WO2016062624A1 - Adhésif pour prothèse dentaire - Google Patents

Adhésif pour prothèse dentaire Download PDF

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Publication number
WO2016062624A1
WO2016062624A1 PCT/EP2015/073982 EP2015073982W WO2016062624A1 WO 2016062624 A1 WO2016062624 A1 WO 2016062624A1 EP 2015073982 W EP2015073982 W EP 2015073982W WO 2016062624 A1 WO2016062624 A1 WO 2016062624A1
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WO
WIPO (PCT)
Prior art keywords
denture
denture adhesive
gum
polymer
composition
Prior art date
Application number
PCT/EP2015/073982
Other languages
English (en)
Inventor
Prasad Sathyavara ADUSUMILLI
Anilkumar Surendrakumar Gandhi
Sanjivani Abhay KULKARNI
Margaret Ann LAMBERT
Nima ROOHPOUR
Original Assignee
Glaxo Group Limited
Glaxosmithkline Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glaxo Group Limited, Glaxosmithkline Llc filed Critical Glaxo Group Limited
Publication of WO2016062624A1 publication Critical patent/WO2016062624A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K6/00Preparations for dentistry
    • A61K6/30Compositions for temporarily or permanently fixing teeth or palates, e.g. primers for dental adhesives
    • A61K6/35Preparations for stabilising dentures in the mouth

Definitions

  • the invention relates to denture adhesives, their use and methods for making denture adhesives.
  • Dentures are substitutes for missing teeth and serve as replacement for all or some of the teeth found in the oral cavity. Despite diligent efforts by dental professionals and designers of dental prostheses, dentures do not always fit perfectly. Over time, even well-fitting dentures can become ill-fitting due to natural shrinkage and changes in the gum or mucous tissues. Therefore, adherent creams, liquids or powders are often used to secure or temporarily fix dentures within the mouth.
  • Denture adhesive compositions are used to fill the interstices between the dentures and the gums or tissues. Prior to placement of the denture in the oral cavity, a denture adhesive or fixative is applied to the denture plate surface, which for a perfect fit, should uniformly contact the gums and oral tissues. Denture adhesive compositions are formulated not only for their adherent properties, but also to provide an interface between the denture and the gums and/or oral tissues, thereby positioning the denture securely in the oral cavity.
  • the denture adhesive should develop a high degree of tack upon contact with saliva, generating a tacky, uniform and viscous mucilage, so that the dentures can be held in place as soon as they are seated in the mouth. It is also highly desirable that the mucilage of the adhesive be spread over the denture-mucosa interface in order to seal the denture in place effectively.
  • the mucilage should possess sufficient cohesive strength to withstand the stresses of mastication, which act to rupture the seal and thus dislodge the denture.
  • the denture adhesive must also exhibit sufficient resistance to degradation under the extreme environmental changes that can occur in the oral cavity during such common actions as drinking hot or cold beverages. Of course, the adhesive must also be releasable so that the denture wearer may remove the dentures for cleaning and maintenance. Denture adhesives are generally sold as a cream, liner or strip, liquid or powder, and many examples are well known in the art.
  • EP1166744 Al discloses a denture adhesive having superior cleanability which can be easily removed from a denture base.
  • the adhesives contain a water-soluble polymer, calcium sulphate and an alginate. The presence of the alginate and calcium produce a gel which adheres the denture to the mucosa surface but also allows for easy removal of the denture.
  • denture adhesives comprising at least one hydrophilic adhesive polymer, and a source of metal cations are useful alternative compositions that do not need to contain either an alginate, polyacrylic acid and/or an alkyl vinyl ether-maleic acid anhydride copolymer. These compositions show a long duration of hold but also use more widely available and affordable ingredients.
  • the denture adhesives of the present invention exhibit sufficient tack upon initial contact with oral mucosa, build up cohesive strength quickly when hydrated with moisture or saliva and are able to resist stresses such as those that occur upon mastication. Summary of the Invention
  • the invention relates to a denture adhesive powder composition, comprising:
  • hydrophilic adhesive polymer which is at least a combination of a cellulosic polymer and a gum
  • composition does not contain an alginate or polyacrylic acid or an alkyl vinyl ether- maleic acid anhydride copolymer.
  • the invention relates to a denture adhesive cream composition, comprising:
  • hydrophilic adhesive polymer which is at least a combination of a cellulosic polymer and a gum
  • composition does not contain an alginate or polyacrylic acid or an alkyl vinyl ether- maleic acid anhydride copolymer.
  • the invention further provides a method for making the denture adhesive compositions.
  • the invention relates to a method for adhering a denture to the oral mucosa resulting from the use of the denture adhesive compositions.
  • Figure 1 Is a chart of hang time comparing the cream adhesive compositions of the present invention.
  • Figure 2 Is a chart of shear strength comparing the cream adhesive compositions of the present invention.
  • Figure 3 Is a graph of adhesion profile data comparing the cream adhesive compositions of the present invention.
  • Figure 4 Is a chart of hang time comparing the powder adhesive compositions of the present invention.
  • Figure 5 (fig 5): Is a chart of shear strength comparing the powder adhesive compositions of the present invention.
  • Figure 6 (fig 6): Is a graph of adhesion profile data comparing the powder adhesive compositions of the present invention.
  • the invention relates to a denture adhesive powder composition, comprising:
  • hydrophilic adhesive polymer which is at least a combination of a cellulosic polymer and a gum
  • composition does not contain an alginate or polyacrylic acid or an alkyl vinyl ether- maleic acid anhydride copolymer.
  • the invention relates to a denture adhesive cream composition, comprising:
  • hydrophilic adhesive polymer which is at least a combination of a cellulosic polymer and a gum
  • the hydrophilic adhesive polymer is a cellulosic polymer.
  • the hydrophilic adhesive polymer is a gum.
  • the hydrophilic adhesive polymer is a combination of a cellulosic polymer and a gum.
  • the hydrophilic adhesive polymer is a combination of two gums and a cellulosic polymer.
  • the hydrophilic adhesive polymer is a combination of two cellulosic polymers and a gum. In one aspect of the invention, the hydrophilic adhesive polymer is a combination of at least a cellulosic polymer, a gum and polyethylene oxide.
  • the hydrophilic adhesive polymer is a combination of two cellulosic polymers and two gums.
  • Cellulosic polymers that are suitable for use in the denture adhesive compositions of the present invention include, but are not limited to, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, carboxymethyl cellulose hydroxyethylmethylcellulose, methyl-cellulose, methylcarboxymethyl cellulose,
  • sulfoethylcarboxymethyl cellulose hydroxyethylhydroxypropyl cellulose, hydroxyethylethyl cellulose, or hydroxyethylsulfoethyl cellulose or a combination thereof.
  • the cellulosic polymer is sodium carboxymethyl cellulose or hydroxypropyl methylcellulose, or a combination thereof. In another aspect the cellulosic polymer is sodium carboxymethyl cellulose. In another aspect the cellulosic polymer is hydroxypropyl methylcellulose. In another aspect the cellulosic polymer is a combination of sodium carboxymethyl cellulose and hydroxypropyl methylcellulose.
  • Gums that are suitable for use in the denture adhesive compositions of the present invention include, but are not limited to, xanthan gum, locust bean gum, konjac gum, guar gum and its derivatives, fenugreek gum and dietary fibres, pectin and its derivatives, chitosan and its derivatives, carrageenan and its derivatives, or karaya gum or a combination thereof.
  • the gum is xanthan gum, locust bean gum, konjac gum or a combination thereof.
  • the gum is xanthan gum.
  • the gum is locust bean gum.
  • the gum is konjac gum.
  • the gum is a combination of xanthan gum and locust bean gum.
  • the gum is a combination of xanthan gum and konjac gum.
  • Polyols that are suitable for use in the denture adhesive compositions of the present invention include, but are not limited to, polyethylene oxide homopolymers or copolymers such as, but not limited to, polyethylene glycol and its derivatives, polyethylene oxide (Polyox ® ) and the like or a combination thereof.
  • the hydrophilic adhesive polymer is polyethylene oxide.
  • the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 10% to about 90%.
  • the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 20% to about 85% by weight.
  • the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 35% to about 85% by weight.
  • the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 30% to about 60% by weight. In another aspect of the invention, the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 40% to about 50% by weight.
  • the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 50% to about 90% by weight. In another aspect of the invention, the hydrophilic adhesive polymer is present in the denture adhesive composition in a total amount of about 60% to about 80% by weight.
  • the "source of metal cations" that are suitable for use in the denture adhesive compositions of the present invention include, but are not limited to a source of zinc, calcium, magnesium, potassium, sodium or strontium ions, or a combination thereof.
  • the "source of metal cations" acts as a cross-linking agent forming a bond between the hydrophilic adhesive polymer chains.
  • the source of metal ions is a source of calcium ions.
  • the source of metal ions is a source of strontium ions.
  • source of metal ions is a combination of a source of calcium ions and a source of strontium ions.
  • a suitable source of calcium ions is a calcium salt, such as calcium chloride (anhydrous or dihydrate) or a calcium phosphate, e.g. dicalcium phosphate dihydrate.
  • a suitable source of strontium ions is a strontium salt, such as strontium chloride.
  • the source of metal cations is present in the compositions of the present invention in an amount to provide from about 0.5% to about 10% of metal cations.
  • the source of metal cations is present in the compositions of the present invention in an amount to provide from about 1% to about 10% of metal cations. In another aspect of the invention, the source of metal cations is present in the compositions of the present invention in an amount to provide from about 3% to about 8% of metal cations.
  • the source of metal cations is present in the compositions of the present invention in an amount to provide from about 0.5% to about 5% of metal cations. In another aspect of the invention, the source of metal cations is present in the compositions of the present invention in an amount to provide from about 1% to about 2% of metal cations.
  • Denture adhesive compositions of the present invention may be used to secure full or partial dentures.
  • the denture adhesive compositions may be formulated with additional components well known in the denture adhesive art including, but not limited to, waxes, oils, preservatives, anti-caking agents, fluoride ions, deodourising agents, anti-bacterial agents, humectants, flavouring agents, colorants, sweetening agents, viscosity modifiers, and so forth.
  • the waxes useful in the invention include, but are not limited to, both natural and synthetic waxes and include without limitation animal waxes such as beeswax, lanolin and shellac wax, vegetable waxes such as carnauba, candelilla and bayberry wax, mineral wax such as petroleum waxes including paraffin, and microcrystalline wax.
  • the wax is petrolatum.
  • the wax is petrolatum blend W-180.
  • the denture adhesive composition comprises from about 13% to about 30% by weight of wax. In one aspect, the denture adhesive composition comprises from about 20% to about 40% by weight of wax. In one aspect, the denture adhesive composition comprises from about 20% to about 40% by weight of petrolatum.
  • oils useful in the invention include, but are not limited to, mineral oil, vegetable oil such as corn, soybean, cottonseed, castor, palm and coconut oils and animal oil such as fish oil, and oleic acid.
  • the oil is mineral oil.
  • the denture adhesive composition comprises from about 0% to about 50% by weight of oil. In another aspect the denture adhesive composition comprises from about 10% to about 25% by weight of oil.
  • Preservatives which may be used in the denture adhesive compositions of the invention include, but are not limited to, those known antimicrobial agents conventionally employed in the art, such as benzoic acid and sodium benzoate, the parabens, sorbic acid and sorbates, propionic acid and propionates, acetic acid and acetates, nitrates and nitrites, sulfur dioxide and sulphites, antibiotics, diethyl pyrocarbonate, epoxides, hydrogen peroxide, and phosphates.
  • the parabens include the methyl, ethyl, propyl, and butyl esters of parahydroxybenzoic acid. In one aspect, a single preservative may be used.
  • a combination of one or more preservatives may be used.
  • the preservative is methyl paraben.
  • the preservative is propyl paraben.
  • the denture adhesive composition comprises a combination of methyl paraben and propyl paraben as the preservatives.
  • the denture adhesive composition comprises from about 0.03% to about 0.25% by weight of the preservative.
  • Anti-caking agents which may be used in the denture adhesive compositions of the invention include, but are not limited to, silica, magnesium stearate and talc.
  • the denture adhesive composition comprises talc.
  • the humectants which may be used in the denture adhesive compositions of the invention include, but are not limited to, polyethylene glycol, propylene glycol and the like or a combination thereof.
  • flavouring agents well known to the denture adhesive art may be added to the compositions of the present invention. These flavouring agents include, but are not limited to, synthetic flavour oils and/or oils derived from plants, leaves, flowers, fruits and so forth, or a combination thereof.
  • flavour oils include spearmint oil, cinnamon oil, oil of wintergreen (methylsalicylate) and peppermint oils. Also useful are artificial, natural or synthetic fruit flavours such as citrus oil including lemon, orange, grape, lime, and grapefruit, and fruit essences including apple, strawberry, cherry, pineapple, and so forth.
  • the flavouring agent may be a liquid, spray dried, encapsulated, or absorbed on a carrier, and mixtures thereof.
  • the flavouring agent is peppermint oil.
  • the flavouring agent is spray dried peppermint.
  • the flavouring agent is spray dried spearmint.
  • the amount of flavouring agent utilized varies depending on such factors as flavour type, adhesive composition and strength desired.
  • the denture adhesive composition comprises from about 0.01% to about 3.0% by weight of the flavouring agent. In another aspect, the denture adhesive composition comprises from about 0.01% to about 2.0% by weight of the flavouring agent. In another aspect, the denture adhesive composition comprises from about 0.05% to 2% by weight of the flavouring agent.
  • the denture adhesive compositions may also include the use of sweeteners well known in the art.
  • the sweetening agent may be selected from a wide range of materials including water-soluble agents, water-soluble artificial sweeteners, and dipeptide based sweeteners, including mixtures thereof.
  • sweeteners include, but are not limited to, (a) sugar alcohols such as sorbitol, xylitol, mannitol, maltitol, hydrogenated starch hydrolysate, and mixtures thereof; (b) water-soluble artificial sweeteners such as the soluble saccharin salts, i.e., sodium or calcium saccharin salts, cyclamate salts, Acesulfame-K, sucralose, and the like, and the free acid form of saccharin; and (c) dipeptide based sweeteners such as L-aspartyl-L-phenylalanine methyl ester, and the like.
  • sugar alcohols such as sorbitol, xylitol, mannitol, maltitol, hydrogenated starch hydrolysate, and mixtures thereof
  • water-soluble artificial sweeteners such as the soluble saccharin salts, i.e., sodium or calcium saccharin salts, cyclamate salts, Aces
  • the denture adhesive composition comprises from about 0.001% to about 5 % by weight of the sweetening agent.
  • the colourants useful in the present invention include the pigments such as titanium dioxide, and may also include dyes suitable for food, drug and cosmetic applications. These colourants are known as FD&C dyes. Illustrative examples include, but are not limited to, D&C Red#30 Aluminium Lake Paste, D&C Red #7 Calcium Lake Paste, Erythrosine Lake Paste, indigo dye, known as FD&C Blue No. 2, which is the disodium salt of 5,5 -indigotindi-sulfonic acid; FD&C Green No.
  • the colorant is FD&C Red No. 3.
  • the denture adhesive composition comprises from about 0% to about 0.2% by weight of colourant.
  • the viscosity modifiers useful herein include, but are not limited to, silica, quaternary ammonium compounds and similar agents, starches, gums, casein, gelatin and semi-synthetic cellulose.
  • All components of the denture adhesive composition are used in safe and adhesively effective amounts, which herein means an amount sufficient to provide adherence to the oral cavity.
  • the denture adhesive compositions may be in the form of a powder, a paste, a cream, or a strip.
  • the denture adhesive composition is in the form of a paste.
  • the denture adhesive composition is in the form of a cream.
  • Means for preparing such compositions are well known in the denture adhesive art, employing conventional types of mixing equipment for blending, heating, and cooling solids and liquids. In one embodiment, mixing is performed at temperatures suitable to melt the components, e.g. petrolatum, to be blended.
  • the components are suitably admixed with flavouring agents and colorants, together with other ingredients such as non-toxic anti-caking agents (silica, magnesium stearate, talc and the like).
  • flavouring agents and colorants such as sica, magnesium stearate, talc and the like.
  • other ingredients such as non-toxic anti-caking agents (silica, magnesium stearate, talc and the like).
  • the mixture of ingredients is thoroughly agitated or stirred to yield a completely homogenous intermixing of all components.
  • the components are suitably admixed with petrolatum along with the previously described waxes, oils, preservatives, flavouring agents, colorants, sweetening agents, viscosity modifiers, and so forth.
  • the components are suitably mixed and then coated onto a non-adhesive self supporting coating layer by any conventional coating techniques, such as by spraying (if the material is liquid or slurry or dissolved or suspended in a liquid such as water) or by sifting (if the denture adhesive is in powder form).
  • the components are admixed with the previously described waxes, oils, preservatives, flavouring agents, colorants, sweetening agents, viscosity modifiers, and so forth.
  • the liner is then formed by any variety of techniques known in the polymer film-forming art, including casting, calendaring, coating, and extrusion.
  • the components are first mechanically softened by a ring roller; smoothed on a hydraulic press, and die-cut as desired into denture liner shapes or other desired shapes.
  • Example 1 Denture adhesive composition - Cream composition
  • Example 2 Denture adhesive composition - Cream composition
  • Example 3 Denture adhesive composition - Cream composition
  • Example 4 Denture adhesive composition - Cream composition
  • Example 6 Denture adhesive composition - Powder Adhesive composition
  • Example 8 Denture adhesive composition - Powder Adhesive composition
  • Adhesion was assessed by shear test performed on Instron 5943 (lnstron,UK) tensile testing machine equipped with a 500 N load cell. The crosshead speed was 0.5 in/min. For each test, the load versus displacement was measured, and the shear stress at break (ultimate adhesion strength or adhesion strength at break) is used to characterize adhesion for each composition. Each test was repeated at least five times.
  • Hang time method was used for assessing the duration of hold of denture adhesives.
  • 0.4 g of powder adhesive was added to 1.2 g of deionized water (1:3 ratio) and mixed for 30 sec. The uniform paste was placed on acrylic slides and pressed with 20lbf for 5 seconds followed by 5 minutes hydration. Similar to powder samples, 0.8 g of paste samples were mixed with 0.4g water and placed on acrylic slides and pressed with 201 bf for 5 seconds followed by 20 minutes hydration.
  • Hang time stability of the samples was measured using a Lasting Adhesive Tester - CZY-6S equipped with 200g hook weight (Qualitest, Canada). Each sample was tested at least five times.
  • compositions of Examples 4-8 were compared and a comparative tabular representation of the tests conducted is shown in Table 10.
  • Adhesion Profile Assessment To test the adhesion profile of denture adhesives in PBS solution an Instron Texture Analyzer (5943) equipped with BioPuls Bath and 500 N load cell was used (Instron, UK). 0.1 g of powder adhesive was added to 0.2 g of deionized water (1:2 ratios) and mixed to form a uniform paste. 0.2 ml of adhesive paste was placed on the texture analyser and initially compressed to lOlbf and then took through a compression cycle for a total of 5 minutes. The cross head was then moved apart with speed of 6lbf/min and the maximum tensile force recorded. This was repeated 12 times (cycles) for each sample.
  • Sample preparation for hang time and shear stress Weigh 0.8g paste and 0.4g of water in a beaker, mix the adhesive and water homogeneously with spatula for 5 seconds. (The initial 2 sec mixing was done slowly to incorporate the water into cream and further 3 sec vigorous mixing was done.) Spread the mixture over a one inch square area of acrylic slide, and cover with a second slide to give a 1 square inch overlap region. Compress to 20 pounds (lbs) for 5 seconds. Allow samples to hydrate for 5 minutes, then compress to 20 lbs for a further 5 seconds.
  • Shear strength Adhesion was assessed by shear test performed on Instron 5943 (lnstron,UK) tensile testing machine equipped with a 500 N load cell. The crosshead speed was 0.5 in/min. For each test, the load versus displacement was measured, and the shear stress at break (ultimate adhesion strength or adhesion strength at break) is used to characterize adhesion for each composition. Each test was repeated at least five times.
  • Hang time stability of the samples was measured using a Lasting Adhesive Tester - CZY- 6S equipped with 200g hook weight (Qualitest, Canada). Each sample was tested at least five times.

Abstract

L'invention concerne des adhésifs pour prothèses dentaires et des procédés de préparation d'adhésifs pour prothèses dentaires.
PCT/EP2015/073982 2014-10-20 2015-10-16 Adhésif pour prothèse dentaire WO2016062624A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB1418602.7 2014-10-20
GBGB1418602.7A GB201418602D0 (en) 2014-10-20 2014-10-20 Denture adhesive

Publications (1)

Publication Number Publication Date
WO2016062624A1 true WO2016062624A1 (fr) 2016-04-28

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Application Number Title Priority Date Filing Date
PCT/EP2015/073982 WO2016062624A1 (fr) 2014-10-20 2015-10-16 Adhésif pour prothèse dentaire

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WO (1) WO2016062624A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3868259A (en) * 1972-04-13 1975-02-25 Warner Lambert Co Denture adhesive preparation
US20050032940A1 (en) * 2002-09-06 2005-02-10 Healthtech Corporation Denture stabilizer
US20090232911A1 (en) * 2005-03-25 2009-09-17 Yoichi Kato Use of sericin for improving feeling in use of denture

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3868259A (en) * 1972-04-13 1975-02-25 Warner Lambert Co Denture adhesive preparation
US20050032940A1 (en) * 2002-09-06 2005-02-10 Healthtech Corporation Denture stabilizer
US20090232911A1 (en) * 2005-03-25 2009-09-17 Yoichi Kato Use of sericin for improving feeling in use of denture

Also Published As

Publication number Publication date
GB201418602D0 (en) 2014-12-03

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