Classifications

• • 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
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
• • 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
  • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
• • 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
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
  • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
  • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
  • A61K9/1605—Excipients; Inactive ingredients
  • A61K9/1629—Organic macromolecular compounds
  • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2004—Excipients; Inactive ingredients
  • A61K9/2009—Inorganic compounds
• • 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
  • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

• the present invention relates to a polyethylene glycol (PEG) -based laxative having improved compliance.
• a medical device according to the invention is suitable for the treatment of chronic constipation.
• Constipation is the delayed discharge of dry and hard stools. It can either be attributed to a slowed intestinal passage or a disturbed discharge reflex.
• the causes of delayed intestinal transit include dietary factors, changes in the intestinal wall, endocrine disorders and functional and organic disorders of the nervous system.
• Drugs, such as sedatives, psychotropic drugs or opioids may also have an obstipating effect.
• a disturbed evacuation reflex can be found in diseases of the anal canal, loss of the rectal stretch reflex or weakness of the abdominal press.
• laxatives are used for a short time to accelerate defecation. Most laxatives work by increasing the intraluminal volume and thus by increasing the internal pressure in the lumen Intestinal trigger peristaltic waves. Basically, one can distinguish here three groups of laxatives, which have such an effect:
• Naturally occurring or synthetically produced swellable, non-digestible polysaccharides such as, for example, flaxseed or Indian psyllium, which swell up in the intestine, are suitable as mild laxatives. These must be taken together with sufficient water to avoid gelatinisation of the intestinal contents.
• the well-known castor oil inhibits sodium ion and water absorption by blocking the sodium ion / potassium ion-dependent ATPase. The laxative effect is reliable. Since it is not taken with pleasure, it is more suitable for therapy of acute constipation.
• Polyethylene glycol a polymeric powder
• the powder binds the water with which it is taken and transports it into the large intestine. There, the osmotic pressure is increased locally and water is released into the intestinal lumen.
• Polyethylengiykol is neither absorbed nor methabolized (Mutschier drug effects: Textbook of Pharmacology and Toxicology by E. Mutschier et al., 8th edition, Stuttgart: Stuttgart Verlagsgesellschaft mbH, 2001, pp. 647-652),
• the object of the present invention is thus to provide a product for the treatment of chronic constipation with improved compliance.
• the essence of the invention is that you can significantly improve the compliance, if polyethylene glycol and electrolyte are taken separately.
• the object underlying the present invention is achieved by a medical device for the treatment of chronic constipation, which is characterized in that it comprises two spatially separated components A and B, wherein component A is a polyethylene glycol (PEG) and component B at least comprises an electrolyte.
• a medical device for the treatment of chronic constipation which is characterized in that it comprises two spatially separated components A and B, wherein component A is a polyethylene glycol (PEG) and component B at least comprises an electrolyte.
• component A is a polyethylene glycol (PEG)
• component B at least comprises an electrolyte.
• the polyethylene glycol preferably has a molecular weight in the range from 2000 g / mol to 6000 g / mol, in particular in the range of 3000 g / mol to 4000 g / mol, in particular of 3350 g / mol.
• Corresponding polyethylene glycols have a particularly good osmotic action in the intestine, which is predominantly responsible for the effect of laxity. For example, a certain amount of PEG 2000 (polyethylene glycol having a molecular weight of 2000 g / mol) causes an approximately twice as high osmotic pressure as the same amount of PEG 4000 (polyethylene glycol having a molecular weight of 4000 g / mol).
• the PEG has a bitter taste. This results in a deteriorated compliance. If the molecular weight of the PEG is too large, the osmotic effect is too low. A sufficient laxative effect is not achieved here.
• the daily dose is usually in the range of 7g to 40g, preferably 13g to 26g, PEG per day. With a supplied amount of less than 7g PEG per day, a sufficient laxative effect can not be ensured. If the amount of ingested PEG is significantly more than 40g per day, it can cause diarrhea. Intake of 13g to 26g PEG per day has been found to be the most preferred dose in adults. However, this value is dependent on individual conditions, such as body weight or cause of constipation.
• the medical device according to the invention in ingredient A has 13.125 g of PEG as a single dose. This corresponds to a daily standard dose for one Adults. If the need is greater, up to three single doses can be taken each day.
• constituent A may additionally comprise one or more flavoring agents which additionally improve compliance.
• flavors are understood to be flavors such as, for example, orange flavors or acidulants, such as, for example, citric acid.
• ingredient A may also comprise sweeteners such as saccharin-Na, sugar and / or Na-cyclamate, etc.
• the contained PEG itself is almost tasteless.
• the inventive addition of flavor and / or sweetener gives a pleasant taste of the medical device. By varying these substances you can adjust the intensity of the aroma and sweetness. Due to the pleasant taste, even after prolonged ingestion no aversion to the medical device according to the invention develops, which leads to a significantly improved compliance even over a longer period of administration.
• Component A is present in an embodiment according to the invention as granules, in particular as drinking granules for dissolution, or as finished solution.
• the medical device according to the invention furthermore comprises at least one electrolyte. This is spatially separated as part B before.
• electrolyte for example, NaCl and / or KCl, and, optionally, sodium bicarbonate may additionally be used.
• Mg.sup. + Salts and / or Ca.sup. Salts for example as citrate, and / or optionally in addition, may furthermore be added.
• the constituent B comprising the electrolyte can be present, for example, in the form of a coated granule or powder, as a tablet, film-coated tablet, capsule and / or dragee.
• component B is present as a film tablet.
• the auxiliaries customary for this purpose can be used.
• the object underlying the present invention is achieved by a combination pack comprising at least two separate containers, wherein in one container 1 component A of the medical device and in another container 2 component B of the medical product is included.
• Container 1 may be a bag according to the invention. In particular bags of coated aluminum are used here. Such a bag is suitable both for receiving the polyethylene glycol-containing granules or the finished drink solution. The drink solution can also be bottled for single and / or multiple use.
• the component B containing the electrolyte is preferably in solid form.
• An appropriate container 2 can thus be a bag and / or a deep-drawn film.
• the electrolyte tablets according to the invention can thus be present, for example, as a biostrap.
• the container 1 and the container 2 can also be separably connected to one another.
• the separation of the two containers from each other must be such that the respective containers 1 and 2 remain intact. This can be done for example by means of a perforation.
• components A and B must not mix with each other.
• Example 1 The separate intake of components A and B ensures a significant improvement in compliance. This also lasts for a longer period. It also ensures the supply of the required electrolytes. Exemplary embodiments: Example 1
• Component A Granules:
• Component B Tablet:
• Component A Solution in aluminum bag:
• Citric acid 0.131 g Component B Tablet:

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• Health & Medical Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Pharmacology & Pharmacy (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Medicinal Chemistry (AREA)
• Animal Behavior & Ethology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Epidemiology (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Inorganic Chemistry (AREA)
• General Chemical & Material Sciences (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Organic Chemistry (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Oil, Petroleum & Natural Gas (AREA)
• Medicinal Preparation (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

Applications Claiming Priority (2)

Publications (1)

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Family Applications (1)

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• 2010
  • 2010-09-07 DE DE202010012256U patent/DE202010012256U1/de not_active Expired - Lifetime
• 2011
  • 2011-09-01 JP JP2013527554A patent/JP2013540726A/ja not_active Withdrawn
  • 2011-09-01 EP EP11760729.1A patent/EP2613790A1/de not_active Withdrawn
  • 2011-09-01 EA EA201390350A patent/EA201390350A1/ru unknown
  • 2011-09-01 CN CN2011800430907A patent/CN103079575A/zh active Pending
  • 2011-09-01 WO PCT/EP2011/065131 patent/WO2012031978A1/de active Application Filing
  • 2011-09-01 US US13/817,499 patent/US20130171255A1/en not_active Abandoned

Patent Citations (1)

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