WO2007037803A2 - Water-soluble colonoscopy lubricant - Google Patents
Water-soluble colonoscopy lubricant Download PDFInfo
- 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
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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),
Abstract
A water-soluble colonoscopy lubricant, comprising a mixture of purified water, glycerin, polyethylene glycol, aloe gel, methylparaben, and a preservative.
Description
1WXTBR-SOLUBLE COLONOSCOPY LUBRICANT
[0001] Priority - This application claims priority from U.S. Provisional Patent Application No. 60/717,615 filed September 16, 2005 entitled "Method For Facilitating The Efficacy And Tolerance Of Colonoscopy". [0002] Field of the invention
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
The performance of 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. Currently, 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.
[0004] 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. Patients with prior abdominal or pelvic surgery are at higher risk for perforation and may experience more pain and distention with the procedure. These preexisting factors also make the performance of colonoscopy more difficult and extend the length of time required to complete the examination. When the practitioner performing colonoscopy encounters portions of the colon that are narrowed, angulated, tortuous or show severe diverticulosis causing difficulty in advancement of colonoscope, several maneuvers may be performed to allow safe passage of the colonoscope beyond these difficult areas. External abdominal wall pressure performed by the nurse or support technician may help in advancing the colonoscope beyond the difficult regions of the colon. Changing the position of the patient, for example from a left lateral to a right lateral, prone position or placement on the patient's back may facilitate colonoscope advancement. Recently, the use of 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.
[0005] Recently, Brocchi, et al. from the department of internal medicine and Gastroenterology at the University of Bologna, Italy performed a study to determine whether performance of colonoscopy could be enhanced by installation of corn oil through the biopsy channel of the colonoscope during the procedure. The biopsy channel provides a direct conduit for instillation of the corn oil and other liquids into the colon. Patients were divided randomly into two groups. One group underwent standard colonoscopy (with no lubricant instillation), while the other had several small volumes of corn oil instilled through the biopsy channel during performance of the procedure. They found that corn oil installation increased the number of successful intubations of the cecum when compared to the standard performance of colonoscopy. 159 of 168 (95 percent) colonoscopies performed with corn oil installations achieved cecal incubation as compared to only 145 of 170 (85 percent) of successful cecal intubations without corn oil installations. In addition, the level of pain described by the patients was less in the corn oil installation group compared to the control group. The physicians performing colonoscopy also described decreased difficulty of the procedures when corn oil installations were performed. This was the first study demonstrating that the use of a lubricant internally instilled into the colon facilitates the performance of colonoscopy. Unfortunately, the placement of oils into the biopsy channel of the colonoscope may result in the development of oil residues within the channel following the procedure. These residues pose a serious risk to patients undergoing colonoscopy as they may
provide a nidus for bacterial colonization of the biopsy channels, since residues represent a foreign substance that could enhance bacterial adherence within the biopsy channel of the colonoscope.
[0006] 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. In addition, although 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. Thus, the instillation of currently available lubricants would also be of questionable safety for instillation into the colon. The most common of these commercially available external lubricants, Surgilube and Lubriderm both contain ingredients that are not on the GRAS list of the FDA. Moreover, due to their excessive viscosity, these products could not be utilized for internal lubrication of the colon for the enhancement of the performance of colonoscopy.
[0007] At present, no safe, usable form of lubricant has been developed to facilitate the performance of colonoscopy, despite the apparent benefits that such substances would have for patients undergoing colonoscopy and for those involved in the performance of the procedure. Therefore, there is a need to develop methods and compositions that may
be used to produce safe, effective agents for installation into the colonoscope for the purpose of lubrication of the colonoscope and enhancement of the procedure.
[0008] Detailed description of the invention
Disclosed is a method for facilitating the efficacy and tolerance of colonoscopy. 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. Additionally, 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.
[0009] According to the method of the present invention, 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.
[00010] According to a presently preferred embodiment, the volume of each instillation is between 20 and 30 mL and 2-4 instillations are required during each colonoscopy.
results have been-oBϊaϊned using about 39 grams of PEG based on 360cc of colonoscopy lubricant. The amount of PEG was determined by multiplying the specific gravity of PEG by the volume of colonoscopy lubricant. In this case, PEG has a specific gravity of 1.09, therefore 1.09 x 36OmL = 392.4 grams x 10% PEG in formulation filtered= 39 grams.
[00013] Other 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.
[00014] Other stabilizing agents and preservatives may also be included in the product. It is anticipated that all ingredients of the product will be contained on the Generally Recognized as Safe (GRAS) list of the Food and Drug Administration, thus securing the safety of the product.
[00015] 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. Additionally, 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
volumes of the lubricating substances when encountering difficulty in advancement of
[00011] In the preferred form of the invention, the colonoscopy lubricant consists of a mixture of glycerin G), polyethylene glycol "PEG" (mean molecular weight 200 - 9,500), aloe gel (A) and methylparaben in a variety of ratios. Satisfactory results have been obtained using 0.49 grams methylparaben 0.1% based on 360cc of colonoscopy lubricant. The amount of methylparaben was determined by multiplying the specific gravity for methylparaben by the volume of colonoscopy lubricant. Methylparaben has a specific gravity of 1.36, therefore, 1.36 x 36OmL = 489.6 grams x 0.1% confiltered= 0.49 grams.
Examples of products containing these ingredients in several of these ratios are shown the chart. Purified, distilled and bacteria-free water will also be added to produce optimal viscosity of the product. Additional water-soluble substances that may be incorporated into the product may include ascorbic acid, ascorbyl palmitate, benzoic acid, calcium sorbate, potassium sorbate, proprionic acid, propylparaben, sodium ascorbate, sodium benzoate, sodium sorbate and tocopherols for preservatives.
[00012] In addition, cholic acid and desoxycholic acid may be added as emulsifying agents. Calcium, potassium or sodium alginate may be used as stabilizers. Note that high and low molecular weight PEG may be included as an ingredient. According to one embodiment, PEG 3350 is included as an ingredient. Satisfactory
the~coloπo£fcopσ 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.
[00016] Another embodiment of the present invention includes the following ingredients by volume: 10% Polyethylene glycol 3350 (Carbowax® PEG 3350),
.1 % Methylparaben, 5 % Aloe vera gel, 40% Glycerin, and the balance H2O.
[00017] The foregoing describes a water-soluble colonoscopy lubricant which only includes ingredients listed on the Federal Drug Administration's GRAS list (Generally
Recognized As Safe). Modifications obvious to those skilled in the art can be made without departing from the scope of the present invention.
Claims
1. A water-soluble colonoscopy lubricant, comprising: a mixture of water, glycerin, polyethylene glycol, aloe gel and methylparaben.
2. The colonoscopy lubricant of claim 1, wherein the polyethylene glycol has a mean molecular weight between about 200 and 9,500.
3. The colonoscopy lubricant of claim 1, wherein the Methylparaben is Methylparaben 0.1%, and the colonscopy lubricant includes 0.49 grams Methylparaben 0.1% per 360cc of colonoscopy lubricant.
4. The colonoscopy lubricant of claim 1, further comprising at least one preservative selected from the group comprising ascorbic acid, ascorbyl palmitate, benzoic acid, calcium sorbate, potassium sorbate, proprionic acid, propylparaben, sodium ascorbate, sodium benzoate, sodium sorbate and tocopherols.
5. The colonoscopy lubricant of claim 1, further comprising at least one emulsifying agent selected from the group comprising cholic acid and desoxycholic acid.
6. The colonoscopy lubricant of claim 1, further comprising at least one stabilizer selected from the group comprising Calcium, potassium, and sodium alginate.
7. A water-soluble colonoscopy lubricant, comprising: a mixture of purified water, glycerin, polyethylene glycol, aloe gel, methylparaben, and a preservative.
8. The colonoscopy lubricant of claim 7, wherein the preservative includes at least one from the group comprising ascorbic acid, ascorbyl palmitate, benzoic acid,
10 calcium sorbate, potassium sorbate, proprionic acid, propylparaben, sodium ascorbate, sodium benzoate, sodium sorbate and tocopherols.
9. The colonoscopy lubricant of claim 8, wherein the polyethylene glycol has a mean molecular weight between about 200 and 9,500.
10. The colonoscopy lubricant of claim 9, wherein the Methylparaben is Methylparaben 0.1%, and the colonscopy lubricant includes 0.49 grams Methylparaben 0.1% per 360cc of colonoscopy lubricant.
11. The colonoscopy lubricant of claim 10, further comprising at least one emulsifying agent selected from the group comprising cholic acid and desoxycholic acid.
12. The colonoscopy lubricant of claim 11, further comprising at least one stabilizer selected from the group comprising Calcium, potassium, and sodium alginate.
11
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 (en) | 2007-04-05 |
| WO2007037803A3 WO2007037803A3 (en) | 2007-12-06 |
Family
ID=37900197
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2006/031356 WO2007037803A2 (en) | 2005-09-16 | 2006-08-11 | Water-soluble colonoscopy lubricant |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2007037803A2 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011046627A1 (en) * | 2009-10-18 | 2011-04-21 | Eli Ehrenpreis | Water soluble colonoscopy lubricant |
| 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)
| 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 |
-
2006
- 2006-08-11 WO PCT/US2006/031356 patent/WO2007037803A2/en active Application Filing
Patent Citations (1)
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011046627A1 (en) * | 2009-10-18 | 2011-04-21 | Eli Ehrenpreis | Water soluble colonoscopy lubricant |
| 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 (en) | 2007-12-06 |
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