PL240883B1 - Liquid cosmetic composition for use on nails - Google Patents

Description

PL 240 883 B1

Description of the invention

Field of the Invention

The present invention relates to a liquid cosmetic composition for use on nails containing specified amounts of methylsulfonylmethane, D-biotin, horsetail extract and hydroxypropyl chitosan, and its use to improve damaged, split and brittle nails.

State of the art

Nails are a product of the cuticle. They have the form of a translucent, convex protective plate with a thickness of 0.5 to 0.7 mm, made of the stratum corneum of the epidermis and keratinized, non-nuclear keratinocytes. The main component of nails is protein-keratin.

Changes in the condition of the nail plates may have various causes: from congenital defects, e.g. nail-patella syndrome, through dermatoses with nail changes, through systemic diseases, nutritional deficiencies, to changes caused by the use of nail varnishes, chemicals, e.g. detergents or the influence of moisture. (A.W. Surma, P. Nockowski, Cosmetology Aesthetic, 1/2016 / vol. 5 27-33). While in the case of dermatoses or nutritional deficiencies, pharmacological and supplementary intervention is necessary, in the case of changes caused by the influence of external factors, e.g. chemicals and moisture (brittleness, brittleness, tendency to split), a sufficient remedy, in addition to at least limiting the exposure of the nails to the influence of harmful factors, can be cosmetic preparations for application on nails, e.g. in the form of varnishes.

There are many cosmetic preparations for topical application on nails available on the market, which, without the need for oral preparations and pharmacological therapies, are supposed to improve the condition of damaged or weakened nails. These preparations can either strengthen and mechanically protect the nail plate by creating a protective layer, or supply the plate with substances supporting the reconstruction of a healthy nail. Among such substances, plant extracts, e.g. horsetail extract, and donors of building substances, e.g. sulfur, play an important role.

Field horsetail herb (Equisetum arvense L.) is a raw material containing various ingredients, the group of which is of significant importance are flavonoids (isoquercetin, galuteolin, equisethrin, apigenin, etc.). The raw material for the preparation of extracts are sterile (green) shoots of the plant. Other essential ingredients are 6-10% silicon compounds, partly in a soluble form - up to 20%. (S. Kohlmunzer, Farmakognozja, Handbook for pharmacy students, 5th edition, PZWL, Warsaw 2003). In terms of effect on nails, among all herbs, field horsetail contains the highest amount of organic silicon, which binds with keratin, leading to remineralization and changes in the structure of the nail plate.

Sulfur donor substances, e.g. 1-methionine, 1-cysteine, methylsulfonylmethane (dimethylsulfone), participate in the formation and / or restoration of the nail keratin.

Preparations for topical application on nails, due to the convenience of use, most often have the form of the so-called varnishes which, after drying, form a thin layer on the nail plate.

Film-forming agents based on natural compounds, e.g. chitin derivatives, are known in the art. These include hydroxyalkyl chitosan derivatives, for example hydroxypropyl chitosan. Hydroxypropyl chitosan (HPCH) is a water-soluble film-forming polymer that forms flexible, smooth and virtually invisible coatings. Chitosan and its derivatives exhibit adhesive properties in relation to various biological tissues due to the positive charge. Moreover, free hydroxyl groups contained in HCPH may interact with keratin through hydrogen bonding and other weak interactions, which may contribute to improved transport of the active ingredient and its release. The HPCH coating also helps to maintain the proper degree of hydration of the nail plate. Clinical studies have shown that nail polishes containing HPCH reduce the depth of the longitudinal grooves and reduce delamination and brittleness of the nail plate.

From WO 2004/112814, a nail polish is known in particular, containing an extract of horsetail (Equisetum arvense L.), a sulfur source compound (methylsulfonylmethane or L-methionine) and hydroxypropyl chitosan as a water-soluble film former. The compositions disclosed therein are described as being useful for treating specific changes in nail structure such as reduced strength, onychoschia, and nail brittleness.

International application WO2017177295 A1 discloses compositions for topical use, for improving the appearance, protecting and strengthening the nails, and supporting

Regeneration in the case of nail diseases. The disclosed compositions contain as mandatory ingredients millet extract and rice extract.

US patent publication US6660251 B1 discloses galenic preparations which obligatorily contain one or more compounds selected from biotin, its physiologically acceptable salts, biotin esters and stereoisomeric forms of these compounds; and one or more compounds selected from urea and urea derivatives. The disclosed formulations are suitable for topical use for the cosmetic and / or medical treatment of the skin, hair and / or nails.

In the publication by Cantoresi F. et al: Randomized controlled trial of a water-soluble nail lacquer based on hydroxypropyl-chitosan (HPCH), in the management of nail psoriasis, Clinical, Cosmetic and Investigational Dermatology 2014: 7 185-190, the studies were described with the use of, among others a water-based varnish composition containing hydroxypropyl chitosan, methylsulfonylmethane and horsetail extract, and its effect on the condition of psoriasis-affected nails.

Disclosure from the website https://archiwum.allegro.pl/oferta/nails-up-biotin-odzyjka-z- -biotin-dop nailsci-7ml-i8241592360.html concerns Verona Cosmetics nail conditioner containing biotin. The information that the composition contains biotin is the only information regarding the composition of the composition. The quantitative content of biotin was not specified.

D-Biotin (biotin, vitamin B7, vitamin H, coenzyme R) in humans is an essential cofactor for four carboxylases that catalyze the attachment of bicarbonate to the substrate and participate in gluconeogenesis and supply of intermediates to the citric acid cycle (pyruvate carboxylase), fatty acid synthesis ( acetyl-CoA carboxylase), leucine catabolism (3-methylcrotonyl-CoA carboxylase) and propionate catabolism (propionyl-CoA carboxylase). Biotin is also essential in the process of cell proliferation. The body's need for this substance increases with age. Biotin deficiency is manifested by hair loss, skin problems (including seborrheic dermatitis, susceptibility to fungal infections) and poor condition of the nails, and sometimes disorders of the central nervous system (including depression, lethargy, muscle pain, parasthesia) . Biotin is well tolerated and safe. So far, no adverse effects of biotin on humans have been found, and any excess of it is excreted from the body with urine.

The beneficial effect of oral biotin on nail quality is known. Biotin taken in this way reduces nail brittleness, their tendency to delaminate or transverse furrowing, and also supports the regeneration of the nail plate. Cosmetic preparations in the form of nail varnishes, the so-called nail hardeners containing biotin.

Object of the invention

In the literature, the effectiveness of available cosmetic preparations in the form of varnishes, however, is assessed quite critically, describing their beneficial effects as "minimal or absent". Particular criticism concerns the so-called nail hardening preparations aimed at mechanical protection of nails. It was found that long and regular use of such preparations paradoxically increases the brittleness of nails - although they become harder, they lose elasticity, showing a tendency to cracks and delamination. Moreover, many of these preparations require the use of nail polish remover, which may additionally weaken the nail plate (Antonella Tosti, Nail Disorders, Elsevier 2018, p. 126).

In addition, many of the cosmetic nail polishes available on the market, intended to improve their condition, cause some unsightly change in the color of the nail plate, i.e. yellowing, when used regularly. This discoloration disappears with the discontinuation of the preparation and the regrowth of the nail plate, but this effect may cause discomfort to people using such a preparation.

Many studies have shown that changes in the nails, especially in the hands, cause a significant deterioration in the quality of life of people affected by such changes. Such people participate in social life to a lesser extent and are less self-confident in private life (A.W. Surma, P. Nockowski, Kosmetologia Estetyczna, 1/2016 / vol. 5 27-33).

There is therefore still a need to provide improved topical preparations for damaged nails, which preparations, in addition to their beneficial cosmetic effects, would also provide convenient application, eliminate aesthetic undesirable effects, and at the same time be safe and easily removable without the use of nail polish remover.

Surprisingly, these needs were met by the cosmetic composition according to the invention. It turned out that when using biotin in a cosmetic composition along with hydroxypropyl chitosan, an extract of

With field horsetail and methylsulfonylmethane, an effect was obtained that reflects the beneficial properties of all of these ingredients, favoring damaged nails and eliminating some of the drawbacks of known compositions.

Description of the invention

The present invention relates to a liquid cosmetic composition for use on nails containing 3.5-7.0 wt. % methylsulfonylmethane, 0.01-0.04 wt. % Of D-biotin and 0.02-0.12 wt. of horsetail extract, as well as 0.5-1.5 wt. hydroxypropyl chitosan, a 1% aqueous solution of which at 20 ° C has a dynamic viscosity in the range of 10-55 mPas, preferably 15-25 mPas, as measured with a Brookfield rotational viscometer, the remainder of the components being one or more the number of solvents, and the basis of the mass balance is the total weight of the liquid composition.

For the purposes of determining the ratio by weight, horsetail extract should be understood as a substance free of solvents, solubilizers and other auxiliary substances used for the extraction, dilution, stabilization or storage of the extract. This extract can be used in a commercially available form, dissolved in a mixture of propylene glycol and water, for example: 2 wt. horsetail extract in a mixture of propylene glycol and water, respectively, in the proportion of 80:20 (parts by weight).

It is known to those skilled in the art that a plant extract is characterized by the parameter DER (Drug Extract Ratio). This parameter determines the ratio of the amount of plant material to the amount of plant extract obtained. Horsetail extracts with a very wide DER range are suitable for the purposes of the present invention, e.g. 4-11: 1 for dry extracts and 1: 1-5 for liquid extracts (Assessment report on Equisetum arvense L., herba, Final, 2 February 2016, European Medicines Agency, EMA / HMPC / 278089/2015).

In a particular embodiment of the liquid cosmetic composition according to the invention, it contains 5.00 wt. % methylsulfonylmethane, 0.02 wt. % D-biotin, 0.05-0.10 wt. of horsetail extract and 1.00 wt. hydroxypropyl chitosan, wherein the accuracy of the amounts stated is + -10%, and the basis of the mass balance is the total weight of the liquid composition.

Preferably, the liquid cosmetic composition according to the invention is characterized in that the one or more solvents are selected from the group consisting of water, ethanol, propylene glycol and diethylene glycol monoethyl ether.

Even more preferably, the liquid cosmetic composition according to the invention comprises a solvent mixture consisting of water, ethanol, propylene glycol and diethylene glycol monoethyl ether, the individual components of this mixture, based on the total weight of the composition, being: water 50-55 wt. %, ethanol 35-40 wt.%, propylene glycol 1-5 wt.%, diethylene glycol monoethyl ether 0.3-0.6 wt.%.

In a preferred embodiment of the liquid composition according to the invention, it consists of:

- water in an amount of 52.98% by weight,

- ethanol in an amount of 36.50% by weight,

- methylsulfonylmethane in an amount of 5.00% by weight,

- propylene glycol in the amount of 3.90% by weight,

- hydroxypropyl chitosan in an amount of 1.00% by weight,

- horsetail extract in the amount of 0.10% by weight,

- diethylene glycol monoethyl ether in an amount of 0.50% by weight,

- D-biotin in an amount of 0.02% by weight, the accuracy of the amounts stated is + -10%, and the basis of the mass balance is the total weight of the liquid composition.

Surprisingly, it is very advantageous if the hydroxypropyl chitosan used to prepare the liquid composition according to the invention is characterized in that its 1% aqueous solution at 20 ° C has a dynamic viscosity in the range 10-55 mPa · s, preferably 15-25 mPa · s. s, as measured with a Brookfield viscometer: Brookfield DV-II + rotational viscometer, 30 rpm, torque> 10%. This particular type of hydroxypropyl chitosan has a positive effect on the properties of the composition according to the invention, making it stick better to the nail plate after drying and not showing a tendency to peel off. In addition, it is preferred that the degree of substitution of the amine and hydroxyl groups with hydroxypropyl groups in the hydroxypropyl chitosan used is high, above 80%.

PL 240 883 Β1

Another object of the present invention is the use of a liquid cosmetic composition as described in any of the above embodiments for improving the condition and appearance of damaged and brittle nails.

The liquid composition can be prepared by methods known to those skilled in the art. A more detailed description of raw materials and common ingredients, as well as the rules for the preparation of such preparations, can be found in standard manuals of cosmetic technology.

Examples include: W.S. Brud and R. Glinka, Cosmetics Technology, MA Oficyna Wydawnicza, Łódź 2001; R. Glinka, Cosmetic recipe, MA Oficyna Wydawnicza, Łódź 2003; Kosmeceutyki, edited by J. S. Dover, Medical Publishing House Urban & Partner, Wrocław 2006; Balsam MS, Sagarin E. (eds) 1972 Cosmetics: science and technology, vol. 1. Wiley-lnterscience, New York and Flick E.W., Cosmetics and Toiletry Formulations, William Andrew Publishing, 2001.

Illustrative of the invention, examples of liquid compositions in the form of a solution for application to nails are presented below. They are not intended to limit the scope of the present invention.

Example 1

Component wt.% Water 51.98 Ethanol 36.50 Methylsulfonylmethane 5.00 Hydroxypropyl chitosan 1.00 Field horsetail extract (2% by weight in a mixture of propylene glycol and water (80:20 by weight) 5.00 Diethylene glycol monoethyl ether 0.50 D-Biotin 0.02

Water and diethylene glycol monoethyl ether are mixed with heating to 37 ° C, and at this temperature D-biotin and hydroxypropyl chitosan are added. The whole is cooled to room temperature while stirring, then successively added: ethanol, horsetail extract as a solution in propylene glycol and water, and methylsulfonylmethane. Everything is mixed until all ingredients are dissolved.

Example 2

Component wt.% Water 52.26 Ethanol 36.70 Methylsulfonylmethane 3.50 Hydroxypropyl chitosan 1.50 Field horsetail extract (2% by weight solution in a mixture of propylene glycol and water (80:20 by weight)) 5.50 Diethylene glycol monoethyl ether 0.50 D-Biotin 0.04

Procedure as in Example 1.

PL 240 883 Β1

Example 3

Component wt.% Water 53.10 Ethanol 37.59 Methylsulfonylmethane 7.00 Hydroxypropyl chitosan 0.50 Field horsetail extract (2% by weight in a mixture of propylene glycol and water (80:20 by weight) 0.03 1.50 Diethylene glycol monoethyl ether 0.30 D-Biotin 0.01

Procedure as in Example 1.

Example 4

Testing the liquid composition of Example 1 and the comparative composition analogous to the composition of Example 1 in which D-biotin was replaced with water.

50 people over the age of 18 were qualified for the study. The study plan was approved by an ethics committee and the enrolled persons signed a declaration of informed consent. The plan and the conduct of the study were in accordance with the applicable regulations and guidelines for cosmetic products.

On the basis of an interview and dermatological examination, the study included generally healthy people, whose nails and skin in the area to which the tested product was to be applied did not show any irritations and changes requiring pharmacological treatment. At the same time, the people qualified for the study had weak, brittle and / or splitting nails, and the severity of the indicated symptoms could be different. Participation in the study was prevented by therapies that could affect the results of the study (e.g. taking antihistamines and steroids) and a tendency to allergies, alcohol abuse, and simultaneous participation in another study.

qualified people were randomly assigned to two groups of 25 people:

- Group 1 used the formulation according to the invention (composition identical to the composition disclosed in Example 1)

- Group 2 used a comparative composition without D-biotin (composition as described in Example 1, with the D-biotin w replaced by an equivalent weight by weight of water).

On the day of starting the study (day 0), the dermatologist assessed the condition of the nails, measured the length and thickness of the nails with a caliper, and the technician took pictures of the fingernails of the participants' right and left hands.

All subjects applied the test preparations in the same way: once a day, in the evening before going to bed, the test composition was applied with a brush to clean and dry fingernails. No other preparations of a similar type or oral preparations, e.g. dietary supplements, were used during the study.

The participants of the study filled out the questionnaire every day, and on the day of the inspection, they reported to a dermatologist, who collected the forms and verified both the fulfillment of the test criteria and the condition of the nails of the examined people (thickness and length measurement, visual assessment and taking photographs of the hands). During the dermatological examination, participants did not have any product applied to their nails. The inspections were carried out on days 7, 14, 21, 56 and 84.

All participants completed the study.

As shown by the application study, both the tested products, according to the invention and the comparative, were very well tolerated at the application site. When used regularly by

PL 240 883 Β1 days no person experienced negative symptoms and sensations that could indicate intolerance to any of the ingredients.

The table below shows the results of the study after 84 days:

Tested feature Group 1 Preparation according to the invention (Example 1) [% of participants] Group 2 Reference preparation (Example 1 without biotin) [% of participants] Healthy appearance of nails * 100 100 Flexible nail plate * 60 60 Smooth nail plate * 93 83 Even and brightened color of the nail plate * 97 87 Faster nail growth ** 60 53 Nail moisturizing * 97 90 Increased resistance to external factors / chemicals, e.g. detergents * 87 80 Harder nails * 97 90 Increase in the thickness of the nail plate ** 53 50

* Application tests under the supervision of a dermatologist

The application test was performed at home under the supervision of a dermatologist (follow-up visits).

The scope of the research included the assessment of the influence of the tested product on the tolerance in the place of use as a result of regular, repeated application of the tested product, in accordance with its intended use and method of use over a specified period of time (repeat test).

** Equipment tests:

Nail length: 7 days before the measurement, the participant shortened the nails by himself. Measurements were carried out using an electronic caliper on the nail plate of the right hand (thumb, middle finger and little finger) and left hand (thumb, index finger and ring finger) - before (DO), after 7 days (D7), after 14 days (D14), 21 days (D21), 56 days (D56) and 84 days (D84) of regular use. Faster nail growth is confirmed when the average nail growth value per day is more than 0.1 mm.

At each follow-up visit, the technician took pictures of the participants' hands with a camera.

Nail thickness: Each participant, 7 days before the measurement, shortened their nails on their own. Measurements were carried out on the nail plate of the right hand (thumb, middle finger and little finger) and left hand (thumb, index finger and ring finger) - before (DO), after 7 days (D7), after 14 days (D14), after 21 days (D21), after 56 days (D56) and after 84 days (D84) of regular use. Product performance is confirmed when the difference between the measurement before (DO)

Claims (6)

The effect of the measurement after regular product application (D7, D14, D21, D56, D84) is statistically significant. The significance level is p <0.05. The results were analyzed using the STATISTICA 13 software. As indicated above, the table presents the results of the study after 84 days, although after the first 7 days, some beneficial changes were noticeable, some changes, especially in the overall healthy appearance of the nail and the state of hydration. A particularly noticeable improvement in relation to the comparative preparation concerns the improvement of the nail color, its smoothness, hydration and hardness. Surprisingly, in Group 1, where the preparation according to the invention was applied, most of the participants of the study additionally observed an improvement in the condition of the cuticles around the nails (93% in Group 1 vs. 77% in Group 2). Moreover, while overall the color of the nail plate also improved from baseline in Group 2, a few participants in this group had a slight yellowing of the nail plate after 84 days of regular use of the D-biotin-free formulation. Surprisingly, a similar adverse effect was not observed in any of the participants using the additionally D-biotin formulation of the invention. This unexpected effect of eliminating in some cases aesthetically undesirable coloration is undoubtedly important for users of such preparations, increasing the beneficial cosmetic effect of the product according to the invention and the acceptability of the preparation for users. P r z k ł a d 5 Effect of the type of hydroxypropyl chitosan used on the properties of the composition In the next application study, the adhesion properties of the product to the nail plate were tested depending on the type of hydroxypropyl chitosan used. The study involved 12 people who met the criteria analogous to the study in Example 4. The qualified persons were randomly divided into 4 groups of 3 persons. Group 3a - preparation as in Example 1, using hydroxypropyl chitosan, the 1% aqueous solution of which had a dynamic viscosity at 20 ° C of 16 mPa · s. Group 3b - preparation as in Example 1, with the use of hydroxypropyl chitosan, the 1% aqueous solution of which had a dynamic viscosity at 20 ° C of 22 mPa · s. Group 3c - preparation as in Example 1, with the use of hydroxypropyl chitosan, the 1% aqueous solution of which had a dynamic viscosity at 20 ° C of 50 mPas. Group 3d - a preparation as in Example 1, with the use of hydroxypropyl chitosan, the 1% aqueous solution of which had a dynamic viscosity at 20 ° C of 105 mPa · s. Viscosity test conditions: Brookfield DV-II + rotational viscometer, 30 rpm, torque> 10%. The participants of the study applied the product to clean and dry nails with a brush for 7 days before going to bed. In the morning they assessed the condition (appearance) of the product film on the nail - exfoliation, bubbles etc. It has been shown that the most durable, smooth, adherent layer on the nail is provided by the composition with hydroxypropyl chitosan, the 1% aqueous solution of which at 20 ° C has a viscosity of 16 mPas and 22 mPas; the hydroxypropyl chitosan used in Group 3c also gave a satisfactory result. The use of hydroxypropyl chitosan in the composition, whose 1% aqueous solution at 20 ° C had a viscosity of 105 mPa-s, made the film of the product peel off. This may adversely affect the cosmetic effectiveness and the acceptability of the preparation for users. Patent claims 1. A liquid cosmetic composition for use on nails comprising 3.5-7.0 wt. % methylsulfonylmethane, 0.01-0.04 wt. % Of D-biotin and 0.02-0.12 wt. of horsetail extract, as well as 0.5-1.5 wt. hydroxypropyl chitosan, a 1% aqueous solution of which at 20 ° C has a dynamic viscosity in the range of 10-55 mPas, preferably 15-25 mPas, as measured with a Brookfield rotational viscometer, the remainder of the components being one or more the number of solvents, and the basis of the mass balance is the total weight of the liquid composition. PL 240 883 B1 2. A liquid cosmetic composition according to claim 1; % Of the composition according to claim 1, characterized in that it contains 5.00 wt. % methylsulfonylmethane, 0.02 wt. % D-biotin, 0.05-0.10 wt. of horsetail extract and 1.00 wt. hydroxypropyl chitosan, wherein the accuracy of the amounts stated is + -10%, and the weight balance is based on the total weight of the liquid composition. 3. A liquid cosmetic composition according to claim 1, The process of claim 1 or 2, wherein the one or more solvents is selected from the group consisting of water, ethanol, propylene glycol and diethylene glycol monoethyl ether. 4. A liquid cosmetic composition according to any one of the preceding claims. The composition of claims 1 to 3, characterized in that it comprises a solvent mixture consisting of water, ethanol, propylene glycol and diethylene glycol monoethyl ether, where the individual components of this mixture, based on the total weight of the composition, are: water 50-55 wt. %, ethanol 35-40 wt.%, propylene glycol 1-5 wt.%, diethylene glycol monoethyl ether 0.3-0.6 wt.%. 5. A liquid cosmetic composition according to claim 1, 1, characterized in that it consists of: - water in an amount of 52.98% by weight, - ethanol in an amount of 36.50% by weight, - methylsulfonylmethane in an amount of 5.00% by weight, - propylene glycol in the amount of 3.90% by weight, - hydroxypropyl chitosan in an amount of 1.00% by weight, - horsetail extract in the amount of 0.10% by weight, - diethylene glycol monoethyl ether in an amount of 0.50% by weight, - D-biotin in an amount of 0.02% by weight, the accuracy of the amounts stated is + -10%, and the basis of the mass balance is the total weight of the liquid composition. 6. Use of a liquid cosmetic composition as defined in any one of claims 1 to 5 for the improvement of damaged, split and brittle nails.