DK202300050U3 - Formulated to maintain, improve and support eye health - Google Patents

Formulated to maintain, improve and support eye health Download PDF

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DK202300050U3
DK202300050U3 DKBA202300050U DKBA202300050U DK202300050U3 DK 202300050 U3 DK202300050 U3 DK 202300050U3 DK BA202300050 U DKBA202300050 U DK BA202300050U DK BA202300050 U DKBA202300050 U DK BA202300050U DK 202300050 U3 DK202300050 U3 DK 202300050U3
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lutein
formula
daily dose
per daily
vitamin
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DKBA202300050U
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Duan Xiaoyun
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Pg Naturpharma Gmbh
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07Retinol compounds, e.g. vitamin A
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/3533,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355Tocopherols, e.g. vitamin E
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365Lactones
    • A61K31/375Ascorbic acid, i.e. vitamin C; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/455Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/51Nanocapsules; Nanoparticles
    • A61K9/5107Excipients; Inactive ingredients
    • A61K9/513Organic macromolecular compounds; Dendrimers
    • A61K9/5169Proteins, e.g. albumin, gelatin

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Den foreliggende opfindelse vedrører en formel, der hjælper med at vedligeholde, forbedre og støtte øjets sundhed ved at indeholde lutein. Formlen består hovedsageligt af lutein, zeaxanthin, E-vitamin, C-vitamin og niacin. Formlen er fri for tilsætning af sukkererstatninger, allergener og GMO-ingredienser og konserveringsmidler. Derudover øges formlens effektivitet ved brug af nanokapslingsteknologi for at forbedre stabiliteten og absorptionen af lutein og øge effekten mod blåt lys.The present invention relates to a formula that helps maintain, improve and support eye health by containing lutein. The formula mainly consists of lutein, zeaxanthin, vitamin E, vitamin C and niacin. The formula is free of added sugar substitutes, allergens and GMO ingredients and preservatives. In addition, the effectiveness of the formula is increased by the use of nanoencapsulation technology to improve the stability and absorption of lutein and increase the effect against blue light.

Description

DK 202300050 U3 1DK 202300050 U3 1

Formel til at vedligeholde, forbedre og støtte øjnenes sundhedFormulated to maintain, improve and support eye health

OMRÅDETERRITORY

Den foreliggende opfindelse vedrører en formel, der hjælper med at vedligeholde, forbedre og . — støtte øjets sundhed ved at indeholde lutein. Formlen består hovedsageligt af lutein, zeaxanthin,The present invention relates to a formula that helps maintain, improve and . — support eye health by containing lutein. The formula consists mainly of lutein, zeaxanthin,

E-vitamin, C-vitamin og niacin. Formlen er fri for tilsætning af sukkererstatninger, allergener ogVitamin E, Vitamin C and Niacin. The formula is free of added sugar substitutes, allergens and

GMO-ingredienser og konserveringsmidler. Derudover øges formlens effektivitet ved brug af nanokapslingsteknologi for at forbedre stabiliteten og absorptionen af lutein og øge effekten mod blåt lys. : BAGGRUNDGMO ingredients and preservatives. In addition, the effectiveness of the formula is increased by the use of nanoencapsulation technology to improve the stability and absorption of lutein and increase the effect against blue light. : BACKGROUND

Bevidstheden om vigtigheden af øjensundhedsprodukter er stigende i Finland og på verdensplan.Awareness of the importance of eye health products is increasing in Finland and worldwide.

I en verden, hvor digitale enheder som computere, smartphones og tablets er allestedsnærværende, er belastningen af øjnene større end nogensinde. Derfor leder flere og flere — mennesker efter måder at holde deres øjne sunde. på og undgå problemer som nærsynethed, tørhed og træthed.In a world where digital devices such as computers, smartphones and tablets are ubiquitous, the strain on the eyes is greater than ever. Therefore, more and more people are looking for ways to keep their eyes healthy. on and avoid problems such as myopia, dryness and fatigue.

De øjenhygiejneprodukter, som fås i Finland og resten af verden, spænder fra vitamin- og mineraltilskud til særlige øjendråber og kontaktlinser. Der er også mange naturlige produkter . > baseret på urter, antioxidanter og andre næringsstoffer, der understøtter øjensundheden.The eye hygiene products available in Finland and the rest of the world range from vitamin and mineral supplements to special eye drops and contact lenses. There are also many natural products. > based on herbs, antioxidants and other nutrients that support eye health.

En af de største udfordringer for øjensundhedsprodukter er aldersrelateret makuladegeneration (AMD), en sygdom, der påvirker nethinden og kan føre til blindhed. Der findes dog en række produkter på markedet, som er specifikt designet til forebyggelse og behandling af AMD.One of the biggest challenges for eye health products is age-related macular degeneration (AMD), a disease that affects the retina and can lead to blindness. However, there are a number of products on the market that are specifically designed for the prevention and treatment of AMD.

Interessen for eyetracking-teknologi og andre innovative produkter, der støtter øjensundheden, er også stigende på verdensplan. For eksempel kan eyetracking-briller bruges til at spore øjenbevægelser og reducere skærmtid, mens øjenmassageapparater kan hjælpe med at øge blodgennemstrømningen til øjnene og lindre spændinger. ; På trods af det store udvalg af produkter til øjensundhed er det stadig en udfordring at vælge det rigtige. Det er vigtigt for forbrugerne at forstå deres behov og individuelle øjenproblemer for at kunne finde det rigtige produkt til dem. Bevidstheden om vigtigheden af øjenplejeprodukter forventes at fortsætte med at stige, og efterspørgslen efter effektive produkter af høj kvalitet vil fortsætte med at vokse.Interest in eye tracking technology and other innovative products that support eye health is also increasing worldwide. For example, eye tracking glasses can be used to track eye movements and reduce screen time, while eye massagers can help increase blood flow to the eyes and relieve tension. ; Despite the large selection of eye health products, choosing the right one is still a challenge. It is important for consumers to understand their needs and individual eye problems in order to find the right product for them. Awareness of the importance of eye care products is expected to continue to rise, and the demand for effective, high-quality products will continue to grow.

DK 202300050 U3 2 øjeblikket får teknologien bag øjenplejeprodukter, der indeholder lutein, stor opmærksomhed. -DK 202300050 U3 2 Currently, the technology behind eye care products containing lutein is receiving a lot of attention. -

Lutein er et carotenoid, der findes i høje koncentrationer i makula i det menneskelige øje og anses for at beskytte mod aldersrelateret makuladegeneration og grå stær. Lutein kan fås fra en række forskellige kilder, herunder grønne bladgrøntsager, æggeblommer og alger.Lutein is a carotenoid found in high concentrations in the macula of the human eye and is thought to protect against age-related macular degeneration and cataracts. Lutein can be obtained from a variety of sources, including green leafy vegetables, egg yolks and algae.

Når det gælder fremstilling af lutein-øjenplejeprodukter, findes der i øjeblikket en række forskellige teknologier og formuleringer på markedet. Nogle af de mest almindelige former er kapsler, tabletter, vingummibamser og drikkevarer. Nogle produkter kombinerer også lutein med andre næringsstoffer som omega-3-fedtsyrer, zeaxanthin og vitaminer. .When it comes to manufacturing lutein eye care products, there are currently a number of different technologies and formulations on the market. Some of the most common forms are capsules, tablets, gummy bears and drinks. Some products also combine lutein with other nutrients such as omega-3 fatty acids, zeaxanthin and vitamins. .

Selvom lutein-øjenplejeprodukter er bredt tilgængelige til voksne, er der stadig mangel på produkter, der er designet specielt til unge. Det skyldes, at det er svært at bestemme en sikker og effektiv dosis til unge mennesker, især dem i den yngre aldersgruppe.Although lutein eye care products are widely available for adults, there is still a lack of products designed specifically for youth. This is because it is difficult to determine a safe and effective dose for young people, especially those in the younger age group.

En anden udfordring for lutein-øjenplejeindustrien er den begrænsede biotilgængelighed af lutein.Another challenge for the lutein eye care industry is the limited bioavailability of lutein.

Lutein er fedtopløseligt og derfor svært at optage fra kroppen. En måde at øge biotilgængeligheden på er at kombinere lutein med fedtstoffer eller olier for at fremme optagelsen.Lutein is fat-soluble and therefore difficult to absorb from the body. One way to increase bioavailability is to combine lutein with fats or oils to promote absorption.

Sammenfattende er teknologien bag lutein-øjenplejeprodukter i øjeblikket på et avanceret niveau, og der findes en række forskellige formuleringer og teknologier på markedet. Der er dog stadig udfordringer med at udvikle produkter til den nye generation af unge mennesker og forbedre biotilgængeligheden af lutein.In summary, the technology behind lutein eye care products is currently at an advanced level and there are a number of different formulations and technologies on the market. However, there are still challenges in developing products for the new generation of young people and improving the bioavailability of lutein.

DETALJERET BESKRIVELSE .DETAILED DESCRIPTION .

Det tekniske problem, som denne opfindelse adresserer, er, at konventionelle metoder til fremstilling af luteinpræparater resulterer i lav biotilgængelighed og begrænset absorption på grund af den lave vandopløselighed af lutein. Derudover er ingredienserne i konventionelle formuleringer og deres utilstrækkelige doseringer måske ikke egnede til unge mennesker.The technical problem that this invention addresses is that conventional methods of preparing lutein preparations result in low bioavailability and limited absorption due to the low water solubility of lutein. In addition, the ingredients in conventional formulations and their insufficient dosages may not be suitable for young people.

For at løse de ovennævnte tekniske problemer anvendes nanokapslingsteknologi i den foreliggende opfindelse til at øge luteins vandopløselighed og biotilgængelighed betydeligt.To solve the above technical problems, nanoencapsulation technology is used in the present invention to significantly increase the water solubility and bioavailability of lutein.

Nanokapslerne beskytter luteinet mod oxidation og muliggør præcis dosering. Derudover er formuleringen specielt tilpasset unges behov for at sikre passende dosering og tolerabilitet.The nanocapsules protect the lutein from oxidation and enable precise dosing. In addition, the formulation is specially adapted to the needs of young people to ensure appropriate dosage and tolerability.

Formuleringen indeholder særlige ingredienser, der forbedrer øjenplejen og beskytter mod blåt lys.The formulation contains special ingredients that improve eye care and protect against blue light.

Det forbedrer synet og reducerer træthed i øjnene, især hos folk, der bruger lang tid foran computerskærmen eller andre digitale enheder.It improves eyesight and reduces eye fatigue, especially for people who spend a long time in front of a computer screen or other digital devices.

DK 202300050 U3 3DK 202300050 U3 3

For at fremstille nanokapslerne anvendes en metode til nanokapsulering, hvor gelatine og saccharose opløses i vand og derefter blandes med lutein, olie, antioxidant og emulgator.To produce the nanocapsules, a nanoencapsulation method is used, where gelatin and sucrose are dissolved in water and then mixed with lutein, oil, antioxidant and emulsifier.

Forvarmningstrinnene involverer blanding af matrixen af lutein, antioxidant og emulgator i oliefasen, som omrøres ved 80-90 °C i 15 minutter.The preheating steps involve mixing the matrix of lutein, antioxidant and emulsifier in the oil phase, which is stirred at 80-90 °C for 15 minutes.

Derefter opvarmes blandingen til 120-140 °C i en rørformet reaktor ved høj frekvens ved hjælp af en skruepumpe i 15-25 sekunder for hurtigt at opløse luteinet. Efterfølgende homogeniseres blandingen i en homogenisator for at opnå en fin dispersion af nanokapsler. Til sidst tørres — blandingen i en spraytørrer, hvor der først udføres termisk sprøjtning efterfulgt af kølesprøjtning.The mixture is then heated to 120-140 °C in a tubular reactor at high frequency using a screw pump for 15-25 seconds to rapidly dissolve the lutein. Subsequently, the mixture is homogenized in a homogenizer to obtain a fine dispersion of nanocapsules. Finally, the mixture is dried in a spray dryer, where first thermal spraying is carried out followed by cooling spraying.

Den særlige formulering af lutein-øjenplejeprodukter til unge voksne, som er fremstillet ved hjælp af nanokapsuleringsteknologi, indeholder en meget effektiv dosis på op til 10 mg lutein om dagen.The special formulation of lutein eye care products for young adults, made using nanoencapsulation technology, contains a highly effective dose of up to 10 mg of lutein per day.

Det særlige ved denne formulering er den høje biotilgængelighed af lutein, som opnås ved hjælp — af nanokapslerne. Det sikrer maksimal absorption i kroppen, så man kan høste alle fordelene ved lutein. ]The special feature of this formulation is the high bioavailability of lutein, which is achieved with the help of the nanocapsules. It ensures maximum absorption in the body so that you can reap all the benefits of lutein. ]

Derudover indeholder formuleringen 5 synergistiske ingredienser til fremme af øjensundheden: lutein, zeaxanthin, E-vitamin, C-vitamin og niacin. Hver af disse ingredienser har en unik rolle i — understøttelsen af øjets sundhed. For eksempel beskytter E-vitamin øjencellerne mod oxidativt stress, mens C-vitamin hjælper med at styrke bindevævet i øjnene.In addition, the formulation contains 5 synergistic ingredients to promote eye health: lutein, zeaxanthin, vitamin E, vitamin C and niacin. Each of these ingredients has a unique role in — supporting eye health. For example, vitamin E protects eye cells from oxidative stress, while vitamin C helps strengthen the connective tissue in the eyes.

Disse synergistiske ingredienser arbejder sammen om at forstærke effekten af lutein og fremme optimal øjensundhed. For eksempel er lutein i kombination med zeaxanthin i forholdet 5:1 mere — velegnet til tilskud. Samlet set er formuleringen af lutein-øjenplejeprodukter til unge voksne en effektiv og sikker måde at støtte øjensundheden på og reducere de skadelige virkninger af blåt lys.These synergistic ingredients work together to enhance the effect of lutein and promote optimal eye health. For example, lutein in combination with zeaxanthin in a ratio of 5:1 is more — suitable for supplementation. Overall, the formulation of lutein eye care products for young adults is an effective and safe way to support eye health and reduce the harmful effects of blue light.

De fordelagtige virkninger af den foreliggende opfindelse er: Nanoindkapslingsteknologien øger luteins vandopløselighed og biotilgængelighed betydeligt, hvilket resulterer i forbedret effekt.The beneficial effects of the present invention are: The nanoencapsulation technology significantly increases the water solubility and bioavailability of lutein, resulting in improved efficacy.

Formuleringen, der er specielt designet til unge mennesker, sikrer passende dosering og tolerabilitet. ,The formulation, specially designed for young people, ensures appropriate dosage and tolerability. ,

EKSEMPLEREXAMPLES

Eksempel 1: Fremstilling af nanoenkapslet luteinExample 1: Preparation of nanoencapsulated lutein

DK 202300050 U3 4DK 202300050 U3 4

Gelatine og sukker blev opløst i vand. Lutein, antioxidant og emulgator blev suspenderet i oliefasen og holdt i 15 minutter ved 80-90 °C under omrøring. Blandingen blev pumpet gennem en peristaltisk pumpe for at føre den gennem spolen og opvarme den til 120-140 °C. Olieopløsningen af lutein blev indført i vandfasen med en højhastighedsdisperger-emulgator og emulgeret. Emulsionen blev > homogeniseret to gange med en højtrykshomogeniseringsmaskine for at opnå en vandig . nanoopløsning. Den vandige opløsning blev sprayet og tørret i en spraytørrer ved en indgangslufttemperatur på ca. 170°C og en udgangslufttemperatur på ca. 70°C. Produktet blev sprayet og kondenseret igen. Efterfølgende blev pulveret sigtet. "10 Eksempel 2: Luteinholdig formel, daglig dosis bestående af 1 filmovertrukken tablet indeholdende følgende ingredienser: fon je : Eksempel 3: Luteinholdig formel i form af vingummi. Den anbefalede daglige dosis omfatter en vingummi med følgende ingredienser: -Gelatin and sugar were dissolved in water. Lutein, antioxidant and emulsifier were suspended in the oil phase and kept for 15 minutes at 80-90°C with stirring. The mixture was pumped through a peristaltic pump to pass it through the coil and heat it to 120-140°C. The oil solution of lutein was introduced into the water phase with a high speed disperser-emulsifier and emulsified. The emulsion was > homogenized twice with a high-pressure homogenizer to obtain an aqueous . nano solution. The aqueous solution was sprayed and dried in a spray dryer at an inlet air temperature of approx. 170°C and an outlet air temperature of approx. 70°C. The product was sprayed and condensed again. Subsequently, the powder was sieved. "10 Example 2: Lutein-containing formula, daily dose consisting of 1 film-coated tablet containing the following ingredients: fon je : Example 3: Lutein-containing formula in the form of wine gum. The recommended daily dose includes a wine gum with the following ingredients: -

Eon loEon laughed

CS CECS CE

Claims (6)

DK 202300050 U3 BRUGSMODELKRAV t. Formel fil at vedligeholde, forbedre og støtte øjets sundhed, indeholdende: a) 38-12 mg lutein pr. daglig dosis; B) 1,5-2,5 mg zeaxanthin pr. daglig dosis; 5 co) — 7 mg E-vitamin pr. daglig dosis; dy 32-48 mg C-vitamin pr. daglig dosis; e) 8-10 mg niacin pr. daglig dosis.DK 202300050 U3 UTILITY MODEL REQUIREMENT t. Formula file to maintain, improve and support eye health, containing: a) 38-12 mg lutein per daily dose; B) 1.5-2.5 mg zeaxanthin per daily dose; 5 co) — 7 mg of vitamin E per daily dose; dy 32-48 mg vitamin C per daily dose; e) 8-10 mg niacin per daily dose. 2. Formel følge krav 1, kendetegnet ved, at forholdet mellem lutein og zeaxanthin i formlen er ca. 5:1.2. Formula following claim 1, characterized in that the ratio between lutein and zeaxanthin in the formula is approx. 5:1. 3. Formel ifølge krav 1 eller 2, kendetegnet ved, at luteinet fremstilles ved hjælp af nancenkapslingsteknologi. 13 3. Formula according to claim 1 or 2, characterized in that the lutein is produced using nance encapsulation technology. 13 4. Formel følge et hvilket som helst af kravene 1 til 3, kendetegnet ved, at den optimerede formel indeholder følgende mængder af næringsstoffer: a) 10 mg lutein pr. daglig dosis; b) — 2 my zeaxanthin pr. daglig dosis; ¢) 6 mg E-vitamin pr. daglig dosis; dy 40 mg C-vitamin pr. daglig dosis; e) 8 mg niacin pr. daglig dosis.4. Formula according to any one of claims 1 to 3, characterized in that the optimized formula contains the following amounts of nutrients: a) 10 mg of lutein per daily dose; b) — 2 ml of zeaxanthin per daily dose; ¢) 6 mg vitamin E per daily dose; dy 40 mg vitamin C per daily dose; e) 8 mg niacin per daily dose. 5. Formel følge et hvilket som helst af kravene 1 til 4, kendetegnet ved, at formlen er tilgængelig i en form valgt fra gruppen bestående af tabletter, vingummi og pulver. , 285. Formula according to any one of claims 1 to 4, characterized in that the formula is available in a form selected from the group consisting of tablets, gum and powder. , 28 6. Formel følge et hvilket som helst af kravene 1 til 5, kendetegnet ved, at anvendelsen af formlen er at vedligeholde, forbedre og støtte øjets sundhed.6. Formula according to any one of claims 1 to 5, characterized in that the use of the formula is to maintain, improve and support the health of the eye.
DKBA202300050U 2023-03-30 2023-08-22 Formulated to maintain, improve and support eye health DK202300050U3 (en)

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