EP2613790A1 - Abführmittel enthaltend polyethylenglykol und elektrolyte - Google Patents
Abführmittel enthaltend polyethylenglykol und elektrolyteInfo
- Publication number
- EP2613790A1 EP2613790A1 EP11760729.1A EP11760729A EP2613790A1 EP 2613790 A1 EP2613790 A1 EP 2613790A1 EP 11760729 A EP11760729 A EP 11760729A EP 2613790 A1 EP2613790 A1 EP 2613790A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- medical device
- component
- polyethylene glycol
- container
- electrolyte
- 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.)
- Withdrawn
Links
- 229920001223 polyethylene glycol Polymers 0.000 title claims abstract description 35
- 239000002202 Polyethylene glycol Substances 0.000 title claims abstract description 34
- 239000003792 electrolyte Substances 0.000 title claims abstract description 19
- 239000008141 laxative Substances 0.000 title abstract description 12
- 230000002475 laxative effect Effects 0.000 title abstract description 8
- 206010010774 Constipation Diseases 0.000 claims abstract description 14
- 230000001684 chronic effect Effects 0.000 claims abstract description 9
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
- 239000003826 tablet Substances 0.000 claims description 8
- 239000008187 granular material Substances 0.000 claims description 6
- 239000000796 flavoring agent Substances 0.000 claims description 5
- 239000011780 sodium chloride Substances 0.000 claims description 5
- 235000019634 flavors Nutrition 0.000 claims description 4
- 239000000843 powder Substances 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 3
- 229910052782 aluminium Inorganic materials 0.000 claims description 3
- 239000002775 capsule Substances 0.000 claims description 3
- 239000008298 dragée Substances 0.000 claims description 3
- 235000003599 food sweetener Nutrition 0.000 claims description 3
- 239000003765 sweetening agent Substances 0.000 claims description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 2
- 239000007931 coated granule Substances 0.000 claims description 2
- 230000035622 drinking Effects 0.000 claims description 2
- 239000007941 film coated tablet Substances 0.000 claims description 2
- 229920001202 Inulin Polymers 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- JYJIGFIDKWBXDU-MNNPPOADSA-N inulin Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)OC[C@]1(OC[C@]2(OC[C@]3(OC[C@]4(OC[C@]5(OC[C@]6(OC[C@]7(OC[C@]8(OC[C@]9(OC[C@]%10(OC[C@]%11(OC[C@]%12(OC[C@]%13(OC[C@]%14(OC[C@]%15(OC[C@]%16(OC[C@]%17(OC[C@]%18(OC[C@]%19(OC[C@]%20(OC[C@]%21(OC[C@]%22(OC[C@]%23(OC[C@]%24(OC[C@]%25(OC[C@]%26(OC[C@]%27(OC[C@]%28(OC[C@]%29(OC[C@]%30(OC[C@]%31(OC[C@]%32(OC[C@]%33(OC[C@]%34(OC[C@]%35(OC[C@]%36(O[C@@H]%37[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O%37)O)[C@H]([C@H](O)[C@@H](CO)O%36)O)[C@H]([C@H](O)[C@@H](CO)O%35)O)[C@H]([C@H](O)[C@@H](CO)O%34)O)[C@H]([C@H](O)[C@@H](CO)O%33)O)[C@H]([C@H](O)[C@@H](CO)O%32)O)[C@H]([C@H](O)[C@@H](CO)O%31)O)[C@H]([C@H](O)[C@@H](CO)O%30)O)[C@H]([C@H](O)[C@@H](CO)O%29)O)[C@H]([C@H](O)[C@@H](CO)O%28)O)[C@H]([C@H](O)[C@@H](CO)O%27)O)[C@H]([C@H](O)[C@@H](CO)O%26)O)[C@H]([C@H](O)[C@@H](CO)O%25)O)[C@H]([C@H](O)[C@@H](CO)O%24)O)[C@H]([C@H](O)[C@@H](CO)O%23)O)[C@H]([C@H](O)[C@@H](CO)O%22)O)[C@H]([C@H](O)[C@@H](CO)O%21)O)[C@H]([C@H](O)[C@@H](CO)O%20)O)[C@H]([C@H](O)[C@@H](CO)O%19)O)[C@H]([C@H](O)[C@@H](CO)O%18)O)[C@H]([C@H](O)[C@@H](CO)O%17)O)[C@H]([C@H](O)[C@@H](CO)O%16)O)[C@H]([C@H](O)[C@@H](CO)O%15)O)[C@H]([C@H](O)[C@@H](CO)O%14)O)[C@H]([C@H](O)[C@@H](CO)O%13)O)[C@H]([C@H](O)[C@@H](CO)O%12)O)[C@H]([C@H](O)[C@@H](CO)O%11)O)[C@H]([C@H](O)[C@@H](CO)O%10)O)[C@H]([C@H](O)[C@@H](CO)O9)O)[C@H]([C@H](O)[C@@H](CO)O8)O)[C@H]([C@H](O)[C@@H](CO)O7)O)[C@H]([C@H](O)[C@@H](CO)O6)O)[C@H]([C@H](O)[C@@H](CO)O5)O)[C@H]([C@H](O)[C@@H](CO)O4)O)[C@H]([C@H](O)[C@@H](CO)O3)O)[C@H]([C@H](O)[C@@H](CO)O2)O)[C@@H](O)[C@H](O)[C@@H](CO)O1 JYJIGFIDKWBXDU-MNNPPOADSA-N 0.000 claims 1
- 229940029339 inulin Drugs 0.000 claims 1
- 229940126601 medicinal product Drugs 0.000 abstract 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 8
- 229940125722 laxative agent Drugs 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- 230000000968 intestinal effect Effects 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 230000003204 osmotic effect Effects 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 4
- 210000000936 intestine Anatomy 0.000 description 4
- 235000011164 potassium chloride Nutrition 0.000 description 4
- 239000001103 potassium chloride Substances 0.000 description 4
- 230000011514 reflex Effects 0.000 description 4
- 239000000470 constituent Substances 0.000 description 3
- 230000013872 defecation Effects 0.000 description 3
- 230000003111 delayed effect Effects 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 239000008151 electrolyte solution Substances 0.000 description 3
- 229940021013 electrolyte solution Drugs 0.000 description 3
- -1 for example Chemical class 0.000 description 3
- 239000007968 orange flavor Substances 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- 229910001415 sodium ion Inorganic materials 0.000 description 3
- 235000019640 taste Nutrition 0.000 description 3
- 206010063659 Aversion Diseases 0.000 description 2
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 2
- FKNQFGJONOIPTF-UHFFFAOYSA-N Sodium cation Chemical compound [Na+] FKNQFGJONOIPTF-UHFFFAOYSA-N 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 239000000625 cyclamic acid and its Na and Ca salt Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 230000006866 deterioration Effects 0.000 description 2
- 235000005911 diet Nutrition 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 2
- 229960003511 macrogol Drugs 0.000 description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 2
- 229940005483 opioid analgesics Drugs 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 235000019643 salty taste Nutrition 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- MJYQFWSXKFLTAY-OVEQLNGDSA-N (2r,3r)-2,3-bis[(4-hydroxy-3-methoxyphenyl)methyl]butane-1,4-diol;(2r,3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O.C1=C(O)C(OC)=CC(C[C@@H](CO)[C@H](CO)CC=2C=C(OC)C(O)=CC=2)=C1 MJYQFWSXKFLTAY-OVEQLNGDSA-N 0.000 description 1
- 108091006112 ATPases Proteins 0.000 description 1
- 102000057290 Adenosine Triphosphatases Human genes 0.000 description 1
- KHOITXIGCFIULA-UHFFFAOYSA-N Alophen Chemical compound C1=CC(OC(=O)C)=CC=C1C(C=1N=CC=CC=1)C1=CC=C(OC(C)=O)C=C1 KHOITXIGCFIULA-UHFFFAOYSA-N 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
- 208000017701 Endocrine disease Diseases 0.000 description 1
- 241001499733 Plantago asiatica Species 0.000 description 1
- 235000003421 Plantago ovata Nutrition 0.000 description 1
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 description 1
- NPYPAHLBTDXSSS-UHFFFAOYSA-N Potassium ion Chemical compound [K+] NPYPAHLBTDXSSS-UHFFFAOYSA-N 0.000 description 1
- 239000009223 Psyllium Substances 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 210000002255 anal canal Anatomy 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
- 229940038472 dicalcium phosphate Drugs 0.000 description 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 229940099198 dulcolax Drugs 0.000 description 1
- 235000006694 eating habits Nutrition 0.000 description 1
- 239000010408 film Substances 0.000 description 1
- 235000004426 flaxseed Nutrition 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 210000003736 gastrointestinal content Anatomy 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- JCQLYHFGKNRPGE-FCVZTGTOSA-N lactulose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 JCQLYHFGKNRPGE-FCVZTGTOSA-N 0.000 description 1
- 229960000511 lactulose Drugs 0.000 description 1
- PFCRQPBOOFTZGQ-UHFFFAOYSA-N lactulose keto form Natural products OCC(=O)C(O)C(C(O)CO)OC1OC(CO)C(O)C(O)C1O PFCRQPBOOFTZGQ-UHFFFAOYSA-N 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 230000001050 lubricating effect Effects 0.000 description 1
- 229940127554 medical product Drugs 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 230000002572 peristaltic effect Effects 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 229910001414 potassium ion Inorganic materials 0.000 description 1
- 229940001470 psychoactive drug Drugs 0.000 description 1
- 239000004089 psychotropic agent Substances 0.000 description 1
- 229940070687 psyllium Drugs 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 230000009967 tasteless effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
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:
Landscapes
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- Veterinary Medicine (AREA)
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- Inorganic Chemistry (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE202010012256U DE202010012256U1 (de) | 2010-09-07 | 2010-09-07 | Abführmittel |
PCT/EP2011/065131 WO2012031978A1 (de) | 2010-09-07 | 2011-09-01 | Abführmittel enthaltend polyethylenglykol und elektrolyte |
Publications (1)
Publication Number | Publication Date |
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EP2613790A1 true EP2613790A1 (de) | 2013-07-17 |
Family
ID=43070368
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP11760729.1A Withdrawn EP2613790A1 (de) | 2010-09-07 | 2011-09-01 | Abführmittel enthaltend polyethylenglykol und elektrolyte |
Country Status (7)
Country | Link |
---|---|
US (1) | US20130171255A1 (ja) |
EP (1) | EP2613790A1 (ja) |
JP (1) | JP2013540726A (ja) |
CN (1) | CN103079575A (ja) |
DE (1) | DE202010012256U1 (ja) |
EA (1) | EA201390350A1 (ja) |
WO (1) | WO2012031978A1 (ja) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2016226380A1 (en) * | 2015-03-02 | 2017-09-21 | Colonaryconcepts Llc | Compounds and methods for PEG metabolite and PEG breakdown product assays |
FR3056109B1 (fr) * | 2016-09-21 | 2019-10-11 | Pierre Fabre Medicament | Utilisation de formulations solides de polyethylene glycol dans le traitement de la constipation |
CN107028876B (zh) * | 2016-10-09 | 2020-09-29 | 舒泰神(北京)生物制药股份有限公司 | 聚乙二醇电解质口服液及其制备方法 |
CN110433174A (zh) * | 2019-07-17 | 2019-11-12 | 华南理工大学 | 一种高依从性的复方聚乙二醇电解质散剂及其制备方法与应用 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2010123901A1 (en) * | 2009-04-21 | 2010-10-28 | Bachwich Dale R | Colon lavage system |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB0409104D0 (en) * | 2004-04-23 | 2004-05-26 | Norgine Europe Bv | Compressed pharmaceutical compositions |
-
2010
- 2010-09-07 DE DE202010012256U patent/DE202010012256U1/de not_active Expired - Lifetime
-
2011
- 2011-09-01 US US13/817,499 patent/US20130171255A1/en not_active Abandoned
- 2011-09-01 EP EP11760729.1A patent/EP2613790A1/de not_active Withdrawn
- 2011-09-01 WO PCT/EP2011/065131 patent/WO2012031978A1/de active Application Filing
- 2011-09-01 JP JP2013527554A patent/JP2013540726A/ja not_active Withdrawn
- 2011-09-01 CN CN2011800430907A patent/CN103079575A/zh active Pending
- 2011-09-01 EA EA201390350A patent/EA201390350A1/ru unknown
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2010123901A1 (en) * | 2009-04-21 | 2010-10-28 | Bachwich Dale R | Colon lavage system |
Non-Patent Citations (2)
Title |
---|
"Moviprep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic acid for Oral solution)", INTERNET CITATION, 2006, pages 1 - 7, XP002716678, Retrieved from the Internet <URL:http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021881lbl.pdf> [retrieved on 20131120] * |
See also references of WO2012031978A1 * |
Also Published As
Publication number | Publication date |
---|---|
CN103079575A (zh) | 2013-05-01 |
EA201390350A1 (ru) | 2013-07-30 |
US20130171255A1 (en) | 2013-07-04 |
JP2013540726A (ja) | 2013-11-07 |
DE202010012256U1 (de) | 2010-11-11 |
WO2012031978A1 (de) | 2012-03-15 |
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