WO2017172816A1 - Formulations destinées au traitement de la constipation - Google Patents

Formulations destinées au traitement de la constipation Download PDF

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Publication number
WO2017172816A1
WO2017172816A1 PCT/US2017/024606 US2017024606W WO2017172816A1 WO 2017172816 A1 WO2017172816 A1 WO 2017172816A1 US 2017024606 W US2017024606 W US 2017024606W WO 2017172816 A1 WO2017172816 A1 WO 2017172816A1
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WIPO (PCT)
Prior art keywords
composition
peg
laxatives
constipation
food
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PCT/US2017/024606
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English (en)
Inventor
Corey A. Siegel
Michael K. ALLIO
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Colonaryconcepts Llc
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.)
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Publication date
Application filed by Colonaryconcepts Llc filed Critical Colonaryconcepts Llc
Priority to CN201780033365.6A priority Critical patent/CN109475544A/zh
Priority to AU2017241904A priority patent/AU2017241904A1/en
Priority to JP2018549545A priority patent/JP2019513355A/ja
Priority to CA3018589A priority patent/CA3018589A1/fr
Priority to US16/084,173 priority patent/US20230158062A1/en
Priority to EP17776492.5A priority patent/EP3436011A4/fr
Priority to KR1020187030503A priority patent/KR20180123136A/ko
Publication of WO2017172816A1 publication Critical patent/WO2017172816A1/fr
Priority to IL261958A priority patent/IL261958A/en

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    • 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
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L13/00—Meat products; Meat meal; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
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    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
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    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
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    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
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    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
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    • A61K31/47—Quinolines; Isoquinolines
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    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K31/74—Synthetic polymeric materials
    • A61K31/765—Polymers containing oxygen
    • 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
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/26—Iron; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23V2200/00—Function of food ingredients
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    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
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Definitions

  • Constipation is a widespread condition worldwide. Constipation is associated with flatus and intestinal swelling, which causes discomfort and abdominal pain to sufferers.
  • Constipation affects millions of people yearly worldwide. The condition is attributed to numerous causes, including certain medical conditions and physiological conditions such as Irritable Bowel Syndrome, GI motility disorders, pregnancy, sedentary lifestyle, and diet. In addition numerous medications are associated with causing constipation as a side-effect.
  • compositions and methods that overcome short comings in traditional therapies by providing a delivery vehicle for one or more laxatives that provides optimal delivery of the one or more laxatives to the colon in order to optimally treat constipation, and further providing a satisfying experience for the individual ingesting the composition thus promoting compliance with the treatment.
  • the delivery vehicle is a food based delivery vehicle.
  • compositions and methods for promoting gastrointestinal motility are known to promote gastrointestinal motility and as such a food based delivery vehicle of a constipation therapeutic as described herein, in solid form, promotes chewing when ingested and as such promotes gastrointestinal motility.
  • compositions and methods for treating constipation in an individual comprises providing an individual with a therapeutic that comprises a food item.
  • Described herein is a method for treating constipation in an individual comprising:
  • the individual provides the individual with a food item comprising one or more food ingredients and one or more laxatives, wherein ingestion of the food item by the individual produces a bowel movement in the individual and thus relieves constipation in the individual.
  • the food item comprises a shelf-stable packaged solid food item.
  • the one or more laxatives wherein the one or more laxatives comprises any of dibasic sodium phosphate, magnesium citrate, magnesium hydroxide (milk of magnesia), magnesium sulfate (Epsom salt), monobasic sodium phosphate, sodium biphosphate, lactulose, polyethylene glycol (PEG), vitamin C, dioctyl sulfosuccinate (Docusate), bisacodyl (Dulcolax), castor oil, and sorbitol.
  • the PEG comprises PEG 3350 in a quantity of 17grams or less.
  • the one or more food ingredients are mixed together with the one or more laxatives.
  • the one or more laxatives comprises a coating of the food item.
  • the bowel movement in the individual is produced within 12 hours of ingestion of the one or more laxatives.
  • the food item comprises a food bar.
  • the food item comprises a shake or similar beverage.
  • the individual uses a medication, a side effect of which is constipation.
  • the medication comprises an opioid.
  • the opioid comprises one or more of morphine, codeine, oxycodone, and dilaudid.
  • the medication comprises an antidepressant.
  • the antidepressant comprises one or more of amitriptyline and imipramine.
  • the medication comprises an anticonvulsant.
  • the anticonvulsant comprises one or more of phenytoin and carbamazepine.
  • the medication comprises an iron supplement.
  • the medication comprises a calcium channel blocker.
  • the calcium channel blocker comprises one or more of diltiazem and nifedipine.
  • the constipation has lasted for a duration of 24 hours or more.
  • the food item comprises a meal.
  • composition comprising: one or more laxatives; one or more food ingredients; wherein the laxative is combined with the one or more food ingredients, and wherein the one or more food ingredients are either of a quantity or of a type such that when the
  • the one or more food ingredients will be digested to an extent that the one or more laxatives will be released within a colon of the individual.
  • the one or more laxatives comprises polyethylene glycol (PEG) 3350.
  • the PEG 3350 comprises a quantity of 17grams or less.
  • the one or more food ingredients are mixed together with the one or more laxatives.
  • the one or more food ingredients comprise a coating of the composition.
  • a bowel movement in the individual is produced within 12 hours of ingestion of the composition.
  • the composition comprises a ready to eat food bar.
  • the composition comprises a ready to drink shake.
  • the composition comprises an edible powder configured to be mixed with a liquid.
  • the composition comprises a meal.
  • the one or more laxatives are 50% or greater by weight of a total weight of the composition.
  • compositions and methods for treating constipation in an individual are described herein.
  • compositions for treating constipation in an individual comprising a food item.
  • the food item comprises any solid or liquid food item.
  • a solid or liquid food item may comprise a discrete food item or a meal.
  • Non-limiting examples of solid food items include food bars, baked goods, meat products, fruit and fruit products, vegetables and plant based products, candies, gums, nuts and nut products.
  • Non-limiting examples of liquid food items include shakes, sodas, milks, coffees, teas, and flavored water based drinks.
  • the food item comprises food ingredients that may comprise any edible food ingredients used to make a food item.
  • the food item comprises one or more ingredients that comply with the standards of the National Formulary of the U.S. Pharmacopeial Convention (USP-NF).
  • ingredients include sugars and natural sweeteners, artificial sweeteners, grain based flour, non-grain based flour, fruit and fruit products, vegetables and vegetable products, dairy products including milk, cream, cheese, and butter, edible oils, chocolate, and nuts.
  • a food item as described herein comprises one or more food ingredients combined with one or more laxatives.
  • laxatives suitable for combination with the one or more food ingredients include dibasic sodium phosphate, magnesium citrate, magnesium hydroxide (milk of magnesia), magnesium sulfate (Epsom salt), monobasic sodium phosphate, sodium biphosphate, lactulose, polyethylene glycol (PEG) (including, for example, PEG 3350, PEG 4000, PEG 6000, and PEG 8000), vitamin C, dioctyl sulfosuccinate (Docusate), bisacodyl (Dulcolax), castor oil, and sorbitol.
  • PEG polyethylene glycol
  • one or more food ingredients and one or more laxatives are combined so that the laxative is incorporated inside of the food item.
  • the food item comprises a food bar and one or more laxatives are incorporated within the food bar.
  • one or more food ingredients are mixed together with one or more laxatives to form the food item.
  • the one or more food ingredients and the one or more laxatives form a homogenous mixture.
  • the one or more food ingredients and one or more laxatives do not comprise a homogenous mixture.
  • one or more laxatives comprise one or more agglomerated collections of laxative that are at least partially surrounded by one or more food ingredients.
  • a single agglomerated quantity of PEG 3350 is surrounded by one or more food ingredients of a baked good such as a brownie so that the agglomerated quantity of PEG 3350 is incorporated within the brownie which comprises the food item.
  • one or more laxatives comprises a coating of an agglomerated quantity of food ingredients.
  • a food item comprises a bar with a coating comprising of one or more laxatives.
  • a coating comprises an icing, frosting, or fondant.
  • a laxative combined with one or more food ingredients comprises PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 130 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 120 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 110 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 100 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 90 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 80 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 70 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 60 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 50 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 40 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 30 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 20 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 19 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 18 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 17 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 16 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 15 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 14 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 13 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 12 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 11 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 10 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 9 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 8 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 7 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 6 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 5 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 9 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 8 grams of PEG 3350.
  • the quantity of PEG 3350 combined with one or more food ingredients comprises 7 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 6 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 5 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 4 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 3 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 2 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 1 grams of PEG 3350.
  • a composition for treating composition comprises 40% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 45% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 50% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 55% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 60% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 65% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 70% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 75% or greater laxative by weight.
  • a composition for treating composition comprises 80% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 85% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 90% or greater laxative by weight. In some embodiments, a composition for treating composition comprises 95% or greater laxative by weight.
  • the location of delivery of the therapeutic agent for treating constipation within the gastrointestinal tract is related to the rate of digestion of the composition in which the therapeutic is incorporated.
  • a composition comprising a thin edible layer takes relatively less time to digest and is digested in the proximal part of the intestinal tract releasing the therapeutic agent for treating constipation in the proximal part of the intestinal tract.
  • a composition comprising a thick edible layer takes relatively more time to digest and is digested in the distal portion of the digestive tract.
  • the composition comprises ingredients that are digested in the proximal portion of the gastrointestinal tract
  • the composition comprises ingredients that are digested in the distal portion of the gastrointestinal tract.
  • Table 1 below shows a formulation for an exemplary composition for treating constipation comprising a lemon bar.
  • a lemon bar comprises 69.8% by weight PEG 3350 with a total amount of PEG of 17.023 grams.
  • One or more food ingredients include invert syrup, cocoa butter, vanilla, citric acid, and lemon oil. In some embodiments, one or more ingredients are USP-NF grade
  • Table 2 shows a formulation for an exemplary composition for treating constipation comprising a white chocolate bar.
  • a white chocolate bar comprises 69.767% by weight PEG 3350 with a total amount of PEG of 17.023 grams.
  • One or more food ingredients include invert syrup, cocoa butter, vanilla, and chocolate flavor. In some embodiments, one or more ingredients are USP-NF grade.
  • Table 3 below shows a formulation for an exemplary composition for treating constipation comprising a white chocolate bar.
  • a coconut bar comprises 69.767% by weight PEG 3350 with a total amount of PEG of 17.023 grams.
  • One or more food ingredients include invert syrup, cocoa butter, vanilla, and coconut flavor. In some embodiments, one or more ingredients are USP-NF grade.
  • Table 4 shows a formulation for an exemplary composition for treating constipation comprising a strawberry banana shake.
  • a strawberry banana shake comprises 94.2623% by weight PEG 3350 with a total amount of PEG of 115.0 grams.
  • One or more food ingredients include USP-NF sucrose, strawberry banana flavor, and USP-NF citric acid.
  • Table 5 below shows a formulation for an exemplary composition for treating constipation comprising a vanilla beverage.
  • a vanilla beverage comprises 95.833% by weight PEG 3350 with a total amount of PEG of 115.0 grams.
  • One or more food ingredients include USP-NF sucrose and vanilla flavor.
  • compositions described herein comprise portable ready to eat food items.
  • Non-limiting examples of flavors suitable for use in the compositions described herein include sweet flavors, savory flavors, spicy flavors, and sour flavors.
  • the compositions and methods described herein are used to treat individual suffering from constipation.
  • the constipation treated by the compositions and methods described herein is caused by a disease process such as, for example, Irritable Bowel Syndrome.
  • the constipation treated by the compositions and methods described herein is caused by a disease process such as an anxiety disorder.
  • the constipation treated by the compositions and methods described herein is caused by aging.
  • the constipation treated by the compositions and methods described herein is caused by a wasting disease such as certain cancers.
  • the constipation treated by the compositions and methods described herein is caused by poor nutrition.
  • the constipation treated by the compositions and methods described herein is caused by a medication. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an opioid. In some embodiments, the constipation treated by the compositions and methods described herein is caused by codeine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by oxycodone. In some embodiments, the constipation treated by the compositions and methods described herein is caused by hydromorphone. In some embodiments, the constipation treated by the compositions and methods described herein is caused by buprenoprhine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by fentanyl.
  • the constipation treated by the compositions and methods described herein is caused by hydrocodone. In some embodiments, the constipation treated by the compositions and methods described herein is caused by meperidine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by methadone. In some embodiments, the constipation treated by the compositions and methods described herein is caused by morphine sulfate. In some embodiments, the constipation treated by the compositions and methods described herein is caused by oxymorphone. In some embodiments, the constipation treated by the compositions and methods described herein is caused by tramadol. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an
  • the constipation treated by the compositions and methods described herein is caused by amitriptyline. In some embodiments, the constipation treated by the compositions and methods described herein is caused by imipramine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by doxepin. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an antihypertensive. In some embodiments, the constipation treated by the compositions and methods described herein is caused by clonidine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a beta blocker.
  • the constipation treated by the compositions and methods described herein is caused by atenolol. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an anti -Parkinson's agent. In some embodiments, the constipation treated by the compositions and methods described herein is caused by bromocriptine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a cholesterol lowering agent. In some embodiments, the constipation treated by the
  • compositions and methods described herein is caused by cholestyramine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a medication for treatment of gastrointestinal ulcers. In some embodiments, the constipation treated by the compositions and methods described herein is caused by sucralfate. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an anticonvulsant. In some embodiments, the constipation treated by the compositions and methods described herein is caused by phenytoin. In some embodiments, the constipation treated by the compositions and methods described herein is caused by carbamazapine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an iron supplement.
  • the constipation treated by the compositions and methods described herein is caused by a calcium channel blocker. In some embodiments, the constipation treated by the compositions and methods described herein is caused by diltiazem. In some embodiments, the constipation treated by the compositions and methods described herein is caused by nifedipine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an NSAID. In some embodiments, the constipation treated by the compositions and methods described herein is caused by ibuprofen. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an NSAID. In some embodiments, the constipation treated by the compositions and methods described herein is caused by ibuprofen. In some embodiments, the constipation treated by the compositions and methods described herein is caused by an
  • the constipation treated by the compositions and methods described herein is caused by diphenhydramine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by cetirizine. In some embodiments, the constipation treated by the compositions and methods described herein is caused by fexofenadine.
  • a method for treating constipation in an individual comprises providing the individual with a composition comprising one or more food ingredients and one or more laxatives as described herein, and wherein the formulation of the composition is such that ingestion of the composition by the individual causes a bowel movement in the individual.
  • Non-limiting examples of processes for assembling a food item as described herein include mixing, cooking, and baking one or more food ingredients and/or one or more laxatives.
  • the heating is done at a temperature wherein the food ingredients tend to coalesce together while the laxatives remain unchanged. In some embodiments, neither the one or more food ingredients coalesce nor are the one or more laxatives changed. In some
  • the one or more food ingredients and the one or more laxatives all coalesce together when heated. Typically, heat is not applied at or above a temperature at which a therapeutic property of one or more laxatives of the compound are affected. [0037] The effect of heating is determined by both the temperature and duration over which heat is applied.
  • a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 350 degrees Fahrenheit.
  • a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 300 degrees Fahrenheit.
  • a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 250 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 200 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 150 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 100 degrees Fahrenheit.
  • a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 95 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 90 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 85 degrees Fahrenheit. In some embodiments, a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 80 degrees
  • a compound for treating constipation comprises a mixture of one or more laxatives and one or more food ingredients which are heated to a temperature at or above 75 degrees Fahrenheit.
  • the duration of heating is 1 hour or greater. In some embodiments, the duration of heating is 45 minutes or greater. In some embodiments, the duration of heating is 30 minutes or greater. In some embodiments, the duration of heating is 20 minutes or greater. In some embodiments, the duration of heating is 15 minutes or greater. In some embodiments, the duration of heating is 10 minutes or greater. In some embodiments, the duration of heating is 5 minutes or greater. In some embodiments, the duration of heating is 1 minute or greater.
  • a compound for treating constipation further comprises a binder, wherein a binder is an element used to bind one or more elements of the compound together.
  • the binder is edible.
  • the binder comprises cocoa butter.
  • the binder comprises coconut oil.
  • a binder is heated and the elements of the compound are added to the heated binder.
  • one or more elements of the compound are added to the binder at the hottest temperature to which it is heated.
  • one or more elements of the compound are added to the heated binder after it has cooled.
  • the binder is a liquid when heated so that when mixed with the elements of the compound, the elements coalesce or are "bound" together by the binder.
  • a binder in the compound is in a solid state at room temperature and a liquid state at a relatively small increase in temperature above room temperature.
  • This exemplary binder is used in binding the elements of the compound when a solid compound is used such as, for example, a bar.
  • the binder In the liquid state the binder can coalesce the elements, and, as stated, the exemplary binder is in a liquid state at temperatures slightly above room temperature, thus the other elements of the compound are not heated due to the binder to a large extent which is especially important with respect to the laxatives that are damaged at high temperatures.
  • a binder is heated to a temperature at or above 95 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it.
  • a binder is heated to a temperature at or above 90 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it. In some embodiments, a binder is heated to a temperature at or above 85 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it. In some embodiments, a binder is heated to a temperature at or above 80 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it. In some embodiments, a binder is heated to a temperature at or above 75 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it.
  • a binder is heated to a temperature at or above 70 degrees Fahrenheit and then one or more elements of the compound for treating constipation are mixed together with it. In some embodiments, after being heated to an initial temperature, the binder is allowed to cool 30 degrees from the initial temperature before one or more elements of the compound for treating constipation are added. In some embodiments, after being heated to an initial temperature, the binder is allowed to cool 25 degrees from the initial temperature before one or more elements of the compound for treating constipation are added. In some embodiments, after being heated to an initial temperature, the binder is allowed to cool 20 degrees from the initial temperature before one or more elements of the compound for treating constipation are added.
  • the binder after being heated to an initial temperature, the binder is allowed to cool 15 degrees from the initial temperature before one or more elements of the compound for treating constipation are added. In some embodiments, after being heated to an initial temperature, the binder is allowed to cool 10 degrees from the initial temperature before one or more elements of the compound for treating constipation are added. In some embodiments, after being heated to an initial temperature, the binder is allowed to cool 5 degrees from the initial temperature before one or more elements of the compound for treating constipation are added. It is understood that numerous other edible binders are suited, non-limiting examples of which include lard, vegetable shortening, palm oil, butter, or margarine.

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Abstract

L'invention concerne des compositions et des procédés permettant de traiter la constipation chez un individu. Selon certains modes de réalisation, la composition et le procédé permettant de traiter la constipation consistent à fournir un agent thérapeutique qui comprend un aliment et un laxatif à un individu.
PCT/US2017/024606 2016-03-29 2017-03-28 Formulations destinées au traitement de la constipation WO2017172816A1 (fr)

Priority Applications (8)

Application Number Priority Date Filing Date Title
CN201780033365.6A CN109475544A (zh) 2016-03-29 2017-03-28 用于治疗便秘的制剂
AU2017241904A AU2017241904A1 (en) 2016-03-29 2017-03-28 Formulations for treating constipation
JP2018549545A JP2019513355A (ja) 2016-03-29 2017-03-28 便秘症を処置するための製剤
CA3018589A CA3018589A1 (fr) 2016-03-29 2017-03-28 Formulations destinees au traitement de la constipation
US16/084,173 US20230158062A1 (en) 2017-03-28 2017-03-28 Formulations for treating constipation
EP17776492.5A EP3436011A4 (fr) 2016-03-29 2017-03-28 Formulations destinées au traitement de la constipation
KR1020187030503A KR20180123136A (ko) 2016-03-29 2017-03-28 변비 치료용 제제
IL261958A IL261958A (en) 2016-03-29 2018-09-26 Formulations for treating constipation

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WO2019140316A1 (fr) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Formulations solides concentrées pour le traitement de la constipation

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WO2019140316A1 (fr) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Formulations solides concentrées pour le traitement de la constipation

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CA3018589A1 (fr) 2017-10-05
AU2017241904A1 (en) 2018-10-18
CN109475544A (zh) 2019-03-15

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