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WO2014191969A1 - A solution for eyelid margin hygiene and a device for its application - Google Patents

A solution for eyelid margin hygiene and a device for its application Download PDF

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Publication number
WO2014191969A1
WO2014191969A1 PCT/IB2014/061842 IB2014061842W WO2014191969A1 WO 2014191969 A1 WO2014191969 A1 WO 2014191969A1 IB 2014061842 W IB2014061842 W IB 2014061842W WO 2014191969 A1 WO2014191969 A1 WO 2014191969A1
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WO
WIPO (PCT)
Prior art keywords
solution
according
eyelid
hygiene
kit according
Prior art date
Application number
PCT/IB2014/061842
Other languages
French (fr)
Inventor
Daniele GIAMMARIA
Original Assignee
Biodue S.P.A.
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
Priority to IT000128A priority Critical patent/ITFI20130128A1/en
Priority to ITFI2013A000128 priority
Application filed by Biodue S.P.A. filed Critical Biodue S.P.A.
Publication of WO2014191969A1 publication Critical patent/WO2014191969A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; MANICURING OR OTHER COSMETIC TREATMENT
    • A45D34/00Containers or accessories specially adapted for handling liquid toilet or cosmetic substances, e.g. perfumes
    • A45D34/04Appliances specially adapted for applying liquid, e.g. using roller or ball
    • A45D34/042Appliances specially adapted for applying liquid, e.g. using roller or ball using a brush or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/045Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05Phenols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET 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
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4412Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K8/00Cosmetics or similar toilet preparations
    • A61K8/18Cosmetics or similar toilet preparations characterised by the composition
    • A61K8/30Cosmetics or similar toilet preparations characterised by the composition containing organic compounds
    • A61K8/33Cosmetics or similar toilet preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34Alcohols
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K8/00Cosmetics or similar toilet preparations
    • A61K8/18Cosmetics or similar toilet preparations characterised by the composition
    • A61K8/92Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof
    • A61K8/922Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products thereof of vegetable origin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61QSPECIFIC USE OF COSMETICS OR SIMILAR TOILET PREPARATIONS
    • A61Q17/00Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A61Q17/005Antimicrobial preparations
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; MANICURING OR OTHER COSMETIC TREATMENT
    • A45D2200/00Details not otherwise provided for in A45D
    • A45D2200/10Details of applicators
    • A45D2200/1009Applicators comprising a pad, tissue, sponge, or the like
    • A45D2200/1018Applicators comprising a pad, tissue, sponge, or the like comprising a pad, i.e. a cushion-like mass of soft material, with or without gripping means
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45DHAIRDRESSING OR SHAVING EQUIPMENT; MANICURING OR OTHER COSMETIC TREATMENT
    • A45D2200/00Details not otherwise provided for in A45D
    • A45D2200/10Details of applicators
    • A45D2200/1009Applicators comprising a pad, tissue, sponge, or the like
    • A45D2200/1036Applicators comprising a pad, tissue, sponge, or the like containing a cosmetic substance, e.g. impregnated with liquid or containing a soluble solid substance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
    • A61K2800/00Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/87Application Devices; Containers; Packaging

Abstract

A solution for eyelid margin hygiene, and a kit comprising said solution with applicators for applying it to the eyelid margins are described.

Description

A SOLUTION FOR EYELID MARGIN HYGIENE AND A DEVICE FOR ITS APPLICATION

Field of the invention

The present invention relates to products for eyelid hygiene and particularly for eyelid margin hygiene.

State of the art

The generic term eyelid hygiene is commonly used to mean all those norms, activities and practices designed to cleanse and/or disinfect the skin of the eyelid, the eyelashes, and the eyelid margins. The most common indications for which ophthalmologists recommend performing eyelid hygiene procedures are eyelid dermatitis, anterior blepharitis, posterior blepharitis, Meibomian gland dysfunction (MGD), recurrent styes and chalazia, and post-operative eyelid cleansing.

When eyelid hygiene has the purpose of cleansing the orifices of the Meibomian glands, as in the case of posterior blepharitis, MGD, internal styes and chalazia, it is fundamentally important for this to be done as precisely and effectively as possible at eyelid margin level. In patients with these conditions and dysfunctions, the orifices of the Meibomian glands are obstructed due to an accumulation of epithelial cells (hyperkeratinization) and the presence of thickened Meibomian sebum.

The products and devices for eyelid hygiene currently available on the market mainly consist of medicated cotton gauze or nonwoven fabric pads packaged singly under sterile conditions. Some products are available in the form of a liquid, gel or foam and sold for use as eyelid cleansers with or without the aid of cotton gauze pads.

As an alternative to the above-mentioned products and devices, the ophthalmologist will often recommend that patients dip the tip of a cotton wool bud in various fluid substances (warm water, baby shampoo, chamomile, antibiotic eye drops, artificial tears) and use it to cleanse the eyelid margins in an effort to keep the glandular orifices clean (see, for instance, Sue Stevens "How to clean eyelids" Community Eye Health Journal Vol. 24, No. 75, 31 October 2011 ).

Both the premedicated cotton pads and the cleansing products are very useful and easy to use when patients need to cleanse the eyelid skin and eyelashes. Patients complain of having severe difficulty, however, when the same products are prescribed for hygiene of the eyelid margin. The dimensions of the cotton pads, their consistency and manageability do not enable a sufficiently precise and effective cleansing of the eyelid margins.

In addition, the above-mentioned alternative practices often expose patients to the classic risks of DIY: the cotton wool buds are never sterile and may be a source of eyelid and eye contamination; the substances used are not always indicated for ophthalmological use; patients rarely have a thorough understanding of the correct procedure to perform and this can expose them to pointless or even hazardous manoeuvres.

The patent application US 2011/0124725 describes a treatment for dry eye involving eye drops or ointments for instilling in the eye, or the treatment of Meibomian gland obstruction/dysfunction. According to said patent application, jojoba oil is used as a carrier of local anaesthetics to prepare patients for the performance of an invasive surgical procedure (intraductal probing) of the Meibomian glands. The text makes no reference to eyelid hygiene or the treatment of (posterior or anterior) blepharitis, chalazion or stye, which form the therapeutic objects of the present patent application, nor to the possible use of jojoba oil in combination with cotton wool buds as a non-invasive self-medication product based on the principles of cleansing both mechanically and by affinity.

The consequence of all the above is that eyelid hygiene performed using the products currently available on the market is not effective for the treatment of disorders such as MGD, posterior blepharitis, seborrhoeic blepharitis, recurrent styes and chalazia. Hence the evident interest in products and devices suitable for cleansing the eyelid margins that are easy to use and designed for said purpose. Brief description of the figures

Figure 1 shows a detail of the device according to the invention.

Summary of the invention

A solution for eyelid margin hygiene, and a kit comprising said solution with applicators for applying it to the eyelid margins are described.

Detailed description of the invention The present invention enables the above-described problems to be overcome by means of a solution for eyelid margin hygiene and a kit comprising said solution and an applicator for applying it to the eyelid margins.

The solution according to the invention consists of jojoba oil, extracted preferably by cold pressing from Simmondsia chinensis seeds, possibly in combination with: natural or synthetic antibacterial, anti-inflammatory and/or antioxidant agents, thinners, and preserving agents.

The antibacterial agent for use according to the invention may be chosen, for instance, from among: terpinen-4-ol, thymol, Mimosa tenuiflora liposoluble extract, piroctone olamine, azythromycin, tetracycline, and their derivatives.

When included, these products are normally in quantities in the range of 0.01 to

0.05%, and preferably 0.03% (w/V calculated on the total volume of the solution).

An example of anti-inflammatory agent for use according to the invention is o bisabolol; when added, it is normally in quantities in the range of 0.01 to 1 %, and preferably 0.5% (w/V calculated on the total volume of the solution).

The antioxidant for use according to the invention may be chosen, for instance, from among: vitamin E (0.1 to 0.5%), butylhydroxyanisole (BHA) and butylhydroxytoluene (BHT) (0.01 to 0.05%).

Suitable thinners for use according to the invention include vegetable oils (e.g. castor oil), mineral oils (e.g. vaseline oil), or synthetic oils (e.g. dicaprylyl carbonate); the thinners are naturally added in the quantities needed to achieve the required final density.

Finally, the preserving agents are those commonly used in solutions for ophthalmological use, such as combinations of parabens, in the quantities commonly used for this purpose.

According to the invention, however, it is preferable to avoid the use of preserving agents, which are not considered essential, partly because the solution is preferably marketed in sterile single doses, as explained in more detail below. A solution according to the invention may thus consist of 100% jojoba oil, extracted from Simmondsia chinensis seeds by cold pressing, or it may, for instance, comprise the following formulation: jojoba oil 99.97% and terpinen-4-ol 0.03%. The jojoba oil used according to the present invention is the product as available commercially, and the compositions containing any of the various additives or other components are prepared according to the known methods normally used in the pharmaceutical sector for the preparation of products of this type.

As shown in Figure 1 , the applicator 10 according to the invention normally consists of a stick 11 that serves as a grip, with at least one of its two ends carrying a bud 12 made of a material suitable for being impregnated with the solution when the product is to be used.

The stick 11 is made of any rigid material suitable for the purpose, such as plastic, wood, metal, etc. (preferably rigid plastic), while the material comprising the one or more bud(s) 12 is cotton, a nonwoven fabric, natural or synthetic bristles, etc.

The buds 12 preferably have a tapered shape, with the end forming a rounded tip that makes it easier to follow the perimeter of the eyelid margin.

The applicators are preferably contained singly or in pairs inside sterile wrappings suitable for the purpose, such as plastic, paper, plastic-coated paper or cellophane sachets, or other material suited to the purpose.

The solution may be contained in a multiple-dose drip-counter container (and in this case it is preferable for the solution to contain appropriate preserving agents, as explained above), or in single-dose phials (ophtioles) made of polyethylene, normally containing a volume in the range of 0.35 to 1 ml, and preferably 0.5 ml, prepackaged and containing a volume of solution corresponding, for instance, to 0.15 - 0.5 ml, and preferably 0.25 ml, and in this case it will be unnecessary to add any preserving agents.

At the time of using the product, having removed the applicator from its sterile container, the user can medicate one of the buds with the solution contained in the single dose or with the required number of drops drawn from the multi-dose drop- counter container, and then apply the solution by rubbing the medicated tip of the applicator along the margins of the eyelids held suitably detached from the eye bulb.

The shape, manageability and stiffness of the applicator enable a straightforward and accurate mechanical cleansing of the orifices of the Meibomian glands, removing cell residues, thickened secretions, bacteria and their toxic metabolites from the eyelid margins. The high wax ester content in jojoba oil enables a cleansing by affinity of the impaired Meibomian sebum and restores the lipid component of the lacrimal film.

A study was conducted on 9 patients with MGD and chronic blepharitis already receiving treatment for dry eye with eye drops and other products. The patients were treated for 4 weeks with the solution according to the invention and using the above-described applicators.

After the treatment, 89% of the patients reported an improvement or stabilisation of their dry eye symptoms and an improvement in the ocular and palpebral clinical signs. During the course of the study, 55% of the patients reduced or suspended their use of eye drops and other products for dry eye syndrome.

Claims

I . A solution for use in treatments for hygiene of the eyelid margin consisting of jojoba oil, possibly in combination with natural or synthetic antibacterial, antiinflammatory and/or antioxidant agents, thinners and preserving agents.
I. A solution according to claim 1 wherein said jojoba oil is extracted by cold pressing from Simmondsia chinensis seeds.
i. A solution according to claims 1 and 2 wherein said antibacterial agents are chosen from among: terpinen-4-ol, thymol, Mimosa tenuiflora liposoluble extract, piroctone olamine, usnic acid, azythromycin, tetracycline and their derivatives, or mixtures thereof, contained in quantities in the range of 0.01 to 0.05%, and preferably 0.03% (wA calculated on the total volume of the solution).
I. A solution according to claims 1 to 3 wherein said anti-inflammatory agent is o bisabolol in quantities in the range of 0.01 to 1 %, and preferably 0.5% (w/V calculated on the total volume of the solution).
5. A solution according to claims 1 to 4 wherein said antioxidants are chosen from among vitamin E in the range of 0.1 to 0.5%, butylhydroxyanisole (BHA) and butylhydroxytoluene (BHT) between 0.01 and 0.05%.
3. A kit comprising a solution according to claims 1 to 6 and an applicator for applying said solution to the eyelid margins.
J. A kit according to claim 6 wherein the solution, preferably containing appropriate preserving agents, is contained inside a multi-dose drop-counter container, or in single-dose phials, or ophtioles.
3. A kit according to claims 6 and 7 wherein said applicator (10) consists of a stick (1 1 ) that serves as a grip, with at least one of the two ends carrying a bud (12) of material suitable for being impregnated with the solution when the product is to be used.
3. A kit according to claim 8 wherein said stick (1 1 ) is made of a rigid material suited to the purpose, while the bud(s) (12) consist of cotton, a nonwoven fabric, natural or synthetic bristles or the like.
10. A kit according to claim 9 wherein said buds (12) have a tapered shape with a rounded tip.
11. A kit according to claims 1 to 10 wherein the applicators are contained singly or in pairs inside sterile wrappings suited to the purpose.
12. The use of a solution according to claims 1 to 5 for eyelid margin hygiene.
PCT/IB2014/061842 2013-05-30 2014-05-30 A solution for eyelid margin hygiene and a device for its application WO2014191969A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
IT000128A ITFI20130128A1 (en) 2013-05-30 2013-05-30 Solution for the hygiene of the eyelid margins and device for its application.
ITFI2013A000128 2013-05-30

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP14738603.1A EP3003300A1 (en) 2013-05-30 2014-05-30 A solution for eyelid margin hygiene and a device for its application

Publications (1)

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WO2014191969A1 true WO2014191969A1 (en) 2014-12-04

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EP (1) EP3003300A1 (en)
IT (1) ITFI20130128A1 (en)
WO (1) WO2014191969A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017103583A1 (en) * 2015-12-15 2017-06-22 The University Of Manchester Compositions and uses and methods relating thereto

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110124725A1 (en) 2004-03-12 2011-05-26 Melbj Holdings, Llc Treatment for Meibomian Gland Dysfunction or Obstruction
EP2633852A1 (en) * 2012-03-01 2013-09-04 Biodue S.p.A. Jojoba oil-containing ophthalmic spray composition

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110124725A1 (en) 2004-03-12 2011-05-26 Melbj Holdings, Llc Treatment for Meibomian Gland Dysfunction or Obstruction
EP2633852A1 (en) * 2012-03-01 2013-09-04 Biodue S.p.A. Jojoba oil-containing ophthalmic spray composition

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
SUE STEVENS: "How to clean eyelids", COMMUNITY EYE HEALTH JOURNAL, vol. 24, no. 75, 31 October 2011 (2011-10-31), pages 20, XP055092840 *
SUE STEVENS: "How to clean eyelids", COMMUNITY EYE HEALTH JOURNAL, vol. 24, no. 75, 31 October 2011 (2011-10-31), XP055092840

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017103583A1 (en) * 2015-12-15 2017-06-22 The University Of Manchester Compositions and uses and methods relating thereto

Also Published As

Publication number Publication date
ITFI20130128A1 (en) 2014-12-01
EP3003300A1 (en) 2016-04-13

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