EP3548040A1 - Composition orale pour le traitement du reflux gastro-oesophagien et du reflux pharyngo-laryngé - Google Patents

Composition orale pour le traitement du reflux gastro-oesophagien et du reflux pharyngo-laryngé

Info

Publication number
EP3548040A1
EP3548040A1 EP17817880.2A EP17817880A EP3548040A1 EP 3548040 A1 EP3548040 A1 EP 3548040A1 EP 17817880 A EP17817880 A EP 17817880A EP 3548040 A1 EP3548040 A1 EP 3548040A1
Authority
EP
European Patent Office
Prior art keywords
composition
salt
active component
alginic acid
reflux
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.)
Pending
Application number
EP17817880.2A
Other languages
German (de)
English (en)
Inventor
Nicola DI TRAPANI
Francesco Palladini
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.)
Nekkar Lab SRL
Original Assignee
Nekkar Lab SRL
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 Nekkar Lab SRL filed Critical Nekkar Lab SRL
Publication of EP3548040A1 publication Critical patent/EP3548040A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728Hyaluronic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726Glycosaminoglycans, i.e. mucopolysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734Alginic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Definitions

  • the present invention relates to a composition
  • a composition comprising at least one salt of alginic acid, hyaluronic acid, a natural molecule, and thickening agents.
  • Said composition has been demonstrated to effectively counteract the discomfort caused by gastroesophageal reflux and laryngopharyngeal reflux, preventing said reflux and alleviating the effects thereof on the mucosa. Indeed, the composition can also play an active role in the regeneration of tissue damaged by previous reflux.
  • the object of the present invention is therefore to offer a practical and effective remedy, which is also well tolerated by patients, for the treatment of gastroesophageal reflux and disorders associated therewith.
  • the present invention relates to a process for preparing the composition. In another aspect, the present invention relates to the use of said composition in the treatment of gastroesophageal reflux and laryngopharyngeal reflux.
  • composition according to the invention has surprisingly shown reparative and regenerative properties with respect to said mucosa, in addition to mucoadhesive and filmogenic characteristics which increase contact time with said mucosa and, consequently, effectiveness.
  • the invention relates to a composition
  • a composition comprising:
  • an active component comprising:
  • - hyaluronic acid or a salt thereof said salt being selected from sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, and mixtures thereof,
  • glycosaminoglycan selected from glycosaminoglycan, glycoprotein, keratin, collagen, and mixtures thereof, and
  • said at least one salt of alginic acid and active component are in a weight ratio of 1: 1 to 1: 15.
  • composition of the invention offers advantageous reparative and regenerative properties with respect to the mucosa, with consequent rapid relief from symptoms, featuring, at the same time, significant rheological characteristics both in terms of transit and in terms of mucoadhesive properties of the components thereof, with a direct causality between contact time and efficacy.
  • composition of the invention therefore benefits from the association of the salt of alginic acid and the active component, i.e. from the mucoadhesive, regenerating and filmogenic characteristics, as well as from the important conveyance of water, hyaluronic acid or the salt thereof, strengthened by the presence of the natural molecule, in synergy with the salt of alginic acid.
  • the efficacy of the association is enhanced and optimised by the contemporaneous presence of at least one thickening agent, which has proper affinity with the proteins of the gastroesophageal mucosa.
  • This allows the composition of the invention to form a film on the surface of the mucosa, thus increasing contact times and therefore supporting the protective and regenerative effect.
  • the presence of at least one salt of alginic acid maximises the effects of the active component.
  • the salt of alginic acid reacts with the gastric acids, releasing alginic acid, which gels in the presence of water.
  • the resulting gel tends to obstruct reflux of the contents of the stomach into the oesophagus.
  • said gel is a floating gel which forms what is known as a "raft" on the surface of the gastric contents, i.e. a "stopper" at the lower oesophageal sphincter level, which acts as a kind of neutral insulator that occupies the oesophageal space when the pressure wave pushes the gastric contents towards the oesophagus.
  • the result is that gastric material is physically prevented from back-flowing into the oesophagus.
  • the salt of alginic acid maintains such properties, without altering the stability, solubility, and rheological properties of the composition. Therefore, one observes a synergy between the action of the active component and the action of the salt of alginic acid, since the latter shields the gastric reflux, while also offering the advantage of longer contact time between the active component and the mucosa to be regenerated.
  • Said salt of alginic acid is preferably sodium alginate, potassium alginate, calcium alginate, magnesium alginate, ammonium alginate, propylene glycol alginate, or a mixture thereof.
  • said salt of alginic acid is magnesium alginate.
  • said active component is present in an amount greater than said at least one salt of alginic acid. More preferably, said at least one salt of alginic acid and active component are in a weight ratio of 1:2 to 1: 10, and even more preferably of 1:3 to 1:8.
  • the composition of the invention has a pH of 6-8, preferably 6.5- 7.5, once dissolved in water.
  • the composition of the invention further comprises water and has a pH of 6-8. More preferably, the composition of the invention further comprises water and has a pH of 6.5-7.5.
  • said at least one salt of alginic acid is in a concentration of 0.1-1.0 wt% more preferably 0.2-0.5 wt%, on the weight of the composition.
  • said active component is in a concentration of 0.1-10 wt%, more preferably 0.2-5 wt%, on the weight of the composition.
  • said hyaluronic acid or a salt thereof has a molecular weight of 100 kDa- 1,500 kDa.
  • the composition of the invention comprises sodium hyaluronate.
  • Said natural molecule is selected from glycosaminoglycan, glycoprotein, keratin, collagen, and mixtures thereof.
  • 'Glycosaminoglycan' is understood as meaning chondroitin sulphate, dermatan sulphate, keratan sulphate, heparin, heparan sulphate or a mixture thereof.
  • 'Glycoprotein' is understood as meaning mucoprotein, integrin, fibronectin, laminin, vitronectin, thrombospondin, tenascin, entactin, nephronectin, fibrinogen, undulin, or a mixture thereof.
  • the natural molecule in the composition of the present invention is natural because such molecule consists of components which are found naturally in the extracellular matrix and therefore offers complete biocompatibility in addition to playing an active role in hydrating and regenerating damaged tissues.
  • Said natural molecule preferably is keratin, and more preferably hydrolysed keratin.
  • hydrolysed keratin noticeably increases the regeneration process of desmosomes, of which it is a fundamental component, providing a significant boost to the regeneration process in the event of any lesions of the mucosa triggered by hyaluronic acid or salt thereof and acting directly on the extracellular matrix.
  • said hyaluronic acid or salt thereof and natural molecule are in a weight ratio of 3: 1 to 1:3.
  • said hyaluronic acid or salt thereof and natural molecule are in a weight ratio of 2: 1 to 1:2.
  • Particularly preferable are the compositions in which said hyaluronic acid or salt thereof and natural molecule are in a weight ratio of about 1: 1.
  • said at least one thickening agent and hyaluronic acid or salt thereof are in a weight ratio of 4: 1 to 12: 1. More preferably, said at least one thickening agent and hyaluronic acid or salt thereof are in a weight ratio of 6: 1 to 10: 1.
  • Particularly preferable are the compositions in which said at least one thickening agent and hyaluronic acid or salt thereof are in a weight ratio of 8: 1 to 9:1.
  • said at least one thickening agent and natural molecule are in a weight ratio of 4: 1 to 12: 1. More preferably, said at least one thickening agent and natural molecule are in a weight ratio of 6: 1 to 10: 1. Particularly preferable are the compositions in which said at least one thickening agent and natural molecule are in a weight ratio of 8 : 1 to 9 : 1.
  • said hyaluronic acid or salt thereof is in a concentration of up to 0.5 wt% based on the active component weight, and more preferably up to 0.3 wt%.
  • Particularly preferable are compositions in which said hyaluronic acid or salt thereof is in a concentration of 0.05-0.2 wt% based on the active component weight.
  • said natural molecule is in a concentration of up to 0.5 wt% based on the active component weight, and more preferably up to 0.3 wt%.
  • Particularly preferable are compositions in which said natural molecule is in a concentration of 0.05-0.2 wt% based on the active component weight.
  • said at least one thickening agent is in a concentration of up to 5 wt% based on the active component weight, and more preferably up to 2.5 wt%.
  • Particularly preferable are compositions in which said at least one thickening agent is in a concentration of 0.5-1.5 wt% based on the active component weight.
  • said at least one thickening agent is xanthan gum, guar gum, tara gum, locust bean gum, fenugreek gum, arabic gum, calcium carboxymethylcellulose, sodium carboxymethylcellulose, ethyl cellulose, gelatin, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polydextrose, carrageenan, methylcellulose, sucrose, sorbitol, xylitol, dextrose, fructose, maltitol, tragacanth gum, pectin, agar-agar, carboxypolymethylene, hydroxypropyl methylcellulose, or a mixture thereof.
  • said at least one thickening agent is xanthan gum, guar gum, tara gum, locust bean gum, fenugreek gum, arabic gum, tragacanth gum, carrageenan or a mixture thereof.
  • Said agents are natural gums, which, due to the chemical characteristics thereof, have a high affinity with the proteins of the gastroesophageal mucosa.
  • the composition of the invention further comprises a mixture of xanthan gum and tara gum.
  • this mixture offers an optimal combination of advantageous aspects, including adequate oesophageal transit time, which is actually comparable to that of a simple food bolus, adequate formation of film on the mucosa, and, contemporaneously, easy swallowability by the patient.
  • the composition of the invention comprises:
  • composition of the invention comprises:
  • said active component comprises:
  • said active component comprises:
  • composition of the invention may also comprise pharmaceutically acceptable excipients, such as antioxidants, tonicity regulators, preservatives, flavourings, sweeteners, thinners, glidants, colourings, binders, adsorbents, release retardants, and mixtures thereof.
  • pharmaceutically acceptable excipients such as antioxidants, tonicity regulators, preservatives, flavourings, sweeteners, thinners, glidants, colourings, binders, adsorbents, release retardants, and mixtures thereof.
  • Suitable excipients may be potassium sorbate, sodium benzoate, ⁇ -polylysine, sucralose, maltodextrin, magnesium carbonate, magnesium stearate, natural starch, partially hydrolysed starch, lactose, calcium phosphate, calcium carbonate, calcium sulphate, polyvinylpyrrolidone, silica, colloidal silica, precipitated silica, magnesium silicates, aluminium silicates, sodium lauryl sulphate, magnesium lauryl sulphate, methacrylate copolymers, sodium dehydroacetate, and mixtures thereof.
  • the composition of the invention consists essentially of (i) at least one salt of alginic acid, and (ii) one active component comprising:
  • - hyaluronic acid or a salt thereof said salt being selected from sodium hyaluronate, potassium hyaluronate, calcium hyaluronate, and mixtures thereof,
  • glycosaminoglycan selected from glycosaminoglycan, glycoprotein, keratin, collagen, and mixtures thereof, and
  • At least one salt of alginic acid and active component are in a weight ratio of 1: 1 to 1: 15.
  • the expression " consists essentially of” means that at least one salt of alginic acid, hyaluronic acid or salt thereof and natural molecule are the only active ingredients for treatment of the gastroesophageal reflux present in the composition, while any other components or excipients do not interfere with the action thereof, and are water-miscible and water-soluble.
  • composition of the invention consists of water (i) at least one salt of alginic acid, and (ii) one active component comprising:
  • glycosaminoglycan selected from glycosaminoglycan, glycoprotein, keratin, collagen, and mixtures thereof, and
  • said at least one salt of alginic acid and active component are in a weight ratio of 1: 1 to 1: 15.
  • composition of the invention can be in the form of a unit dose.
  • said unit dose comprises:
  • said unit dose comprises:
  • the active component comprises: - up to 50 mg of hyaluronic acid or salt thereof,
  • said unit dose comprises:
  • said unit dose comprises:
  • unit doses comprising:
  • composition of the present invention may be prepared using methods known in the art.
  • the present invention therefore also concerns a process for the preparation of the composition of the invention, comprising the steps of: i) dissolving said hyaluronic acid or salt thereof in water,
  • step i) the hyaluronic acid or salt thereof is stirred for at least five minutes at a temperature no higher than 40°C. More preferably, step i) is carried out under vacuum.
  • step ii) is carried out under vacuum.
  • step iii) is carried out under vacuum.
  • step iv) is carried out under vacuum.
  • the present invention relates to the use of the composition described above in the treatment of gastroesophageal reflux and laryngopharyngeal reflux.
  • the composition of the invention offers advantageous reparative and regenerative properties with respect to the mucosa, with consequent rapid relief from symptoms, featuring, at the same time, significant rheological characteristics both in terms of transit and in terms of mucoadhesive properties of the components thereof, with a direct causality between contact time and efficacy.
  • composition of the invention therefore benefits from the association of the salt of alginic acid and the active component, i.e. from the mucoadhesive, regenerating and filmogenic characteristics, as well as from the important conveyance of water, hyaluronic acid or the salt thereof, strengthened by the presence of the natural molecule, in synergy with the salt of alginic acid.
  • the efficacy of the association is enhanced and optimised by the contemporaneous presence of at least one thickening agent, which has proper affinity with the proteins of the gastroesophageal mucosa.
  • This allows the composition of the invention to form a film on the surface of the mucosa, thus increasing contact times and therefore supporting the protective and regenerative effect. Therefore, a synergy was observed between the action of the active component and the action of the salt of alginic acid, since the latter shields the gastric reflux, while also offering the advantage of longer contact time between the active component and the mucosa to be regenerated.
  • composition of the invention is not only efficacious in the treatment of gastroesophageal reflux, but also of disorders associated therewith which also affect the otorhinolaryngological, pharyngeal, and pneumological systems, including the oropharynx, nasopharynx, the middle ear, the nasal/sinusoidal cavities, and even the conjunctival mucosa.
  • Etiological agents include hydrochloric acid and (more predominantly) pepsin, which - since located in an environment other than the gastroesophageal environment - cause significant changes in the mucosa of the upper airways, which are responsible for symptoms such as: pyrosis, epigastralgia, hiccups, acid regurgitation, retrosternal pain, dysphonia, foreign body sensation, excess mucus in the pharynx, coughing, oropharyngeal burning, laryngeal spasms, odynophagia, halitosis, dyspnoea, rhinorrhea, nasal obstruction, ear fullness, through to conjunctival burning, and lacrimation.
  • hydrochloric acid and (more predominantly) pepsin which - since located in an environment other than the gastroesophageal environment - cause significant changes in the mucosa of the upper airways, which are responsible for symptoms such as: pyrosis, epigastralgia
  • composition of the invention has a biological polyvalence which ranges from modulation of the inflammatory process both directly (by inhibiting GER) and indirectly, i.e. by acting - in association with the properties of the hyaluronic acid or salt thereof - to modulation of the mucosa re-epithelisation process, through the action of the natural molecule and the hyaluronic acid or salt thereof.
  • composition of the invention does not interfere with the action of antisecretory drugs (known as 'proton pump inhibitors' or PPIs) and can therefore be administered contemporaneously therewith.
  • antisecretory drugs known as 'proton pump inhibitors' or PPIs
  • composition of the invention is administered orally.
  • composition of the invention is provided in a single-dose form of 1- 50 ml, more preferably 5-30 ml, and even more preferably 7-20 ml.
  • composition was prepared: % w/w mg
  • composition stated above was marked with methylene blue and orally administered to patients.
  • the methylene blue allows to follow the movement of the composition along the gastroesophageal mucosa by means of endoscopic viewing and, for two minutes, the presence of the composition was observed at the upper third, middle and lower level of the oesophagus, in addition to the gastric cavity.
  • composition stated above was marked with methylene blue and orally administered to patients.
  • the methylene blue allows to follow the movement of the composition along the gastroesophageal mucosa by means of endoscopic viewing and, for two minutes, the presence of the composition was observed at the upper third, middle and lower level of the oesophagus, in addition to the gastric cavity.
  • Example 3 The following composition was prepared:
  • composition stated above was marked with methylene blue and orally administered to patients.
  • the methylene blue allows to follow the movement of the composition along the gastroesophageal mucosa by means of endoscopic viewing and, for two minutes, the presence of the composition was observed at the upper third, middle and lower level of the oesophagus, in addition to the gastric cavity.
  • composition stated above was marked with methylene blue and orally administered to patients.
  • the methylene blue allows to follow the movement of the composition along the gastroesophageal mucosa by means of endoscopic viewing and, for two minutes, the presence of the composition was observed at the upper third, middle and lower level of the oesophagus, in addition to the gastric cavity.
  • composition stated above was marked with methylene blue and orally administered to patients.
  • the methylene blue allows to follow the movement of the composition along the gastroesophageal mucosa by means of endoscopic viewing and, for two minutes, the presence of the composition was observed at the upper third, middle and lower level of the oesophagus, in addition to the gastric cavity.

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

Abstract

La présente invention concerne une composition comprenant au moins un sel de l'acide alginique, de l'acide hyaluronique, une molécule naturelle et des agents épaississants. Ladite composition a été démontrée pour contrer efficacement l'inconfort provoqué par le reflux gastro-oesophagien, empêcher ledit reflux et soulager les effets de celui-ci sur la muqueuse. En effet, la composition peut également jouer un rôle actif dans la régénération de tissu endommagé par un reflux précédent.
EP17817880.2A 2016-11-30 2017-11-21 Composition orale pour le traitement du reflux gastro-oesophagien et du reflux pharyngo-laryngé Pending EP3548040A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102016000121601A IT201600121601A1 (it) 2016-11-30 2016-11-30 Composizione orale per il trattamento del reflusso gastroesofageo e del reflusso laringo-faringeo
PCT/IB2017/057291 WO2018100468A1 (fr) 2016-11-30 2017-11-21 Composition orale pour le traitement du reflux gastro-oesophagien et du reflux pharyngo-laryngé

Publications (1)

Publication Number Publication Date
EP3548040A1 true EP3548040A1 (fr) 2019-10-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP17817880.2A Pending EP3548040A1 (fr) 2016-11-30 2017-11-21 Composition orale pour le traitement du reflux gastro-oesophagien et du reflux pharyngo-laryngé

Country Status (3)

Country Link
EP (1) EP3548040A1 (fr)
IT (1) IT201600121601A1 (fr)
WO (1) WO2018100468A1 (fr)

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IT201700057635A1 (it) * 2017-05-26 2018-11-26 Drugs Minerals And Generics Italia S R L In Forma Abbreviata D M G Italia S R L Composizione per uso nel trattamento dei sintomi extra-esofagei del reflusso gastrico
IT201800007771A1 (it) * 2018-08-02 2020-02-02 Drugs Minerals And Generics Italia Srl In Forma Abbreviata Dmg Italia Srl Combinazione per uso nel trattamento dei sintomi extra-esofagei del reflusso gastrico
CN110353271B (zh) * 2019-06-13 2022-07-22 陕西科技大学 一种抑制食道反流的特殊医学食品增稠组件及其制备方法
IT202000016531A1 (it) * 2020-07-08 2022-01-08 Italian Devices S R L Composizioni mucoadesive e filmogene
IT202000031433A1 (it) * 2020-12-18 2022-06-18 Drugs Minerals And Generics Italia S R L In Forma Abbreviata D M G Italia S R L Composizioni comprendenti saccarosio octasolfato per il trattamento del reflusso gastrico
IT202000031421A1 (it) * 2020-12-18 2022-06-18 Drugs Minerals And Generics Italia S R L In Forma Abbreviata D M G Italia S R L Composizione multicomponente comprendente saccarosio solfato o suoi derivati per il trattamento del reflusso gastrico
WO2022130359A1 (fr) * 2020-12-18 2022-06-23 Drugs Minerals And Generics Italia S.R.L. In Forma Abbreviata D.M.G. Italia S.R.L. Composition à composants multiples comprenant du sulfate de saccharose, de l'alginate, de la gomme gellane pour le traitement du reflux gastrique
IT202100011879A1 (it) * 2021-05-10 2022-11-10 Aurora Biofarma S R L Composizione orale per il trattamento delle esofagiti

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