US20060051428A1 - Aspartame and citrate flavored phosphate salt laxative - Google Patents

Aspartame and citrate flavored phosphate salt laxative Download PDF

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Publication number
US20060051428A1
US20060051428A1 US10/934,638 US93463804A US2006051428A1 US 20060051428 A1 US20060051428 A1 US 20060051428A1 US 93463804 A US93463804 A US 93463804A US 2006051428 A1 US2006051428 A1 US 2006051428A1
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Prior art keywords
sodium phosphate
flavorant
composition
aspartame
kit
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Abandoned
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US10/934,638
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English (en)
Inventor
Nelson Ayala
Michael Caswell
Sarah Post
Sherrie Scott
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CB Fleet Co Inc
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Individual
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Priority to US10/934,638 priority Critical patent/US20060051428A1/en
Assigned to C.B. FLEET COMPANY INCORPORATED reassignment C.B. FLEET COMPANY INCORPORATED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SCOTT, SHERRIE S., POST, SARAH S., AYALA, NELSON, CASWELL, MICHAEL L.
Priority to US11/574,635 priority patent/US7867521B2/en
Priority to PCT/US2005/028132 priority patent/WO2006028632A1/fr
Priority to TW094127772A priority patent/TW200621271A/zh
Publication of US20060051428A1 publication Critical patent/US20060051428A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/42—Phosphorus; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame

Definitions

  • Colonoscopy screening should be repeated more frequently for subjects who have previously undergone a polypectomy due to their increased risk of recurrent polyp formation.
  • at least 20% of subjects who had previously undergone polypectomies failed to return for their follow-up screening.
  • 2,704 (30.5%) were diagnosed with recurrent polyps.
  • a statistical analysis based on the data from this report projected that 50% of subjects will have recurrent polyps within 7.6 years. Despite this level of risk, many subjects do not undergo additional screening.
  • Aqueous solutions of sodium phosphate salts are very effective oral laxatives and are extensively used prior to colonoscopy, radiographic procedures, and surgery.
  • a split regimen is often preferred that includes one 45 mL dose given the evening before colonoscopy and a second 45 mL dose given at least three hours prior to the procedure on the following morning.
  • the materials and methods of the present invention provide phosphate salt laxatives that are significantly more palatable than conventional phosphate salt laxatives.
  • Colonoscopy screening coupled with polyp removal significantly reduces the incidence of colon cancer.
  • the colon Prior to colonoscopy, the colon must be cleansed so the surgeon may see any polyps that exist on the interior wall of the colon.
  • Aqueous solutions of sodium phosphate salts such as FLEET® PHOSPHO-SODA®, are very effective oral laxatives and are extensively used prior to colonoscopy.
  • FLEET® PHOSPHO-SODA® are very effective oral laxatives and are extensively used prior to colonoscopy.
  • One of the main reasons subjects cite for avoiding colonoscopy re-screening is the unpleasant taste of these phosphate salt based laxative solutions.
  • the present invention makes use of the discovery that adding a flavorant that includes aspartame and a citrate, such as citric acid and citrate salts, such as sodium and potassium citrate, to a phosphate salt laxative significantly increases the palatability of the laxative.
  • the resultant flavorant/phosphate salt formulations may increase the subject's willingness to consume the laxative, thus decreasing the repeat rate for initial colonoscopy procedures attributed to incomplete colon cleansing and increasing the subject's willingness to undergo follow-up procedures.
  • the invention is a composition for colonic cleansing that may include a phosphate salt and a flavorant that comprises aspartame and a citrate.
  • the invention is a kit for colonic cleansing that may include monobasic sodium phosphate, dibasic sodium phosphate, aspartame, and a citrate.
  • the invention is a method of colonic cleansing that may include administering orally to a subject an aqueous preparation including monobasic sodium phosphate, dibasic sodium phosphate, aspartame, and a citrate.
  • FIG. 1 depicts a cut-away view of a colonic cleansing kit having aspects of the present invention.
  • FIGS. 2A-2D depict individual components that may be found in a colonic cleansing kit having aspects of the present invention.
  • the present invention makes use of the discovery that adding a flavorant that includes aspartame and a citrate to a phosphate salt laxative significantly increases the palatability of the laxative.
  • the resultant flavorant/phosphate salt formulations may improve subject compliance for both primary screening of asymptomatic colorectal carcinoma, and for return surveillance in those subjects who may benefit from more frequent colonoscopy.
  • the discovery that flavorants that include aspartame and a citrate are substantially preferred in comparison to other flavoring regimes was unexpected.
  • Phosphate salt laxatives such as commercially available FLEET® PHOSPHO-SODA® (C.B. Fleet, Lynchburg, Va.; National Formulary Monograph USP 23/NF18, p. 1430), include monobasic sodium phosphate (sodium dihydrogen phosphate, monohydrate) (NaH 2 PO 4 .H 2 O) and dibasic sodium phosphate (disodium hydrogen phosphate, heptahydrate) (Na 2 HPO 4 .7H 2 O) in water.
  • the phosphate salt laxative includes from 0.05 to 1.5 gram/mL of monobasic sodium phosphate and from 0.02 to 0.6 gram/mL of dibasic sodium phosphate.
  • Phosphate salt laxatives have a pH from about 4.4 to about 5.2 and may be produced in multiple ways, such as by combining phosphoric acid with dibasic sodium phosphate or with caustic soda. Laxatives of this type are very stable, thus having a long shelf-life, and are considered to work in a mild and very effective manner.
  • the phosphate salt laxative includes from 0.25 to 1 or from 0.4 to 1 gram/mL of monobasic sodium phosphate and from 0.1 to 0.4 or from 0.13 to 0.25 gram/mL of dibasic sodium phosphate.
  • an especially preferred phosphate salt laxative includes about 0.48 g/mL of monobasic sodium phosphate and about 0.18 g/mL of dibasic sodium phosphate.
  • the phosphate salt laxative may be incorporated into a gel.
  • an aqueous solution containing the phosphate salts may be combined with a gelling agent to form a gel.
  • Suitable gelling agents may include gelatin, such as Gelatin, Type A, 25 Bloom, 50 mesh, from Great Lakes Gelatin, PO Box 917, Grayslake, Ill.; agar, such as Sigma brand Agar A-7002 Lot 71K0093; commercially available products that includes flavorings, such a JELL-O® brand desert mix, and the like.
  • JELL-O® may be boiled in about 130 mL of water and combined with a near-boiling solution containing 45 mL of FLEET® PHOSPHO-SODA® diluted with about 65 mL of water and the flavorant. Additional details regarding the incorporation of a phosphate salt laxative into a gel may be found in U.S. Pat. App. 20040071779 A1.
  • the flavorant Prior to consumption, the flavorant may be added to the phosphate salt laxative to increase its palatability.
  • the flavorant includes aspartame and a citrate.
  • the citrate may include citric acid, salts, such as sodium or potassium citrate, derivatives of citrate, such as a citrate derivatized with ester functionality, and the like.
  • the flavorant also may include natural and/or artificial flavorings, such as natural and/or artificial fruit flavors, to further increase the palatability of the laxative.
  • the flavorant may be in the form of a commercially available aspartame-based drink mixture.
  • One such product is CRYSTAL LIGHT® powder available from Kraft Foods, Northfield, Ill.
  • CRYSTAL LIGHT® powder includes aspartame, citric acid, and fruit flavors that result in various drink flavors when the powder is combined with water.
  • lemonade flavored CRYSTAL LIGHT® powder includes citric acid, potassium citrate, aspartame, maltodextrin, magnesium oxide, natural flavor, acesulfame potassium, lemon juice solids, artificial color, yellow 5 lake, and BHA.
  • CRYSTAL LIGHT® powder may be obtained that will make various drink flavors, including pink lemonade, lemonade, orange, tangerine-strawberry, raspberry-peach, and raspberry ice.
  • Other drink favors such as raspberry lemonade, raspberry, strawberry-kiwi, strawberry-orange-banana, pineapple-orange, and grapefruit also may be used as flavorants.
  • Pink Lemonade CRYSTAL LIGHT® powder is an especially preferred flavorant for combination with the phosphate salt laxative.
  • Less preferred flavorants include natural sugars that may be digested, especially when the natural sugars are present in significant amounts. Digestion of such natural sugars may lead to hydrogen gas formation in the colon that can ignite during polypectomy.
  • compositions may include from 15 to 75 mL, from 30 to 60 mL, or from 40 to 50 mL of phosphate salt laxative in combination with from 1 to 10 grams, from 2 to 6 grams, or from 4 to 5 grams of CRYSTAL LIGHT® drink mix.
  • the composition also may include from 240 to 480 mL, from 300 to 420 mL, or from 270 to 450 mL of water.
  • an especially preferred composition includes about 45 mL of a phosphate salt laxative that includes about 0.48 g/mL of monobasic sodium phosphate and about 0.18 g/mL of dibasic sodium phosphate, about 4.4 g of CRYSTAL LIGHT® Pink Lemonade powder, and about 360 mL of water.
  • the flavorant may be in the form of a reduced-filler aspartame-based mixture.
  • a reduced-filler aspartame-based mixture has a reduced amount of maltodextrin.
  • the reduced-filler mixture also contains less natural flavoring and flowability enhancers than commercially available drink mixtures.
  • a preferable reduced-filler flavorant includes aspartame, citrates, artificial lemon flavoring, and plant extract.
  • an especially preferred plant extract for use in a reduced-filler flavorant is available from WILD Flavors, Inc., Erlanger, Ky. and is referred to as RESOLVER®. It is believed that the plant extracts in RESOLVER®occupy the receptors on the tongue that are responsible for bitter tastes, thus neutralizing the otherwise bitter aspects of the flavorant and/or the phosphate salt laxative.
  • an especially preferred composition includes about 45 mL of a phosphate salt laxative that includes about 0.48 g/mL of monobasic sodium phosphate and about 0.18 g/mL of dibasic sodium phosphate, 2.0 g+/ ⁇ 100% by weight of the reduced-filler aspartame-based mixture, and about 360 mL of water.
  • the phosphate salts and the flavorant are provided as dry powders that are mixed with water before administration to a subject.
  • the phosphate salts are provided in water and mixed with the powdered flavorant.
  • the phosphate salts and the flavorant are each provided in separate solutions, which are mixed before administration. If a gelling agent is used, the phosphate salts and the flavorant may be incorporated into the gel.
  • a kit is provided that includes a water-based composition including the phosphate salts that is mixed with the powdered flavorant before administration.
  • the powdered flavorant also may include a powdered gelling agent. Additional water also may be added to the formulation.
  • the composition also may include ascorbic acid or a salt thereof. Due to the poor stability of ascorbic acid in solution, the ascorbic acid may be separately packaged and added to the phosphate salt laxative before use.
  • the ascorbic acid when the flavorant is packaged as a dry powder, the ascorbic acid may be packaged as a dry powder with the flavorant.
  • the ascorbic acid When packaged as a dry powder, such as with the flavorant, the ascorbic acid may be coated to improve its stability. Suitable coatings include silicone, ethyl cellulose, and the like.
  • enough ascorbic acid is added to provide a pre-administration solution concentration of from 0.25 to 50 g/L or from 1 to 25 g/L. Additional details regarding the use of ascorbic acid in laxative preparations may be found in U.S. Pat. No. 5,274,001.
  • FIG. 1 depicts a cut-away view of a colonic cleansing kit 100 having aspects of the present invention.
  • the kit 100 includes an exterior package 110 , one or more plastic containers 120 , and one or more envelope containers 130 and 140 .
  • the exterior package 110 may have paper and/or plastic components.
  • the exterior package 110 may enclose multiple containers, such as containers 120 , 130 , and 140 , one or more supporting structures for the multiple containers, usually having paper and/or plastic components, instructions for use, and the like.
  • the supporting structures may be formed from stiff paper, STYROFOAMTM, and the like.
  • FIGS. 2A-2D depict the individual components that may be found in the colonic cleansing kit 100 .
  • the exterior package 110 may take the form of a plastic jar 112 having a removable screw-type lid 114 .
  • the diameter of the jar 112 may be about 8 cm.
  • the diameter of the lid 112 may allow attachment to the jar 112 .
  • FIGS. 2B-2D depict various types of containers that may be included in the colonic cleansing kit 100 .
  • the containers may take the form of bottles, tubs, sachets, envelopes, tubes, ampoules, and the like, which may be formed in part or in whole from plastic, glass, paper, foil, MYLAR®, wax, and the like.
  • the containers may be equipped with fully or partially detachable lids that may initially be part of the containers or may be affixed to the containers by mechanical, adhesive, or other means.
  • FIG. 2B depicts two plastic bottles 120 having screw-top lids 122 , each containing about 45 mL of FLEET® PHOSPHO-SODA® liquid 124 .
  • FIG. 2C depicts two packets 130 made from foil-lined paper 132 that enclose the flavorant (not shown).
  • the packets 130 may be rectangular in shape, having a width of about 4.1 to about 4.4 centimeters (cm) and a length of about 6.3 to about 7.6 cm.
  • FIG. 2D depicts separate foil-lined paper envelopes 140 enclosing anorectal wipes 142 .
  • the anorectal wipes 142 may be in the form of pads and the like, such as FLEET® Pain-Relief Pre-Moistened anorectal pads. In one aspect, four individually wrapped wipes are preferred.
  • the anorectal wipes 142 may be rectangular in shape, having dimensions of about 4 cm by about 7 cm.
  • the anorectal wipes 142 may be made from any suitable substrate, such as cloth, paper, or combinations thereof, and may be wetted with an aqueous solution that may include one or more active ingredients, such as a local anesthetic (Pramoxine Hydrochloride, for example) and a protectant (Glycerin, for example).
  • the aqueous solution also may include one or more inactive ingredients, such as cetylpyridinium chloride, citric acid, disodium EDTA, eucalyptol, menthol, octoxynol-9, sodium benzoate, and sodium citrate.
  • the exterior package 110 of the kit 100 also may enclose an instruction sheet (not shown) that includes directions regarding when to consume the colonic cleansing composition in relation to the time of a colonoscopy procedure, how to combine the FLEET® PHOSPHO-SODA® liquid with the flavorant to form the colonic cleansing composition, and how to apply the relief wipes to provide the desired soothing effect.
  • an instruction sheet (not shown) that includes directions regarding when to consume the colonic cleansing composition in relation to the time of a colonoscopy procedure, how to combine the FLEET® PHOSPHO-SODA® liquid with the flavorant to form the colonic cleansing composition, and how to apply the relief wipes to provide the desired soothing effect.
  • the colon may be cleansed.
  • the compositions are administered so that from 0.4 to 0.85 grams of monobasic sodium phosphate and from 0.1 to 0.5 grams of dibasic sodium phosphate per kilogram of body weight are consumed.
  • a first aliquot of the composition may be administered to the subject about 14 hours prior to the colonoscopy. This initial dose may be followed by a second aliquot of the composition administered about 3 hours prior to the colonoscopy.
  • the subject should consume large amounts of liquids, 3 to 4 Liters for example, in addition to the composition to maintain adequate hydration.
  • These additional liquids may include aqueous solutions that include oral re-hydration salts and/or electrolytes, such as GATORADE® and other oral re-hydration beverages.
  • FLEET® PHOSPHO-SODA® laxative preparation flavored with flavoring regimes A through D in multiple subjects.
  • Each 45 mL portion of FLEET® PHOSPHO-SODA® laxative included about 21.6 g of monobasic sodium phosphate (monohydrate) and about 8.1 g of dibasic sodium phosphate (heptahydrate).
  • Flavoring regimes A through D are summarized as follows:
  • the study employed a randomized, single-blind, balanced incomplete block (BIB) design for sequence (order of administration) and gender.
  • BIOB balanced incomplete block
  • Adult men and women who were scheduled to undergo colonoscopy were randomly given one of the flavoring regimes A through D at approximately 7:00 pm on the evening before the colonoscopy.
  • a second, but different, flavoring regime A through D was given to the subject on the following morning, approximately 10-12 hours after the first dose and approximately 3 hours before the colonoscopy.
  • a single subject could receive flavoring regime A on the night before the procedure and flavoring regime B on the morning of the procedure to generate an “AB” preparation regimen.
  • Each of 72 subjects was randomly assigned to one of the twelve possible flavoring regimens (AB, BA, CB, BC, AD, DA, CD, DC, DB, BD, AC, and CA). This was accomplished by assigning each subject the next available flavoring regime depending on the subject's gender, based on the order in which they completed the screening evaluations; and then assigning the subject to the corresponding regimen from the randomization list. Two randomization lists were used, one for males and one for females, to assure balance of genders across the 12 treatment groups in the study.
  • the subjects completed a questionnaire to evaluate their acceptance, the tolerability, and the palatability of each flavoring regime after each of the two doses. After the morning flavoring regime was consumed, each subject also was asked questions regarding their preferences for the two flavor regimens they had experienced. These questions were directed preference questions, and also an open-ended question for the subjects to describe their experience.
  • Table 1 illustrates the number of subjects that underwent each flavoring regimen (Total) and their overall preference rating (no preference between the morning and evening regimen, some preference for the morning or the evening regimen, or a large preference for the morning or the evening regimen), depending on when they were given the flavoring regimen. Generally, for pairs of flavoring regimens, preference ratings were similar regardless of which flavor was given first. All subjects who received the D regimen (FLEET® PHOSPHO-SODA® and CRYSTAL LIGHT® Pink Lemonade as a flavorant) expressed a preference for this regimen over all other regimens, regardless of their respective flavors.
  • a linear model based on perceived intensity score was utilized to analyze each adverse event. Each event was scored twice by the subject, once in the evening and once in the morning, using the assigned flavoring regimen. The model had gender, flavor regimen, and time of administration as the factors. Models were tested for interactions, but the p-values were above the specified 0.10 level of significance; thus, the interaction terms were deleted and the models repeated with only the main effect terms.
  • the least squares means are presented below in Table 2 for each adverse event, in addition to the standard deviations and p-values by gender, flavoring regime, and time of administration.
  • Table 2 shows that adverse events were scored worse by females than by males.
  • abdominal cramps, abdominal bloating, and indigestion were more intense during the evening administration than during the morning administration, while weakness/faint feeling, and thirst/dry mouth were worse during the morning.
  • flavor regimen was significantly related to anal irritation and abdominal cramping.
  • Flavor regime D FLEET® PHOSPHO-SODA® and CRYSTAL LIGHT® Pink Lemonade flavorant
  • Flavor regime D also showed from 60% to 54% less abdominal cramping than the other flavoring regimes.
  • the intensity of abdominal bloating, weakness/faint feeling, and chills was also perceived to be lower by the subjects when using flavoring regimen D.

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US10/934,638 2004-09-03 2004-09-03 Aspartame and citrate flavored phosphate salt laxative Abandoned US20060051428A1 (en)

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US10/934,638 US20060051428A1 (en) 2004-09-03 2004-09-03 Aspartame and citrate flavored phosphate salt laxative
US11/574,635 US7867521B2 (en) 2004-09-03 2005-08-09 Aspartame and citrate flavored phosphate salt laxative
PCT/US2005/028132 WO2006028632A1 (fr) 2004-09-03 2005-08-09 Laxatif a base de sels de phosphate aromatise a l'aspartame et au citrate
TW094127772A TW200621271A (en) 2004-09-03 2005-08-15 Aspartame and citrate flavored phosphate salt laxative

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Cited By (13)

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US20070082061A1 (en) * 2005-10-07 2007-04-12 Nelson Ayala Reduction of saltiness with sweeteners
US20070207216A1 (en) * 2006-03-03 2007-09-06 Caswell Michael L Flavored colonic cleansing system
US20080044489A1 (en) * 2006-08-17 2008-02-21 Caswell Michael L Low dose colonic cleansing system
US20080145445A1 (en) * 2004-09-03 2008-06-19 Nelson Ayala Aspartame and Citrate Flavored Phosphate Salt Laxative
US20090062387A1 (en) * 2007-08-31 2009-03-05 Caswell Michael L Method of preventing nephrocalcinosis
WO2012102799A3 (fr) * 2011-01-28 2012-10-18 Shaver William A Procédé, composition et module pour le nettoyage de l'intestin
US8293299B2 (en) 2009-09-11 2012-10-23 Kraft Foods Global Brands Llc Containers and methods for dispensing multiple doses of a concentrated liquid, and shelf stable Concentrated liquids
WO2014131024A2 (fr) 2013-02-25 2014-08-28 Synergy Pharmaceuticals Inc. Agonistes de la guanylate cyclase et applications associées
EP2879715A4 (fr) * 2012-08-03 2016-03-23 Msm Innovations Inc Méthode et coffret pour la préparation de l'intestin
US9352044B2 (en) 2011-12-07 2016-05-31 Msm Innovations, Inc. Method for bowel preparation
WO2017198477A1 (fr) * 2016-05-18 2017-11-23 University Of Copenhagen Composition comestible semi-solide pour utilisation chez des patients subissant une endoscopie, notamment une coloscopie
CN108420830A (zh) * 2018-05-02 2018-08-21 江苏四环生物制药有限公司 一种磷酸钠盐口服溶液及其制备方法
US11013248B2 (en) 2012-05-25 2021-05-25 Kraft Foods Group Brands Llc Shelf stable, concentrated, liquid flavorings and methods of preparing beverages with the concentrated liquid flavorings

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AU2010239378B2 (en) * 2009-04-21 2013-11-21 Dark Canyon Laboratories, Llc Colon lavage system

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