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WO2012128520A2 - Composition liquide utilisée pour traiter le reflux gastro-œsophagien - Google Patents

Composition liquide utilisée pour traiter le reflux gastro-œsophagien Download PDF

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Publication number
WO2012128520A2
WO2012128520A2 PCT/KR2012/001949 KR2012001949W WO2012128520A2 WO 2012128520 A2 WO2012128520 A2 WO 2012128520A2 KR 2012001949 W KR2012001949 W KR 2012001949W WO 2012128520 A2 WO2012128520 A2 WO 2012128520A2
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WO
WIPO (PCT)
Prior art keywords
liquid composition
alginate
acid
cellulose
gel strength
Prior art date
Application number
PCT/KR2012/001949
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English (en)
Korean (ko)
Other versions
WO2012128520A3 (fr
Inventor
김정훈
진성규
강경훈
김보견
이혜주
Original Assignee
동아제약 주식회사
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 동아제약 주식회사 filed Critical 동아제약 주식회사
Publication of WO2012128520A2 publication Critical patent/WO2012128520A2/fr
Publication of WO2012128520A3 publication Critical patent/WO2012128520A3/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

Definitions

  • the present invention relates to a low viscosity liquid type oral administration composition for use in the treatment of gastroesophageal reflux disease by forming a floating gel in the stomach.
  • Gastroesophageal reflux disease is a condition in which complications of gastroesophageal disease are caused by gastric contents refluxed into the esophagus. Among these, morphological changes such as ulcers and erosions in the esophagus due to reflux are called reflux esophagitis or erosive esophagitis. The most important pathogenesis of gastroesophageal reflux disease is believed to be due to temporary relaxation of the lower esophageal sphincter (LES), in addition to anatomical defects such as esophageal hernia and low pressure of the lower esophageal sphincter. Etc. may be the cause. Typical symptoms of gastroesophageal reflux disease are heartburn and acid reflux symptoms, which usually occur after a large amount of food or in lying down.
  • LES lower esophageal sphincter
  • Etc. may be the cause.
  • Typical symptoms of gastroesophageal reflux disease are heartburn and acid
  • Gastroesophageal reflux disease is a chronic disease, and the symptoms often return when treatment is stopped or the dose of the drug is reduced, requiring continuous treatment.
  • the most known effective treatment for gastroesophageal reflux disease is to reduce gastric acid secretion with histamine H2 receptor antagonists or proton pump inhibitors.
  • the dosage of the drug is determined by the extent of the disease and symptoms, and the goal of drug administration is to raise the acidity in the stomach above pH 4 during the daytime when reflux occurs frequently. The greater the degree of pathological gastric acid exposure in the esophagus, the stronger the method of gastric acid suppression is needed.
  • the treatment can not only prevent reflux but also prevent reflux disease. Rather, due to lack of gastric acid, diarrhea caused by infection with C. difficile bacteria in the stomach, decreased digestive function, increased fracture incidence, Side effects such as elevations, headaches, dermatitis and hypersensitivity have been reported.
  • Another treatment method for gastroesophageal reflux disease is to contact gastric acid to form a raft gel in the stomach to prevent backflow of the gastric contents first, and secondly, the floating gel reflux before the gastric contents.
  • British Patent No. 1,524,740 discloses preparations containing alginic acid, sodium bicarbonate and calcium carbonate and are commercially available as Gaviscon (TM Reckitt & Colman Product Ltd.).
  • the formulation relieves gastroesophageal reflux disease by allowing low viscosity alginic acid to form crosslinks with calcium, the polyvalent metal ion, in the stomach and by floating the alginate gel with carbonic acid produced from sodium bicarbonate and calcium carbonate.
  • British Patent No. 2,298,365 discloses a flowable liquid composition comprising at least 8% sodium alginate which can solve the above problem.
  • US Pat. No. 4,744,986 discloses an aqueous antacid composition having a stable viscosity, which may consist of an antacid substance and an alginate and may comprise magnesium carbonate.
  • the prior arts are inconvenient for swallowing because they are all suspension gel compositions having a certain viscosity or more. That is, when a polyvalent metal cation is present in the formulation, it gels immediately upon reaction with alginic acid and does not dissolve in the formulation. Therefore, in the prior art, insoluble salts having the property of liberating a polyvalent metal cation under acidic conditions such as the stomach environment are used together. However, these insoluble salts increase the physical strength of the alginic acid gel in the stomach, but are inconvenient in the formulation, and are inevitably made of a formulation having a high viscosity to prevent precipitation of the suspended substance, which is very inconvenient for patients to take medicine. Do.
  • the formulation prepared in the prior art may have a low storage stability because the suspended gelled material is separated into gel and water under high pressure or high temperature.
  • the problem of the prior art as described above is due to the fact that all are due to the suspension gel composition having a high viscosity, the present inventors while studying a formulation that can solve the problem of the prior art enteric polymers, polysaccharides and cellulose derivatives
  • the formulation is excellent in convenience of medication and easy to manufacture the formulation. It was.
  • the present invention provides a composition for the treatment of gastroesophageal reflux disease, a low viscosity liquid type oral administration composition which is excellent in the convenience of medication, good storage stability, and can be easily prepared without adding an excess of a synthetic preservative. It aims to do it.
  • the present invention provides a low viscosity liquid composition in a completely dissolved form, rather than a suspension gel composition having a high viscosity as in the prior art.
  • the present invention relates to a gel strength enhancer which can maintain a low viscosity liquid composition in a dissolved form and improve gel strength in a pharmaceutical composition for treating gastroesophageal reflux disease containing alginic acid or alginate.
  • Gel strength enhancer in the present invention means that it is possible to improve the gel strength while maintaining a low-viscosity liquid composition dissolved in the composition for treating gastroesophageal reflux disease containing alginic acid or alginate, the gel according to the present invention
  • Strength enhancers are selected from enteric polymers, polysaccharides and cellulose derivatives.
  • the enteric polymers of the present invention are purified shellac, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose acetate succinate, methacrylate polymer, acrylate copolymer, acrylic acid / methacrylic acid copolymer, methacrylic acid / methacryl Acid methyl copolymer, polysaccharides are xanthan gum, guar gum, gum arabic, maltodextrin, pectin, cellulose derivatives are carboxymethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose.
  • Alginic acid meets stomach acid to form a gel, but its strength is not strong.
  • a method of crosslinking alginic acid, which is a water-soluble polymer, by a polyvalent metal cation is known as a method for forming an alginic acid gel having high physical strength.
  • the method can increase the physical strength of alginic acid by crosslinking alginic acid with a polyvalent metal cation, but the formulation composition is present in suspension and is not suitable for liquid formulations.
  • insoluble salts having the property of releasing polyvalent metal cations under acidic conditions, such as the stomach environment, are used together.
  • these insoluble salts increase the physical strength of the alginic acid gel in the stomach, but are present in the form of a suspension, which is inevitably prepared to have a high viscosity to prevent precipitation of the suspension.
  • a water-soluble substance for improving the gel strength of alginic acid is not known.
  • the gel strength forming agent according to the present invention it is possible to prepare a low viscosity liquid composition in a completely dissolved form, unlike the prior art.
  • the present invention also relates to a low viscosity liquid composition in a fully dissolved form containing alginic acid or alginate, an alkali metal bicarbonate or an alkali metal carbonate and the gel strength enhancer as a low viscosity liquid composition in a fully dissolved form.
  • Alginic acid or alginate according to the present invention has a content of 2 to 20% based on the total weight of the composition, and exhibits a low viscosity having a viscosity of 1000 mPa ⁇ s or less.
  • Alginate in the present invention means sodium alginate, magnesium alginate, potassium alginate, triethanolamine alginate or propylene glycol monoyl acid.
  • Alginic acid is a viscous natural polysaccharide obtained from natural algae, composed of carbon, hydrogen, and oxygen, and has a molecular weight ranging from 10,000 to 600,000, and is composed of (1,4) ⁇ -Mannuronate and (1,4) ⁇ -L-Gluronate. It consists of a continuous chain and has different physical properties depending on the nature of their arrangement. Alginic acid or alginate is soluble in water and its physical properties vary depending on pH, which is characterized by selective gel formation at pH below 3.5.
  • the alginic acid or alginate salt of the present invention is present in the liquid phase in the composition, and when taken, passes through the esophagus to reach the stomach and then meets stomach acid in the stomach to form a gel.
  • the alkali metal bicarbonate or alkali metal carbonate according to the present invention is present in an amount of 1 to 10% of the total weight of the composition of the present invention.
  • Examples of the alkali metal bicarbonate in the present invention include sodium bicarbonate, potassium bicarbonate, and the like. Examples include sodium carbonate and potassium carbonate, and one or more other alkali metal bicarbonates or alkali metal carbonates may be used.
  • the alkali metal bicarbonate or alkali metal carbonate of the present invention is used for the purpose of generating a gas for suspending the gel produced from alginic acid. That is, the gel is suspended by reacting with gastric acid to generate carbon dioxide gas so that the carbon dioxide gas is not captured by the alginic acid gel and escapes.
  • a liquid composition containing alginic acid or alginate, an alkali metal bicarbonate or an alkali metal carbonate may be prepared in a low viscosity liquid composition in a completely dissolved form unlike the conventional art by adding the gel strength enhancer.
  • the present invention is complicated by the high viscosity of the manufacturing method, difficult to sterilization process, and can solve the problems of the prior art, which is less convenient for the patient's medication, as well as good storage stability, without adding an excessive amount of synthetic preservatives Formulations can be readily prepared.
  • the liquid composition for oral administration according to the present invention may be a syrup, a liquid solution, a lemonade agent, an elixyl agent, and the like, and most preferably a liquid solution.
  • liquid composition for oral administration may include one or more pharmaceutically acceptable solvents or additives, and according to a specific form, a surfactant which is a conventional additive used in the preparation of oral formulations. It may further contain, but is not limited to, dissolution aids, pH regulators, buffers, viscosity regulators, sweeteners, preservatives, flavoring agents and the like.
  • Surfactants used in the present invention include, for example, polyoxyl 40 hardened castor oil, polyoxyethylene nonylphenyl ether, polysorbate, poloxamer, sodium lauryl sulfate, sorbitan oleate, sorbitan stearate.
  • Solubilizing agents include, for example, propylene glycol, polyethylene glycol, purified water, ethanol, glycerin.
  • pH adjusting agents include, for example, sodium acetate, sodium chloride, sodium hydroxide, sodium hydrogen phosphate.
  • Buffers include, for example, sodium bicarbonate, potassium dihydrogen phosphate, sodium dihydrogen phosphate, tromethamine.
  • Viscosity modifiers include, for example, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, sodium polyacrylate, polyvinyl alcohol, povidone, carbomer, methylcellulose, povidone.
  • Sweetening agents include stevia, stevioside, polydextrose, refined white sugar, xylitol, erythritol, liquid fructose, aspartame, acesulfame, sorbitol, saccharin, sucralose, fructose, licorice extract.
  • Preservatives propyl paraoxybenzoate, methyl paraoxybenzoate, paraoxybenzoic acid, butyl paraoxybenzoate, chlorocresol, chlorhexidine acetate, benzalkonium chloride, sodium benzoate, sorbic acid, sodium dihydroacetate, butylated hydroxyanidine Includes a brush.
  • the liquid composition according to the present invention provides a gastroesophageal reflux disease treatment formulation that forms a floating gel in the stomach in a low viscosity liquid type.
  • the present invention can improve the discomfort when taking compared to the prior art, which is a high viscosity suspension agent, and problems such as the quality control and the increase in the manufacturing cost which may occur due to the manufacturing process, which is difficult to fill the correct amount due to the characteristics of the high viscosity suspension.
  • problems such as the quality control and the increase in the manufacturing cost which may occur due to the manufacturing process, which is difficult to fill the correct amount due to the characteristics of the high viscosity suspension.
  • an excess amount of synthetic preservatives must be used because a separate sterilization process cannot be applied when preparing the suspension, and the liquid composition can reduce the use of synthetic preservatives by allowing a filter and a high temperature sterilization process. . Reducing the use of synthetic preservatives can reduce side effects such as allergic reactions.
  • 1 is a graph showing the difference between the viscosity of the liquid composition according to the present invention and the viscosity of a commercial product.
  • the Gaviscon peppermint suspension which is currently commercially available in Korea was purchased and evaluated as Comparative Example 1.
  • the composition and content indicated on the product of Comparative Example 1 are as follows.
  • the viscosity of the formulation was measured at 50 rpm using a Brookfield viscometer equipped with No. 6 Spindle for Examples 4, 8-22 and Comparative Example 1, and is shown in Table 7 and FIG. 1.
  • the commercial gabiscon peppermint suspension of Comparative Example 1 had a viscosity value of 2430 cps.
  • the examples according to the present invention showed a viscosity of 20 times lower than the commercial product of Comparative Example 1.
  • Comparative Example 1 since calcium carbonate is suspended in the formulation, in order to prevent calcium carbonate from settling due to aggregation or the like, a viscosity other than alginic acid should be used to increase the viscosity.
  • the high viscosity of the formulation leads to an increase in the manufacturing time and the manufacturing cost, for example, because the mixing time is long during the manufacturing process and it is difficult to fill the correct amount.
  • the suspension as in Comparative Example 1 has a disadvantage in that it is difficult to attempt a sterilization process such as filtration due to the high viscosity, so a large amount of synthetic preservative should be used.
  • Comparative Example 1 contains 0.46% of a synthetic preservative in the suspension, and when taken, it is difficult to drink at one time, must be eaten by hand squeezing, there is inconvenience such as foreign body in the mouth.
  • the embodiments according to the present invention can be seen that the manufacturing method is simple due to the low viscosity of the liquid composition, sterilization process through filtration, etc., is easy for patients to take.
  • Example and commercially available Comparative Example 1 according to the present invention was stored in a 40 ° C and 60 ° C chamber for 4 weeks, and then the properties of the formulations were visually evaluated. The evaluation results are summarized in Table 8 below.
  • phase separation did not occur in all of the stability evaluation stored in the 40 °C and 60 °C chamber for 4 weeks, Comparative Example 1, although the phase separation did not occur in the 40 °C chamber, precipitated material precipitated in the 60 °C chamber Phase separation phenomenon appeared.
  • the phase separation occurs due to the suspension composition, the uniformity of the formulation is poor, and it is difficult for the patient to take the correct amount when taking the drug, but the present invention can maintain a homogeneous state without phase separation phenomenon even at a high temperature. It can be seen that the stability is excellent.
  • the amount of gas generating material is very important in the liquid composition of the present invention because the floating force in the artificial gastric fluid can prevent the backflow of the actual gastric fluid due to the nature of the preparation.
  • the present invention can be confirmed that even if a low-viscosity liquid composition containing a gel strength enhancer in the completely dissolved form has a floating force equivalent to or more than a commercially available product.
  • Gel strength refers to the strength of the physical barrier that can prevent gastric juice from flowing back into the esophagus in the gastrointestinal tract.
  • the British Pharmacopoeia sets the standard for strength of suspended gels in the Alginate Raft-forming Oral Suspension category to more than 7.5g.
  • Table 10 shows the floating capacity and the maximum gel strength of the Examples and Comparative Example 1 according to the present invention.
  • the maximum gel strength was evaluated using a texture analyzer, 200ml of artificial gastric juice (pH 1.2) was added to the beaker, and maintained at 37 ° C., followed by 20ml of the preparation, and a floating gel was formed for 30 minutes.
  • the texture analyzer was measured for 30mm at the speed of 1mm / s in tension mode and stored 50 times per second.
  • Comparative Example 1 is to improve the strength of the gel using a polyvalent metal cation, showing a high viscosity, but the present invention improved the strength of the floating gel by using a gel strength enhancer to improve the gel strength of alginic acid It can be seen.
  • the present invention provides a low-viscosity liquid composition in a completely dissolved form, unlike the prior art, complicated manufacturing method due to high viscosity, difficulty in sterilization process, and solves the problems of the prior art in which the patient's medication convenience is also poor.
  • the storage stability is good, and the preparation can be easily prepared without adding an excess of a synthetic preservative.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Cette invention concerne une nouvelle composition permettant de traiter le reflux gastro-œsophagien. La composition liquide de l'invention est administrée par voie orale, sa faible viscosité permet au patient de l'avaler facilement, son procédé de fabrication est simple, elle est facile à stériliser et traite avec efficacité le reflux gastro‑œsophagien en produisant un gel flottant de résistance structurelle supérieure.
PCT/KR2012/001949 2011-03-23 2012-03-19 Composition liquide utilisée pour traiter le reflux gastro-œsophagien WO2012128520A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2011-0025860 2011-03-23
KR1020110025860A KR20120108218A (ko) 2011-03-23 2011-03-23 위식도 역류질환 치료용 액상 타입 조성물

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WO2012128520A2 true WO2012128520A2 (fr) 2012-09-27
WO2012128520A3 WO2012128520A3 (fr) 2012-11-15

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024030936A1 (fr) 2022-08-02 2024-02-08 Nutrition & Biosciences Usa 1, Llc Composition à base d'alginate à libération modifiée
WO2024030933A1 (fr) 2022-08-02 2024-02-08 Nutrition & Biosciences Usa 1, Llc Nouvelle composition à base d'alginate et de dérivé de cellulose de la formulation anti-reflux liquide

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20160036005A (ko) * 2014-09-24 2016-04-01 주식회사태준제약 알긴산 또는 알긴산 염 및 감초 추출물을 포함하는 위장관 질환 치료용 조성물
KR102309593B1 (ko) * 2019-06-26 2021-10-07 재단법인 강릉과학산업진흥원 알긴산 나트륨을 주성분으로 함유한 위건강용 기능성 음료 조성물 및 이의 제조 방법

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4744986A (en) * 1986-03-07 1988-05-17 Rorer Pharmaceutical Corporation Process for the preparation of a viscosity-stable antacid composition
WO1996027368A1 (fr) * 1995-03-03 1996-09-12 Reckitt & Colman Products Limited Compositions pharmaceutiques liquides aqueuses contenant de l'alginate de sodium et du bicarbonate de potassium
US20050089577A1 (en) * 2002-03-04 2005-04-28 Hideakira Yokoyama Liquid matrix undergoing phase transfer in vivo and liquid oral preparations
US20080317855A1 (en) * 2005-07-28 2008-12-25 Reckitt Benckiser Healtcare (Uk) Limited, Particulate Compositions Comprising Alginate and/or Alginic Acid

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4744986A (en) * 1986-03-07 1988-05-17 Rorer Pharmaceutical Corporation Process for the preparation of a viscosity-stable antacid composition
WO1996027368A1 (fr) * 1995-03-03 1996-09-12 Reckitt & Colman Products Limited Compositions pharmaceutiques liquides aqueuses contenant de l'alginate de sodium et du bicarbonate de potassium
US20050089577A1 (en) * 2002-03-04 2005-04-28 Hideakira Yokoyama Liquid matrix undergoing phase transfer in vivo and liquid oral preparations
US20080317855A1 (en) * 2005-07-28 2008-12-25 Reckitt Benckiser Healtcare (Uk) Limited, Particulate Compositions Comprising Alginate and/or Alginic Acid

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024030936A1 (fr) 2022-08-02 2024-02-08 Nutrition & Biosciences Usa 1, Llc Composition à base d'alginate à libération modifiée
WO2024030933A1 (fr) 2022-08-02 2024-02-08 Nutrition & Biosciences Usa 1, Llc Nouvelle composition à base d'alginate et de dérivé de cellulose de la formulation anti-reflux liquide

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WO2012128520A3 (fr) 2012-11-15
KR20120108218A (ko) 2012-10-05

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