WO2017172816A1 - Formulations for treating constipation - Google Patents

Formulations for treating constipation Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
composition
peg
laxatives
constipation
food
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2017/024606
Other languages
French (fr)
Inventor
Corey A. Siegel
Michael K. ALLIO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Colonaryconcepts LLC
Original Assignee
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.)
Filing date
Publication date
Application filed by Colonaryconcepts LLC filed Critical Colonaryconcepts LLC
Priority to EP17776492.5A priority Critical patent/EP3436011A4/en
Priority to JP2018549545A priority patent/JP2019513355A/en
Priority to AU2017241904A priority patent/AU2017241904A1/en
Priority to CA3018589A priority patent/CA3018589A1/en
Priority to KR1020187030503A priority patent/KR20180123136A/en
Priority to US16/084,173 priority patent/US20230158062A1/en
Priority to CN201780033365.6A priority patent/CN109475544A/en
Publication of WO2017172816A1 publication Critical patent/WO2017172816A1/en
Priority to IL261958A priority patent/IL261958A/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • 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 OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • 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
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/21—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
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/41—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
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • 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
    • A61K31/435—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
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • 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
    • A61K31/435—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
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K31/435—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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • 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
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
    • 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
    • A61K33/24—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/32—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the digestive tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Confectionery (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Non-Alcoholic Beverages (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Described herein are compositions and methods for treating constipation in an individual. In some embodiments, the composition and method for treating constipation comprises providing an individual with a therapeutic that comprises a food item and a laxative.

Description

FORMULATIONS FOR TREATING CONSTIPATION
CROSS-REFERENCE
[0001] This application claims the benefit of U.S. Provisional Application No. 62/314,883, filed March 29, 2016, which is incorporated herein by reference in its entirety.
BACKGROUND
[0002] Constipation is a widespread condition worldwide. Constipation is associated with flatus and intestinal swelling, which causes discomfort and abdominal pain to sufferers.
[0003] There are numerous causes of constipation including medical conditions and iatrogenic constipation resulting from certain prescribed medications.
SUMMARY
[0004] 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.
[0005] Traditional laxative based therapies for constipation do not provide a palatable, convenient, appealing, or easily portable method for treating constipation. As such, traditional laxative based therapies do not provide a mechanism for encouraging individual compliance with the treatment.
[0006] Described herein are 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. In some embodiments, the delivery vehicle is a food based delivery vehicle.
[0007] Described herein are compositions and methods for promoting gastrointestinal motility. Chewing is 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.
[0008] Described herein are compositions and methods for treating constipation in an individual. In some embodiments, the composition and method for treating constipation comprises providing an individual with a therapeutic that comprises a food item.
[0009] Described herein is a method for treating constipation in an individual comprising:
providing 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. In some embodiments, the food item comprises a shelf-stable packaged solid food item. In some embodiments, 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. In some embodiments, the PEG comprises PEG 3350 in a quantity of 17grams or less. In some
embodiments, the one or more food ingredients are mixed together with the one or more laxatives. In some embodiments, the one or more laxatives comprises a coating of the food item. In some embodiments, the bowel movement in the individual is produced within 12 hours of ingestion of the one or more laxatives. In some embodiments, the food item comprises a food bar. In some embodiments, the food item comprises a shake or similar beverage. In some embodiments, the individual uses a medication, a side effect of which is constipation. In some embodiments, the medication comprises an opioid. In some embodiments, the opioid comprises one or more of morphine, codeine, oxycodone, and dilaudid. In some embodiments, the medication comprises an antidepressant. In some embodiments, the antidepressant comprises one or more of amitriptyline and imipramine. In some embodiments, the medication comprises an anticonvulsant. In some embodiments, the anticonvulsant comprises one or more of phenytoin and carbamazepine. In some embodiments, the medication comprises an iron supplement. In some embodiments, the medication comprises a calcium channel blocker. In some embodiments, the calcium channel blocker comprises one or more of diltiazem and nifedipine. In some embodiments, the constipation has lasted for a duration of 24 hours or more. In some embodiments, the food item comprises a meal.
[0010] Described herein is a 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
composition is ingested by an individual, 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. In some embodiments, the one or more laxatives comprises polyethylene glycol (PEG) 3350. In some embodiments, the PEG 3350 comprises a quantity of 17grams or less. In some embodiments, the one or more food ingredients are mixed together with the one or more laxatives. In some embodiments, the one or more food ingredients comprise a coating of the composition. In some embodiments, a bowel movement in the individual is produced within 12 hours of ingestion of the composition. In some embodiments, the composition comprises a ready to eat food bar. In some embodiments, the composition comprises a ready to drink shake. In some embodiments, the composition comprises an edible powder configured to be mixed with a liquid. In some embodiments, the composition comprises a meal. In some embodiments, the one or more laxatives are 50% or greater by weight of a total weight of the composition.
DETAILED DESCRIPTION
[0011] Described herein are compositions and methods for treating constipation in an individual. Compositions for treating constipation
[0012] Described herein are compositions for treating constipation in an individual comprising a food item.
[0013] In some embodiments, 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.
[0014] In some embodiments, the food item comprises food ingredients that may comprise any edible food ingredients used to make a food item. In some embodiments, 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). Non-limiting examples of 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.
[0015] A food item as described herein comprises one or more food ingredients combined with one or more laxatives. Non-limiting examples of 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.
[0016] In some embodiments, one or more food ingredients and one or more laxatives are combined so that the laxative is incorporated inside of the food item. For example, in some embodiments, the food item comprises a food bar and one or more laxatives are incorporated within the food bar. In some embodiments, one or more food ingredients are mixed together with one or more laxatives to form the food item. In some embodiments, the one or more food ingredients and the one or more laxatives form a homogenous mixture. In some embodiments, the one or more food ingredients and one or more laxatives do not comprise a homogenous mixture. [0017] In some embodiments, one or more laxatives comprise one or more agglomerated collections of laxative that are at least partially surrounded by one or more food ingredients. For example, in some embodiments, 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. In some
embodiments, one or more laxatives comprises a coating of an agglomerated quantity of food ingredients. For example, in some embodiments, a food item comprises a bar with a coating comprising of one or more laxatives. In some embodiments, a coating comprises an icing, frosting, or fondant.
[0018] In some embodiments, a laxative combined with one or more food ingredients comprises PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 130 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 120 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 110 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 100 grams of PEG 3350. In some embodiments, the quantity of PEG 3350 combined with one or more food ingredients comprises 90 grams of PEG 3350. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. 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 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.
[0019] In some embodiments, 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. In some embodiments, 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.
[0020] In some embodiments, 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. For example, 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. For example, a composition comprising a thick edible layer takes relatively more time to digest and is digested in the distal portion of the digestive tract. Thus, by, for example, controlling the thickness of the composition, a point of release of the therapeutic agent for treating constipation within the gastrointestinal tract is controlled. Similarly, in some embodiments, the composition comprises ingredients that are digested in the proximal portion of the gastrointestinal tract, and in some embodiments, the composition comprises ingredients that are digested in the distal portion of the gastrointestinal tract.
[0021] Table 1 below shows a formulation for an exemplary composition for treating constipation comprising a lemon bar.
Table 1
Figure imgf000007_0001
[0022] As shown in table 1, 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
[0023] Table 2 below shows a formulation for an exemplary composition for treating constipation comprising a white chocolate bar. Table 2
Figure imgf000008_0001
[0024] As shown in table 2, 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.
[0025] Table 3 below shows a formulation for an exemplary composition for treating constipation comprising a white chocolate bar.
Table 3
Figure imgf000008_0002
[0026] As shown in table 3, 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.
[0027] Table 4 below shows a formulation for an exemplary composition for treating constipation comprising a strawberry banana shake. Table 4
Figure imgf000009_0002
[0028] As shown in table 4, 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.
[0029] Table 5 below shows a formulation for an exemplary composition for treating constipation comprising a vanilla beverage.
Table 5
Figure imgf000009_0001
[0030] As shown in table 5, 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.
[0031] In some embodiments, the compositions described herein comprise portable ready to eat food items.
[0032] Non-limiting examples of flavors suitable for use in the compositions described herein include sweet flavors, savory flavors, spicy flavors, and sour flavors.
Constipation treatment
[0033] In some embodiments, the compositions and methods described herein are used to treat individual suffering from constipation. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a disease process such as, for example, Irritable Bowel Syndrome. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a disease process such as an anxiety disorder. In some embodiments, the constipation treated by the compositions and methods described herein is caused by aging. In some embodiments, the constipation treated by the compositions and methods described herein is caused by a wasting disease such as certain cancers. In some embodiments, the constipation treated by the compositions and methods described herein is caused by poor nutrition. In some embodiments, 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. In some embodiments, 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
antidepressant. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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
anticholinergic. In some embodiments, 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.
[0034] In some embodiments, 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.
Manufacture
[0035] 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.
[0036] When the one or more food ingredients and/or the one or more laxatives are heated in order to manufacture the food item, 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
embodiments, 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. 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 350 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 300 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 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. 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 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
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 75 degrees Fahrenheit. In some embodiments, 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.
[0038] In some embodiments, 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. In some embodiments, the binder is edible. In some embodiments, the binder comprises cocoa butter. In some embodiments, the binder comprises coconut oil.
[0039] In some embodiments, a binder is heated and the elements of the compound are added to the heated binder. In some embodiments, one or more elements of the compound are added to the binder at the hottest temperature to which it is heated. In some embodiments, one or more elements of the compound are added to the heated binder after it has cooled. In some embodiments, 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. In an exemplary embodiment, 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. 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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. In some embodiments, 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.
[0040] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMS WHAT IS CLAIMED IS:
1. A method for treating constipation in an individual comprising:
providing 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;
wherein the food item comprises a shelf-stable packaged solid food item.
2. The method of claim 1, 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.
3. The method of claim 2, wherein the PEG comprises PEG 3350 in a quantity of 17grams or less.
4. The method of claim 1, wherein the one or more food ingredients are mixed together with the one or more laxatives.
5. The method of claim 1, wherein the one or more laxatives comprises a coating of the food item.
6. The method of claim 1, wherein the bowel movement in the individual is produced within 12 hours of ingestion of the one or more laxatives.
7. The method of claim 1, wherein the bowel movement in the individual is produced within 24 hours.
8. The method of claim 1, wherein the food item comprises a ready to eat food bar.
9. The method of claim 1, wherein the food item comprises an edible powder either with or without flavoring and configured to be mixed with a liquid.
10. The method of claim 1, wherein the individual uses a medication, a side effect of which is constipation.
11. The method of claim 10, wherein the medication comprises an opioid.
12. The method of claim 11, wherein the opioid comprises one or more of morphine, codeine, oxycodone, and dilaudid.
13. The method of claim 10, wherein the medication comprises an antidepressant
14. The method of claim 13, wherein the antidepressant comprises one or more of amitriptyline and imipramine.
15. The method of claim 10, wherein the medication comprises an anticonvulsant.
16. The method of claim 15, wherein the anticonvulsant comprises one or more of phenytoin and carbamazepine.
17. The method of claim 10, wherein the medication comprises an iron supplement.
18. The method of claim 10, wherein the medication comprises a calcium channel blocker.
19. The method of claim 18, wherein the calcium channel blocker comprises one or more diltiazem and nifedipine.
20. The method of claim 1, wherein the constipation has lasted for a duration of 24 hours or more.
21. The method of claim 1, wherein the food item comprises a meal.
22. The method of claim 1, wherein the one or more laxatives are 50% or greater by weight of a total weight of the food item.
23. A 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 composition is ingested by an individual, 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.
24. The composition of claim 23, wherein the one or more laxatives comprises polyethylene glycol (PEG) 3350.
25. The composition of claim 23, wherein the PEG 3350 comprises a quantity of 17grams or less.
26. The composition of claim 23, wherein the one or more food ingredients are mixed together with the one or more laxatives.
27. The composition of claim 23, wherein the one or more food ingredients comprise a coating of the composition.
28. The composition of claim 23, wherein a bowel movement in the individual is produced within 12 hours of ingestion of the composition.
29. The composition of claim 23, wherein the composition comprises a ready to eat food bar.
30. The composition of claim 23, wherein the composition comprises a ready to drink shake.
31. The composition of claim 23, wherein the composition comprises an edible powder configured to be mixed with a liquid.
32. The composition of claim 23, wherein the composition comprises a meal.
33. The composition of claim 23, wherein the one or more laxatives are 50% or greater by weight of a total weight of the composition.
PCT/US2017/024606 2016-03-29 2017-03-28 Formulations for treating constipation Ceased WO2017172816A1 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP17776492.5A EP3436011A4 (en) 2016-03-29 2017-03-28 FORMULATIONS FOR TREATMENT OF CONSTIPATION
JP2018549545A JP2019513355A (en) 2016-03-29 2017-03-28 Preparation for treating constipation
AU2017241904A AU2017241904A1 (en) 2016-03-29 2017-03-28 Formulations for treating constipation
CA3018589A CA3018589A1 (en) 2016-03-29 2017-03-28 Formulations for treating constipation
KR1020187030503A KR20180123136A (en) 2016-03-29 2017-03-28 Constipation treatment agent
US16/084,173 US20230158062A1 (en) 2017-03-28 2017-03-28 Formulations for treating constipation
CN201780033365.6A CN109475544A (en) 2016-03-29 2017-03-28 Preparations for the treatment of constipation
IL261958A IL261958A (en) 2016-03-29 2018-09-26 Formulations for treating constipation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662314883P 2016-03-29 2016-03-29
US62/314,883 2016-03-29

Publications (1)

Publication Number Publication Date
WO2017172816A1 true WO2017172816A1 (en) 2017-10-05

Family

ID=59966423

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/024606 Ceased WO2017172816A1 (en) 2016-03-29 2017-03-28 Formulations for treating constipation

Country Status (8)

Country Link
EP (1) EP3436011A4 (en)
JP (1) JP2019513355A (en)
KR (1) KR20180123136A (en)
CN (1) CN109475544A (en)
AU (1) AU2017241904A1 (en)
CA (1) CA3018589A1 (en)
IL (1) IL261958A (en)
WO (1) WO2017172816A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019140316A1 (en) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Solid concentrated constipation treatment formulations
WO2019140319A1 (en) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Constipation specific treatment formulations
US12171879B2 (en) 2019-08-12 2024-12-24 Massachusetts Institute Of Technology Articles and methods for administration of therapeutic agents

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030073746A1 (en) * 2001-05-02 2003-04-17 Sucampo, A.G. Method for treating drug-induced constipation
US20110288180A1 (en) * 2008-07-09 2011-11-24 Joshua Korzenik Dietary purgatives
US20120107430A1 (en) * 2009-05-01 2012-05-03 Jeffery Dale Scott Pre-procedure meal regimen
US20130317050A1 (en) * 2011-12-19 2013-11-28 Enoch Bortey Methods for treatment and prevention of opioid induced constipation using oral compositions of methylnaltrexone
US20150306046A1 (en) * 2014-04-29 2015-10-29 ColonaryConcepts, LLC Foods, systems, methods, and kits for providing electrolyte replacement
WO2017040860A1 (en) * 2015-09-01 2017-03-09 Colonaryconcepts Llc Laxative formulations and manufacture

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5232699A (en) * 1990-07-26 1993-08-03 The Proctor & Gamble Company Laxative compositions
US5234916A (en) * 1992-06-12 1993-08-10 The Proctor & Gamble Company Psyllium drink mix compositions
JP2007511610A (en) * 2003-11-17 2007-05-10 ブレーントリー ラボラトリーズ インコーポレーティッド PEG solution concentrate for treatment
AU2006244112B2 (en) * 2005-05-06 2011-02-17 Salix Pharmaceuticals, Inc. Polyethylene glycol colonic purgative composition
CN101002832B (en) * 2006-09-02 2011-01-05 江西农业大学 Granulated quickly dissolving medicine for relaxing bowel
CN101589806A (en) * 2008-05-29 2009-12-02 北京亿利高科生物工程技术研究所有限公司 A kind of solid low-energy food that is rich in dietary fiber and polyethylene glycol and preparation method thereof
JP2014532725A (en) * 2011-11-06 2014-12-08 エスエスブイ セラピューテクス，リミティド ライアビリティ カンパニー Concentrated prunes and prebiotic formulations as laxatives and food supplements
CA2880432C (en) * 2012-08-21 2023-03-14 Ardelyx, Inc. Compounds and methods for inhibiting nhe-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders
KR20150046310A (en) * 2012-08-29 2015-04-29 샐릭스 파마슈티컬스 인코포레이티드 Laxative compositions and methods for treating constipation and related gastrointestinal diseases and conditions

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030073746A1 (en) * 2001-05-02 2003-04-17 Sucampo, A.G. Method for treating drug-induced constipation
US20110288180A1 (en) * 2008-07-09 2011-11-24 Joshua Korzenik Dietary purgatives
US20120107430A1 (en) * 2009-05-01 2012-05-03 Jeffery Dale Scott Pre-procedure meal regimen
US20130317050A1 (en) * 2011-12-19 2013-11-28 Enoch Bortey Methods for treatment and prevention of opioid induced constipation using oral compositions of methylnaltrexone
US20150306046A1 (en) * 2014-04-29 2015-10-29 ColonaryConcepts, LLC Foods, systems, methods, and kits for providing electrolyte replacement
WO2017040860A1 (en) * 2015-09-01 2017-03-09 Colonaryconcepts Llc Laxative formulations and manufacture

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3436011A4 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019140316A1 (en) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Solid concentrated constipation treatment formulations
WO2019140319A1 (en) * 2018-01-12 2019-07-18 Colonaryconcepts Llc Constipation specific treatment formulations
US12171879B2 (en) 2019-08-12 2024-12-24 Massachusetts Institute Of Technology Articles and methods for administration of therapeutic agents

Also Published As

Publication number Publication date
KR20180123136A (en) 2018-11-14
AU2017241904A1 (en) 2018-10-18
IL261958A (en) 2018-10-31
EP3436011A1 (en) 2019-02-06
EP3436011A4 (en) 2019-12-04
CA3018589A1 (en) 2017-10-05
CN109475544A (en) 2019-03-15
JP2019513355A (en) 2019-05-30

Similar Documents

Publication Publication Date Title
JP5249941B2 (en) Granular jelly drink for medicine and method for producing the same
JP5937573B2 (en) Methods and compositions for inducing satiety
KR20040105737A (en) Compositions and methods for treatment of body weight conditions with milk minerals and casein fractions
CN101331947A (en) Formula and preparation method of biscuit with bowel relaxing function
JPH07242539A (en) Composition having laxative effect
JP6728071B2 (en) Muscle synthesis promoter
CN105658231A (en) Muscle repair promoter
EP3436011A1 (en) Formulations for treating constipation
WO2007044663A1 (en) Compositions and methods for inducing satiety and reducing caloric intake
KR20190001654A (en) Chocolate Pie Containing Coffee, and Method for Manufacturing the Same
JP3462535B2 (en) Mineral absorption promoting composition
KR100877050B1 (en) How to prepare low calorie sugar-free syrup
CN108024975A (en) Charthartic preparation and its preparation
CN118805891B (en) Composition for inhibiting fat absorption and controlling body weight and preparation method thereof
JP2009189286A (en) Rare chocolate and method of producing the same
WO2006132042A1 (en) Nutritional supplement powder and fat for food or medicine
US20230158062A1 (en) Formulations for treating constipation
JP2015142542A (en) High protein pancake mix
JP2011239774A (en) Composition inducing sense of fullness
DE2254045A1 (en) DIET FOOD WITH LOW CALORIES
CN1134219C (en) Low-sugar ice cream powder
US20020110531A1 (en) Cholesterol reducing composition and method of making the same
JP2013508338A (en) Use of an extract derived from Salumum Glaucophyllum for the treatment of bone metabolism disorders and kidney disorders
CN102461666A (en) A kind of preparation method of water-soluble dietary fiber milk drink
US20200360423A1 (en) Solid concentrated constipation treatment formulations

Legal Events

Date Code Title Description
ENP Entry into the national phase

Ref document number: 2018549545

Country of ref document: JP

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 3018589

Country of ref document: CA

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 2017241904

Country of ref document: AU

Date of ref document: 20170328

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 20187030503

Country of ref document: KR

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2017776492

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 2017776492

Country of ref document: EP

Effective date: 20181029

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 17776492

Country of ref document: EP

Kind code of ref document: A1