de polyéthylène-glycol, de gel d'aloès, de méthylparaben, et d'un conservateur.
PCT/US2006/031356 2005-09-16 2006-08-11 Lubrifiant hydrosoluble pour coloscopie WO2007037803A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US71761505P 2005-09-16 2005-09-16
US60/717,615 2005-09-16

Publications (2)

Publication Number Publication Date
WO2007037803A2 true WO2007037803A2 (fr) 2007-04-05
WO2007037803A3 WO2007037803A3 (fr) 2007-12-06

Family

ID=37900197

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/031356 WO2007037803A2 (fr) 2005-09-16 2006-08-11 Lubrifiant hydrosoluble pour coloscopie

Country Status (1)

Country Link
WO (1) WO2007037803A2 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011046627A1 (fr) * 2009-10-18 2011-04-21 Eli Ehrenpreis Lubrifiant pour coloscopie soluble dans l'eau
US8999313B2 (en) 2012-09-11 2015-04-07 Norgine Bv Compositions
US9592252B2 (en) 2011-03-11 2017-03-14 Norgine Bv Colonoscopy—preparation

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020192273A1 (en) * 2001-06-15 2002-12-19 Teri Buseman Therapeutic patch useful for the treatment of hemorrhoids

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020192273A1 (en) * 2001-06-15 2002-12-19 Teri Buseman Therapeutic patch useful for the treatment of hemorrhoids

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011046627A1 (fr) * 2009-10-18 2011-04-21 Eli Ehrenpreis Lubrifiant pour coloscopie soluble dans l'eau
US8716203B2 (en) 2009-10-18 2014-05-06 Eli D Ehrenpreis Water-soluble colonoscopy lubricant
US9592252B2 (en) 2011-03-11 2017-03-14 Norgine Bv Colonoscopy—preparation
US10646512B2 (en) 2011-03-11 2020-05-12 Norgine Bv Colonoscopy - preparation
US10780112B2 (en) 2011-03-11 2020-09-22 Norgine Bv Colonoscopy-preparation
US10792306B2 (en) 2011-03-11 2020-10-06 Norgine Bv Colonoscopy—preparation
US11529368B2 (en) 2011-03-11 2022-12-20 Norgine Bv Colonoscopy—preparation
US8999313B2 (en) 2012-09-11 2015-04-07 Norgine Bv Compositions
US9326969B2 (en) 2012-09-11 2016-05-03 Norgine Bv Compositions
US9707297B2 (en) 2012-09-11 2017-07-18 Norgine Bv Compositions
US10016504B2 (en) 2012-09-11 2018-07-10 Norgine Bv Compositions
US10918723B2 (en) 2012-09-11 2021-02-16 Norgine Bv Colon cleansing compositions and methods of use

Also Published As

Publication number Publication date
WO2007037803A3 (fr) 2007-12-06

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